2013 AER Conference Guide

Please note the following updates to our conference guide: BLOG SQUAD Stay tuned to PRIM&R’s blog, Ampersand, for daily reflections on the 2013 AER Conference from our Blog Squad members: Julie Fine, Stephanie Pyle, László M. Szabó, David R. Van Houten, and Jennifer Vergara Jimenez. Visit Ampersand at www.primr.org/blog.

EXHIBITORS Please note the following additions to our Exhibitors: Iritzi 1.866.410.4427| www.iritzi.com Booth: 121 We teamed up with some of the foremost professionals in their fields, their institutions, and their review boards to develop a better, trackable, social method to IRBs today. Iritzi IRB management software deals with some of your most common headaches and manages your studies from inception, the IRB decision process, and the life of the study.

Seton Hall University School of Law 973.642.8482| www.law.shu.edu Booth: 116 Seton Hall Law now offers Online Graduate Certificates, created specifically for non-lawyers, in Clinical Research and the Law. Explore regulatory, ethical, and compliance issues relevant to individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and institutional review boards.

POSTER PRESENTATIONS Please note the following change to authors in the Poster Presentations: 1. A Comparative Study on the Effectiveness of a Preliminary Review Process in the Reduction of Study Deferrals Dorean J. Flores, BS, CIP; Richard Ramdeo, BA North Shore-Long Island Jewish Health System Please note the following poster number changes: 50. (Was poster #79) Starting from Scratch: Training Medical Students to Write Understandable Consent Forms Adam G. Lamm, MD/MA candidate; Nicole M. Deming, JD, MA Case Western Reserve University School of Medicine 79. (Was poster #50) Improving Efficiency and Review Quality by Applying Continuous Performance Improvement Principles to the IRB Review Process Kelly Hebner, JD; Tara Polek, PhD; Joan Doherty, JD Seattle Children's Research Institute The following posters will no longer be presented at the conference: 6. A Protocol Navigation Training Program at the National Institutes of Health National Institutes of Health Marcia L. Vital, MS; Beverly Barham, RN, MSN, CCRC 13. Awareness and Attitude of Behavioural Scientists to Research Ethics Committee in Nigerian Universities University of Ibadan Olufunke Arojo, BSc, MSW, MSc; Ayodele Jegede, BSc, MSc, MHSc, PhD

SESSION CHANGES & UPDATES Please note the following changes to sessions: B1 WILL BE HELD IN ROOM 200 A Dialogue with the Department of Defense (DOD): Updates for DOD-Funded Researchers (A Dialogue with the Feds I Track) GF6 ANNOUNCEMENT! Film Screening: Finding Dr. Schatz: The Discovery of Streptomycin and a Life It Saved During this session, Dr. Auerbacher will also be selling and signing copies of her companion book, Finding Dr. Schatz.

REVISED DESCRIPTORS A6: Educational Theory and Practice for 21st Century Adult Learning (Educating Research Teams Track) Joni K. Barnard, Francis DiMario This session will present current best practices for teaching 21st century adult learners. A combination of theory and applied examples will be presented. In this session, faculty will: • • •

Discuss how to engage learners so that lessons and concepts presented are remembered and applied.

Review the use of technology in making learning efficient and meaningful.

Describe adult education principles as they relate to the characteristics of adult learners.

A10: Informed Consent: Elevating the Process and Improving the Form (Informed Consent Track) Laura M. Beskow, Mina Busch, Elizabeth Senft In this session, faculty and attendees will: Review what research literature on informed consent tells us.

Address how attending to comprehension can help elevate the informed consent process and lead to improvements in consent forms.

Explore background issues such as: What is the state of health literacy? What works best for patients and subjects?

Discuss general strategies to adjust consent forms for reading level, translation, and overall readability.

Review recommendations for the development and formatting of easy-to-read and easy-to-comprehend informed consent forms.

B15: “State” it Like it Is: The Impact of State Laws on Informed Consent and Other Aspects of Research (Legal Track) Valerie Gutmann Koch, Susie A. Han, Laura Odwazny – OHRP Resource Person State laws can complicate the requirements imposed on researchers and institutions in many ways. New York state laws may be utilized as examples and case studies, which may highlight the categories of state laws that IRBs and investigators often have to consider when engaged in certain types of research. In this session, faculty will: • • •

Explore state law issues that should be analyzed in connection with any federal Common Rule and FDA requirements, including state law requirements that impact the content of informed consent, research involving vulnerable populations, surrogate appointment, and more.

Review the interaction between overlapping state and federal requirements, for example: research involving donated biospecimens, including issues related to state and federal genetic privacy laws and newborn screening programs.

Discuss the challenges of various research requirements, such as: how to define who is a research participant for purposes of consent/assent; issues raised by the increase of social media and internet research; and issues around what constitutes the “standard of care” in clinical research.

C15: “Research Free or Die”: Legal Protections Against Challenges to Academic Freedom in Research (Legal Track) Ann Hardy, Julia Hesse, Ellen Marakowitz The recent litigation concerning whether researchers from Boston College must release tapes to Great Britain from an oral history research project related to murders allegedly committed by the Irish Republican Army has brought to light the legal challenges that can be associated with researchers’ academic freedom.

In this session, faculty will: • •

Define best practices for structuring institutional policies and research agreements to defend against similar challenges.

Discuss the scope of legal protection and privilege afforded to researchers under Certificates of Confidentiality (CoC) and considerations around when it would be prudent to obtain a CoC.

FACULTY UPDATES Please note the following faculty additions: Justin P. McCarthy, JD, senior vice president and associate general counsel at Pfizer, Inc., has joined Panel VII: Data Sharing on Steroids: Demands for Transparency of Subject-Level Research Data, which will be held on Friday, November 8, from 8:00 to 9:30 AM in Ballroom C. Justin P. McCarthy, JD, is the senior vice president and associate general counsel at Pfizer, Inc. in New York, NY, and is the chief counsel for Pfizer’s Worldwide Research and Development division. He is responsible for coordinating legal support for the company’s research and development activities worldwide, and, in this role, he advises the company on a broad range of regulatory, policy, and bioethics matters. He is also responsible for Pfizer's global Intellectual property activities, and has extensive experience negotiating novel research collaborations with academia, governments, and other biopharmaceutical companies. Mr. McCarthy joined Pfizer in 1993, providing regulatory law support for all Pfizer businesses. He relocated to Brussels in 1998, where he provided legal support to Pfizer’s European Operations, and he returned to the United States in 2001, to support Pfizer’s expanded research and development operations after the merger with Warner-Lambert. Prior to joining Pfizer, Mr. McCarthy was an associate at the law firm of Keller & Heckman in Washington, DC, where he focused on food and drug law. Mr. McCarthy sits on the SACHRP Subcommittee on Harmonization of Regulations. He holds a BS in pharmacy from the University of Rhode Island, and a JD from the Catholic University of America.

Lester J. Arnold, JD, senior corporate counsel, Pfizer, Inc., has joined session B9: New Policies for Clinical Trials in India: Promises and Pitfalls (Global Research Track), which will be held on Friday, November 8, from 11:15 AM to 12:30 PM in Room 308.

Dean R. Gallant, assistant dean and IRB executive officer (retired), Harvard University, has joined session B22: Speed it Up: Exempt… Expedite… Relax! (SBER I – Basic Track), which will be held on Friday, November 8, from 11:15 AM to 1:45 PM in Room 101.

Ann Hardy, DrPH, extramural human research protection officer, NIH, has joined session C15: “Research Free or Die”: Legal Protections Against Challenges to Academic Freedom in Research (Legal Track), which will be held on Friday, November 8, from 2:00 to 3:15 PM in Room 103.

Susan Z. Kornetsky, MPH, director, clinical research compliance, Boston Children’s Hospital, has joined The Drama of DNA: An Interactive Play Exploring the Ethical, Legal, and Psychosocial Implications of Genomic Research and Medicine with Children, which will be held on Friday, November 8, from 5:30 to 7:00 PM in Ballroom C. Lindsay Motz, CIM, human subjects research database manager, United States Department of Energy, Oak Ridge Associated Universities, has joined session D2: A Dialogue with the Department of Energy (A Dialogue with the Feds II Track), which will be held on Saturday, November 9, from 9:30 to 10:45 AM in Room 301.

Kristen Grace, MD, PhD, senior scientist-investigator, Office of Research Integrity Division of Investigative Oversight, United States DHHS, has joined session D18: Alleged Misconduct in Clinical Research: Challenges for IRBs and Research Integrity Officers (RIOs) (Potpourri Track), which will be held on Saturday, November 9, from 9:30 to 10:45 AM in Room 204.

Mark Barnes, JD, LLM, partner, Ropes & Gray Law Firm, has joined session E9: Sea Change in Europe: The Impact of the New EU Clinical Trials and Data Protection Regulations (Global Research Track), which will be held on Saturday, November 9, from 11:15 AM to 12:30 PM in Room 109.

DEMONSTRATIONS November 7: Demonstration of PRIM&R’s Online Course—1:00-1:15 PM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our interactive online resource—Ethical Research Oversight Course (EROC). A 15 minute presentation on E-ROC will provide you with an introduction to utilizing this tool to strengthen your understanding of human subjects protections.

Demonstration of PRIM&R’s People and Perspectives (P&P)—5:30-5:45 PM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our newest interactive online initiative— People and Perspectives (P&P).

P&P is an online archive that seeks to uncover, collect, catalogue, preserve, and share the stories of those performing the essential work of advancing ethical research. P&P features both the oral histories and reflections of those “in the trenches,” as well as information about the field’s founders, shared via video, audio and text stories. This 15-minute presentation will introduce you to some of the stories and participants on the site so far, and give a brief overview on how to contribute your own story to this living archive!

November 8: Demonstration of PRIM&R’s Online Course—3:30-3:45 PM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our interactive online resource—Ethical Research Oversight Course (EROC). A 15 minute presentation on E-ROC will provide you with an introduction to utilizing this tool to strengthen your understanding of human subjects protections.

Demonstration of PRIM&R’s People and Perspectives (P&P)—4:00-4:15 PM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our newest interactive online initiative— People and Perspectives (P&P).

P&P is an online archive that seeks to uncover, collect, catalogue, preserve, and share the stories of those performing the essential work of advancing ethical research. P&P features both the oral histories and reflections of those “in the trenches,” as well as information about the field’s founders, shared via video, audio and text stories. This 15-minute presentation will introduce you to some of the stories and participants on the site so far, and give a brief overview on how to contribute your own story to this living archive!

November 9: Demonstration of PRIM&R’s People and Perspectives (P&P)—7:30-7:45 AM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our newest interactive online initiative— People and Perspectives (P&P).

P&P is an online archive that seeks to uncover, collect, catalogue, preserve, and share the stories of those performing the essential work of advancing ethical research. P&P features both the oral histories and reflections of those “in the trenches,” as well as information about the field’s founders, shared via video, audio and text stories. This 15-minute presentation will introduce you to some of the stories and participants on the site so far, and give a brief overview on how to contribute your own story to this living archive!

Demonstration of PRIM&R’s Online Course—10:45-11:00 AM in Exhibit Hall C Join us in the PRIM&R Booth for a demonstration of our interactive online resource—Ethical Research Oversight Course (EROC). A 15 minute presentation on E-ROC will provide you with an introduction to utilizing this tool to strengthen your understanding of human subjects protections.

INTERNET USE The Hynes Convention Center offers free wireless connectivity for conference attendees; please see page 6 in this Guide for details.

Coverage in the facility includes exhibition halls and meeting rooms. This complimentary service is an open unsecured network provided for your convenience. All use of the wireless service is solely at your own risk. The Hynes Convention Center and PRIM&R cannot, and do not, guarantee the privacy or security of your data or communications while using the service. It is recommended that users take steps to protect their own devices and computer systems and data.

The Hynes Convention Center and PRIM&R expressly disclaim any and all liability or responsibility for your use of this service including without limitation loss of data, viruses, damage to equipment, or unauthorized security breaches. By using the wireless network you acknowledge and agree that you are doing so at your own risk and hereby release the Hynes Convention Center and PRIM&R and their directors, officers, employees, and representatives from any and all liability whatsoever (including, but not limited to, liability for any loss, damage, personal injury, expense, delay, inconvenience, or irregularity that may arise in connection use of the service).

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Contents

16 17 20

SUPPORTERS & EXHIBITORS Visting Hours and Map of The Conference Connection Supporters Exhibitors

24 25 26 27 28 30 32 34

RECOGNITION CIP® Thanks to Those Who Made This Conference Possible Board of Directors Staff Lifetime Achievement Award ARENA Legacy Award Pillars of PRIM&R In Memoriam

36 37 38 40 79

SCHEDULES Schedule: November 6 Your Guide to the Conference Schedule Your Guide to the Tracks Schedule: November 7-9 Continuing Medical Education Credits

posters

80 90

POSTERS Posters Selected for Presentation Posters Selected for “Innovations in…” Series

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MAPS

146

NOTES

151

CERTIFICATE

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FACULTY Faculty List Plenary Biographies

faculty

102 114

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CONFERENCE INFORMATION Welcome from PRIM&R’s Executive Director Welcome from the Conference Co-Chairs Announcements & Reminders Affinity Groups Continuing Education Supporting the Growth of Research Ethics Evaluation Guide

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supporters & exhibitors

2 4 6 10 12 13 14

notes

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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Welcome from PRIM&R’s Executive Director Dear Friends, Welcome to 2013 Advancing Ethical Research (AER) Conference! Although I have long since lost count, I suspect that I’ve written well over 100 letters of welcome to PRIM&R conference attendees.

The first was written in April of 1977 on my trusty IBM Selectric typewriter, and then hand carried to the dusty copy shop in Harvard Square for reproduction (few offices had photocopy machines back then, and if they did, they were slow moving and odiferous). Along with words of welcome, it included an admonition to please “refrain from smoking during the conference sessions.”

My second, written in April of 1978, repeated the “please don’t smoke” request, added a note about where the pay phones could be found, and also referred to the fact that since PRIM&R could not afford the cost of transcribing audiotapes of the sessions, we would instead take notes “that will be written up and published in the next six weeks in the form of conference proceedings.” Those desiring a copy were asked to write or call our office and to send us $5.

In many ways, those were the good ol’ days…life was simpler, conferences smaller, and everyone knew each other by name, or at least by sight. There were no personal computers, cell phones, tablets, or anything wired or digital for that matter, and, although rumor had it that one was about to be marketed, I had not yet seen one of those new-fangled facsimile machines. The issues, though, were neither simple nor “small,” and they were thus in need of serious examination and discussion from the ethical, legal, social, scientific, philosophical, and regulatory perspectives.

The fields of research ethics and regulation had recently been born from the ashes of the Holocaust and in the wake of the United States Public Health Service Syphilis Study exposé, and the PRIM&R community was integral to their upbringing. As one former director of the Office for Human Research Protections (OHRP) was fond of saying, “If PRIM&R did not already exist, the federal government would have to invent it.” Thankfully, though, it does exist, and it has been my distinct privilege to lead this remarkable organization for almost 39 years. It is thus a bittersweet task to be writing to you for the last time, since I will be stepping down from my post next April.

As a result of that impending transition, this letter has a twofold purpose—to welcome you and to bid you p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

farewell, so I’m dubbing it my “wel-well” mash-up message. All kidding aside, finding the right words to bid you both sentiments is not easy, but swan songs never are. Thank you for indulging my search for the right words, and the right number of words, when there is so much I want to say.

First the welcome (“a word used to greet someone in a glad or friendly way”), which I extend with a heart full of gratitude for your support of PRIM&R’s work. PRIM&R was founded to advance ethical research by helping educate those who work in the subject protections and research regulation fields, but it has thrived only because you responded to that mission, as evidenced by your presence here today.

I remember someone asking at one of our earliest Board meetings what would happen to PRIM&R if we met our mission, i.e., when everyone who worked with institutional review boards, or IRBs (this was 25 years before the term “human research protection program,” or “HRPP,” was coined), had been “trained.” Another member responded that “training” might be needed only when one began a new job, and occasionally thereafter, but that “learning” was a lifelong pursuit. Those words proved wise and prophetic, since here you are, and thus here we are, 40 years later. PRIM&R’s work is intertwined with yours, and our existence depends on your support of our mission.

My “welcome” is thus heartfelt and enduring, since had you not believed that learning is life long, PRIM&R’s organizational life would have been a short one indeed.

Welcome also means “to receive and treat someone hospitably,” and that’s what my coworkers and I intend to do while you’re here, so if you need anything, head to the Help Desk where you’ll find a member of our weaim-to-please staff ready, willing, and wanting to answer your questions.

PRIM&R prides itself on being a welcoming community (“a group of people having common interests, and characterized by sharing, participation, and fellowship”).

Since you’re a part of that large and diverse community, please help create the caring connections that have come to characterize these conferences by joining me in

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extending an especially warm welcome to our first-time attendees (you’ll know them by their rainbow ribbons), our scholars (read about PRIM&R’s scholarship programs on page 13), and to the research subjects and community members in our midst.

Throughout my tenure here, I have tried to practice the gratitude attitude (“a state of mind or disposition of appreciative awareness and thankfulness”), since whatever PRIM&R has accomplished is attributable to the many hands, hearts, and minds that have been in the mix. In that spirit, some highly deserved words of thanks are due to the planning committees, who gave large chunks of their winters, springs, and summers to plan this educational feast before us (the full committee rosters can be found on the inside cover of this Guide). The three planning committees were led by Susan Kornetsky and David Strauss (Core Conference Planning Committee), Susie Hoffman and Elyse Summers (Workshop/ Didactic Sub-Committee), and Susan Fish and Nancy Olson (Poster Abstract Sub-Committee). They were joined by exceptionally smart and hardworking members who brainstormed about, wrestled with, and finally wrought this amazing program that you’re about to experience. Thank you, planning committee members, for developing such a staggering number of stellar sessions!

Talented though they are, the planning committees cannot teach each of those sessions or create each of those posters, so my next huzzahs go out to the faculty and poster presenters, who are the oxygen that will bring this conference to life. A learning community needs high-quality teachers in order to be effective, and those teaching here have gone above and beyond the call of either volunteerism or any other duty, in order to ensure that the learning will be interactive and lively, and the knowledge gained current and reliable.

There’s so much else I’d like to share about what awaits, but this Guide covers that ground too well to bear repeating. The one new offering that is especially near and dear to my heart is People & Perspectives (P&P), PRIM&R’s online archive that gathers and shares stories about the people, perspectives, and experiences of those whose lives have been touched by the fields of research ethics and regulation. I hope you will think about participating either while onsite or when you return home, as we cannot be a truly connected community unless we share our stories, our struggles, and our successes.

Before I harm more trees, I shall say farewell, which is “a wish of well-being upon parting.” That is my wish for you as I prepare to leave this job, which has been so much more than “just” a job. It has been a wonderful way of life, and it has provided me with a second family, a wellspring of energy, ideas, curiosity, connections, and with more joy, meaning, and fulfillment than I ever thought possible in the world of work. I received and experienced those many gifts because of the people I’ve met along the way, many of whom have become dear friends and cherished teachers. I thank each and every one of you for giving me the privilege of serving this extraordinary organization.

I know that PRIM&R will continue to flourish after I pass the baton because of an incredible staff that is as caring as it is competent, and because of Board members who are wise, visionary, hardworking, and committed stewards. With their continued vigilance, and with the ongoing support of this community, “the center will hold” (with apologies to William Butler Yeats). In other words, so long as you keep coming, PRIM&R will keep going.

Both welcome and farewell share the root well, which means “a pool fed by a spring,” “in a good or proper manner…justly, rightly,” “satisfactorily with respect to conduct or action,” “with careful or close attention,” “with skill and aptitude,” and “to an extent approaching completeness or thoroughness.” These definitions all reflect how I feel about the work you do…and I thank you for doing it so well and so faithfully.

These are still the good ol’ days, and they will last so long as we have wholehearted people to share our journeys.

Thank you for helping to make my days here the good ol’ type, and for the magnificent gift of working for and with you.

Now I shall say farewell before I wear out my welcome, but one last request before signing off…if you see me in the Hynes’ halls, please say hello! I’m not so good at goodbyes, but I love hellos!

Be well always, and in all ways!

Joan Rachlin, JD, MPH Executive Director, PRIM&R

“It is good to have an end to journey toward; but it is the journey that matters, in the end.”

- Ursula K. LeGuin n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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Welcome from the Co-Chairs Welcome to the 2013 AER Conference. As your conference co-chairs, we are delighted to welcome you to Boston, and we are eager to share with you the exciting program developed by our planning committees.

Each year, PRIM&R strives to create a forum at the AER Conference where research professionals can meet to exchange ideas, discuss best practices, and grapple with the complex ethical issues raised by research with human subjects. We are confident the next several days will provide you with insight and inspiration, challenge you to think about the larger issues related to research ethics and human subjects protections, offer you concrete tools to strengthen your knowledge and skills, and provide ample opportunities for networking with your colleagues from all over the world.

The crafting of this year’s program was a collaboration involving more than 50 volunteers representing expertise from every corner of the field. This energetic, dedicated, and hardworking group was responsible for selecting five keynote speakers; designing 17 plenary sessions; planning 134 breakout and grand finale sessions; identifying more than 250 faculty members best suited to bringing the content to life; and reviewing 145 poster submissions. It was a vast undertaking, and we believe it has paid off in a program that is as timely and contentrich as they come.

This year’s conference will feature five stellar keynote speakers. Joan Rachlin, JD, MPH, who will be retiring as PRIM&R’s executive director after 39 years of leading the organization, will provide her unique perspective on the development of research ethics and PRIM&R’s important role in this history. Surgeon and influential author Atul Gawande, MD, MPH, will share his thoughts about the value of research protections and speculate about a “checklist” for research ethics. Esther Duflo, PhD, will discuss lessons from her work using rigorous research methods to understand and relieve global poverty. Pioneering oncologist George D. Demetri, MD, will present on the ethical implications of moving toward precision or “personalized” medicine in cancer research and the lessons other sciences can learn from oncology research. And, psychiatrist and leading research ethics scholar Paul S. Appelbaum, MD, will speak about the historical and conceptual development of the therapeutic misconception and its implications for addressing inadequacies in the informed consent process. p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

This year’s program will also feature 38 breakout sessions derived from PRIM&R’s Call for Session Proposals and Speaker Suggestions. We received more than 110 ideas through this process, and we cannot thank our community enough for taking the time to submit their proposals for the program. Finally, we are proud to announce that 98 exemplary posters are being featured in The Conference Connection this year, and that 13 of these posters have been selected for presentation during PRIM&R’s new “Innovations in…” series taking place on November 7 from 2:00 to 3:15 PM. Overall, we would like to thank all those who contributed to this year’s conference. We rely on our community for fresh ideas and perspectives, and the program is, without a doubt, stronger for those contributions.

We encourage everyone to consider submitting a session proposal or poster abstract for the 2014 AER Conference! The Call for Session Proposals and Speaker Suggestions and the Call for Poster Abstracts for 2014 are already open; please visit www.primr.org/aer14 for details.

So, welcome, once again, to Boston and to the 2013 AER Conference. We hope you will not only enjoy the meeting, but will return to your institutions with innovative strategies and strong collegial networks that you can use to enhance your research programs. We encourage you to make the most of this stimulating environment and the unique opportunities for dialogue, hard work, and fun offered in the 2013 program.

Warmly, Susan Z. Kornetsky, MPH Director, Clinical Research Compliance Boston Children’s Hospital David H. Strauss, MD Deputy Director for Research, New York State Psychiatric Institute; Associate Clinical Professor of Psychiatry, Columbia University; Vice Chairman for Research Administration, Ethics and Policy, Department of Psychiatry, Columbia University College of Physicians and Surgeons

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Announcements & Reminders Registration and Help Desk

Registration, Conference check-in, and the Help Desk are located in Pre-Function C on the second level of the Hynes Convention Center, and will be open during the following hours: • Tuesday, November 5: 4:00-7:00 PM • Wednesday, November 6: 7:00 AM-6:00 PM • Thursday, November 7: 7:00 AM-6:00 PM • Friday, November 8: 7:00 AM-5:30 PM • Saturday, November 9: 7:00 AM-12:00 PM* Please stop by the Help Desk with questions, and a PRIM&R staff member will be happy to assist you. *Please note the Help Desk will be open until 3:00 PM on Saturday, November 9.

Message Board

Looking for a colleague? Please post messages to the bulletin board in the Registration area located in PreFunction C. Also, please make sure to check the bulletin board for any messages you might receive.

Networking Ribbons

Are you a first-time attendee, IRB administrator, IRB chair, IRB member, researcher, institutional official, university faculty member, or research subject/ advocate? Then don’t forget to pick up the networking ribbons that indicate these professional affiliations (and many others!) in the Registration area located in Pre-Function C. Networking ribbons are designed to enhance community building and to help you connect with colleagues who share similar professional experiences.

Name Badges and Agendas

Please wear your name badge at all times. Please note the personalized agenda included with your name badge may not reflect the most recent schedule changes or cancellations, so please double check your schedule with the daily schedules available in the Registration area.

First-Time Attendees

Please help us welcome first-time attendees! You’ll know who they are by the rainbow-colored ribbon attached to their name badges.

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Internet Café and Wireless Internet

Want to check email or review conference handouts electronically? You are welcome to utilize one of the computers in the Internet Café located in Pre-Function C, or you may connect wirelessly from anywhere in the Hynes Convention Center. To access the wireless internet, please select the wireless device (SSID) called Hynes Wireless from your wireless browser list. No password is required.

Important Reminder

As a courtesy to the speakers and to the other registrants, please turn off or silence all cell phones and electronic devices during sessions.

Meals and Special Meals

Breakfast and lunch will be served in Exhibit Hall D located on the second level of the Hynes Convention Center. Please see the schedule for meal times. If you ordered a special meal, please alert a server to your needs and provide them with your name before you are seated. Please see a PRIM&R staff member at the Help Desk with questions.

Sessions

In order to keep the conference running on time, please familiarize yourself with the location of the sessions you plan to attend. Maps are included on pages 130-133 in this Guide, and our staff is ready to help with directions or with any questions you might have. It’s important that you attend the sessions you signed up for in advance, as space is limited. Please refer to the schedule in this Guide for more information.

The Conference Connection

Join us in The Conference Connection, which is home to the supporters and exhibitors, the poster presentations, morning and afternoon breaks, and two receptions. The Conference Connection will be open during the following hours: Thursday, November 7: • 7:00-8:00 AM • 10:00-10:30 AM • 11:45 AM-1:45 PM • 3:15-3:45 PM • 5:15-7:00 PM

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Friday, November 8: • 11:00-11:15 AM • 12:30-1:45 PM • 3:15-5:15 PM Saturday, November 9: • 7:00-8:00 AM • 10:45-11:15 AM • 12:30-1:45 PM

Lead Retrieval at the 2013 AER Conference

In an effort to help facilitate connections between our attendees and supporters and exhibitors, we will be using lead retrieval during this year’s event. Included on your name badge is a QR code that stores your contact information (name, title, institution, and email address) as it appears in our database. While you’re in The Conference Connection, supporters and exhibitors participating in the lead retrieval program may ask to scan your badge in order to collect your contact information. Please note this service is only meant to be helpful to those looking for information and those wanting to provide it. Thus, you may decline to have your badge scanned. Please visit the Help Desk if you have questions.

Bookstore

We are pleased to once again offer our very own version of the “corner bookstore.” Ours has been stocked with your professional interests in mind.

Spotlighting books and other reference materials on human subjects protections, research ethics, and IRB management, the Bookstore will offer the latest resources to help guide you in your work. The Bookstore is located in Pre-Function C and will be open during the following hours: • Thursday, November 7: 7:00 AM-5:30 PM • Friday, November 8: 7:00 AM-5:15 PM • Saturday, November 9: 7:00 AM-3:00 PM

Conference Dialogue and Discourse

PRIM&R promotes communication that is respectful, honest, and direct. Though there may be different philosophies, opinions, and views among our community, it is essential that attendees treat one another with respect and dignity. PRIM&R embraces ethical communication and respectful public discussion and opposes efforts that encourage threats, hateful or derogatory language, and mistruths, which are harmful to our collective mission.

Aisle microphones will be set up in the keynote and plenary sessions, so please come forward with questions and/or comments. The workshops and didactic sessions will also provide a chance to be heard, but please remember that workshops have more time for discussion, while the didactic sessions have less.

In Case of Emergency

In case of an emergency, please dial 2111 from any house phone and ask for security. You may also see a PRIM&R staff member at the Help Desk for assistance in case of an emergency.

If friends or family need to contact you and cannot reach you directly, they should call Hynes Convention Center Command Center, which is staffed 24 hours a day, seven days a week, at 617.954.2111.

First Aid Office

If you have a first aid emergency or situation while onsite at the conference, we encourage you to visit the First Aid Station located outside of Exhibit Hall A on the first floor of the Hynes Convention Center. The First Aid Office will be open during the following hours: • Wednesday, November 6: 7:00 AM-6:00 PM • Thursday, November 7: 7:00 AM-7:00 PM • Friday, November 8: 7:00 AM-5:15 PM • Saturday, November 9: 7:00 AM-5:45 PM The First Aid Office provides services from aspirin to defibrillation, and can perform blood sugar, EKG, and oxygen level tests. Each office is equipped with over-the-counter medications and select emergency prescriptions. The Nurse Manager is a registered nurse and an emergency medical technician, and the First Aid team is comprised of 16 registered nurses. The Hynes Convention Center also has a physician on staff.

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Announcements & Reminders Say Cheese!

We are working hard to create a rich and enduring archive of photos and video, and hope that each of you is willing to be a part of this. Some of the photos and video taken at this year’s conference may be used on our website and/or for other promotional purposes.

If you prefer to opt out of having your photograph taken and used by PRIM&R, please be sure to alert the photographer and/or videographer during the conference. We are using passive consent for this project, but the photographer and videographer have been instructed to honor the request of anyone not wishing to be photographed and/or videotaped. Thank you for understanding our desire to capture these exciting moments and, at the same time, respect your right to opt out.

Nursing Mothers

For those requiring a quiet and private space to pump during our conference, PRIM&R has set aside a room for your convenience. Please visit the Help Desk to obtain access to this room.

Religious Observance and Prayer

For those requiring a quiet space to pray and/or observe other religious practices during our conference, PRIM&R has set aside Room 105 for your use.

This room will remain open to all during the hours of the conference.

Help us be Green!

Recycle your name badge holder and/ or lanyard in the Registration area upon conclusion of the Closing Reception on November 9. Thank you.

Shipping, Fax, and Photocopy Services

The Hynes Convention Center’s business center, FedEx Office, offers shipping, mailing, faxing, and photocopying services. The FedEx Office is located outside Exhibit Hall A on the first floor of the Hynes Convention Center, and is open Monday through Friday from 9:00 AM to 5:00 PM, and on Saturday from 9:00 AM to 6:00 PM.

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Conference Job Board

Please visit our 2013 AER Conference job board, located in the Registration area in Pre-Function C, to browse employment opportunities in the field of human subjects protections. Looking to fill a position at your institution? Please stop by the Help Desk, and a PRIM&R staff member will be happy to assist you.

Luggage Storage

On the morning of your departure, we recommend that you check your luggage at the bell stand of your hotel and plan to return there prior to your departure, as the Hynes Convention Center does not have an official taxi stand and it may be difficult to get a taxi to the airport from this location. If you need to depart soon after the close of the conference on November 9, please bring your personal items with you and check them at the luggage stand on level one outside the café area in the Hynes Convention Center. Please note the fee to check bags is $3 per item, and the luggage check will be open from 7:00 AM to 6:00 PM on November 9 only.

Random Acts of Conference Kindness (ROCK) You’ve heard about “random acts of kindness” and “paying it forward,” no? Well, the PRIM&R staff embraces this idea of spreading positive energy. Thus, please be on the lookout for ROCKs during the 2013 AER Conference, which are tiny tokens of our gratitude for joining us in Boston, and be sure to pay those ROCKs forward to another conference attendee.

PRIM&R would like to thank IRBNet for supporting this year’s ROCK program.

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Help Us Improve

Our goal is to make each AER Conference a positive experience for all who attend, but we cannot do this without your help. We want to hear your thoughts on what we did well and what we could do better. Please use the notepaper in the back of this Guide to capture your thoughts, and then take a few minutes to complete the evaluation, which will be emailed to you at the conclusion of the conference. Thank you in advance for your feedback.

Conference Passport

The Conference Passport includes select session handouts, a link to the conference program, an attendee list, keynote and plenary biographies, venue details, and information about PRIM&R. After the conference, audio and video recordings for designated presentations will be added to the Passport.

Materials are now available for your use and reference. To access them, please follow these instructions: 1. Open your internet browser, and go to www.eventscribe.com/2013/primr-aer.

2. Enter the Conference Passport Code found on the back of your name badge (this was also emailed to you prior to the conference).

3. Select “Continue.”

4. Using the left-hand navigation titled “Program Content,” select one of the available search options to locate a specific session.

5. If materials are available for a session, a document icon will appear next to or below the title. Click on the icon to access the materials for that session. Please note that not all sessions have handouts.

People & Perspectives (P&P)

PRIM&R has a long and strong commitment to community building, and P&P is our latest initiative in that tradition. P&P is an online archive for uncovering, collecting, cataloguing, preserving, and sharing the stories of those advancing ethical research. P&P features both the oral histories and reflections of the field’s founders, as well as those tasked with the daily implementation of ethical principles in research.

These stories and this history are shared via multiple platforms: audio and video recordings, interviews, short narratives, essays, photographs, and content from PRIM&R’s program archives.

We invite you to become a part of P&P by sharing your story about your personal history, observations, experiences, and/or reflections on your involvement with research. Tell us about your introduction to the field; recount a key event that affected or influenced you; and/or describe the changes you’ve seen since you first began your work.

Stop by the PRIM&R booth in The Conference Connection to view a demo of the P&P website, watch footage of stories from contributors, or sign up to participate. Also, please join us for the Grand Finale Session P&P: Bring Your Story, on Saturday, November 9, 3:30-4:45 PM, in Room 310.

Visit www.peopleandperspectives.org for more information, or contact peopleandperspectives@primr.org.

Please check the Conference Passport periodically, as additional materials will be posted as they are received. You may print materials for any and all of the sessions that interest you. Printers are available at the FedEx Office outside of Exhibit Hall A on the first floor of the Hynes Convention Center.

If you have questions, please email us at info@primr.org or call 617.423.4112.

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Affinity Groups To help those attending the 2013 AER Conference connect with colleagues who have similar professional responsibilities and interests, PRIM&R hosts Affinity Groups (AGs), which are small groups of people who share areas of specialized professional interest. AGs are designed to foster networking and community building before, during, and after the conference.

This year, PRIM&R will host the following 10 groups (listed along with names of group co-facilitators and sessions and tracks that may be of particular interest): Diversity: Melissa Epstein and Dorotha Love Hall This AG is for individuals who are responsible for addressing the issue of diversity at their institution and in the research being conducted at that institution; who are interested in addressing the lack of diversity in the human research protections professions; and/or who want to engage around the question of why diversity is not directly addressed in the federal regulations governing human subjects research.

Sessions: A9, A23, A24, A25, Innovations C, Innovations D, B6, B9, B18, C6, C7, C17, D3, D12, D13, E17, GF4 Educators/Trainers: Mina Busch and Charlotte Coley This AG is intended for those responsible for educating/training their IRB chairs, members, administrators, other compliance personnel, researchers, research staff, research nurses, or clinical research organization (CRO) employees on human subjects protections, the federal regulations, ethical issues of importance, and best practices.

Track: Educating Research Teams Sessions: A13, B3, B19, D13, E24, GF2 Global Research: Karen Hansen and Rosemary Musesengwa This AG is for non-US-based research professionals and US-based professionals working outside North America who are interested in the conduct of ethical research across geographic and cultural borders.

Track: Global Research Sessions: A14, A23, Panel IV, GF2 Human Specimen/Tissue Banking: Marianna J. Bledsoe and Nicole Sieffert This AG is for those working with the complex evolving ethical and regulatory issues for the collection and banking of biological specimens for both clinical and genetic research.

Track: Out of Body Experiences: Research Involving Tissue and Data Sessions: Innovations B, D9, GF2 Institutional Officials (IOs): Jeffrey P. Braff and Celia Molvin This AG is for IOs (and others with oversight responsibilities) interested in discussing shared concerns, problems, strategies, best practices, and other useful innovations.

Tracks: IOs, Accreditation of HRPPs, Legal, and Small Research Programs Sessions: A18, A21, C5, D18, GF2 IRB Chairs: Kari Babski Reeves and Bruce Gordon This AG is for IRB chairs interested in engaging with each other about “hot button” issues and everyday aspects of their jobs.

Tracks: Accreditation of HRPPs, Advanced Forum for IRB Professionals, Ethical Issues, IRB Operations and Toolkit, Out of Body Experiences: Research Involving Tissue and Data, Populations Requiring Additional Protections, Regulatory Balance, Research Involving the Internet & Social Networking, and Small Research Programs Sessions: A18, Panel I, Panel III, Panel V, B18, Panel VIII, C14, C18, D14, D15, D18, E15, E18, Panel XII, GF2

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Quality Assurance/Quality Improvement (QA/QI): Jessica Randall-Aprea and Sarah White This AG is for those working in or with QA/QI programs, post-IRB approval monitoring programs, or other institutional entities charged with activities such as not-for-cause study reviews, follow-up after monitoring, review visits, reports, corrective action plans, and education.

Track: QA/QI and Post-Approval Monitoring Sessions: C4, C24, D23, GF2 Small Research Programs: Greg E. Manship and Erica Tauriello This AG facilitates networking among those in small research programs, recognizing that “small” is typically a self-imposed designation, and may be indicative of protocol workload, number of full time employee (FTE) IRB staff, research budget, number of IRB members, and/or the character of the institution/researcher community. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.

Tracks: A Dialogue with the Feds I and II, Accreditation of HRPPs, IRB Operations and Toolkit, Legal, Potpourri, Regulatory Balance, and Small Research Programs Session: GF2 Social, Behavioral, and Educational Research (SBER): Emily E. Anderson and Marguarette M. Bolton-Blatt This AG is for those involved and/or interested in the conduct and review of SBER. Tracks: SBER I – Basic, SBER II – Advanced, and Small Research Programs Sessions: A21, A24, Panel I, Panel II, Panel IX, GF2 Unaffiliated/Community Members: Dahron Johnson and Kenneth A. von Kluck This AG is for unaffiliated/community IRB members interested in discussing our roles and responsibilities as members of an IRB, how we relate to the scientific members of our IRB, what we can accomplish as members of our IRB, strategies for successful and meaningful participation on an IRB, and other aspects of our unique position, as well as connecting with others in the same role.

Tracks: A Dialogue with the Feds I and II, IRB Bootcamp, IRB Operations and Toolkit, Unaffiliated and Non-Scientist IRB Members Session: GF2 Attendees who signed up for one of these AGs have access to the following opportunities at the 2013 AER Conference: • Color-coded networking ribbons to help AG members identify one another • A dedicated message board in the Registration area • An AG lounge located in Room 201 for meetings with group facilitators, informal discussions with peers, or just to relax • Office hours with AG facilitators on November 7 and 8 (sign-up at the AG booth in the Registration area) • AG Networking Continental Breakfast on Thursday, November 7, from 7:00 to 8:00 AM in Room 200 • Designated section at the Welcome Reception on Thursday, November 7, from 5:15 to 7:00 PM • Informal dinners with other AG members on Thursday, November 7 at 7:00 PM (sign-up at the AG message board in the Registration area) • AG Networking Lunch on Friday, November 8, from 12:45 to 1:45 PM in Room 210 • Grand Finale AG on Saturday, November 9, from 3:30 to 4:45 PM, which will address how the groups will stay connected after the conference, as well as address any remaining questions or concerns that came up at the conference (see schedule for locations) • LinkedIn group for connecting with members and co-facilitators after the conference

Interested in participating in an AG at the 2013 AER Conference?

Visit the AG booth located in Pre-Function C on the second level of the Hynes Convention Center and a PRIM&R staff member will happily assist you.

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Continuing Education A certificate of attendance for the 2013 AER Conference, November 7-9, is included in the back of this Guide. Certificates for the pre-conference programs on November 6 are included in the individual course materials.

Certificates are useful for obtaining continuing education (CE) credits from various professional associations. Please note each association’s guidelines for acceptance of conference credit hours may differ, and you should consult the appropriate association representative for information as to if, and how many, credits from PRIM&R’s 2013 AER Conference may be used.

A maximum of 17.5 CE credit hours are available for the 2013 AER Conference. Credit hours for the preconference programs vary depending upon the duration of the course.

Certified IRB Professional (CIP®) Recertification

A maximum of 16.25 CE credit hours from the 2013 AER Conference may be used by CIPs who are eligible to recertify by CE. Sessions that meet CIP recertification requirements are designated with a icon on the conference schedule. Additional information on qualifying CE activities for CIP recertification purposes can be found at www.primr.org/certification. Please contact certification@primr.org with any questions.

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Continuing Medical Education (CME)

CME credits are available for designated sessions, and are noted with a icon on the conference schedule.

Boston University School of Medicine, the CME provider for this conference, designates this live activity for a maximum of 17.5 AMA PRA Category 1 CreditsTM. This program meets the criteria of the Massachusetts Board of Registration in Medicine for 17.5 hours of risk management study. Physicians should claim only the credit commensurate with the extent of their participation in the activity. CME applications will be available online and may be accessed at https://www.surveymonkey.com/s/PRIMR2013.

Attendees must complete the online claim for credit and evaluation form within four weeks of the conference to receive a CME certificate. Once the forms are completed, a certificate will be issued by Boston University School of Medicine. For more information about CME credits, please visit the Help Desk in the Registration area.

Please note we do not offer specific credits for nurses, pharmacists, and members of other professions not already listed here. You are welcome to apply for such credits on your own using the Certificate of Attendance that is included in this Guide, as noted above.

PRIM&R’s three scholarship programs have made it possible for more than 400 individuals to attend AER Conferences since 2006. Brief descriptions of each program are below.

International Scholarship Program

PRIM&R is dedicated to improving communication among research ethics committees (RECs), researchers, and other professionals involved in international research. This is especially important today as more and more research is being conducted outside of the United States. Many RECs in developing countries have significantly fewer resources than HRPPs in the United States and lack adequate funding to develop their research programs. Therefore, there is an urgent need to increase awareness and facilitate networking and collaboration among those involved in research globally. This year, PRIM&R welcomes scholars from Argentina, Azerbaijan, Bangladesh, China, Costa Rica, Egypt, Kenya, Liberia, Nigeria, Papua New Guinea, Poland, Russia, Tanzania, Turkey, and Zimbabwe.

Institutional Capacity Building Scholarship Program

Many small, underfunded institutions of higher education in the United States need and lack fully functioning IRBs or HRPPs. Of these, many institutions support primarily minority populations with educational disparities, such as Historically Black Colleges and Universities, Hispanic-Serving Institutions, and Tribal Colleges and Universities. Others are health institutions serving minority populations with significant health disparities, such as community clinics, regional or area Indian Health Boards, and tribal governments. In addition, many of these institutions are being asked to take on greater roles in research by participating in studies or initiating their own research activities.

Community (Unaffiliated/NonScientific) IRB Member Scholarship Program

Developed in response to feedback from advocates and IRB community members, the goal of this program is to ensure that community members and unaffiliated IRB members receive equal educational opportunities to other IRB members, so as to develop and progress in their IRB service. This program strives to extend educational and development opportunities to community members who are committed to advancing ethical research practices and to provide a networking base among collegial practitioners and peers.

Many thanks to WIRB-Copernicus Group for helping to support this year’s International Scholarship Program! PRIM&R is also grateful to Felix A. Khin-Maung-Gyi for his donation to the Institutional Capacity Building Scholarship Program, and to John Isidor and Sandy Kaltman, Elizabeth Bankert, and Susan Miller for their donations to the International Scholarship Program.

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Supporting the Growth of Research Ethics

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Evaluation Guide Since the Conference Evaluation will be electronic (you’ll find it in your email inbox on November 9!), we’ve included these pages to help you jot down your impressions of the sessions you attend.

Please refer to the notes you record here when you complete your evaluation. We look forward to reading your comments! Thank you.

Thursday, November 7

Keynote Address: Atul Gawande, MD, MPH ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Keynote Address: George D. Demeteri, MD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session A A___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel I or “Innovations in” Series___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel II, Panel III, or Panel IV Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ _____________________________________________________________________________________

Friday, November 8

Panel V, Panel VI, or Panel VII Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

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Keynote Address: Esther Duflo, PhD or Paul S. Appelbaum, MD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session B___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel VIII, Panel IX, or Session C___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Saturday, November 9

Keynote Address: Joan Rachlin, JD, MPH ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session D___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session E___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel X, Panel XI, or Panel XII Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Grand Finale___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

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supporters & exhibitors

Supporters & Exhibitors PRIM&R is grateful to our Supporters and Exhibitors!

Visiting Hours

Please visit our Supporters and Exhibitors in The Conference Connection, located in Exhibit Hall C on the second level of the Hynes Convention Center, during the following hours: Thursday, November 7: 7:00-8:00 AM 10:00-10:30 AM 11:45 AM-1:45 PM 3:15-3:45 PM 5:15-7:00 PM

Friday, November 8: 11:00-11:15 AM 12:30-1:45 PM 3:15-5:15 PM

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Saturday, November 9: 7:00-8:00 AM 10:45-11:15 AM 12:30-1:45 PM

Supporters & Exhibitors Platinum Supporters

WIRB-Copernicus Group 360.252.2485 | www.wcgirb.com Booths: 300, 302, and 304 The WIRB-Copernicus Group is the world’s largest provider of regulatory and ethical review services for human research. With eight individual AAHRPP-accredited panels, over 100 experienced board members, and over 60 years of combined experience in protocol and study-related review, the WIRB-Copernicus Group brings more expertise to the industry than any other ethical solutions provider. The WIRB-Copernicus Group is comprised of Western IRB and Copernicus Group IRB, the nation’s leading independent IRBs, as well as IRBNet, the top institutional research compliance software solution. PRIM&R would like to thank the WIRB-Copernicus Group for helping to support this year’s International Scholarship Program. More information can be found on page 13 of this Guide.

Gold Supporter Quorum Review IRB 206.448.4082 | www.quorumreview.com Booths: 310 and 312 Quorum Review IRB is an independent ethics review board that is fully accredited by the AAHRPP. Our primary focus is to safeguard the rights and well-being of research participants. We provide sponsors, CROs, institutions, and sites with reliable and responsive service that ensures efficient study start-up and management. PRIM&R would like to thank Quorum Review IRB for supporting the key cards provided at the Sheraton Boston Hotel.

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The Collaborative Institutional Training Initiative (CITI) Program at the University of Miami 305.243.7970 | www.citiprogram.org Booths: 311 and 410 The CITI Program at the University of Miami offers customizable, webbased research ethics training in animal care and use, biosafety and biosecurity, conflicts of interest, export control, good clinical practice, human subjects research, information privacy and security, and responsible conduct of research. PRIM&R would like to thank The CITI Program at the University of Miami for supporting the “What’s New at the CITI Program” Continental Breakfast on November 9 from 7:00-8:00 AM in Ballroom A.

Supporters & Exhibitors supporters & exhibitors

Silver Supporters Huron Life Sciences 503.601.4001 | www.huronconsultinggroup.com Booth: 210 Huron Life Sciences helps clients optimize their ability to comply with regulatory requirements and aspire to the highest ethical and professional standards for all research endeavors. Huron Life Sciences provides assistance with compliance assessments, policy and process creation and improvement, interim IRB staffing and management, education and training, and preparing AAHRPP applications in as little as four weeks. Huron’s Click® Portal Software further assists research organizations by streamlining and improving IRB, conflict of interest, and other research compliance processes. PRIM&R would like to thank Huron Life Sciences for supporting breakfast on November 7 in Exhibit Hall D.

InfoEd Global 518.713.4200 | www.infoedglobal.com Booths: 200, 202, and 204 InfoEd Global provides research institutions worldwide with superior technology to reduce costs, improve data integrity, streamline processes, and accelerate compliance. Thousands of researchers across the globe rely on InfoEd Global software and services to support their operations. The fully integrated InfoEd eRA Suite includes Solutions for Grants and Contracts, IRB and IACUC Submissions, COI, Clinical Trials, Animal Facilities, Technology Transfer, and Research Outputs.

PRIM&R would like to thank InfoEd Global for supporting the breakfast on November 8 in Exhibit Hall D.

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The PEER Consulting Group 551.265.2040 | www.peercg.com Booths: 100 and 101 The PEER Consulting Group (PEER) helps institutions, researchers, and sponsors enhance Performance, Excellence, Efficiency in Research. PEER consists of three divisions: Associates for IRB/HRPP Solutions (AIS), Associates for Clinical Trials (ACT) Management, and Associates for Research Compliance (ARC). The PEER Consulting Group is complemented with a team of over 70 consultants who have extensive expertise in all areas of research administration and clinical trials management. PRIM&R would like to thank PEER for supporting the drink tickets at the Welcome Reception on November 7, 5:15-7:00 PM in Exhibit Hall C.

Supporters & Exhibitors Bronze Supporters

HRP Consulting Group, Inc. 347.862.9321 I www.thehrpconsultinggroup.com Booths: 313 and 315 HRP Consulting Group focuses solely on human research protections, providing expert advice both internationally and domestically to research-driven universities, hospitals, government, and military organizations. HRP Consulting Group offers the following services: education and training; IRB process development; program evaluations; investigator monitoring; collaborative IRB development; IRB and ethics committee start-up; IRB management; accreditation assistance; assistance responding to federal agencies; retention plan; and HRP monitor. PRIM&R would like to thank HRP Consulting Group for supporting the afternoon break on November 7 in Exhibit Hall C.

iMedRIS 951.520.9164 | www.imedris.com Booths: 411 and 413 At iMedRIS we provide state-of-the-art electronic research administration software. Welcome to iRIS, the premier integrated research management system designed to reduce redundancy of data input while providing maximum data availability to all those who need it. This innovative system is called iRIS (“integrated Research Information System”). iRIS™ modules include: IRB Assistant™, IACUC Assistant™, COI Assistant™, PreAward Assistant™, and Grants & Contracts, Site Assistant™. PRIM&R would like to thank iMedRIS for supporting the morning break on November 8 in Exhibit Hall C.

IRBNet 617.758.4202 | www.irbnet.org Booths: 201 and 203 IRBNet, a WIRB-Copernicus Group company, offers the most widely used electronic research compliance solution, with more than 1,800 sites and boards on the National Research Network®.

Integrated modules enable institutions to seamlessly manage local and external IRBs, conflict of interest, IACUC, biosafety, R&D, sponsored programs, and other critical research oversight activities while connecting with existing institutional systems. Objective National Research Network Benchmark Report performance metrics make it easier than ever for universities, hospitals, and federal and state agencies to benchmark internal performance and drive continuous improvement. PRIM&R would like to thank IRBNet for supporting this year’s ROCK Program.

Solutions Institute 855.226.4472 | www.solutionsinstitute.com Booths: 211 and 213 Solutions Institute provides quality education and training for independent and institutionally affiliated researchers. Courses examine federal regulations in an engaging and interactive environment. Solutions Institute delivers expert content, facilitated discussions, extensive media, and exceptional customer service. Each module receives 1.0 CE units from the State of California Board of Registered Nursing. PRIM&R would like to thank Solutions Institute for supporting the morning break on November 7 in Exhibit Hall C. n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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EnterpriseWeb LLC and the Ideate™ Framework 646.502.8062 x446 | www.enterpriseweb.com Booths: 104 and 110 EnterpriseWeb is the developer of the patent-pending Ideate™ framework, an innovative new choice for research management systems. Ideate™ is designed to make the management of research as compelling as the pursuit of discovery. It combines rich web 2.0 functionality with robust open web architecture to deliver a next generation solution for enterprise research management. Research organizations can take advantage of a comprehensive suite of ready-to-use applications for managing the lifecycle of proposals, protocols, and publications. The EnterpriseWeb team has 100 years collective experience working with leading research organizations worldwide.

Ideate is Research 2.0™. PRIM&R would like to thank the EnterpriseWeb LLC and the Ideate™ Framework for supporting this year’s chair massages at the Welcome Reception on November 7, 5:15-7:00 PM in Exhibit Hall C.

Supporters & Exhibitors supporters & exhibitors

Exhibitors

Alion Science and Technology 202.756.3817 | www.alionhrpp.com Booth: 317 The Alion HRPP Accreditation Program offers experienced comprehensive accreditation services for organizations involved in conducting, managing, or reviewing research involving humans.

Alion’s objective is to help the largest number of organizations possible develop and maintain effective and compliant human research protections programs.

Aspire IRB 619.469.0108 | www.aspire-irb.com Booth: 214 Aspire IRB is committed to protecting people and empowering research. We are focused on accuracy, we are driven by integrity, and the difference is service. Aspire’s Simple Automated Portal (ASAP) is very intuitive, easy to navigate, and powerful in its search, save, and print functions. Aspire IRB: The difference is service!

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) 202.783.1112 | www.aahrpp.org Booth: 417 A nonprofit organization, AAHRPP works with groups that conduct human research in order to raise the level of protection for research participants. AAHRPP accredits organizations that can demonstrate their participant safeguards exceed US federal requirements. The accreditation program uses a voluntary, peer-driven, educational model.

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Axiom Education 513.382.9196 | www.axiomeducation.com Booth: 217 From social science to clinical research, the Mentor paperless IRB system from Axiom Education is designed to be tailored to your IRB’s specific needs. Mentor supports multiple IRBs within an institution, each with its own custom settings. With custom communication templates, scheduled notifications, automatic meeting agendas, custom forms, and a host of other features, Mentor makes the management of the IRB review and oversight process simple and elegant.

The Bioethics Program of Union Graduate College and the Icahn School of Medicine at Mount Sinai 518.631.9860 | www.bioethics.uniongraduatecollege.edu Booth: 212 The Bioethics Program of Union Graduate College and the Icahn School of Medicine at Mount Sinai offers a 12-course competency-based Masters of Science in Research Ethics and Clinical Ethics program. A fourcourse Graduate Certificate in Research Ethics is also available. The majority of the courses are taught online by internationally recognized experts in bioethics and research ethics, complemented by individual master’s projects, an on-site seminar, practica, and capstone assessment courses.

Chesapeake IRB 443.283.1581 | www.chesapeakeirb.com Booth: 415 Chesapeake IRB has been providing central independent IRB services since 1993. Chesapeake IRB earned AAHRPP accreditation in 2004, and was reaccredited a second time in June 2010. Chesapeake IRB offers a 21 CFR Part 111 compliant, electronic IRB platform (CIRBI) that streamlines protocol submissions and decreases investigator review turnaround times resulting in faster subject enrollments.

Supporters & Exhibitors

CureLauncher 248.515.0097 | www.curelauncher.com Booth: 112 CureLauncher redefines the approach to clinical trial enrollment. It is a personalized clinical trial matching service that matches patients to any enrolling trial based on their unique conditions. CureLauncher is patient-centric. It focuses on the person first; then seeks out the best clinical trial options.

Emmanuel College Graduate Studies 617.735.9859 | www.emmanuel.edu/graduatestudies-nursing/academics/management/researchadministration.html Booth: 119 Emmanuel College responds to the specialized needs of research administrators with the opportunity to earn an academic credential and expand professional networks through a rigorous curriculum developed by sponsored research experts. Our programs are offered in a class format and fully online. Our Master of Science in Management with specialization in research administration takes two years to complete its 11 courses, and the Graduate Certificate in Research Administration takes one year to complete its six courses.

Evisions 714.824.5252 | www.evisions.com Booth: 414 The Evisions Research Suite, which includes Cayuse 424 and Cayuse SP, comes from a company with over 16 years of experience in research administration. Our customers drive everything we do—research, products, service, and support. When you work with us, you are part of the Evisions team.

The Health Care Compliance Association (HCCA) 952.405.7900 | www.hcca-info.org Booth: 412 HCCA exists to improve the quality of healthcare compliance. Members enjoy a subscription to Compliance Today magazine, and special pricing for our meetings, including our Research Conference and our Research Compliance Academies.

Infonetica Ltd. +44 (0)208 334 6900 | www.infonetica.net Booth: 118 Infonetica provides a global-leading range of clinical research solutions including Clinical Research Application and Management Systems, IRB Software, Research Management Software, Human Tissue Tracking Software, and Online Training.

Infonetica products are in use internationally, with government and private sector contracts in Europe, United States, Canada, and Australia. Infonetica is proud to announce the launch of its new Ethical Review Manager software based on the latest web technologies and incorporating configurable forms and review processes.

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supporters & exhibitors

Columbia University School of Continuing Education 212.854.8451 | www.ce.columbia.edu Booth: 102 Columbia University’s School of Continuing Education offers a portfolio of master’s degrees, courses for career advancement, and graduate school preparation and certificates. These rigorous, innovative programs integrate knowledge across disciplinary boundaries, combine theory with practice, leverage student and faculty expertise, and connect global constituencies

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Supporters & Exhibitors IRBManager 516.627.3800 | www.irbmanager.com Booth: 215 With its IRBManager and SMART offerings, Tech Software continues to deliver best-of-breed solutions for research ethics oversight and clinical trial financial management. Modern cloud solutions, IRBManager supports all your research oversight needs, from IRB and IBC to IACUC and Export Control, including electronic submissions, online reviews, agendas and minutes, and, of course, reporting. SMART supports the clinical trial office with recruitment, budgets, contracts billing and collections, and everything you need to manage the finances of today’s complex clinical trials. Be sure to visit us and find out more!

Key Solutions, Inc. 510.456.4502 | www.keyusa.com Booth: 105 Key Solutions is the Integrated Research Administration and Compliance Software leader.

Products include: Human Subjects (IRB), Bio Safety (IBC), Animals (IACUC), Chemical Safety (CSC), Radiation Safety (RSC), Lab Animal Resource Management (LARS), Lab Animal Health Records (LAHS), Post-Approval Monitoring (PAM), Conflict of Interest (COI), Material Transfer Agreement (MTA), and Grant Management Systems (eGrants).

Kuali Coeus Consortium 617.253.8048 | www.kuali.org/kc Booth: 316 The Kuali Coeus Consortium creates, maintains, and supports the most robust electronic solution to manage all components of research administration— including IRB, IACUC, and COI—while fostering best practices by joining innovative technology with the knowledge base of a national consortium of research stakeholders.

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Medical College of Wisconsin Center for Bioethics and Medical Humanities 414.955.4299 | www.mcw.edu/ bioethicsandmedhumanities.htm Booth: 115 The Medical College of Wisconsin Center for Bioethics and Medical Humanities offers a graduate level certificate program in research ethics. This engaging online educational program builds a solid foundation in human subjects research regulations, examines the historical and philosophical foundations of these regulations, and broadly surveys current topics in research ethics.

Office for Human Research Protections (OHRP) 240.453.8127 | www.hhs.gov/ohrp Booth: 416 The Department of Health and Human Services’ (DHHS’) OHRP oversees the protection of human subjects in DHHS-funded research activities and accomplishes its mission through assurances, compliance oversight, education, and the quality improvement program. Staff will be available to discuss ethical principles, regulations, policy guidance, and educational resources.

RosterTech™ 801.585.3492 | www.rostertech.com Booth: 314 RosterTech™ is the premier research compliance and training software delivering cost-effective, customizable solutions for your organization! “Built by trainers for trainers,” RosterTech™ provides efficient registration, tracking, and reporting of any live lectures and online classes required by your institution and federal funding agencies. RosterTech™ fully integrates with different software platforms enabling secure authentication, centralized data management, creation of rosters and certificates, and email distribution lists. The RosterTech™ team of professionals offers high-quality client services, including development and conversion of training content into online educational programs, learning management support, and instructional design.

Supporters & Exhibitors supporters & exhibitors

Schulman Associates IRB 513.794.5757 | www.sairb.com Booth: 113 Schulman Associates IRB provides independent ethical review services for sponsors, CROs, institutions, and research sites in the United States and Canada. Our comprehensive suite of services includes dedicated review capabilities for all phases of research.

Established in 1983, Schulman is AAHRPP accredited and has an unparalleled audit history with FDA. We are committed to providing high quality, rigorous IRB reviews via streamlined processes, customized technology solutions, and responsive customer service.

TOPAZ Technologies, LLC 512.249.8080 | www.topazti.com Booth: 216 TOPAZ Technologies, LLC provides animal and clinical research software solutions for the medical research industry. With more than 33 years in the industry, TOPAZ is an established leader in delivering softwarebased solutions for complex regulatory environments.

The Society for Clinical Trials (SCT) 215.320.3878 | www.sctweb.org Booth: 114 SCT is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct, and analysis of government and industry-sponsored clinical trials and related health care research methodologies. The 35th Annual Meeting will take place on May 18-21, 2014, in Philadelphia, PA.

Society of Research Administrators (SRA) International 703.741.0140 | www.srainternational.org Booth: 103 SRA International is a professional society comprised of over 4,500 research administrators working in all facets of research management. From those new to the field of research administration to vice presidents of research, SRA’s focus is to provide professional development, educational, and networking opportunities to increase your institution’s success in research and your career.

Collaboration of research administrators from multiple settings including universities, nonprofits, hospitals, government agencies, and commercial businesses sets us apart in enriching your experience and network base.

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Thanks to Those Who Made This Conference Possible

Our thanks also go out to members of the conference faculty for lending their expertise and enthusiasm to the content of this year’s program. Each faculty member has made essential and inspired contributions to this meeting, and we could not provide high-quality educational opportunities without their input and commitment.

Among PRIM&R’s most esteemed partners with us at this year’s conference are federal agency representatives. Our field is blessed with a team of incredibly considerate, conscientious, and helpful government employees. We thank them for their guidance and support in this shared educational venture.

PRIM&R extends a special thanks to the Association of American Medical Colleges (AAMC) and The Hastings Center for generously providing copies of the recent Hastings Center Report supplement “Ethical Oversight of Learning Health Care Systems” for all conference attendees.

We would also like to extend our sincere thanks to those who submitted abstracts for the Poster Presentations. The program has been greatly enriched by their contributions, and we appreciate the effort and initiative that went into their submissions. We hope you will explore these posters located in The Conference Connection, as they are filled with helpful strategies, creative ideas, and useful information regarding research protections and HRPP operations.

We are also featuring some of the most outstanding posters in a new format this year in our “Innovations in…” series on Thursday, November 7, from 2:00 to 3:15 PM. Additional information about these sessions can be found on page 90.

Thank you to our many wonderful conference volunteers! As networking meal hosts, booth attendants, conference greeters and ushers, book group discussion facilitators, first-time attendee breakfast discussion facilitators, Blog Squad members, and mentors, you enrich our conference and make our valuable special events possible.

Finally, we’d like to express gratitude to everyone who submitted a session idea or speaker suggestion through our Call for Speaker Suggestions and Session Proposals. We truly value these contributions as we strive for a program that fully represents and responds to the needs of our community. Sessions generated from the Call for Speaker Suggestions and Session Proposals are marked with a on the conference schedule.

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Thank you to all those who contributed their time, effort, and energy to this meeting. We are completely indebted to the conference planning committees for their important work developing this conference. We are grateful for their direction, efficiency, dedication, and leadership. Please see the inside front cover of this Guide for a listing of the hardworking volunteers who helped bring this conference to life.

Board of Directors Conference Information

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Officers

Alexander M. Capron Chair University of Southern California

Susan Z. Kornetsky Vice Chair Boston Children’s Hospital

Members

Cynthia A. Gómez San Francisco State University

A. Cornelius Baker FHI 360

Joseph J. Byrne Tufts University

Leonard Glantz Boston University

Christine Grady National Institutes of Health Serves in Personal Capacity

Tanise L. Jackson Florida Agricultural and Mechanical University

Moira Keane University of Minnesota (retired)

Chris Newcomer AAALAC International

Judy Norsigian Our Bodies, Ourselves

P. Pearl O’Rourke Partners HealthCare Systems

Ada Sue Selwitz University of Kentucky

Barbara Stanley Columbia University

Walter L. Straus Merck Vaccine Division

Jeremy M. Sugarman The Johns Hopkins University

Hugh Tilson University of North Carolina at Chapel Hill

Robert J. Levine Yale University

Susan S. Fish Secretary Boston University

David A. Borasky Treasurer University of North Carolina at Chapel Hill

Joan Rachlin Ex officio PRIM&R

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Staff Senior Staff

Staff

Avery Avrakotos Education and Policy Manager

Joanna Cardinal Assistant Director for Membership and IT Operations

Elizabeth Cooper Executive Administrator

Mariellen Diemand Assistant Director for Conferences

Kimberly Hensle Lowrance Managing Director

Megan Frame Membership Coordinator

Alessandra Frissora Program Assistant

Jen Levine-Fried Staff Accountant

Ali Hall Educational Program Assistant

Elisa A. Hurley Education Director

Maeve Luthin Professional Development Manager

Anne Meade Senior Manager for Website and Social Media

Dana Mikaelian Communications Coordinator

Alysa Perry Program Coordinator

Alexandra Shlimovich Webinar and Publications Specialist

Caroline Slymon Registration and Operations Assistant

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Joan Rachlin Executive Director

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Lifetime Achievement Award Conference Information PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics was created in 2000 to recognize and honor individuals who have made a major and sustained contribution to the development and dissemination of the ethical principles that govern research. Previous recipients include some of the chief architects of the research ethics field such as Jay Katz, MD (2001), Charles McCarthy, PhD (2003), Robert J. Levine, MD (2005), Albert R. Jonsen, PhD (2009), and Ruth R. Faden, PhD, MPH, and Tom L. Beauchamp, PhD, who received the award jointly (2011).

This year, the Board of Directors has selected PRIM&R’s executive director, Joan Rachlin, JD, MPH, to receive the Lifetime Achievement Award for Excellence in Research Ethics.

One would be hard pressed to find another professional in the field of research ethics who has done more in the last 39 years to disseminate the ethical principles that govern research in this country. Ms. Rachlin’s career spans the evolution of the field of research ethics. She came to PRIM&R in 1975, a year after the passage of the National Research Act and the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

During her first decade at PRIM&R, the public was grappling with the revelation of the US Public Health Service Syphilis Study at Tuskegee, The Belmont Report was published, and human research regulations were advancing. During her second decade, significant amendments were made to the Animal Welfare Act, the “Common Rule” was adopted by 16 federal agencies, and the Radiation Experiments were exposed. During

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her third decade at PRIM&R, AIDS activists and cancer survivors radically changed the public’s view of human subjects research, from an ominous enterprise to be feared to a hopeful opportunity for saving lives.

Ironically, the terrible tragedy of Jesse Gelsinger’s death also occurred during that decade, spawning widespread recognition of the urgency for effective education in research ethics and the responsible conduct of research. And during Ms. Rachlin’s fourth decade of service, the internet and other technological advances dramatically altered the way research is conducted, giving rise to new ethical problems that were difficult to accommodate within a regulatory framework developed in a previous century.

With near clairvoyance, Ms. Rachlin understood the need for research ethics education from the start of her career with PRIM&R. She organized PRIM&R’s first educational conference in 1977, and, fueled by the events of these decades, never relented in her quest to offer more and better educational programming during each of the years that followed. Ms. Rachlin’s

And then there are the achievements accumulated before her tenure at PRIM&R. Prior to her full-time commitment to PRIM&R, Ms. Rachlin practiced law, concentrating in the areas of women’s health, civil rights, and criminal and civil litigation. She holds a JD from the Suffolk University School of Law, and an MPH from the Harvard School of Public Health.

It is not possible to describe in a paragraph the achievements of a lifetime, but here are a few highlights. Over the course of her tenure at PRIM&R, Ms. Rachlin planned and organized more than 200 conferences and educational events, as well as produced and distributed their proceedings. In collaboration with two of PRIM&R’s Board members, she produced a CD-ROM for research scientists, Investigator 101, the rights to which were acquired by the OHRP for distribution to every major academic health center and university in the country. Under Ms. Rachlin’s stewardship, PRIM&R developed its highly acclaimed educational programs, for both IRB and IACUC professionals, including IRB 101sm, IRB Administrator 101, and Essentials of IACUC Administration. She shepherded the development of PRIM&R’s two certification programs, the Certified IRB Professional (CIP®) and the Certified Professional IACUC Administrator (CPIA®) credentials, both of which have successfully certified thousands of research professionals, contributing to excellence in their respective fields. One of PRIM&R’s accomplishments in which Ms. Rachlin takes great pride is the growth of its membership from a small group of 61 Charter Members in 1986 to the large and active membership community of today that includes more than 4,000 research professionals from around the world.

Anyone who knows Ms. Rachlin recognizes that her greatest passion is to build and nurture relationships, both professional and personal, with an eye toward improving society. She believes that advancement of any kind is achieved through networking, mentoring, collaborating, and celebrating. The PRIM&R community, which largely owes its existence to her efforts, is proud to celebrate Ms. Rachlin and her extraordinary achievements.

PRIM&R’s 2013 Lifetime Achievement Award will be presented to Ms. Rachlin on November 9 at 8:00 AM in the Veterans Auditorium at the Hynes Convention Center.

Ms. Rachlin’s work in research ethics education extends beyond PRIM&R. She played a seminal role in the creation of AAHRPP, the first voluntary accreditation program. She developed and launched WISH-net, a website for women and girls interested in, or already pursuing, careers in science and medicine.

She served on the faculty of several colleges, where she taught women’s health, health law, and research ethics. Ms. Rachlin is a contributor to the well-known resource, Our Bodies, Ourselves, and serves on its Advisory Committee. She is a past member of the editorial board of the journal, IRB: A Review of Human Subjects Research, and of Boston-area IRBs.

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passion and leadership in developing and providing this education was singular. Through her extraordinary efforts, force of will, and commitment, PRIM&R came to fill a unique role in the emerging field of research ethics education. PRIM&R’s programs provide practical tools for the application of ethical principles, and have had an extraordinary impact on the field.

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ARENA LegacyInformation Award Conference The Applied Research Ethics National Association (ARENA) Legacy Award recognizes a PRIM&R member who has made an exemplary contribution to the mission and goals of PRIM&R by significantly promoting the ethical conduct of research through mentoring, teaching, and leadership. This award was developed to honor not only the recipient, but also the living legacy created by ARENA, which was the membership division of PRIM&R from 1986 to 2005.

PRIM&R is proud to announce that Daniel K. Nelson, MSc, CIP, has been selected as the 2013 recipient of the ARENA Legacy Award.

Mr. Nelson is a longtime national, institutional, and organizational leader whose career has been characterized by a passionate and tireless commitment to protecting the rights and welfare of research subjects. One of the many ways in which he has demonstrated this exceptional commitment is through tireless service to PRIM&R, as well as via his generosity in mentoring and supporting countless professionals working in the field.

As noted by the individual who nominated Mr. Nelson: ““Dan is known to most, if not all, in the PRIM&R community as a frequent and well-respected faculty member at PRIM&R conferences, on webinars, and as part of the At Your Doorstep program. He was instrumental in developing many of PRIM&R’s most popular and informative programs, and continues to assist in the development of new programs, both proactively and as new needs are identified. He is always willing to listen, offer advice, and help those in the field, both new and experienced, learn.

Dan has in-depth knowledge of the field of human research ethics from all sides, giving him valuable experience and an invaluable perspective. His involvement in many national initiatives is further testament to his leadership and mentoring.”

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These remarks are emblematic of the many positive comments we have received over the years regarding Mr. Nelson’s outstanding skills as a teacher, mentor, friend, and national leader, all of which make him eminently qualified for the ARENA Legacy Award.

We’d like to share some of our honoree’s impressive background: Mr. Nelson received his bachelor’s degree in biology and psychology from Luther College, and his master’s degree in physiology from Southern Illinois University, Carbondale. Trained in medical physiology, Mr. Nelson has held faculty appointments at the Mayo Clinic and at the University of Rochester, where he was director of research in a clinical gastroenterology unit.

He made his first foray into human subjects protections work when he became the IRB chair at a hospital affiliated with the University of Rochester.

Mr. Nelson is currently a professor of social medicine, an adjunct professor of pediatrics, and the director of the Office of Human Research Ethics at the University of North Carolina (UNC), Chapel Hill. Since joining UNC in 1998, he has worked to transform the UNC IRB system from a fragmented, school-based IRB model into a centralized, comprehensive human research protections program that provides IRB oversight for the entire university. On campus, Mr. Nelson is viewed as a leader who has successfully built bridges between the IRB and the research community.

Mr. Nelson is also a co-investigator on several projects, including a National Institutes of Health (NIH) study examining the clinical, ethical, and social questions surrounding the responsible use of whole exome sequencing; a pilot study comparing local and central IRB review; and a project designed to strengthen the bioethical training and research capacity in the Democratic Republic of Congo.

Beyond his remarkable professional achievements, Mr. Nelson is a sterling human being who models wisdom, thoughtfulness, common sense, integrity, and “respect for persons” in all he does. He has worked continuously and energetically to promote the ethical conduct of research, and so many of those working in the field today have been touched by his generous willingness to mentor, support, teach, and otherwise help them.

PRIM&R’s 2013 ARENA Legacy Award will be presented to Mr. Nelson on November 7 at 8:00 AM in the Veterans Auditorium at the Hynes Convention Center.

Given this long and venerable list of high profile and high impact professional activities, it is all the more remarkable that Mr. Nelson has been able and willing to devote so much time to PRIM&R for almost 20 years.

He served as the president of ARENA, PRIM&R’s former membership division in 2002; as a member of the Council for Certification of IRB Professionals (CCIP); as faculty for countless PRIM&R programs; and as a member of several of our conference planning committees. Additionally, in 2003, he received PRIM&R’s Special Service Award.

Mr. Nelson’s service to the field extends well beyond his “day job” and PRIM&R activities, as he is also a highly sought after member of innumerable committees and councils for many other nonprofit and governmental organizations. He is a charter member of the AAHRPP Council for Accreditation; consults for the OHRP; was a founding co-chair of the IRB Sponsor Roundtable; and served as a liaison to the National Bioethics Advisory Commission. For the past nine years, he has cochaired the Subpart A subcommittee of the Secretary’s Advisory Committee on Human Research Protections

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In addition to being a hands-on researcher and skilled instructor, Mr. Nelson is an accomplished writer who has made extensive contributions to textbooks, journals, and the news media. Among his publications are: “Obtaining Consent from Both Parents for Pediatric Research: What Does ’Reasonably Available’ Mean?”

(Pediatrics, 2013); “IRB Chairs’ Perspectives on Genotype-Driven Research Recruitment” (IRB: Ethics and Human Research, 2012); “Recommendations for Ethical Approaches to Genotype-Driven Research Recruitment” (Human Genetics, 2012); “Researcher Conflict of Interest” and “IRB Member Conflict of Interest” (with E. Bankert and R. Amdur in Institutional Review Board Member Handbook (3rd edition), 2010); and “Getting from A to IRB: Developing an Institutional Review Board at a Historically Black University” (Journal of Empirical Research on Human Research Ethics, 2010).

(SACHRP), the body that advises the DHHS on the regulations that govern human research protections (the “Common Rule”).

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Pillars of PRIM&R Conference Information Since its founding in 1974, PRIM&R has been infused with the wisdom, devotion, and vision of a number of highly respected and uncommonly committed members of its Board of Directors. To recognize these contributions, in 2007, PRIM&R established the Pillars of PRIM&R Award and Pillars of PRIM&R Memorial Fund to support early-career professionals whose scholarship in the field of research ethics reflects PRIM&R’s mission and core values, as it was believed that providing such assistance would further PRIM&R’s mission and honor the legacy of PRIM&R Board members who had passed away.

Pillars Louis Lasagna, MD, (19232003) the “Father of Clinical Pharmacology,” was a vital member of the PRIM&R Board of Directors for nearly 20 years. He first became involved with the organization when he spoke at a PRIM&R conference in 1980.

Thereafter, he consistently contributed time, wisdom, spirit, warmth, humor, principled leadership, and endless hard work to every PRIM&R project he undertook. When Dr. Lasagna first became involved with PRIM&R, he was already a prominent figure in the field of pharmacology, as well as in the emerging area of the responsible and ethical conduct of research. Everything he did was informed by his humanity, as well as by his concern that science and life in general must be a search for logic, wisdom, truth, meaning, and justice.

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Herman “Wig” Wigodsky, MD, PhD, (1915-2005) was actively involved in promoting research ethics throughout his career, which spanned more than 60 years. Dr. Wigodsky served in the United States Air Force (USAF) during World War II as the director of research at the USAF School of Aviation Medicine from 1944 to 1947. He worked for the Atomic Bomb Casualty Commission and then for the National Academy of Sciences prior to moving to the University of Texas Health Science Center in San Antonio in 1950. Dr. Wigodsky loved PRIM&R and he was, in turn, loved by all those who met him. When he gave a talk or facilitated a breakout session at a PRIM&R meeting, his comments were always strong, fiery, and right on target.

Harry Rozmiarek, DVM, PhD, (1939-2013) served on the PRIM&R Board of Directors from 1990 to 2013, and was an active and valued member of executive, finance, and certification committees, and the Board treasurer and secretary. Dr. Rozmiarek had a long and distinguished career that spanned the Armed Forces and academia. Upon his death, Dr. Rozmiarek was professor emeritus of laboratory animal medicine at the University of Pennsylvania, a visiting professor of laboratory animal medicine at the Ross University School of Veterinary Medicine, and the laboratory animal facility director at the Fox Chase Cancer Center. He authored more than 60 publications and presentations.

The Pillars of PRIM&R Memorial Fund underwrites the distribution of the Pillars of PRIM&R Award, which is given to people who have demonstrated exceptional potential for leadership in advancing ethical research. In recognition of those accomplishments, awardees receive small grants to further their professional development.

2013-2014 Pillars of PRIM&R Award Recipient: Jeanelle Graham, MPH We are thrilled to announce that Jeanelle Graham, MPH, has been selected as this year’s Pillars of PRIM&R Award recipient.

Ms. Graham is a research compliance specialist at the University of Alabama at Tuscaloosa. She brings a unique perspective to her current role, as she has experience not only in research oversight, but also as a research specialist, research recruiter, and a student researcher. Ms. Graham firmly believes that effective communication between investigators and research oversight staff is the key to a successful research program. She is using her award to measure efficiency and assess satisfaction with the university’s nonmedical IRB. Ms. Graham will be presenting a poster of her project’s findings at the 2014 AER Conference in Baltimore, MD, December 5-7.

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Sanford Chodosh, MD, (1928-2010) was a cofounder of PRIM&R and served as president of PRIM&R’s Board of Directors from 1979 to 2001.

Dr. Chodosh, a clinical investigator for more than 40 years, retired from the Boston University School of Medicine where he was an associate professor, and from the U.S. Department of Veterans Affairs (VA) Outpatient Clinic in Boston, Massachusetts, where he was chief of staff for 14 years. Dr. Chodosh served as the IRB chair at the Boston City Hospital from 1971 to 1984.

Through the time of his passing, he continued to be deeply involved with the protection of human subjects and animals in research, and in 2005, he received PRIM&R’s Founders’ Award in recognition of his extraordinary service to the organization.

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InConference Memoriam

Information

Harry Rozmiarek, DVM, PhD, a cherished member of the PRIM&R Board of Directors since 1990 and a longtime leader in the laboratory animal medicine world, passed away on June 15, 2013 at age 74.

Dr. Rozmiarek’s career began in the US Army where he held the position of attending veterinarian at Fort Myer in Virginia. There he led the public health preventive medicine inspection services for the Washington, DC area. Dr. Rozmiarek also had the privilege of serving as a consultant for laboratory animal medicine to the Surgeon General of the Army and as the veterinarian to a number of US presidents. He cared for President Lyndon B. Johnson’s dogs, Caroline Kennedy’s pony, “Macaroni,” and several deer that had been given to the Kennedy family by the President of Ireland, and was also responsible for the horses that pulled the caissons for President Harry S. Truman, General Douglas MacArthur, and President John F. Kennedy.

Upon his retirement from the Army in 1983, Dr. Rozmiarek had achieved the rank of Colonel, completed a master’s degree and residency in laboratory animal medicine, become Board certified in the field, earned his doctorate in immunology from The Ohio State University, and been elected national President of the American Association for Laboratory Animal Science (AALAS).

The remainder of his career was spent in academia.

At The Ohio State University, Dr. Rozmiarek was a professor of laboratory animal medicine and director of the Office of University Laboratory Animal Resources through 1987. Dr. Rozmiarek next joined the University of Pennsylvania as a professor of laboratory animal

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medicine, where he established and served as the first director of the university’s Laboratory Animal Resources program. During this time, Dr. Rozmiarek also served as the university veterinarian, associate director for laboratory animal welfare in the Office of Regulatory Affairs, and as director of postdoctoral residency training for veterinarians in laboratory animal medicine. He retired from the university in 2004, but continued to serve until his death as professor emeritus of laboratory animal medicine, visiting professor of laboratory animal medicine at the Ross University School of Veterinary Medicine, and laboratory animal facility director at the Fox Chase Cancer Center.

Upon learning of Dr. Rozmiarek’s passing, Alexander M. Capron, LLB, Chair of PRIM&R’s Board of Directors, said, “We will remember and celebrate his warmth, humor, and dedication to the welfare of humans and animals, and we will always be grateful for his wise counsel and unswerving support of PRIM&R.” Dr. Rozmiarek served as an active and valued member of PRIM&R’s executive, finance, and certification committees and as PRIM&R’s Board treasurer and secretary. He taught at PRIM&R’s annual Institutional Animal Care and Use Committee (IACUC) Conferences for many consecutive years, and was one of the founding members of the Council for Certified Professional IACUC Administrators (CCPIA).

In Memoriam

Dr. Pellegrino received a bachelor’s degree in chemistry from St. John’s University in New York and a medical degree from New York University in 1944 before serving in the US Air Force. He recalled that during his own medical school education, the concept of medical ethics was taught in about two hours. Dr. Pellegrino began teaching the subject in 1959 at the University of Kentucky. His concern with the fundamental doctorpatient relationship and commitment to remaining connected to the realities of medicine kept Dr. Pellegrino actively involved in seeing patients even as his academic duties became more consuming.

at the University of Kentucky; chancellor and vice president for the health sciences at the University of Tennessee; president of the Yale-New Haven Medical Center; president of The Catholic University of America; director of the National Endowment for Humanities (NEH)-sponsored Institute for Human Values in Medicine; and John Carroll Professor of Medicine and Medical Ethics at Georgetown University. Dr. Pellegrino authored or co-authored over 600 published items and 23 books in medical science, philosophy, and ethics, and was the founding editor of the Journal of Medicine and Philosophy.

Dr. Pellegrino held various high-level positions in academia, including: founding chairman and medical director at the Hunterdon Medical Center in Flemington, NJ; founding chairman of the department of medicine

Dr. Pellegrino’s contributions to the fields of medicine and bioethics have been invaluable, and his passing marks a profound loss.

Tora Kay Bikson, PhD, renowned advocate for ethics in social science research, died on February 1, 2013 at age 72. Dr. Bikson worked at RAND Corporation, a nonprofit institution that helps improve policy and decision-making through research and analysis, since 1974, and headed the human subjects protections committee there for over 25 years.

In a field where the focus of human subjects protections rests primarily on biomedical research, Dr. Bikson worked to highlight the unique ethical issues associated with protecting individuals who take part in social science and behavioral research. Dr. Bikson’s contributions to the field included participation on a 2003 panel organized by the National Research Council that issued a widely influential report with recommendations on strengthening human subjects protections in social science research.

Dr. Bikson received a PhD in philosophy from the University of Missouri (Columbia) and a PhD in psychology from the University of California, Los Angeles (UCLA). She lectured and taught at many universities during her career. Dr. Bikson had been a PRIM&R member since 2004 and served as a speaker and affinity group leader at PRIM&R’s past AER Conferences.

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Edmund Pellegrino, MD, MACP, a leading figure in the field of bioethics and a pioneer in teaching humanities in medical schools, died on June 13, 2013 at the age of 92. Both physician and philosopher, Dr. Pellegrino’s research interests covered a broad range of topics, including: clinical and laboratory studies in cardio-renal physiology and electrolyte metabolism; electrolyte metabolism in renal disease; and comparative biochemistry of calcified tissues. In the later part of his career, Dr. Pellegrino’s research interests were focused on moral philosophy and ethics of medicine.

Schedule: Wednesday, November 6 Recognition Conference Information PRIM&R’s pre-conference programs will be held on Wednesday, November 6, 2013. As registration for these programs is now closed, only those attendees who pre-registered are able to participate.

A continental breakfast will be served 7:00-8:30 AM in Ballroom A. Boxed lunches will be provided for all sessions, also in Ballroom A. Please review your program’s agenda, as lunch times differ for each course.

schedules

At the conclusion of the pre-conference programs, you will be sent an email containing a link to an online evaluation. Your feedback is essential to improving the quality and scope of our educational programming, and we would appreciate your completion of this survey.

Pre-Con I: Advanced Research Ethics 8:30 AM-4:30 PM Room 311 Faculty: Neal Dickert, MD, PhD; Emily Largent, RN; Amulya Mandava, BA; Joseph Millum, PhD; Seema Shah, JD; Alan Wertheimer, PhD Pre-Con II: Central IRB Models: Benefits, Challenges, and Role in Clinical Trial Networks 8:30 AM-4:30 PM Room 310 Faculty: Emily C. Fogler, Esq.; Elizabeth Hohmann, MD; Julie Kaneshiro, MA; P. Pearl O’Rourke, MD Pre-Con III: Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent 8:30 AM-4:30 PM Room 303 Faculty: Moira Keane, MA, CIP; Daniel K. Nelson, MSc, CIP Pre-Con IV: Contemporary Issues in Biobanking: Engagement, Governance, and Trust Co-sponsored by Genetic Alliance and the International Society for Biological and Environmental Repositories (ISBER) 8:30 AM-5:00 PM Room 302 Faculty: Susan Bankowski, MS, JD; Marianna J. Bledsoe, MA; Elizabeth Frank, EdM; William Grizzle, MD; Kristen B. Rosati, JD; Michele Russell-Einhorn, JD; Nicole Sieffert, BA, CCRC; Sharon Terry, MA; Wendy A. Wolf, PhD Pre-Con V: Ethical Issues in Global Research 8:30 AM-5:00 PM Room 300 Faculty: A. Cornelius Baker; Karen Hansen; Caroline Kithinji, BS, MS; Greg Koski, PhD, MD; Robert J. Levine, MD; Bebe Loff, PhD; Sana Loue, PhD, JD, MPH, MSSA; Susan M. Miller, MD, MPH; Joseph Millum, PhD; Rosemary Musesengwa, MPH, CRA; Jan Piasecki, PhD, MA; Carla Saenz, PhD; Steven Wakefield; Marcin Waligora, PhD p rim&r’ s 20 1 3 2 adv anci ng e ti thhi cal re se a rc h c on f e r e n c e

Pre-Con VI: Hot Topics for Institutional Officials 8:30 AM-4:30 PM Room 308 Faculty: Janet Donnelly, RAC, CIP; F. Lisa Murtha, Esq., CHC, CHRC; Ivor A. Pritchard, PhD; Rebecca Rousselle, CIP; Peter Vasilenko, PhD; David L. Wynes, PhD Pre-Con VII: IRB 101sm 8:30 AM-4:30 PM Room 309 Faculty: Elizabeth Bankert, MA; Dean R. Gallant; Bruce Gordon, MD; Ada Sue Selwitz, MA Pre-Con VIII: IRB 201: An In-Depth Analysis of the Criteria for Review 8:30 AM-4:30 PM Room 312 Faculty: Karen Hale, RPh, MPH, CIP; Susan Z. Kornetsky, MPH Pre-Con IX: IRB 202: Review and Application of the Regulatory Criteria for Approval 8:30 AM-4:45 PM Room 306 Faculty: Troy Brinkman, JD, MA, CIP; Jeffrey A. Cooper, MD, MMM; Jonathan M. Green, MD; Amanda Hammond, JD Pre-Con X: Regulatory, Ethical, and Technical Challenges in Internet Research 8:30 AM-5:00 PM Room 304 Faculty: Elizabeth Buchanan, PhD; Joseph A. Konstan, PhD; Laura Odwazny, JD, MA Pre-Con XI: Research Involving Children: Framing and Applying Additional Protections 8:30 AM-4:00 PM Room 313 Faculty: Robert W. Frenck, MD; Steven Joffe, MD, MPH; Robert “Skip” Nelson, MD, PhD Pre-Conference Programs Networking Reception 4:00-6:00 PM Boylston Hallway, 3rd floor All those registered to attend a pre-conference program are welcome to join us for a networking reception immediately following the conclusion of their program.

Light refreshments will be served.

Your Guide to the Conference Schedule The 2013 AER Conference features a wide variety of breakout sessions on a multitude of topics. To make the breakout sessions easier to navigate, they are organized into 25 thematic categories called “tracks.” We organize sessions into tracks to assist you in choosing the sessions that will help you gain the most from your conference experience.

Within the tracks, we offer three types of breakout sessions: workshops (interactive), didactic sessions (presentation-based), and double sessions (hybrid workshop/didactic sessions that are twice as long as the regular breakout sessions).

1. Double sessions are held over lunch and include a boxed meal (provided prior to the start of the session at the session room). Pre-registration was required to ensure meal availability and seating. If you preregistered for a double session and are unable to attend, please let a staff member at the Help Desk know so another person may attend in your place.

2. Please note that not every topic is a perfect fit for one of the 25 tracks. We request your indulgence if you come across an occasional round peg in a square hole.

3. The tracks are not meant to be exclusive, and any person is welcome to attend any session. For example, feel free to attend a session in the Legal Track even if you’re not a lawyer or a session in the IOs Track even if you’re not an IO. 4. Sessions that are marked as “basic” will provide an introduction to the topic for those who have little or no prior knowledge of it, or for those in need of a refresher on the fundamentals. Teaching styles will be largely didactic, and the focus will be on introducing, explaining, and illustrating basic concepts, principles, regulations, policies, or best practices relevant to the topic.

5. Sessions that are marked as “advanced” a) assume mastery of central ethical concepts and principles, of the regulations, and of the processes of applying them to the day-to-day work of protocol review or other research oversight activities, and b) aim to provide attendees with the in-depth knowledge of an area and robust set of skills required for addressing

Icon Key Indicates a didactic session (presentation-based) Indicates a workshop (interactive) Indicates session will be recorded for conference proceedings Qualifies for CME credit Qualifies for CIP® (CE) credit Pre-registration required. Please visit the Help Desk to inquire about registration.

Indicates a session chosen from our Call for Session Proposals Indicates a double session, which includes both lecture and discussion. Double sessions are held over lunch and will end at 1:45 PM on November 8. Pre-registration is required to attend and a lunch ticket will be included on your name badge. A boxed lunch will be served before the start of the session.

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schedules

We advise you to use the descriptors that follow the session titles to identify the sessions that are the most relevant to your needs and interests. As you consult these descriptions, please also note the following:

difficult problems, improving their HRPP, shaping their institutional cultures, or advancing their careers.

Sessions will make heavy use of active learning techniques, such as case studies and question-based lectures. Attendees are expected to have sufficient experience and understanding in order to actively contribute to discussion and the solution of difficult problems discussed. These sessions will not review basic concepts.

6. Sessions that do not have a learning level are intended for all audiences.

Your Guide to the Tracks Recognition Conference Information TRACKS A Dialogue with the Feds I and II

These tracks will provide attendees with an opportunity to hear from and ask questions of federal agency representatives.

Accreditation of HRPPs

This track will focus on strategies for achieving and maintaining accreditation. Topics to be covered include preparing for a site visit, collecting and analyzing metrics, draft site visit reports, achieving accreditation for smaller HRPPs, and dispelling rumors about the accreditation process.

4

Activities Along the Boundaries Between Research and Practice

This track will explore the definitional, ethical, and jurisdictional issues that arise in a range of health-related activities that are often said to occur along the imprecisely drawn borders of human subjects research. Each of these workshops will dig into questions specific to a particular activity while also highlighting issues that are common to a range of activities that PRIM&R is exploring in its ongoing “Boundaries of Research” Project.

5

Advanced Forum for IRB Professionals

This track will provide experienced IRB professionals with a series of sessions covering “hot button” issues and everyday aspects of their jobs.

6

Educating Research Teams

This track will provide those conducting clinical research studies—investigators, research nurses, research staff, CRO employees—with sessions addressing operational and regulatory challenges.

7

Ethical Issues

This track will explore the underlying ethical principles of human subjects research and issues for HRPPs/IRBs as they are translated from the theoretical to the human research setting.

8

FDA Regulations

This track will provide attendees with an opportunity to learn about and discuss with representatives from FDA regulations and guidance pertaining to FDA-regulated clinical investigations. This track will cover both basic and advanced topics.

9

Global Research

This track is designed for non-US-based research professionals and US-based professionals working outside North America. Sessions will examine issues relating to the conduct of ethical research across geographic and cultural borders.

10

Informed Consent

This track is designed to look at informed consent from various angles and examine how to optimize the form and the process.

11

Institutional Officials

This track will provide institutional officials (and others with oversight responsibilities) with an opportunity to discuss shared concerns, problems, strategies, best practices, and other useful innovations.

12

IRB Bootcamp

This track is designed for those new to the field of human subjects protections and IRB review and administration. As the name implies, IRB Bootcamp will provide a rigorous training in IRB basics, including five critical elements of IRB operations that are key to success in the human subjects protections and IRB fields.

13

IRB Operations and Toolkit

This track is designed to provide IRB professionals with practical tools and strategies to achieve administrative efficiency and effectiveness. This track will cover both basic and advanced topics.

1&2

3

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Descriptors

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TRACKS

Descriptors

Issues for Pharma/Biotech

15

Legal

This track will cover legal, legislative, and compliance issues. Methods for effective communication and collaboration among legal counsel, sponsors, HRPP professionals, and other stakeholders will also be discussed.

16

Out-of-Body Experiences: Research Involving Tissue and Data

This track will explore the complex evolving ethical and regulatory issues for the collection and banking of biological specimens for both clinical and genetic research.

17

Populations Requiring Additional Protections

This track will explore issues related to vulnerable populations, including: regulations; guidance; best practices; ethical principles; and community engagement. This track will include both basic and advanced sessions, and will redefine vulnerability by looking beyond populations recognized in the federal regulations.

18

Potpourri

This track includes a variety of sessions that are current, complex, or late breaking.

19

QA/QI and Post-Approval Monitoring

This track will address current topics and issues faced by QA/QI programs, post-IRB approval monitoring programs, or other institutional entities charged with activities such as: not-for-cause study reviews; follow-up after monitoring; review visits; reports; corrective action plans; and education.

20

Regulatory Balance

This track will explore potential models for streamlining IRB processes through an examination of existing regulatory flexibility, alternative review models, and best practices.

21

Research Involving the Internet and Social Networking

This track will explore the risks, benefits, and challenges of using the internet and social media as research tools.

22 & 23

SBER I and II

These tracks will cover issues related to the conduct and review of social, behavioral, and educational research (SBER).

24

Small Research Programs

This track will address the special challenges faced by small research programs at entities such as community hospitals, colleges, and research institutions. The sessions in this track recognize that the designation “small� is typically self-imposed, and may be given on one or more of the following bases: protocol workload, number of FTE IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.

25

Unaffiliated and Non-Scientist IRB Members

This track will introduce unaffiliated and non-scientist IRB members and staff to essential, basic scientific topics and foundational strategies for IRB review.

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14

This track will provide representatives from HRPPs and drug, device, and biotechnology industries with an opportunity to discuss topics of mutual interest, including: the role of pharmaceutical companies, biotechnology companies, and CROs in conducting research abroad; adaptive clinical trial design; unanticipated problems; adverse events; and more.

Schedule Recognition Conference Information Thursday, November 7 7:00 AM-6:00 PM

of Health Policy and Management, Harvard School of Public Health

Pre-Function C

Registration Open 7:00-8:00 AM

Exhibit Hall D

Continental Breakfast 7:00-8:00 AM

Continental Breakfast to Welcome First-Time Attendees

Ballroom A

All first-time conference attendees are welcome! Join us for this continental breakfast to connect with colleagues and hear from the PRIM&R staff.

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7:00-8:00 AM

Room 200

Affinity Group (AG) Networking Continental Breakfast

Book Signing with Author and Keynote Speaker Atul Gawande, MD, MPH

Pre-Function C

Join us at the onsite Bookstore in Pre-Function C for a book signing with author and keynote speaker Atul Gawande, MD, MPH. Copies of Dr. Gawande’s books are available in the onsite Bookstore.

8:00-8:30 AM

Veterans Auditorium

Welcome and Presentation of PRIM&R’s ARENA Legacy Award to Daniel K. Nelson, MSc, CIP

Director, Office of Human Research Ethics; Professor of Social Medicine and Adjunct Professor of Pediatrics, University of North Carolina at Chapel Hill

8:30-9:15 AM

Keynote Address: The Century of the System

Veterans Auditorium

Keynote Address: “Best Medical Care” vs. “Research” in an Era of Expanding Technologies: Blurred Lines and Best Intentions

George D. Demetri, MD Director, Ludwig Center at Dana-Farber/Harvard Cancer Center and Sarcoma Center; Senior Vice President for Experimental Therapeutics, Dana-Farber Cancer Institute; Professor of Medicine, Harvard Medical School

10:00-10:30 AM

Break

Exhibit Hall C

Join us in The Conference Connection for coffee.

10:30–11:45 AM

AG members are invited to join us for this continental breakfast where they can connect and network with their fellow group members. This lunch is SOLD OUT.

7:15-7:45 AM

9:15-10:00 AM

Veterans Auditorium

Atul Gawande, MD, MPH Director, Ariadne Labs; General and Endocrine Surgeon, Brigham and Women’s Hospital; Professor of Surgery, Harvard Medical School; Professor in the Department

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Didactic Sessions and Workshops Series A A1

A Dialogue with the OHRP (A Dialogue with the Feds I Track)

Room 304

Faculty: Kristina C. Borror, Julie Kaneshiro, Irene Stith-Coleman This session will be led by representatives from OHRP. Attendees are encouraged to come with questions of interest to all. In this session, attendees will: • Hear from OHRP representatives about evolving initiatives, issues, and guidance.

• Participate in an open discussion about topics relevant to OHRP stakeholders.

• Ask questions of OHRP representatives.

A2

A Dialogue with the National Science Foundation (NSF) (A Dialogue with the Feds II Track)

Room 308

Faculty: Kellina M. Craig-Henderson This session will be led by a representative from NSF. Attendees are encouraged to come with questions of interest to all. In this session, attendees will: • Hear from a NSF representative about evolving issues, initiatives, and guidance.

• Participate in an open discussion of topics relevant to NSF stakeholders.

• Ask questions of a NSF representative.

Thursday, November 7 A3

Building a Comprehensive HRPP: An Overview of the Accreditation Process and Standards (Accreditation of HRPPs Track)

Room 204 Basic

A4

Room 309

Public Health Studies: Surveillance or Research?

Models for Ethical Review (Activities Along the Boundaries Between Research and Practice Track)

Faculty: Nancy Ondrusek, Walter L. Straus, Hugh Tilson, Laura Youngblood In this session, faculty will: • Explore the nature of public health studies, specifically the distinction between (and overlap of) surveillance and research.

• Explore the different ethical and regulatory implications and challenges of public health surveillance and public health research.

• Discuss tools for streamlining ethics review and encouraging investigators to engage in ethical reflection during project planning.

• Consider issues and potential solutions for ethics review of research during public health emergencies.

Room 313

Introducing “Essential Elements of Ethics”: A Rigorous Method for Ensuring Key Ethical Issues Have Been Incorporated into Your Protocol (Advanced Forum for IRB Professionals Track)

Faculty: Susan Callery D’Amico, David G. Forster, Rebecca Li, Maeve Luthin In this session, faculty will: • Identify essential ethical elements that should be considered and addressed in each clinical protocol.

• Describe the launch of a new and innovative “Essential Elements of Ethics” tool developed by Multi-Regional Clinical Trials (MRCT) and PRIM&R to facilitate crafting a dedicated ethics section of a protocol.

• Explain the rationale and methodology by which these essential ethical elements were derived and the potential impact this tool will have to raise the bar on clinical trials, especially those involving the developing world.

• Discuss survey data from a pilot study looking at the essential elements in clinical protocols submitted to IRBs.

A6

Educational Theory and Practice for 21st Century Adult Learning (Educating Research Teams Track)

Room 206

Faculty: Joni K. Barnard, Francis DiMario This session will present current best practices for teaching 21st century adult learners. A combination of theory and applied examples will be presented. In this session, faculty will: • Discuss how to engage learners so that lessons and concepts presented are remembered and applied.

• Review the use of technology in making learning efficient and meaningful.

A7

How to Read the Empirical Ethics Literature (Ethical Issues Track)

Room 108

Faculty: Paul S. Appelbaum, Paul Christopher In this session, faculty and attendees will: • Discuss key aspects of research methods relevant to assessing empirical studies of ethical issues.

• Consider common logical fallacies in drawing conclusions from empirical data.

• Review and discuss an empirical study with a critical eye.

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Faculty: Wesley Byerly, Sujatha Sridhar, Elyse Summers This session will focus on building the infrastructure of a comprehensive HRPP through accreditation. In this session, faculty will: • Provide an overview of the accreditation standards related to the organization, the IRB or Ethics Committee, the researcher, and the research staff.

• Discuss the accreditation process and how to prepare for a site visit.

• Review how to develop effective HRPP programs and provide institutional guidance in this area to researchers.

• Outline how to meet the AAHRPP standards (Element I.4.B. and I.4.C.), including evaluating community outreach activities.

A5

Schedule Recognition Conference Information A8

Nontraditional Access to Investigational Drugs and Devices (FDA Regulations Track)

Room 202 Basic

Faculty: Owen Faris, Richard Klein In this session, faculty will: •R eview the FDA requirements related to nontraditional uses of FDA-regulated test articles.

•D iscuss the similarities and differences in the expanded access provisions for investigational drugs, biologics, and medical devices.

•P rovide an overview of the roles of the patient, doctor, sponsor, FDA, and the IRB.

schedules

A9

It Takes a Village: Models for Community Consultation in International Research (Global Research Track)

Room 110

Faculty: Steven Wakefield In this session, faculty will: •R eview models for community engagement in international settings.

•D iscuss mechanisms for interaction between community advisory groups and ethics review committees, including training on research ethics for community members.

•O utline considerations for population-based research when a target group is not represented on the IRB or ethics review committee through the use of HIV case studies.

A10

Informed Consent: Elevating the Process and Improving the Form (Informed Consent Track)

Room 200

Faculty: Laura M. Beskow, Mina Busch, Elizabeth Senft In this session, faculty and attendees will: •E xplore background issues such as: What is the state of health literacy? What works best for patients and subjects? What does research literature on informed consent tell us?

•D iscuss general strategies to adjust for reading level, translation, and overall readability.

•R eview recommendations for the development and formatting of easy-to-read and easy-to-comprehend informed consent forms.

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A11

The “Sunshine” Act Regulations: Implications for Research and Human Subjects Protections (Institutional Officials Track)

Room 102 Advanced

Faculty: F. Lisa Murtha, Robyn S. Shapiro In this session, faculty will: • Outline the final Physician Payment Sunshine Act regulations.

• Discuss the implications of the Sunshine Act (a core part of the 2010 Patient Protection and Affordable Care Act [PPACA]) on research.

• Identify strategies for research sites to assure compliance with the PPACA requirements.

A12

Essential Documentation: IRB Membership, Recordkeeping, Meeting Minutes, and More (IRB Bootcamp Track)

Room 310 Basic

Faculty: Julia Gorey, Patrick McNeilly, Ada Sue Selwitz In this session, faculty and attendees will: • Outline the basic federal requirements for IRB documents.

• Discuss federal requirements for maintenance of accurate, complete, and timely IRB records.

• Identify the components of a complete record of IRB meeting activities as reported in IRB meeting minutes.

A13

Practical Tools for Dealing with Conflict: Helping IRB Staff Communicate More Effectively with Investigators (IRB Operations and Toolkit Track)

Room 203

Faculty: Helen Panageas, Suzanne M. Rivera This interactive session will use studies, concrete examples, and role-playing exercises. In this session, faculty and attendees will: • Review techniques for delivering information (good or bad) to investigators in clear, concise, and tactful ways.

• Discuss strategies for using email more effectively to transmit IRB findings and stipulations.

• Explore the skills needed to diffuse frustration and resolve conflicts in a professional manner.

Thursday, November 7 A14

Room 107

Faculty: Albert J. Allen, Barry Mangum In this session, faculty will: • Discuss the changing regulatory landscape as it pertains to conducting research abroad.

• Address challenges in designing and conducting studies across different regions of the world.

• Address if and how capacity-building needs across different continents have changed over the past five years.

With the explosion of new technology and the need for high quality specimens for research, there is an increased level of interest in obtaining “front door” consent for the future use of specimens during the course of routine care. In this session, faculty will: • Discuss when front-door mechanisms are feasible and what makes this approach to consent work.

• Address the ethical and regulatory responsibilities of an institution and its researchers.

• Review the challenges and benefits of an institutionwide biospecimen banking initiative and explore a practical approach to evaluating barriers, risks, and benefits in implementing “front door” consent.

• Discuss research subject perspectives, as expressed by a patient advocate.

A15

A17

Emerging Issues for Pharmaceutical/Biotechnology Companies and Contract Research Organizations in Research Conducted Abroad (Issues for Pharma/Biotech Track)

Room 306 Basic

Faculty: Emily C. Fogler, Kate Gallin Heffernan, Christina Heide As of September 2013, HIPAA-covered entities must be compliant with the Omnibus Final Rule. The final regulations contain a number of changes affecting clinical research activities. In this session, faculty will: • Review the 2013 changes to the HIPAA regulations affecting human subjects research, including changes to the compound authorization rules and the ability to use protected health information (PHI) for future research, as well as the sale of PHI, the definition of breach, and other definitional changes.

• Discuss practical implementation issues and strategies for compliance.

• Offer the opportunity to hear the Office for Civil Rights’ perspective on the research-related changes.

A16

Room 312

“Front Door” Consent: Making it Work (Out of Body Experiences: Research Involving Tissue and Data Track) Faculty: Marianna J. Bledsoe, Liz Frank, Michele Russell-Einhorn, Nicole Sieffert

Pediatric Medical Countermeasure (MCM) Research: Enumerating Ethical Considerations to Aid with Policy Decisions (Populations Requiring Additional Protections Track)

Room 109 Advanced

Faculty: Michelle Groman, Lisa M. Lee, Jeremy M. Sugarman DHHS Secretary Kathleen Sebelius asked the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) to enumerate the ethical considerations of conducting pediatric clinical trials of MCMs, which are interventions to protect children in the event of a bioterrorism attack.

The Bioethics Commission recently released its report, Safeguarding Children: Pediatric Medical Countermeasure Research, in response to the Secretary’s request. In this session, staff of the Bioethics Commission will: • Outline the four ethical principles that form the ethical foundation of its deliberations—respect for persons, beneficence, justice, and democratic deliberation.

• Review its recommendations concerning trials conducted before an event occurs (pre-event), which involve a hypothetical condition with an unknown likelihood of occurring, and explain the Bioethics Commission’s conclusion that in pre-event MCM research with no prospect of direct benefit, children

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Taking the Ominous Out of the Omnibus Rule: Implications of the Final Health Insurance Portability and Accountability Act (HIPAA) Changes for Research (Legal Track)

Schedule Recognition Conference Information generally should not be exposed to research risks that are greater than those they would encounter in everyday life or routine medical examinations.

• Examine how the ethical considerations change if MCM research is conducted after the occurrence of an attack (post-event), when children could tangibly benefit from the knowledge resulting from such research, and review its recommendations concerning post-event studies.

• Describe how the Bioethics Commission offers a unique perspective on how advisory bodies can aid with difficult policy decisions such as the decision whether to conduct pediatric anthrax vaccine adsorbed trials.

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A18

Streamlining IRB Review for Multi-Site Research: Results of a Randomized, Controlled Trial of Central Versus Local IRB Review (Potpourri Track)

Room 311 Advanced

Faculty: Daniel K. Nelson Oversight of multicenter clinical trials is complicated by the traditional approach of redundant review of identical protocols by multiple local IRBs. There have been calls for streamlining this process, and some academic institutions are relying on a central IRB for these scenarios. However, this model has its own drawbacks, and there are few data to guide decisions. In this session, faculty will: •R eview the challenges presented by current system(s) for oversight of multicenter trials, and possible solutions.

•D escribe a novel pilot project that employed a randomized, controlled, blinded study design to test reliance on any central IRB already involved with a multicenter trial, provided certain criteria were met. resent results from this pilot project, including data •P on efficiency and effectiveness of IRB processes, and summarize conclusions that can be applied more broadly.

A19

Room 301

Nuts and Bolts of Setting up a QA/QI Program (QA/QI and Post-Approval Monitoring Track)

Faculty: Kelly Dornin-Koss, Sarah White In this session, faculty will: • Address the points to consider when developing a QA/QI program.

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• Review basic auditing concepts.

• Discuss details involved in audits/onsite reviews including determining a sample size, advantages of standard observations, and follow up after the audit/ onsite review.

• Compare and contrast how two established QA/QI programs work (audience participation and ideas encouraged).

A20

Finding Flexibility in the Federal Regulations: Basic Considerations and Applications (Regulatory Balance Track)

Room 101 Basic

Faculty: Lois Brako, Cindy Shindledecker In this session, faculty and attendees will: • Review the multiple opportunities to find flexibility in the regulations.

• Explore the pros and cons of “unchecking the box.”

• Discuss the basic ways to use regulatory flexibility throughout the HRPP.

A21

Room 302

Research Data Security: Protecting Human Subjects’ Identifiable Data in the University Setting (Research Involving the Internet & Social Networking Track)

Basic

Faculty: Adrienne Tanner, Leon Wong Subjects volunteer to participate in research with the understanding that the researcher(s) will protect their identity and other personal information from inadvertent or inappropriate disclosure. The principle that the IRB upholds in assessing the benefits and risks of the research is expressed in The Belmont Report as “beneficence.” Issues surrounding data security, privacy, and confidentiality have become more complex since the advent of computers and the internet, with the Cloud becoming common data storage space, and with more investigators utilizing software and networks. Thus, it is not clear whether users always understand the risks. In this session, faculty will: • Address data security issues (with a special focus on data stored and transmitted electronically) concerning both social and behavioral and biomedical human subjects research.

• Review different methods and levels of data storage, including the appropriateness of these methods given the risks involved.

• Discuss ways to educate an institution’s research community about data security.

Thursday, November 7 A22

The What, Why, When, and How of Informed Consent (SBER I – Basic Track)

Room 104 Basic

A23

Aligning IRB Review with Community Cultural Ethics and Standards (SBER II – Advanced Track)

Room 103 Advanced

Faculty: Edward Bartlett, David A. Borasky In this session, faculty will: • Review the human research regulations in various countries.

• Explore responses to culturally sensitive concerns including those that arise regarding study design, study procedures and risk assessment, and community-engaged partnerships and accountability.

• Examine the individual participation decisions of those with non-proxy status such as cultural leaders, e.g., a Samoan elder.

• Outline the US regulatory requirements for waivers of assent and consent and associated documentation.

• Discuss risk assessment factors including investigator skills and experience, study sites, security, etc.

Developing an HRPP at an Institution with a Small Social and Behavioral Research Portfolio (Small Research Programs Track)

Room 303 Basic

Faculty: Shannon Harr, Patricia MacCubbin This session will focus on the challenges of developing an effective HRPP at an institution with a small social and behavioral research program, and may be especially appropriate for attendees from small colleges or other institutions conducting primarily non-biomedical research. The interactive format will help attendees explore structural and operational aspects common in small HRPPs and identify solutions that work effectively in this environment. In this session, faculty and attendees will: • Discuss what makes small HRPPs unique.

• Outline how to establish an effective HRPP in an institution with a small research program.

• Identify strategies for engaging senior leadership, investigators, IRB members, and those who work in other components of the HRPP. • Review suggested action priority lists and time lines.

• Identify effective institutional change agents, offices, mechanisms, etc.

A25

The Roles and Responsibilities of the Unaffiliated and Non-Scientist Member of the IRB (Unaffiliated and Non-Scientist IRB Members Track)

Room 111 Basic

Faculty: Dahron Johnson, Susan L. Rose As key members of the IRB, unaffiliated/non-scientist members join with the other IRB members to shape the culture and conduct of research within their institutions.

In this session, faculty will: • Examine the ethical and regulatory responsibilities of the unaffiliated/non-scientist member.

• Discuss recent academic articles about the perceptions of the role of the unaffiliated/nonscientist member.

• Review research on and guidance for the unaffiliated/non-scientist member.

• Provide an overview of the responsibilities and challenges of lay review in a variety of IRB scenarios.

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Faculty: Michelle Feige, Suzanne Stone In this session, faculty will: • Explore the concept of informed consent and the ethical principles that underlie it.

• Review when informed consent is mandatory, when it can be altered or waived, and how to implement an alteration or a waiver of documentation of consent.

• Examine the challenging issues of “passive consent,” minor assent, and short forms.

• Examine barriers to providing ethically valid consent arising from study subjects, researchers, and IRB members.

• Discuss best practices and innovations for providing a dynamic consent process for subjects who have diminished decisional or other cognitive capacities.

• Evaluate complex case studies to determine ways to improve the informed consent process.

A24

Schedule Recognition Conference Information A26

Room 305

schedules

Bioethics Funding at the National Institutes of Health (NIH)

Faculty: Liza Dawson, Samual Garner, Valery M. Gordon, Ann Hardy, Joseph Millum, Holly A. Taylor Presenters of this session will include NIH program officers responsible for bioethics grants, and time will be allocated for questions and answers about the grant funding process. In this session, faculty and attendees will: • Review the NIH’s record of funding for bioethics research.

• Explore currently available NIH bioethics funding opportunities.

• Review the application process for NIH grants.

• Discuss what types of empirical or conceptual bioethics projects are most informative for the human research oversight community, and what bioethics research topics and questions are of most interest and importance in the field.

12:00-1:00 PM

Exhibit Hall D

Common Ground Networking Lunch

Time to connect… over lunch! Meet peers for conversation and networking. The tables will be divided by institution type: University/College (Medical), University/College (Non-Medical), Hospital/Medical Center, Government Agency, Pharma/Biotech Company, and Small Research Programs. We will also have tables available for those wishing to “just lunch.”

12:00-1:00 PM

Ballroom A

Research Ethics Book Group Lunch: The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects

Participate with your peers in a vibrant discussion of The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects by Roberto Abadie. Copies of Dr. Abadie’s book are available at the onsite Bookstore.

12:00-1:45 PM

Exhibit Hall C

Meet and Greet the Conference Supporters, Exhibitors, and Poster Presenters

Network with this year’s conference Supporters, Exhibitors, and Poster Presenters in The Conference Connection during or after lunch.

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2:00-3:15 PM

Veterans Auditorium

Panel I: When Research Offends: Ethics, IRB Review, and the Risk of Stigma

Moderator: David H. Strauss Panelists: Walter Bockting, Carl Hart, Susan Brown Trinidad Are there scientific questions, which by their very nature risk offending subject populations and therefore should not be asked? What are the obligations of the IRB around protecting groups of subjects from stigma or burden resulting from research findings and their application? This panel will examine research and the role of research oversight in relation to stigma and stereotype with a focus on race, ethnicity, and sexuality.

2:00-3:15 PM

Innovations A: Innovations in Research on Controversial Topics

Ballroom C

Moderator:Steven Joffe Panelists: Hila Berger, Lindsay McNair, Holly A. Taylor, Dorothy E. Vawter The Belmont Report outlines three basic ethical principles as particularly relevant to research with human subjects: respect for persons, beneficence, and justice. In the most straightforward settings, balancing these principles requires careful consideration. When research is conducted on controversial topics or in sensitive settings about which there may be limited literature, deliberations about how to balance ethical principles can be particularly complex. This panel will highlight the ethical and practical challenges of conducting controversial research using four examples: protocols using sex offenders as subjects, surgical innovation and research, placebo and lesion controlled surgical trials, and research conducted in disaster settings.

2:00-3:15 PM

Innovations B: Innovations in Genomics and Biobanking

Ballroom B

Moderator: Paul S. Appelbaum Panelists: Francesca Gould, Erin Luetkemeier, Jennifer Shaw Research involving the use of biospecimens is becoming more prevalent, yet many questions about best practices remain. For instance, what are the implications of the possibility of genomic findings when the biospecimens are those of children? How is pharmacogenomics research perceived in communities where past research has cultivated and perpetuated

Thursday, November 7 harm? What best practices exist for biorepositories and how might an accreditation program improve the quality of biorepositories? Using these questions as a framework, this panel will share examples and make suggestions for how the panelists’ experiences and knowledge can inform the practice of attendees.

2:00-3:15 PM

Innovations C: Innovations in Influences on Research Participation

Room 302

2:00-3:15 PM

Innovations D: Innovations in Communication with Research Subjects

Room 312

Moderator: Cynthia A. Gómez Panelists: Leah R. Eisenberg, A. Robert Schleipman, Sharon Zack Clear communication with subjects regarding all aspects of their participation in research is a necessary condition for performing ethical research. Considerable efforts are undertaken by research teams and IRBs to ensure subjects are fully informed of the relevant details of their participation, including risks, benefits, privacy, confidentiality, and more. Yet many questions remain about how best to communicate with research subjects.

For example, what do subjects want to know about radiation risks? How can we ensure youth subjects understand what they are assenting to? Can complex information such as that contained in the HIPAA Notice of Privacy Practices be communicated effectively in

3:15-3:45 PM

Break

Exhibit Hall C

Join us in The Conference Connection for coffee.

3:15-3:45 PM

Book Signing with Author and Panelist Carl Hart, PhD

Pre-Function C

Join us at the onsite Bookstore in Pre-Function C after Panel I for a book signing with panelist and author Carl Hart, PhD. Copies of Professor Hart’s book, High Price: A Neuroscientist’s Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society, are available in the onsite Bookstore.

3:45-5:15 PM

Panel II: Internet Research: Is it Different? Is it “Special”? Points to Ponder for Social and Behavioral Investigators, IRBs, and Subjects

Ballroom B

Moderator: Laura Odwazny Panelists: Jeffrey M. Cohen, Joseph A. Konstan, B.R. Simon Rosser The internet is a research tool of enormous potential in the social and behavioral sciences. Yet many IRBs and investigators worry about the conduct of internet research, risks to subjects (known or unknown), and whether some research is appropriate—or even possible—using the internet. During this session, panelists will present specific examples of internet research, including surveys, data harvesting, experimental research, and ethnographic research, and will explore strategies for understanding and addressing ethical and technical concerns regarding such research.

Other IRB review considerations will also be discussed.

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Moderator: Jeffrey R. Botkin Panelists: Mary Cataletto, Karen Leggett Dugosh, Rosemary Musesengwa The public is often presented with mixed messages regarding research participation. Contrary findings across clinical trials and conflicts of interest among investigators performing pharmaceutical studies cast a negative light on the research enterprise for some, while others remain committed to participating in and lobbying for more clinical research. What ultimately tips the scales and convinces members of the public that they should or should not participate in research? What is the role of voluntariness in the decision-making process?

How are the benefits of research perceived? Can the demographics of the researcher affect participation, and how? The panelists will address these and related questions using their own research findings.

comic form? This panel will address these questions while also highlighting how attendees might apply the presented methodologies at their own institution.

Schedule Recognition Conference Information 3:45-5:30 PM

Veterans Auditorium

schedules

Panel III: The Increasingly Blurry Distinction Between Medical Research and Practice: Implications for Ethical Oversight

Moderator: Robert J. Levine Panelists: Thomas L. Beauchamp, Alexander M. Capron, Ruth R. Faden, Nancy E. Kass, (Please note that in order to provide our slate of speakers adequate time to cover this complex topic, this panel will run from 3:45 to 5:30 PM) In a special supplement to The Hastings Center Report titled “Ethical Oversight of Learning Healthcare Systems,” a team from The Johns Hopkins University argues that the traditional distinction between research and treatment, and the human subjects protections framework that rests on and reinforces it, are no longer tenable within the larger category of activities that the Institute of Medicine calls “learning healthcare systems.” Furthermore, they argue, we need a new ethical framework for overseeing the sorts of activities conducted within those systems. Some are seeing these proposed changes as a radical paradigm shift in thinking about human subjects research. PRIM&R has recently addressed similar issues, at a more practical level, through its project on the Boundaries Between Research and Practice. In this session, representatives from both projects will discuss the following questions: What are the salient features of a healthcare learning system, and how does it blend the roles of researcher/ health care provider and patient/research subject?

Which activities should continue to be reviewed by IRBs, which might better be referred to alternative committees for ethical review, and which do not require ethical review beyond the regular mechanisms provided by professional organizations? Should participation in some of these activities be considered obligatory and carried out without informed consent? And, what are the implications for the definition of “research”?

3:45-5:15 PM

Panel IV: Applying the Belmont Principles Across Borders and Cultures

Moderator: Eric M. Meslin Panelists: Clement Adebamowo, Sara Lavinia Brair, Sana Loue, Masayuki Yoshida This panel will feature speakers from diverse global settings who will discuss how the Belmont principles are understood and applied in those settings and contexts, and contrast them with traditional Western interpretations and applications of the principles. Topics to be highlighted include the role of gender, religion, and class in understanding the principles; the practical realities of interpreting and making relevant ethical concepts such as autonomy, beneficence, and justice in non-Western settings; and the challenges of putting the principles into practice in diverse contexts (e.g., the informed consent process). The panel will also include a discussion of the role of local research ethics committees as the standard-bearers for ethical research, as well as their capacity for implementing effective research review.

5:15-7:00 PM

Exhibit Hall C

2013 AER Conference Welcome Reception

Join us in The Conference Connection to celebrate the opening of the 2013 AER Conference, toast the kick-off of PRIM&R’s 40th year, and extend your best wishes to Joan Rachlin, PRIM&R’s longtime executive director, who will be retiring in early 2014. You’ll also be able to meet our Conference Supporters and Exhibitors, view the Poster Presentations, and receive a complimentary mini-massage. Light refreshments will be served.

7:00 PM

WIRB-Copernicus Group Evening Reception

Republic Ballroom, Sheraton Hotel

The WIRB-Copernicus Group is pleased to host their signature celebration at PRIM&R’s 2013 AER Conference. All PRIM&R attendees are invited to join the WIRB-Copernicus Group for an evening of cocktails, light supper, and entertainment at the Sheraton Boston Hotel, located just steps from the Hynes Convention Center. More information about the WIRB-Copernicus Group, a 2013 AER Conference Platinum Supporter, can be found on page 17 of this guide.

Friday, November 8

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Ballroom C

Friday, November 8 Friday, November 8 7:00 AM-5:30 PM

Registration Open

Pre-Function C

7:00-8:00 AM

Exhibit Hall D

7:00-8:00 AM

Ballroom A

Continental Breakfast CIP® Continental Breakfast

Interested in earning your CIP credential? Want to connect with other CIPs? Attend this continental breakfast to learn more about the credential, meet representatives of the Council for Certification of IRB Professionals, network with fellow CIPs, and ask questions of those already certified.

8:00-9:30 AM

Veterans Auditorium

Moderator: Jeremy M. Sugarman Panelists: Leonard Glantz, Robert D. Truog In March 2013, OHRP issued a compliance oversight determination letter about the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) conducted at 22 sites with 1,300 subjects.

Because, even after years of research and practice, clinicians did not know how much oxygen to provide to extremely low birth weight infants to minimize retinopathy of prematurity without increasing impaired brain development or death, the SUPPORT study randomized extremely low birth weight infants to lower or higher levels of oxygen saturation, all within the range of oxygenation provided by clinicians as standard care at the institutions at which the research was conducted.

The consent documents for the study did not include information about the risks of retinopathy of prematurity, impaired brain development, or death posed by receiving either low or high oxygen saturation levels. On this basis, OHRP found that consent was deficient and violated the regulatory requirements. More generally, pragmatic clinical trials comparing interventions already in use in clinical care are proliferating in the effort to find more effective and less expensive therapies. OHRP’s view of such research when it involves randomization to “standard of care” interventions, as evidenced by the determinations made regarding the SUPPORT

8:00-9:30 AM

Panel VI: The Ethics of Research Without Consent

Ballroom B

Moderator: Alan Wertheimer Panelists: Neal Dickert, Patricia A. Marshall, Franklin G. Miller The purpose of this panel is to examine whether and when it is justifiable to engage in research with human subjects without their valid consent. Although the “Common Rule” specifically allows for the waiver of informed consent when certain criteria are met, there is no standard account of whether and when it is morally justifiable to engage in research without seeking consent, or with deceived consent, for instance, in the context of observational research, emergency research, and “mystery shopping” studies. Panelists will discuss each of these examples. The central questions to be addressed are: Does the “Common Rule” get it basically right and, if so, why? Does it exempt too much? Does it exempt too little? And, what is properly exempted under these criteria?

8:00-9:30 AM

Ballroom C

Panel VII: Data Sharing on Steroids: Demands for Transparency of Subject-Level Research Data

Moderator: Mark Barnes Panelists: Elizabeth Hohmann, Justin McCarthy, Sharon F. Terry There is increasing demand for transparency in clinical research. The expansion of clinical trial registries means more public access to both research studies open to participation and to reporting of aggregate research results from protocols. The demand for transparency of research data has now expanded to include access to individual-level raw data. Perhaps the most publicized

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Panel V: A Moderated Debate – Doctor Knows Best? Risk and Consent When Research Involves “Standard of Care” Interventions

study, may not be shared widely within the research community. The months of heated controversy that followed OHRP’s original determination and subsequent letter suspending all compliance actions against the SUPPORT sites reveal a lack of consensus within the research community around many of the ethical issues underlying the conduct of research randomizing subjects to two or more “standard of care” interventions. This session will use a moderated debate format to explore these contentious issues, including how IRBs should assess this type of clinical trial design, how the risks of the “standard of care” interventions should be evaluated if subjects would be receiving these “standard of care” interventions as treatment outside of the research, and whether informed consent is ethically necessary.

Schedule Recognition Conference Information example of this push is a recent initiative from the European Medicines Agency. Some pharmaceutical/ biotechnology industry sponsors have also started their own transparency initiatives that involve sharing of data.

The primary goals of these initiatives include not only review and monitoring of completed research, but the possibility of secondary use of the data collected. While the current focus of discussion about “big data” sharing is on industry-sponsored research, it is important to consider the potential expansion of scope to include all research. The panel will begin with an overview of several concrete initiatives and proposals under development. Representatives from a patient advocacy group, the pharma/biotech industry, and an institutional oversight body will then discuss the potential benefits as well as concerns of such transparency.

schedules

9:30-9:45 AM

Break

Please note the Welcome and Membership Update will be given in both Ballroom B and the Veterans Auditorium, as we have two concurrent Keynote Addresses immediately following these announcements.

9:45-10:15 AM

Ballroom B

10:15-11:00 AM

Ballroom B

Welcome and Membership Update Keynote Address: Social Science Research and the Fight Against Poverty

Esther Duflo, PhD Abdul Latif Jameel Professor of Poverty Alleviation and Development Economics, Massachusetts Institute of Technology; Director, Abdul Latif Jameel Poverty Action Lab

9:45-10:15 AM

Veterans Auditorium

10:15-11:00 AM

Veterans Auditorium

Welcome and Membership Update

Keynote Address: Therapeutic Misconception in Clinical Research: A 30-Year Retrospective

Paul S. Appelbaum, MD Dollard Professor of Psychiatry, Medicine, and Law; Director, Division of Law, Ethics, and Psychiatry; and Director, Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics, Department of Psychiatry, Columbia University College of Physicians and Surgeons

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11:00-11:15 AM

Break

Exhibit Hall C

Join us in The Conference Connection for coffee.

11:15 AM-12:30 PM

Didactic Sessions and Workshops Series B B1

A Dialogue with the Department of Defense (DOD): Updates for DOD-Funded Researchers (A Dialogue with the Feds I Track)

Room 109

Faculty: Laura Ruse Brosch, Jessica Candia, L. Andrew Jones This session will be led by a representative from the DOD, and is for researchers who have or are seeking extramural DOD funding. Attendees are encouraged to come with questions of interest to all. In this session, attendees will: • Hear from DOD staff about policies affecting the conduct of DOD-funded research.

• Ask questions about current issues and initiatives.

• Participate in an open discussion about DOD-related topics relevant to the research community.

B2

A Dialogue with the Presidential Commission for the Study of Bioethical Issues (A Dialogue with the Feds II Track)

Room 104

Faculty: Michelle Groman, Lisa M. Lee This session will be led by representatives from the Bioethics Commission. Attendees are encouraged to come with questions of interest to all. In this session, faculty and attendees will: • Review the Bioethics Commission’s latest work.

• Discuss topics relevant to Bioethics Commission stakeholders, such as the federal research protections regulations that informed the Bioethics Commission’s recent recommendations on pediatric MCM research; the Human Subjects Research Landscape Project – Analysis Dataset posted for public use on bioethics.gov, and Bioethics Commission educational materials.

• Participate in a question and answer session with Bioethics Commission staff.

Friday, November 8 B3

Improving Relationships Between Researchers and the IRB (Accreditation of HRPPs Track)

Room 311

Faculty: John Baumann, Eifaang Li, Elyse Summers This session will focus on how to achieve effective communication between researchers and IRB members.

In this session, faculty will: • Share ideas on the pre-submission advising of researchers (the example of an initiative started at Cedars-Sinai will be used).

• Discuss transparent and clear policies and standards, enhanced communication techniques, and improving efficiency.

• Highlight innovative research from Indiana University concerning proven relationshipstrengthening strategies.

Room 304

Cutting Edge Science in the Operating Room: Ethical Advanced Issues in Surgical Innovation and Research (Activities Along the Boundaries Between Research and Practice Track)

Faculty: Lindsay McNair, Sean Philpott Clinical research in operating rooms shares many ethical concerns with other types of biomedical research. However, additional ethical considerations arise in studies involving invasive surgical interventions.

This session will review current definitions, policies, and practices with respect to surgical innovation and research, including recent recommendations from the Society of University Surgeons on the establishment and role of institutional Surgical Innovation Committees.

In this session, faculty and attendees will: • Define surgical practice, innovation, and research as described in the current literature.

• Discuss particular challenges around study design and assessment of surgical research studies, including the innovation versus research distinction and deviation from standard of care, informed consent, randomization to receive invasive and often irreversible surgical procedures, use of control groups (including sham surgery), and the feasibility of post-trial access to interventions that demonstrate benefit.

B5

Room 312

Key Decision Points: Is it Human Subjects Research? Is it Exempt?

Advanced Is IRB Review Required?

(Advanced Forum for IRB Professionals Track)

Faculty: Karen Hale, Daniel K. Nelson This session will provide attendees with an opportunity to: • Review when an activity is considered “research” and when that activity involves “human subjects,” as defined in the DHHS and FDA regulations.

• Examine the federally mandated exemption categories and the differences between the DHHS and FDA regulations with regard to exempt research.

• Use case studies to explore in depth the nuances around these crucial decisions and the impact of personal and institutional attitudes on such determinations.

B6

Room 204

The Making of a Successful Research Team: Essential Components of an Educational Program (Educating Research Teams Track)

Faculty: Donna Buckley, Mina Busch In this session, faculty and attendees will: • Discuss activities for facilitating educational programs for researchers, including mentoring of research students by faculty.

• Compare elements of a structured educational program for researchers.

• Identify job aids and tools that provide value to researchers.

• Review what “current” means in clinical research training.

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B4

• Examine existing and proposed methods of ethical oversight for surgical innovation and research.

• Explore issues in clinical study design and conduct that may have unique ethical implications in surgical research compared to other types of biomedical research.

Schedule Recognition Conference Information B7

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Assessing the Prospect of Direct Benefit in Pediatric Studies and Component Analysis (Ethical Issues Track)

Room 102 Advanced

Faculty: Susan Z. Kornetsky, Robert “Skip” Nelson In this session, faculty and attendees will: • Examine the process for reviewing research interventions that offer the prospect of direct benefit to a pediatric population.

• Discuss the application of component analysis in the IRB’s review of pediatric studies.

• Outline the expectations for documenting the prospect of direct benefit and use of component analysis during the review of pediatric studies.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B8

An Overview of FDA’s Investigational New Drug (IND) Regulations: Understanding the Sponsor’s Responsibilities (FDA Regulations Track)

Room 203 Basic

Faculty: Diane M. Maloney, Walter L. Straus In this session, faculty will: • Examine the federal regulations for INDs (21 CFR 312).

• Review sponsor and investigator responsibilities for IND studies.

• Present IND issues unique to the FDA’s Center for Biologics Evaluation and Research (CBER).

B9

New Policies for Clinical Trials in India: Promises and Pitfalls (Global Research Track)

Room 308

Faculty: Mark Barnes, Justin McCarthy, Jeremy M. Sugarman India has become an international hub for clinical research.

Earlier this year, as part of an effort to address ethical concerns about some of this research, India introduced the Drug and Cosmetics (First Amendment) Rules 2013. The new policy, which is aimed at protecting human subjects in research, is generating much discussion both within India and worldwide. In this session, faculty will: • Review the research context and climate in India that led to the creation of the new policy.

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• Outline the new policy’s central features, including the provision of compensation for research injuries and the required registration of ethics review committees.

• Examine the implications of the new policy, including the unintended consequences of potentially reducing valuable research activities and capacity in India.

• Discuss international responses and implications for clinical research conducted in other global settings.

B10

Informed Consent: To Waive or Not to Waive (Informed Consent Track)

Room 306 Advanced

Faculty: Elizabeth Bankert, Marinna Banks-Shields, Jeffrey A. Cooper In this session, faculty and attendees will: •D iscuss the appropriate use of waivers for obtaining informed consent. eview the regulatory applicability of waivers.

•R •E xplore a variety of cases in which a waiver would add more protections and help facilitate research.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B11

Operationalizing the PHS Financial Conflict of Interest (FCOI) Rule (Institutional Officials Track)

Room 108 Advanced

Faculty: Wayne Patterson, Robyn S. Shapiro In this session, faculty will: •P rovide a brief summary of the major changes to the regulation including those regarding the definition of significant financial interests; disclosure thresholds; making information accessible to the public; and investigator training. iscuss ways in which universities and hospitals •D have implemented the PHS FCOI rule.

• Address difficulties that institutions have experienced when implementing the new requirements.

Friday, November 8 B12

The Basics and Beyond: Research with Prisoners, Pregnant Women and Fetuses, and Children (IRB Bootcamp Track)

Room 310

Faculty: Paul Christopher, Julia Gorey, Josiah D. Rich In this session, faculty will: • Review the DHHS regulations governing research with prisoners, children, pregnant women, fetuses, i.e., 45 CFR 46 subparts B, C, and D. • Outline best practices for research with these populations and discuss other relevant guidance.

• Discuss challenges and ethical considerations for research involving prisoners.

B13

Room 107 Advanced

Faculty: Melissa Abraham, Elizabeth Hohmann In this session, faculty will: • Review common problems with protocols submitted for IRB review.

• Share strategies for working with difficult investigators.

• Explore best practices for managing the challenges and stressors that come with being an IRB chair.

B14

An Update on the Clinical Trials Transformation Initiative (CTTI) Central IRB Project (Issues for Pharma/Biotech Track)

Room 111

Faculty: Sara Calvert, Cynthia Hahn The CTTI Use of Central IRBs for Multicenter Clinical Trials project published results and recommendations in January 2013. Implementation of these recommendations may increase the quality and efficiency of clinical trials. In this session, faculty will: • Review the results and recommendations of the CTTI Use of Central IRBs for Multicenter Clinical Trials project.

• Describe the purpose and utility of the Considerations Document, a CTTI developed guide to support communication and contractual relationships between institutions and a central IRB. • Share case examples of the successful adoption of the recommendations and use of the Considerations Document.

Room 202

“State” it Like it Is: The Impact of State Laws on Informed Consent and Other Aspects of Research (Legal Track)

Faculty: Valerie Gutmann Koch, Susie A. Han, Laura Odwazny – OHRP Resource Person State laws can complicate the requirements imposed on researchers and institutions in many ways. While specific state laws may be utilized as examples and case studies, the focus of this session will be on the categories of state laws that IRBs and investigators often have to consider when engaged in certain types of research. In this session, faculty will: • Explore state law issues that should be analyzed in connection with any federal Common Rule and FDA requirements, including requirements that impact the content of informed consent, research on fetuses and fetal remains, the use of decedents’ information and tissue in research, the scope of insurance coverage for research-related services, and more.

• Review the interaction between overlapping state and federal requirements, for example: Certificate of Confidentiality requirements versus state law public health reporting requirements.

• Discuss the challenges of conducting multijurisdictional research across varying state requirements, such as: how to define who is a “child” under state law for purposes of consent/ assent; when electronic signatures may be used in the consent process; issues raised by the increase of social media and internet research; and issues around what constitutes the “practice of medicine” in multi-jurisdictional clinical research.

B16

Room 302

Beyond the Genome: Data Security and Privacy Advanced Concerns Surrounding Genomic Research (Out of Body Experiences: Research Involving Tissue and Data Track) Faculty: Stacey Donnelly, Laura Lyman Rodriguez, Julie Kaneshiro – OHRP Resource Person Increasing amounts of detailed genomic data often linked with healthcare and other information are being released in both research and non-research settings.

Access to more data by more diverse entities for more varied purposes will inevitably increase the risks to

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Protocol Rage and Meeting Fatigue: Therapeutic Options for IRB Chairs (IRB Operations and Toolkit Track)

B15

Schedule Recognition Conference Information data-subjects, even though the chances of identifying the subjects may be minimal. Should it be the research community’s responsibility to protect the identifiability, privacy, and confidentiality of genomic data? What is the best way to ensure this protection? In this session, faculty and attendees will: • Review genomic research and describe genomic risk.

• Outline the implications of the Common Rule and the HIPAA Privacy Rule for genomic data security.

• Examine issues surrounding informed consent.

• Describe matching, linking, and profiling for identifying individuals from genotype data.

• Share best approaches to protecting subjects’ identities.

schedules

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B17

Redefining Vulnerability: People with Disabilities and Beyond (Populations Requiring Additional Protections Track)

Room 206 Basic

Faculty: Jeremy Block, Susan Delano, Michelle Feige – OHRP Resource Person In this session, faculty will: • Discuss an expanded view of vulnerability beyond that outlined in the human subjects protections regulations, reframing vulnerability in the context of laws, policies, and processes in other fields.

• Provide examples of different types of vulnerabilities, such as homelessness and disability, and explore how to think about these examples in the context of clinical research.

• Review the threshold questions an IRB should address before permitting research with these subjects.

• Discuss examples of risks to subjects that may be different in nature or frequency for these subjects.

B18

New Tactics in Recruiting and Retaining Unaffiliated or NonScientist IRB Members (Potpourri Track)

Room 305

Faculty: Charlotte Coley, Elmer Freeman

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In this session, faculty will: • Examine different techniques for identifying and recruiting unaffiliated and/or non-scientist IRB members from the local community.

• Review how to integrate unaffiliated and/or nonscientist IRB members onto the board and retain them once they are recruited.

• Consider ways to pay, thank, and reward unaffiliated and/or non-scientist IRB members in ways that keep them interested in continued membership.

B19

Room 313

Making Your QA/QI Program Work for You (QA/QI and Post-Approval Monitoring Track)

Faculty: Leslie Howes, Delia Wolf In this session, faculty will: • Provide an overview of the elements needed to develop and customize a QA/QI program that fits your institution’s needs and available resources.

• Describe a wide range of QA/QI activities and services specific to different types of research, from social and behavioral to biomedical/clinical, and from domestic to international.

• Discuss how to identify, establish, and evaluate benchmarks to assess the quality of your HRPP. • Describe strategies for developing effective education and training opportunities for your investigators.

• Share and discuss QA/QI sample documents, including onsite review/audit checklists, QA/QI report templates, and various study management tools.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B20

Finding and Applying Flexibility in the Federal Regulations: Cooperative Review Agreements and Other Advanced Considerations (Regulatory Balance Track)

Room 309 Advanced

Faculty: Irene Stith-Coleman, Laura Youngblood, Tracy Ziolek This advanced session will explore various procedures that incorporate flexibilities within the regulations while providing equivalent protections to research subjects. In this session, faculty and attendees will:

Friday, November 8 • Review the flexibilities in Subpart B, including the definition of “pregnancy” as an important decision point in assessing Subpart applicability.

• Consider the flexibilities in Subpart C, including the circumstances under which a subject is a “prisoner,” and a prisoner is a “subject.” Use of a DHHS Secretarial Waiver for inclusion of prisoners in epidemiology will also be discussed.

• Examine the flexibilities in Subpart D, including the regulatory definition of a “child,“ and issues around assent, parental permission, and documentation of assent/permission.

• Discuss best practices for forming and utilizing cooperative review agreements with partner institutions, even on a small scale, using the existing University of Pennsylvania/The Children’s Hospital of Philadelphia agreement as a case study.

Room 103

Informed Consent Realities and Possibilities in Internet Research (Research Involving the Internet & Social Networking Track)

Faculty: Elizabeth Buchanan, Donna Spruijt-Metz This session will focus on the elements of consent and internet research, with a review of the different types of internet research. In this session, faculty and attendees will: • Identify specific internet research settings and conditions for consent.

• Examine how to apply the Common Rule regulatory requirements for informed consent to internet research and review regulatory flexibilities applicable to consent in such research.

• Consider parental consent and child assent in internet research involving minors.

• Discuss the applicability of informed consent waivers and/or waivers of documentation.

• Share sample language for informed consent documents for internet research that emphasizes data security and confidentiality of research-related information.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

Speed it Up: Exempt… Expedite… Relax!

(SBER I – Basic Track)

Room 101 Basic

Faculty: Jeffrey M. Cohen, Dean Gallant, Samantha Smith – OHRP Resource Person In this session, faculty and attendees will: • Discuss the procedural review process for social, behavioral, and educational research through a sequence of questions including: Is this activity research? Does it involve human subjects? Is my institution engaged? Is the research exempt? And may review be expedited?

• Use test scenarios to explore each of the aforementioned questions.

• Identify regulatory flexibilities that can be used while still assuring research is conducted ethically.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B23

Scientific Merit, Generalizability, and the Risks Associated with Qualitative Research Methodologies (QRM) (SBER I – Advanced Track)

Room 301 Advanced

Faculty: Ellen Marakowitz, Julie Simpson, Karen Szala-Meneok In this session, faculty will: • Explain and illustrate QRM. • Explore the IRB review process for assessing scientific merit and risk minimization in QRM studies.

• Engage the audience in a discussion of how to assess scientific merit and risk minimization in QRM studies.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

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B21

B22

Schedule Recognition Conference Information B24

schedules

Outsourcing IRB Review While Maintaining a Robust HRPP at an Institution with a Small Research Program (Small Research Programs Track)

Room 303 Basic

Faculty: Felix A. Khin-Maung-Gyi, Scott Lipkin This session will describe how an institution with a small research program can maintain an effective HRPP while outsourcing IRB review, and it will be appropriate for individuals from institutions that selfidentify as having a small research program according to any of the criteria laid out in the track descriptor.

During the session, faculty will: • Explore the considerations associated with outsourcing IRB review to a central or single partner IRB. • Review the delineation of responsibilities, accountabilities, and liabilities between the institution and the independent IRB when protocol review is outsourced.

• Discuss how to measure and maintain an effective HRPP when protocol review is outsourced.

B25

Statistics Without Tears (Unaffiliated and Non-Scientist IRB Members Track)

Room 110

Faculty: Susan S. Fish, Janice Weinberg This session will explain the intimidating statistical terms that make your eyes glaze over! To begin, attendees will review the statistical basics and then, half-way through, the group will split so those who need more study of the basics can obtain that information, while others ready for the next level can move on to more advanced topics.

In this session, faculty and attendees will: • Review the basic concepts of testing.

• Discuss different ways to be right and wrong, e.g., type 1 and type 2 errors.

• Review the concept of “power,” the types of statistical tests, and when to bring in a statistician.

• Explore the relationship between statistics and ethics.

• Apply statistical vocabulary.

Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

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B26

Room 300

Organ Donor Management Research: Building Consensus in the Donation and Transplantation Community

Faculty: Alexandra K. Glazier, Kate Gallin Heffernan This session will focus on the challenging issues raised by research on deceased organ donors (i.e., interventions on donors who have been declared brain dead and who are on artificial ventilation prior to recovery of organs for transplantation), and research on organs ex vivo (i.e., interventions on organs after they have been recovered from the donor, such as putting an organ on an oxygen perfusion device prior to transplantation). In this session, faculty and attendees will: • Discuss why this research is critical to improving recipients’ outcomes and to advancing the field of transplantation.

• Review the complex legal, ethical, and logistical challenges for this research, including: (i) Who is a human subject in these projects? (ii) When is IRB oversight warranted? (iii) Which IRB should review the project (the donor hospital and/or the recipient hospital)? (iv) What type of consent is appropriate and from whom? (v) How does the existing organ allocation process interfere with identifying the recipient/human subject (and even the recipient site) in advance?

• Examine the movement toward consensus around these issues at a recent conference sponsored jointly by the Health Resources and Services Administration and the Organ Donation & Transplantation Alliance.

12:45-1:45 PM

Exhibit Hall D

12:45-1:45 PM

Room 210

Lunch

Affinity Group (AG) Networking Lunch

Join your AG facilitators and fellow members during lunch to connect and network. All attendees registered for an AG are welcome, and the lunch room will be divided by group.

12:45-1:45 PM

Luncheon with Keynote Speaker Paul S. Appelbaum, MD

Ballroom A

This event will provide attendees the opportunity to talk with and ask questions of this distinguished and provocative researcher in an intimate and informal environment.

Friday, November 8 2:00-3:15 PM

Panels VIII and IX, and Didactic/ Workshops Series C 2:00-3:15 PM

Veterans Auditorium

Panel VIII: Taking Control: Ethical Challenges for ParticipantCentered and Participant-Led Research

Panel IX: Nearly Unavoidable: Cluster Randomized Trials in Social and Behavioral Research

Ballroom C

Moderator: Dean R. Gallant Panelists: John Y. Baker, Robert F. Boruch, Rachel Glennerster Social and behavioral research studies sometimes involve interventions designed to influence behavior and are delivered at a group, institutional, or community level. Individuals who are the objects of the interventions may be unaware of their participation in research. Even when they are aware, it may be difficult or impossible for them to avoid those interventions. In addition, individual consent is often impracticable. The decision to field such trials is often made at a political level through negotiations between investigators and gatekeepers controlling the means to deliver the interventions to the targeted populations.

Community consultation of some kind may or may not occur. Depending on the source of funding and the type of intervention, the trial may or may not require IRB review and, consequently, may or may not need to satisfy such criteria as minimizing risks, equitable selection of subjects, or justifiable waiver of informed consent. Panelists will discuss different types of research “clusters,” including issues such as whether these features of cluster randomized trials are inevitable, given their design, and whether and when those features are problematic from a human research protections perspective.

C1

A Dialogue with the FDA (A Dialogue with the Feds I Track)

Room 311

Faculty: Owen Faris, Joanne Less, Diane M. Maloney, Catherine Parker This session will be led by representatives from the FDA. Attendees are encouraged to come with questions of interest to all. In this workshop, attendees will: • Hear from representatives of the FDA about new and evolving issues, initiatives, regulations, and guidance.

• Participate in an open discussion about topics relevant to FDA stakeholders.

• Ask questions about evolving issues at the FDA, including warning letters.

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Moderator: Susan Z. Kornetsky Panelists: Greg Biggers, P. Pearl O’Rourke, Sharon F. Terry Social media and digital technologies have facilitated the formation of online communities engaged in establishing and conducting health research projects.

In these scenarios, participants become the driving force behind the initiation and sometimes conduct of research projects such as self-surveillance, analyses of genomic data, genome-wide association studies (GWAS), data collection, formal studies, and even “citizen science.” This form of research therefore represents a bottom-up approach, often by lay individuals, as opposed to a top-down approach, led by traditional scientists. Potential benefits of such research may include more representative and broader participation of the public, outcomes-focused research, enhancement of personal autonomy and empowerment of the research community, transparency and openness about research, accelerated research, and lack of profit-seeking and career-enhancing motives for conducting research. While this research approach may be innovative and valuable, it raises many logistical, regulatory, and ethical questions from the perspective of human subjects protections. This panel will address some of those questions, including: What are the requirements for ethical oversight? Are the “principal investigators” and the “research participants” one and the same, or is a continuum possible? Are “research sponsors” indistinguishable from “research participants?” Can standard processes around “informed consent” bear the weight of these new interactions? For example, do the Terms of Agreement used on a social networking site suffice as informed consent, is one-time static consent sufficient, or should consent be responsive to context and changing lifespan values? Are the norms and mechanisms for regulating standard biomedical research applicable to participantled research? And, to what extent is IRB review suitable for participant-centered research?

2:00-3:15 PM

Schedule Recognition Conference Information C2

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Applying the Definition of Children and State Law to Biomedical and Social-Behavioral Research

Room 206 Advanced

Faculty: Laura Odwazny, Peter Vasilenko The federal regulations related to the definition of children defers to state and local laws as to who qualifies as a child; however, who is legally considered a child varies from state to state, and state law definitions of who may be considered a child or an emancipated minor are complicated. Thus, determining whether subjects are children and whether the additional protections of Subpart D apply, is problematic for IRBs reviewing multisite studies. This session will highlight the challenges of applying the various definitions of ‘children’ to biomedical and social-behavioral research and provide a strategy for investigators and IRBs seeking to address these issues. In this session, faculty and attendees will use case studies to: •R eview the federal regulatory definition of children and discuss how OHRP interprets the various components of that definition.

•E xamine how the federal definition of children operates in relation to state law.

•D iscuss an analytic framework investigators and IRBs can use to work through these issues.

C3

Using Metrics for Quality Improvement of HRPPs (Accreditation of HRPPs Track)

Room 111

Faculty: David G. Forster, Jeremy Corsmo In this session, faculty will: •R eview the AAHRPP-collected metrics for 2012.

•O utline how to collect performance metrics in both large and small HRPPs. •D iscuss how to use performance metrics to drive quality improvement.

•E xplore specific information on measuring and maintaining high quality, efficient HRPPs using the metrics collected by AAHRPP.

C4

Room 312

QA/QI/Program Evaluation: Is it or is it Not “Research”?

Advanced (Activities Along the Boundaries Between Research and Practice Track) Faculty: George Gasparis, Sean Philpott

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In this session, faculty will: • Use case studies to highlight distinctions between QA/QI, program evaluation, and research.

• Address how to determine whether an activity is human subjects research, and discuss generalizability.

• Discuss the issues raised by an investigator’s involvement in another institution’s QA/QI research, including whether, in such cases, the home institution is engaged in research.

C5

Room 306

Future Trends in the Relationship Between Central/Independent IRBs and Research Institutions: Risk/Benefit Ratio (Advanced Forum for IRB Professionals Track)

Faculty: Barry B. Bercu, Ernest D. Prentice Innovation and progress in pharmaceutical drug development is stifled by redundancy, inefficiency, and rising and exorbitant costs. Despite several recent documents by DHHS, FDA, and NIH suggesting central IRB review is logical, appropriate, and efficient, there is still resistance by many academic institutions.

Why is this? And, what can be done to keep the US IRB infrastructure competitive in this global marketplace? In this session, faculty and attendees will: • Discuss the genesis of nonprofit and for-profit independent IRBs, as well as the events that led to the first academic health science center using a commercial IRB. • Contrast the characteristics, complexities, and subtleties of an academic health science center IRB with those of a commercial IRB. • Identify the advantages and disadvantages of an academic health science center using a commercial IRB for its protocol review.

• Review the Advance Notice of Proposed Rulemaking (ANPRM) recommendations on the use of one IRB for multicenter clinical trials.

C6

The CIP® Credential: What’s it About?

(Educating Research Teams Track)

Room 109

Faculty: Jaime Arango, Gregorio Lim, Kelley O’Donoghue During this session, attendees and faculty will: • Discuss the CIP credential and the steps involved in pursuing it.

• Review eligibility and recertification requirements.

• Outline the types of questions on the CIP exam.

• Share exam preparation strategies.

Friday, November 8 C7

Room 204

Looking Beyond Responsible Conduct of Research: Ethical Research from Design to Data Collection to Dissemination of Results (Ethical Issues Track)

C8

Room 203

Emergency Research and Exception from Informed Consent (EFIC): Interesting Challenges and Lessons Learned About Community Consultation from a Multicenter Network (FDA Regulation Track)

Faculty: Michelle Biros, Neal Dickert, Sara F. Goldkind, Deneil Harney In this session, faculty and attendees will: • Discuss a combination of interesting experiences and lessons learned through the first two EFIC trials conducted through Neurological Emergencies Treatment Trials (NETT), a multicenter network of 17 hub sites funded to conduct clinical trials of interventions to address neurological emergencies.

• Review data collected on investigator and study coordinator perspectives of community consultation.

• Discuss network-wide data regarding community consultation, subjects’ perspectives on EFIC research and NETT studies, and network-wide experiences using different methods of community consultation.

C9

Telling it Like it Is: Challenges in Informed Consent in International Settings (Global Research Track)

Faculty: David A. Borasky, Caroline Kithinji

Room 313

C10

Regulatory Requirements and Ethical Considerations Regarding Pediatric Assent in Research (Informed Consent Track)

Room 108 Basic

Faculty: Lisa Buchanan, Robert W. Frenck, Steven Joffe In this session, faculty will: • Review the regulatory requirements for child assent and waivers of assent.

• Discuss developmental issues, with an emphasis on determining when a child acquires the capacity to provide assent and consent.

• Explore ethical issues, including how to proceed when there is a disagreement between children and their parents or legal guardians about research participation.

C11

Identifying, Reducing, and Managing Institutional Conflicts of Interest (Institutional Officials Track)

Room 104 Basic

Faculty: Mark Barnes, Jennifer Kulynych In this session, faculty will: • Discuss how to create and maintain an organizational culture that understands, acknowledges, and addresses potential institutional conflicts of interest.

• Review how to handle institutional conflicts of interest, including those that arise when institutional officials don’t follow HRPP/IRB policies.

C12

Writing Stellar Standard Operating Procedures (SOPs) (IRB Bootcamp Track)

Room 305 Basic

Faculty: Karen Hale, Elyse Summers In this session, faculty and attendees will: • Discuss the components of comprehensive and effective HRPP/IRB SOPs. • Understand the resources, input, and/or approvals needed to develop specific SOPs.

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Faculty: Philip M. Alberti In this session, faculty will: • Describe how a clinical trial conducted entirely in accordance with Responsible Conduct of Research guidelines for review, approval, and oversight might still fall short of ethical responsibilities in the broader social contract of research.

• Discuss how the conduct of research fits along a continuum from concept and funding through the dissemination of results, and what other entities bear responsibility for ensuring the results of research reach those populations that could benefit most.

• Review the ethical implications of health disparities.

In this session, faculty will: • Review the international standards for informed consent and documentation of consent.

• Describe challenges around obtaining meaningful informed consent, such as varying degrees of literacy, translation issues, and differences in cultural norms.

• Review measures taken to adapt the Western informed consent model to international settings.

Schedule Recognition Conference Information C13

Evaluating and Improving IRB Operations (IRB Operations and Toolkit Track)

Room 304 Basic

schedules

Faculty: Melissa Epstein, Cheryl Savini In this session, faculty and attendees will: • Review techniques such as evaluating the “life” of a protocol, identifying bottlenecks and inefficiencies, conducting desk audits, analyzing IRB metrics, evaluating staff morale and workload, evaluating resources, and obtaining feedback from investigators.

• Discuss ways to improve operations and streamline processes, including using a computer-based record keeping system, maximizing staff efficiency, using flexibility in the regulations, and adopting written SOPs. •B ring and share solutions that have worked at their respective institutions.

C14

Flexible Adaptive Clinical Trial Designs: Understanding Such Designs, and Implications for Informed Consent and IRB Review (Issues for Pharma/Biotech Track)

Room 107

Faculty: Scott Berry, William J. Meurer In this session, faculty will: •P rovide a general overview of the why, when, and how of adaptive clinical trial designs.

•P resent a case study of an actual trial for discussion of the clinical, logistical, and ethical issues.

•D iscuss some of the challenges of preparing an informed consent form for, and conducting IRB review of, an adaptive clinical trial protocol.

C15

“Research Free or Die”: Legal Protections Against Challenges to Academic Freedom in Research (Legal Track)

Room 103 Advanced

Faculty: Anne Hardy, Julia Hesse, Ellen Marakowitz The recent litigation concerning whether researchers from Boston College must release tapes to Great Britain from an oral history research project related to murders allegedly committed by the Irish Republican Army has brought to light the legal challenges that can be associated with researchers’ academic freedom. In addition, the Office of Science and Technology Policy

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(OSTP) recently issued a proposed policy about how to approach so called “dual use research of concern”— research with legitimate scientific aims that might arguably be co-opted and used for harmful ends if results are made public. In this session, faculty will: • Define best practices for structuring institutional policies and research agreements to defend against similar challenges.

• Outline the intricacies of the OSTP proposed policy and its implications for the review and conduct of dual use research in the United States.

• Discuss the scope of legal protection and privilege afforded to researchers under Certificates of Confidentiality (CoC) and considerations around when it would be prudent to obtain a CoC.

C16

Room 302

The Impact of the NIH’s Draft Genomic Data Sharing (GDS) Policy on the IRB’s Role in Reviewing Genetic Research (Out of Body Experiences: Research Involving Tissue and Data Track)

Faculty: Dina N. Paltoo, Laura Lyman Rodriguez Rapid advances in DNA sequencing and other highthroughput technologies have increased the volume, complexity, and types of data generated in genomic studies. To ensure the full value of genomic data in light of this growth, the NIH has drafted the GDS Policy, which updates and expands on the 2007 NIH Policy for Sharing of Data Obtained in NIH-Supported or NIH-Conducted GWAS. The draft NIH GDS Policy is founded on the principle of maximizing public benefit by facilitating broad data sharing to advance the understanding of public health needs, while ensuring the responsible oversight of genomic data sharing. In this session, faculty will: • Review the scope of the draft NIH GDS Policy and how it differs from current NIH Policy for Sharing of Data Obtained in NIH-Supported or NIH-Conducted GWAS. • Discuss the NIH public consultation process for obtaining public comment and testimony on the draft NIH GDS Policy.

• Review a summary of the comments received and their impact on revising the draft Policy and potential data management strategies.

• Outline the expected processes and procedures for data submission and access to NIH genomic data repositories when the NIH GDS Policy is implemented.

Friday, November 8 C17

Research Involving Native American Populations (Populations Requiring Additional Protections Track)

Room 308 Advanced

C18

Room 310

Forming Medical and Non-Medical Data Repositories: Review and Oversight Responsibilities for the IRB (Potpourri Track)

Faculty: Julie Kaneshiro, Andrew Rusczek In this session, faculty will identify key regulatory issues (including issues related to confidentiality and privacy) involved in building medical and non-medical data repositories for research purposes. During this session, faculty will: • Review when the collection of institutional evaluative data becomes research.

• Address how the IRB decides whether the collection of new types of data constitutes “research” as defined by the federal regulations, and how these activities compare with quality assurance projects in medical settings.

• Discuss how the IRB reviews data repositories formed by ongoing, prospective non-research for research purposes.

• Outline the issues that arise when merging data from different sources into a data repository.

C19

Room 101

An IRB-Based Clinical Research Quality Assurance Advanced (QA) Program (QA/QI and Post-Approval Monitoring Track)

Faculty: Rebecca Dahl, Pramod M. Lad Despite the acknowledged importance of QA in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been adequately addressed. In addition, although QA is expected in programs that accredit IRBs, very little is known about the role of the IRB in programs of clinical research QA. In this session, faculty will: • Review the definition of clinical research QA and the types of programs designed to achieve it.

• Identify key elements of a QA program, including education at the site level (with both mandatory and voluntary components), and an auditing and monitoring program, which reinforces education on QA. • Analyze audits related to patient safety, patient rights, regulatory compliance, and data quality and integrity, including audits of the informed consent process.

• Discuss corrective measures for noncompliance.

• Explore the pros and cons of an IRB-based QA program.

C20

You’ll Know it When You See it: Defining “Human Subjects Research” Under the DHHS Regulations (Regulatory Balance Track)

Room 102

Faculty: Christina Booth, Cheri Pettey, Samantha Smith – OHRP Resource Person Evaluating whether an investigator is engaging in research involving human subjects has many important ramifications for both the institution and the investigator in terms of cost, time, and requirements for the activity.

Since interpretation of key definitions in the regulations – including “systematic,” “generalizable,” “engaged,” and “human subject” – can be tricky, thorough consideration is needed to ensure appropriate application of the

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Faculty: William Freeman, Scarlett Hopkins, Cynthia Pearson In this session, faculty will: • Review the unique training challenges for the responsible conduct of community-engaged research in general and in Native American (including American Indian/Alaskan Native) communities in particular.

• Identify elements of and strategies for developing and maintaining long-term and trusting relationships with rural and Native American communities.

• Discuss the importance of establishing an ongoing dialogue and fostering cultural sensitivity in research with Native American populations.

• Explore methods for adapting the CITI Program modules to the needs of ethnic minorities.

• Examine the case of the Center for Alaska Native Health Research, a community-based participatory research center aimed at understanding risk and protective factors for obesity and related chronic disease in native Alaskans living in Southwest Alaska.

• Define what confidentiality and privacy protections should be required by the IRB. • Review what the IRB should consider in determining whether consent must be obtained.

Schedule Recognition Conference Information regulations. In this advanced session, faculty will use case examples to: • Outline a process and set of criteria for determining whether an activity is research involving human subjects according to the federal regulations.

• Explore key decision points for determining that one is “engaged” in a research activity, and the impact of institutional determinations on other institutions/ investigators involved in the project.

• Discuss when evaluation of data or specimens involves human subjects, with attention to what constitutes “identifiable” data without the use of a non-disclosure agreement.

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C21

Room 309

Ethical Challenges for Evaluating Research Using Internet-Based Social Media (Research Involving the Internet & Social Networking Track)

Faculty: Brenda Curtis, Celia B. Fisher The expanding use of social media in human subjects research is posing major challenges for IRBs. Participants will discuss specific case examples of social media research recruitment for HIV risk behaviors and drug use research. In this session, faculty and attendees will: • Review the most recent forms of internet-based research recruitment utilizing Google, Facebook, and other popular social media sites.

• Discuss how social media websites are currently used for recruitment for legally and socially sensitive research, and identify the specific challenges this presents for privacy and confidentiality, informed consent, and validity of data collection.

• Explore current guidelines and strategies for protecting privacy and confidentiality, providing adequate consent information, and validating the nature of data collected.

• Use case studies to explore how to develop IRB decisional strategies for reviewing legally and socially sensitive research that utilizes social media for recruitment.

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C22

What You Need to Know about Privacy and Confidentiality (SBER I – Basic Track)

Room 110 Basic

Faculty: Joseph A. Konstan, Lauren B. Solberg In this session, faculty will: • Discuss the question of public versus private behavior, including what counts as a reasonable expectation of privacy.

• Review identifiable versus anonymous participation and data.

• Address the tension between the public recognition of research participation and de-identification of results to ensure that subjects are not individually identifiable.

• Examine the adequacy of confidentiality protections and procedures designed to avoid or minimize privacy invasion.

C23

Ethical Issues with Introductory Psychology Subject Pools (SBER II – Advanced Track)

Room 202 Advanced

Faculty: Robert Hendersen, Sangeeta Panicker In this session, faculty will: • Address risk of harm to regular and at-risk college students from emotional upset, distress, anxiety, etc. in research on personal behaviors (self-harm, sex, drug use, etc.), thoughts about one’s own death, partner violence, etc.

• Review the respective roles and qualifications of undergraduate research assistants and principal investigators.

• Discuss the risk of informational harm (privacy, confidentiality, data security) in research involving sensitive, personally identifiable information.

• Examine the value of participation in studies for teaching research ethics to undergraduate students.

• Outline how to avoid conflict of interest when the researcher is the instructor.

• Explore alternatives to participating in subject pools.

• Discuss research participation as service learning.

• Review waivers of consent for minors.

Friday, November 8 C24

Room 301

Managing the HRPP in an Institution with a Small Research Portfolio (Small Research Programs Track)

Basic

C25

Let’s Review a Protocol!

Regulatory Considerations in the Approval Process (Unaffiliated and Non-Scientist IRB Members Track)

Room 303 Basic

Faculty: Kristina C. Borror, Dario Kuzmanovic, Matthew Stafford In this session, faculty and attendees will: •R eview the regulatory criteria for approval.

•D iscuss fundamental strategies and tools used to facilitate protocol review.

•S ystematically review sample protocols and participate in the decision-making process that leads to approval or request for revisions.

3:15-5:15 PM

Networking Reception in The Conference Connection

Exhibit Hall C

Meet and greet the Supporters and Exhibitors and view this year’s Poster Presentations. Light refreshments will be served.

Speed Mentoring

Exhibit Hall C

Gather with your colleagues for a one-on-one networking event where you can connect with HRPP professionals, the Feds, ethicists, and other experts to receive answers to your regulatory, ethical, and/or operational questions. Light refreshments will be served.

5:30-7:00 PM

Ballroom C

The Drama of DNA: An Interactive Play Exploring the Ethical, Legal, and Psychosocial Implications of Genomic Research and Medicine with Children

Moderators: Lynn Bush and Karen H. Rothenberger Actors: Mark Barnes, Barbara E. Bierer, Jeffrey R. Botkin, Ruth L. Fischbach, Christine Grady, Elisa A. Hurley, Steven Joffe, Nancy E. Kass, Susan Z. Kornetsky, Laura Lyman Rodriguez, Robert “Skip” Nelson, P. Pearl O’Rourke This interactive session weaves together audience participation with an original, four-act genomics play that illuminates ethical, psychological, social, legal, and policy concerns surrounding the attaining and sharing of the massive amounts of information generated by next-generation sequencing, particularly when used with “unaffected” children and pregnant women.

The fictional vignettes that make up each act evolve from an IRB meeting through the informed consent process to a clinical ethics consultation and then to the disclosure of incidental findings. Between each act, the audience and bioethicist actor-panelists will engage in lively discussion around a focused, ethically oriented question. Following the play, the actor/panelists will join the moderators to explore with attendees the complex implications of genomic information, delving further into controversial research ethics issues brought to life in the play including how much and what should be reported to whom, and under what circumstances.

8:00-10:00 PM

Young Professionals (YPs) Networking Reception

Champions Sports Bar Boston Marriott Copley Place Hotel

Calling all YPs! Connect with other YPs interested in research ethics, talk about current issues and experiences in the field, and relax after a busy day in Boston at this fun, after-hours reception.

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Faculty: Shannon Harr, Lori Roesch This session will focus on addressing the HRPP management challenges that are unique to institutions with small research programs, and is appropriate for individuals from institutions that self-identify as having a small research program according to any of the criteria laid out in the track descriptor. During this session, faculty and attendees will: •O utline effective HRPP management strategies in institutions with small research programs.

•D iscuss effective ways to provide investigator, IRB member, and community education.

•E xamine inter-institutional agreements and qualityimprovement activities. iscuss the value of developing meta-activities such •D as program assessments and HRPP metrics.

•E xplore processes for managing conflicts of interest, noncompliance, post-approval monitoring, and unanticipated problems.

3:30-4:45 PM

Schedule Recognition Conference Information Saturday, November 9 7:00 AM-12:00 PM

Registration Opens

Pre-Function C

7:00-8:00 AM

Exhibit Hall D

7:00-8:00 AM

Ballroom A

Continental Breakfast What’s New at the CITI Program?

Continental Breakfast

Staff members from the CITI Program at the University of Miami will demonstrate new features that will help participants get the most from their use of the CITI Program, including site navigation, refresher modules, and non-English language capabilities.

schedules

8:00-8:30 AM

Veterans Auditorium

Welcome and Presentation of PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics to Joan Rachlin, JD, MPH, Executive Director, PRIM&R

Presented by Alexander M. Capron, Chair, PRIM&R Board of Directors

8:30-9:15 AM

Veterans Auditorium

Keynote Address: PRIM&R and the Field of Research Ethics: Passages, Linkages, and Villages

Joan Rachlin, JD, MPH Executive Director, PRIM&R

9:15-9:30 AM

Break

9:30-10:45 AM

Didactic Sessions and Workshops Series D D1

A Dialogue with the NIH (A Dialogue with the Feds I Track)

Room 309

Faculty: Valery M. Gordon, Christine Grady, Dina N. Paltoo This session will be led by representatives from the NIH. Attendees are encouraged to come with questions of interest to all. In this workshop, attendees will: • Hear from representatives of the NIH Office of Science Policy, the NIH Office of Extramural

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Research, and the National Cancer Institute about activities that are pertinent to clinical research policy and the protection of human subjects in research.

• Participate in an open discussion about topics relevant to NIH stakeholders.

• Ask questions about new and ongoing initiatives at the NIH.

D2

A Dialogue with the Department of Energy (DOE) (A Dialogue with the Feds II Track)

Room 301

Faculty: Elizabeth White, Lindsay Motz This session will be led by representatives from the DOE. Attendees are encouraged to come with questions of interest to all. In this workshop, attendees will: • Learn about DOE’s Human Subjects Research Database.

• Participate in an open discussion of issues relevant to DOE stakeholders.

• Ask questions about new and ongoing initiatives at the DOE. Please note this presentation will be given via Skype.

D3

Succeeding at Community Engagement (Accreditation of HRPPs Track)

Room 109

Faculty: Lois Brako, Martha Jones, Sarah Kiskaddon, Elyse Summers In this session, faculty will: • Identify the ethical principles that guide all community-engaged research.

• Define community-based research (CBR)/ community-based participatory research (CBPR).

• Outline the innovative ways some organizations are a) enhancing understanding of research by subjects and the community at large, and b) understanding and conducting CBR/CBPR. • Review how to develop effective programs and provide institutional guidance to researchers in this area.

• Discuss how to meet the AAHRPP standards (Element I.4.B. and I.4.C.), including evaluation of community outreach activities.

Saturday, November 9 D4

Room 312

Clinical Databases and Electronic Medical Records: When Do They Become Research?

(Activities Along the Boundaries Between Research and Practice Track)

Faculty: Richard Platt, Sebastian Schneeweiss, Walter L. Straus, Hugh Tilson Electronic medical records present a large amount of data for potential study. In this session, faculty will: • Discuss when examination of electronic medical records crosses the line from quality improvement to research.

• Review how to manage clinical databases to ensure they are appropriately used for quality improvement or research.

• Examine management and tracking strategies for these uses.

Room 202

Making Subpart Determinations When Reviewing Research Advanced Involving Vulnerable Populations: Case Studies (Advanced Forum for IRB Professionals Track) Faculty: Jeremy Block, Bruce Gordon, Irene StithColeman – OHRP Resource Person In this session, faculty and attendees will: • Use case studies to examine research protections for vulnerable populations in biomedical and behavioral studies.

• Examine the protections that must be in place in order to include vulnerable populations in research.

• Review the ethical and regulatory guidelines for including these groups in research.

D6

Anybody Can Be an Investigator, Right?

(Educating Research Teams Track)

Room 305

Faculty: Ann C. Bonham, Greg Koski The skills necessary to be a good researcher are neither innate nor part of most graduate curricula, especially in medical school, and the risks to subjects can be great. Yet, prior certification is required of clinicians who use new clinical procedures or new techniques and instruments. Is this asymmetry reasonable? This session will review the preliminary results of a pilot

D7

Risk Tolerance and Risk Recalibration: Are You Overdoing it?

(Ethical Issues Track)

Room 304 Advanced

Faculty: Moira Keane In this session, faculty and attendees will: • Review how to measure risk tolerance in IRB administration and review.

• Discuss options for recalibrating risk and evaluating how to make changes in practice.

• Explore ways to introduce flexibility in practice while maintaining regulatory compliance.

D8

FDA’s Investigational Device Exemption (IDE) Decisions and Communications: What You Need to Know (FDA Regulations Track)

Room 302 Basic

Faculty: Owen Faris In this session, faculty will: • Discuss the FDA’s device classification, what an IDE is, and the different types of IDE studies.

• Discuss the FDA’s decision-making process for determining IDEs. • Discuss the regulatory requirements for risk determination of medical device studies.

D9

Private Sector Concerns Regarding Biorepositories and Tissue Banking (Global Research Track)

Room 206

Faculty: Lester Arnold, Amelia Wall Warner Pharmaceutical companies consider specimens collected for future biomedical research to be critical resources for understanding patient variability to drug response. In this session, faculty will:

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D5

study to ascertain the need for certification of clinical investigators. In this session, faculty will: • Explore the need for training and certification programs for clinical researchers based on study data.

• Identify deficient knowledge, according to the research.

• Review recommended elements for researcher training programs.

• Explore one model of certification for clinical investigators.

Schedule Recognition Conference Information • Explore how discussions of issues such as tiered consent, return of results to subjects, sharing of coded genomic data sets, and scope of research differ between academic and commercial settings, given the latter does not maintain ongoing relationships with patients participating in clinical trial specimen collection and storage.

•R eview how changes in global regulations are driving discussions about how commercial companies will structure specimen collection procedures in the future.

D10

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Empowering Terminally Ill Subjects Through the Informed Consent Process (Informed Consent Track)

Room 111

Faculty: Lauren B. Solberg When conducting and reviewing research with terminally ill subjects, researchers and IRBs are faced with a variety of issues that must be carefully considered. The consent process can be particularly complicated with terminally ill subjects, as it is especially important for them to understand whether the study offers any potential therapeutic benefit.

For terminally ill people who enroll in research and subsequently lose medical decision-making capacity, researchers may be challenged with seeking surrogate consent for their continued participation. The regulatory requirements around informed consent appear to be sufficient to ensure that terminally ill subjects receive the information necessary to make an informed decision about whether to participate. In this session, faculty will: •D iscuss the potential vulnerabilities of terminally ill individuals who may enroll in research.

•E xamine landmark cases and statutes that govern the rights of, and thus empower, terminally ill individuals.

• I dentify strategies that researchers and IRBs can implement as a part of the informed consent process to ensure terminally ill individuals are empowered as well as adequately protected.

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D11

Academic-Industry Partnerships: Maximizing Benefits and Reducing Inefficiencies While Promoting Ethical Research (Institutional Officials Track)

Room 104 Advanced

Faculty: Barbara E. Bierer, Kate Gallin Heffernan In this session, faculty will: • Define the areas where the research interests and missions of academia and industry intersect and complement one another, and how these synergies can be maximized.

• Review the ways in which principled partnerships between industry and academia can be undermined through frictions, miscommunications, and inefficiencies.

• Discuss common ground and solutions to the identified challenges to maximize the benefits of these principled partnerships without sacrificing the quality or ethics of the research under collaboration.

D12

The Ins and Outs of IRB Offices (IRB Bootcamp Track)

Room 101

Faculty: Sharon Freitag, Hallie Kassan, Brenda Ruotolo In this session, faculty and attendees will: • Explore the different ways of processing IRB submissions through an IRB office.

• Identify responsibilities of different staff in an IRB office.

• Review processes that work well for IRB offices in facilitating the approval process.

D13

Evaluating Member Performance (IRB Operations and Toolkit Track)

Room 110

Faculty: Yvonne Higgins, Tara Moore, Melissa Schlenker Evaluating IRB member performance may benefit institutions. In this session, faculty will: • Review what to do if a performance issue is found with an IRB member.

• Address how to include IRB members in the solution so as to enhance the relationship and make IRB members feel appreciated, which, in turn, could benefit the HRPP.

Saturday, November 9 • Discuss how ongoing education for IRB members is a way to keep members informed, as well as reinforce their responsibilities.

D14

Unanticipated Problems and Adverse Events: A Practical Approach for IRBs (Issues for Pharma/Biotech Track)

Room 102 Basic

Faculty: Albert J. Allen, Jeffrey A. Cooper In this session, faculty will: •D iscuss what is considered an unanticipated problem involving risk to subjects or others, and the overlap with adverse events.

• Present case examples to determine whether certain events should be considered unanticipated problems.

•R eview the practical mechanisms for IRB receipt and review of reports of unanticipated problems.

When Noncompliance Processes Collide: How to Manage Multiple Different Internal Investigations of an Event (Legal Track)

Room 103 Advanced

Faculty: Megan Kasimatis Singleton, Andrew Rusczek One allegation or problem in a clinical study, such as a concern that a researcher has falsified research data, can invoke multiple requirements and policies for investigation and resolution. In this session, faculty will: • Identify the various institutional policies and processes that may be triggered by a noncompliance event, including IRB serious/continuing noncompliance investigations, research misconduct proceedings, HIPAA privacy/security breach determinations, conflict of interest reviews, human resources investigations, risk management and morbidity/mortality peer reviews, and IBC reviews.

•H elp institutional representatives recognize the ways in which the requirements and standards applicable to different processes may overlap or be in tension.

•D iscuss appropriate roles for individuals and oversight boards involved in these processes.

•S uggest strategies for coordinating and conducting multiple investigations in a way that maximizes efficiency, but also maintains the integrity of the various processes.

Room 313

Unique Challenges in Pediatric Biobanking (Out of Body Experiences: Research Involving Tissue and Data Track) Faculty: Julia Gorey, Steven Joffe, Carol Weil This session will explore the ethical and regulatory issues surrounding pediatric donors of biological specimens and the implications that arise when those donors reach the age of majority. In this session, faculty will: • Provide a working knowledge of the regulatory requirements for parental permission and child assent in the context of pediatric biobanking protocols.

• Address the ethical and legal issues involved in seeking consent from former pediatric biospecimen donors at age of majority.

• Review the ethical and regulatory controversies surrounding the return of research results for pediatric biospecimen donors.

D17

Populations on the Edge: The Homeless, Substance Abusers, and More (Populations Requiring Additional Protections Track)

Room 311 Advanced

Faculty: Christina Booth, Jeffrey M. Cohen There are many populations that have vulnerabilities related to their marginalized status. Thus, it is important for IRBs to understand the expertise needed to review studies with these populations and some of the special or heightened concerns related to these groups. In this session, faculty and attendees will: • Identify vulnerable populations beyond those addressed by the federal regulations who are nonetheless vulnerable because of homelessness, substance abuse, or other issues.

• Examine the special considerations that study teams should address when designing a study involving these populations, and that IRBs should be aware of when reviewing these studies, such as payment and undue influence.

• Review the threshold questions an IRB should address before permitting research with these subjects.

• Discuss complex issues such as how to assure confidentiality, balancing concerns about criminal liability with the need to protect subjects and

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D16

Schedule Recognition Conference Information conduct valuable research, the need for assistance to avoid individual harm, and whether Certificates of Confidentiality should be a prerequisite for these studies.

• Explore how to recruit and maintain contact with subjects from these populations.

D18

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Alleged Misconduct in Clinical Research: Challenges for IRBs and Research Integrity Officers (RIOs) (Potpourri Track)

Room 204

Faculty: Mark Barnes, Kristina C. Borror, George Gasparis, Kristen Grace Alleged misconduct in clinical research presents challenges for both IRBs and RIOs. SACHRP, the Office of Research Integrity, and OHRP have all addressed such challenges. In this session, faculty and attendees will: • Explore the challenges of alleged misconduct in clinical research.

• Review potential solutions by which both IRBs and RIOs can perform their duties in a manner that will not compromise each office’s ability to fulfill their oversight responsibilities.

D19

Room 107

Developing Effective Corrective Action (QA/QI and Post-Approval Monitoring Track)

Faculty: Marinna Banks-Shields, Eunice Yim Newbert, Jessica Randall-Aprea In this session, faculty and attendees will: • Identify and develop effective and novel corrective actions and corrective action plans (CAPs) depending on the noncompliance identified.

• Discuss common pitfalls with the CAPs researchers provide.

• Explore how to build educational elements into each CAP to help ensure the specific noncompliance finding doesn’t happen again.

D20

Beyond the Regulations: Strategies for Obtaining Informed Consent (Regulatory Balance Track)

Room 303 Basic

Faculty: Elizabeth Bankert, Susie Hoffman Researchers continue to struggle with the consent form and process, and they are looking for practical methods

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to improve both in order to obtain truly informed consent. In this session, faculty will: • Review methods and concepts to improve the consent form and process.

• Discuss the components of the Valid Optimization of Informed Consent Evaluation (VOICE) Program.

D21

Internet Research with Minors (Research Involving the Internet & Social Networking Track)

Room 306 Basic

Faculty: Laura Odwazny, Donna Spruijt-Metz In this session, faculty will: • Review the basic ethical and regulatory elements of research with minors.

• Discuss unique issues with internet research involving minors and age verification.

• Provide suggestions and guidance for researchers and IRBs in preparing and executing informed consent and assent with minors in internet settings.

D22

School Rules! Conducting Research in Elementary and Secondary Public Schools (SBER I – Basic Track)

Room 310 Basic

Faculty: Eric Allen, Jonathan Miller In this session, faculty and attendees will: • Discuss the investigator’s role in facilitating the development of local school district policies/ practices in regard to communication with parents about the authority to conduct research.

• Review the use of consent alterations and waivers at schools with historically low parental involvement and high student absence.

• Explore special considerations for research involving students engaged in distance learning.

• Discuss how the interpretation of what constitutes “routine educational practices” (exempt category 1) evolves over time, e.g., videotaping in classrooms.

• Distinguish exemption eligibility factors related to different research designs, e.g., whether the generalizable knowledge sought is focused on (i) teachers; (ii) students; or (iii) effectiveness/ satisfaction of innovative learning techniques.

Saturday, November 9 D23

Room 203

Identifying, Assessing, and Resolving Issues in Advanced Greater than Minimal Risk Social, Behavioral, and Educational Research (SBER II – Advanced Track)

D24

Room 308

Institutional Memory: How Did We Handle this the Last Basic Time? Consistency in Protocol Review Procedures and Approval Standards When Reviewing Low Volume Protocol Submissions Involving Greater than Minimal Risk (Small Research Programs Track)

Faculty: Maria Arnold, Paul Reitemeier This session will explore ways of identifying and tracking infrequent but significant IRB determinations that affect protocol approvability, and is appropriate for individuals from institutions that self-identify as having a small research programs according to any of the criteria laid out in the track descriptor. In this session, faculty will: • Identify study-related features that significantly affect IRB protocol approval decisions, including external authorizations and oversight, investigator qualifications, study site adequacy, and risk to subjects including data security.

• Explore ways to identify, record, track, and retrieve key information from prior IRB approval decisions

D25

Scientific Aspects of Clinical Study Design: A Primer for Non-Scientists (Unaffiliated and Non-Scientist IRB Members Track)

Room 108

Faculty: Susan S. Fish, Lindsay McNair In this session, faculty and attendees will: • Begin with a review of the scientific process, from observation to hypothesis generation and testing to peer review/critique of conclusions.

• Review the basics of clinical study design.

• Discuss the clinical research process.

• Describe the norms and expectations of the community regarding scientific design from multiple perspectives, including those of a biomedical scientist and a social-behavioral scientist.

10:45-11:15 AM

Break

Exhibit Hall C

Join us in The Conference Connection for coffee.

11:15 AM-12:30 PM

Didactic Sessions and Workshops Series E E1

A Dialogue with SACHRP (A Dialogue with the Feds I Track)

Room 311

Faculty: Jeffrey R. Botkin, David G. Forster, Julia Gorey, Daniel K. Nelson This session will be led by representatives from SACHRP. Attendees are encouraged to come with questions of interest to all. In this session, attendees will: • Hear from SACHRP representatives about evolving initiatives, issues, and guidance, including forthcoming recommendations on Certificates of Confidentiality, engagement, and cluster randomized trials.

• Participate in an open discussion about topics relevant to SACHRP stakeholders.

• Discuss best practices currently under consideration

by SACHRP. • Ask questions of SACHRP representatives.

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Faculty: Monika S. Markowitz, Cynthia J. Monahan In this session, faculty will: • Identify the need for and mechanisms of IRB review relevant to the following: risk identification and minimization applied to individual research subjects, groups, and the subjects’ community; post-approval harm monitoring and reporting procedures; and postfacto risk determination (for similar future studies).

• Examine examples of greater than minimal risk social, behavioral, and educational research, including: FOIA-mediated survey research (in which there is no voluntary consent and inappropriate or nonresponders may face disciplinary action); survey or interview research in vulnerable and at-risk populations; psychology 100 research involving very sensitive information about students; and research about topics such as domestic violence, academic dishonesty, recreational drug use, and varsity athlete gambling.

• Define minimal risk in research involving first time offender and recidivist prisoners.

using both paper-based and electronic record systems.

• Discuss when IRB approval practices and standards should become formal policies.

Schedule Recognition Conference Information E2

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Considering Incidental Findings (IFs) in HIV Research: A Must in Today´s Environment (A Dialogue with the Feds II Track)

Room 111 Advanced

Faculty: Linda Ehler, Betto Ortiz Determining what constitutes an IF in clinical research and determining whether, and when, it should be returned to the participant has been a topic of discussion in the field of subject protections for the last 10 years. Implementing a comprehensive approach that addresses both the responsibility of researchers to return these findings and the expectation of participants upon receiving this information can be not only logistically challenging, but also costly. In this session, faculty involved in National Institute of Allergy and Infectious Diseases-sponsored HIV research will: • Address possible approaches for considering and returning IFs in clinical research, drawing on their experience with IFs in HIV research.

• Use examples to describe how study teams developing a research plan can better integrate the response to IFs discovered during research participation.

• Review a new informed consent template being used by a diverse group of HIV researchers worldwide, examine its approach to addressing IFs, and discuss how that approach might apply to clinical research more broadly.

E3

Making Accreditation Happen in Small Research Programs (Accreditation of HRPPs Track)

Room 101 Basic

Faculty: Francis DiMario, Scott Lipkin, Elyse Summers Attendees should come with questions. In this session, faculty and attendees will: • Discuss the special challenges faced by small research organizations in building a comprehensive HRPP. • Identify strategies for mustering resources and embarking on accreditation.

• Examine effective strategies used by small research organizations and offer guidance based on their own experience.

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E4

Room 310

Decedent Research: When Is IRB Review Required?

(Activities Along the Boundaries Between Research and Practice Track)

Faculty: Chris Asmann-Finch, Paula Bistak The federal definition of a human subject notes the regulations protect “living” individuals. However, there are areas where decedent research may have an impact on the living including a) tissue and data findings from the deceased that may be relevant to living family members; b) legal status of transplant donors on life support; and c) ethnic communities’ views about respect for the dead. In this session, faculty will: •D iscuss the current federal definition of a human subject.

• I dentify federal and state regulations, laws, or statutes that deal with decedent research. xamine the implications of varied ethnic and •E religious views of the sanctity of the deceased.

E5

Room 305

Cautions Against Breaking the Blind at the End of Randomized Controlled Psychopharmacology Studies Involving Minors: Protecting the Patient Versus Protecting the Science (Advanced Forum for IRB Professionals Track) Faculty: Albert J. Allen, Laurence Greenhill, David H. Strauss Industry-sponsored psychotropic medication randomized-controlled trials follow strict guidelines about not breaking the blind until all subjects have completed the study and the database is locked. This practice raises challenges for determining the benefit/ risk ratio for minors, since it is a benefit if a family can learn the identity of the medication when an individual child completes a protocol. This is particularly true in phase IV studies that involve medications already approved for adults and widely available from physicians. In such cases, a child could be randomly assigned, under double-blind conditions, to a medication she/he could readily receive at a physician’s office, but which may give her/him no benefit. In this session, faculty will: •R eview the federal regulations that apply to research in youth under the age of 18 involving minimal risk and minor increment over minimal risk.

Saturday, November 9 • Discuss arguments for maintaining double blind status in phase IV trials until all subjects have been through the trial.

• Address the controversy around suggestions for breaking the blind with a separate treating staff who are advised to keep information about whether a specific subject was treated with placebo or study drug from the investigators.

• Ask attendees to discuss a) the strength of the evidence that breaking the blind at a site corrupts the study data, b) alternative arrangements that might be acceptable to the FDA and industry, and c) what perspective could help an IRB balance the benefits and risks to minors without stopping the research.

E6

Room 306

Faculty: Lisa Buchanan, Charlotte Coley, Bruce Gordon In this session, faculty will: • Present a root cause analysis of noncompliance issues.

• Examine how to identify knowledge gaps that lead to noncompliance issues in research.

• Review one retraining model for filling in knowledge gaps that lead to noncompliance on the part of research staff.

• Present a model to address these deficits through training of investigators and staff.

E7

The Ethics of Paying Research Subjects (Ethical Issues Track)

Room 309

Faculty: Alan Wertheimer In this session, faculty will: • Evaluate concerns and address justifications surrounding the topic of payment to research subjects.

• Demonstrate IRB members’ trepidations about payment.

• Offer guidance as to which concerns merit the attention of the IRB. • Discuss pseudoprotectionism and hyperprotectionism.

In Vitro Diagnostic (IVD) Devices Used as Integral Parts of Therapeutic Clinical Trials: IRB Issues and Significant Risk Determinations (FDA Regulations Track)

Room 202 Advanced

Faculty: Ernest D. Litwack In this session, faculty will: • Examine the issues IRBs should consider when IVD devices are used as an integral part of therapeutic clinical trials.

• Review guidance on IVD devices related to IRB review and oversight, and discuss the initiatives developed by the National Cancer Institute and FDA to manage the use of investigational tests in clinical investigations of drugs.

• Discuss considerations for distinguishing significant risk from non-significant risk in IVD investigations.

E9

Sea Change in Europe: The Impact of the New EU Clinical Trials and Data Protection Regulations (Global Research Track)

Room 109

Faculty: Edward Bartlett, Rebecca Li, Mark Barnes In this session, faculty will: • Explain the main provisions of the current EU Clinical Trials Directive and the key changes in the proposed Clinical Trials Regulation.

• Outline the key provisions of the current EU Data Protection Directive and the main changes in the proposed Data Protection Regulation.

• Describe how the proposed changes in the European research landscape are likely to affect IRBs based in the United States.

• Review the current requirements around, as well as barriers to, clinical trials data sharing.

• Examine how to formulate potential solutions to clinical trial data sharing.

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What to Do When Things Go Wrong?

(Educating Research Teams Track)

E8

Schedule Recognition Conference Information E10

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The Ethics and Practice of Proxy Decision Makers in Informed Consent Procedures (Informed Consent Track)

Room 103 Advanced

Faculty: Ilene Wilets Many research protocols investigate procedures and products that may contribute primarily or secondarily to changes in mental status or cognition. Changes in cognition may result in incapacity and/or incompetence to continue to give voluntary informed consent to participate in ongoing research. The use of proxy decision makers may alleviate the ethics and human research protections questions this raises. In this session, faculty and attendees will: • Reinforce the importance of obtaining ongoing informed consent throughout the duration of study participation.

• Discuss the relationship between medical consent statutes and informed consent procedures for research.

• Develop strategies for ensuring and obtaining ongoing informed consent when subjects become incapacitated and/or incompetent.

E11

Understanding the Elements of a Strong Compliance Program (Institutional Officials Track)

Room 206 Basic

Faculty: Wesley Byerly, F. Lisa Murtha In this session, faculty will: • Identify the key components and characteristics of a strong compliance program.

• Discuss the challenges of day-to-day operations.

• Outline compliance program performance metrics.

E12

What Happens After the Protocol Is Approved?

(IRB Bootcamp Track)

Room 308 Basic

Faculty: Kaarkuzhali Babu Krishnamurthy, Samantha Smith In this session, faculty will: • Describe the responsibilities and obligations of researchers and IRBs in the post-approval phase of research.

• Discuss how modifications are made through protocol amendments.

• Review expectations for managing and reporting adverse events, unanticipated problems involving

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risks to subjects or others, and other deviations from the original protocol.

• Outline the steps in the approval process of FDA investigational applications.

E13

How to Develop Effective IRB Forms to Ensure Compliance and Keep Investigators Happy (IRB Operations and Toolkit Track)

Room 203

Faculty: Kelley O’Donoghue, James Riddle In this session, faculty will: • Review practical strategies for using IRB forms to help ensure IRB compliance, auditability, and ease of IRB member review, including options for adjusting form layout or question sequences.

• Describe how researchers view IRB forms and how to use that perspective to the greatest advantage.

• Identify practical and accessible techniques for helping researchers select the right form, complete their forms accurately, and ensure they attach all the right supporting materials.

• Discuss strategies for transitioning from a paper-based form to an online submission system and for improving the use of an online system once implemented.

• Share case studies from two institutions to show how they improved the effectiveness of their forms and facilitate the sharing of ideas about best practices.

E14

Ethical and Regulatory Issues in Clinical Trials Websites and Social Media (Issues for Pharma/Biotech Track)

Room 108 Basic

Faculty: Lindsay McNair, James Warner In this session, faculty will: • Discuss the use of clinical trial websites and/or social media in recruiting and/or managing the participation of subjects in research studies.

• Explore how online platforms like Research Match, TrialX, and Patients Like Me work, and the regulatory and ethical issues that arise with their use.

• Provide an overview of Pfizer’s online clinical trial experience.

Saturday, November 9 E15

The Rules of Engagement: Analyzing Challenging Scenarios Under the Existing OHRP Engagement Framework (Legal Track)

Room 312 Advanced

E16

Room 304

Tissue Issues: Ethical and Regulatory Issues in Banking Basic Biological Specimens for Research (Out of Body Experiences: Research Involving Tissue and Data Track)

Faculty: Marianna J. Bledsoe, Julie Kaneshiro, Ada Sue Selwitz The content presented during this breakout session will provide attendees with a basic introduction to the ethical and regulatory issues in banking specimens for research.

In this session, faculty will: • Provide an overview of specimen banking.

• Discuss the ethical and regulatory principles that guide biobanking for research purposes.

• Review informed consent and waivers for use of tissue for research purposes.

CBPR as a Corrective Lens for Research: Case Studies in Psychiatric Research (Populations Requiring Additional Protections Track)

Room 301 Advanced

Faculty: Celia Brown, Kathleen O’Hara Despite regulatory safeguards, traditional research approaches often stigmatize marginalized and vulnerable communities. CBPR emerges as an effective paradigm that aims to make research more inclusive and democratic by fostering partnerships between communities and scientists to address disparities and community-relevant priorities. This workshop fosters capacity building in the practice and ethics of CBPR through case studies in psychiatric research. In this session, faculty will: • Consider, identify, and problem solve ethical conflicts in CBPR that might affect community subjects, researchers, institutions, and research outcomes.

• Examine best practices for weighing risks to individuals and the community.

• Discuss how to anticipate ethical concerns and recognize boundary issues within the practice and situated ethics of a CBPR collective, including the practice of “process consent,” transparency for an authentic CBPR research agenda, inside-outside tensions, and more.

• Explore social validity and the value of hybrid knowledge as benefits of research.

• Provide tools for ethics in practice through two lenses: the “community of interest” and the research enterprise.

E18

Empirical Research on Research Ethics: How Can Data Inform IRB Deliberations?

(Potpourri Track)

Room 313 Advanced

Faculty: Emily E. Anderson, James DuBois The amount of empirical research on research ethics is growing exponentially, and it should be read and integrated by IRBs to improve the protection of research subjects. This session will suggest ways of gathering evidence and applying it to particular “sticky” problems that frequently arise during IRB deliberations, e.g., whether or not incentive payment amounts are acceptable; whether subjects should be required to pass a knowledge test for informed consent and, if so,

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Faculty: Kate Gallin Heffernan, Emily Wood Even beyond the challenges presented by multi-site research and large-scale banking and repository research, the varied and complex ways investigators and other physicians are contributing to the design, management, technical advancement, statistical analysis, and oversight of research they are not necessarily directly conducting raise new questions under the existing rules of engagement. How should IRBs presented with such research respond, and what oversight role should an institution play, even when there is no formal “engagement”? In this session, faculty and attendees will: • Review the framework under the current OHRP Guidance on Engagement of Institutions in Human Subjects Research (2008), as well as the more recent correspondence on “Non-Engaged” Scenarios (2011).

• Discuss several challenging case studies (that will be made available to workshop participants in advance).

• Think through the role of the IRB and institutional officials in managing risks presented when their physicians and investigators contribute significantly to research in which they are not technically “engaged,” and which is not under their direct oversight and control.

E17

Schedule Recognition Conference Information the best measures to use; what are the actual risks of certain diagnostic procedures used for research purposes or sensitive survey questions; and how these risks should be communicated to subjects. In this session, faculty and attendees will: •D iscuss where (e.g., key journals) and how (e.g., common Medline subject headings) to identify appropriate empirical evidence that can inform research ethics/IRB review.

•D escribe the steps of an evidence-based research ethics/IRB review.

•R eview how to apply empirical evidence to a common dilemma that arises during IRB review in light of ethical principles and regulatory requirements.

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E19

Room 107

Assessing the Quality of a HRPP: Quality Indicators (QIs) for HRPP Assessment (QA/QI and Post-Approval Monitoring Track)

Faculty: Min-Fu Tsan While human subjects protection cannot be directly measured, it is possible to assess the quality of a HRPP. The Department of Veterans Affairs (VA) has recently developed a set of HRPP QIs to do so. In this session, faculty will: •E xplore what the VA’s data show about the effects of using different IRBs (i.e., VA IRBs versus affiliated university IRBs) on VA facility’s HRPP QI data, and the effects of program size on VA facility HRPP QI data.

•D iscuss how to develop QIs for your institution’s HRPP. •E xamine how to use QIs to assess the quality of your institution’s HRPP. •D iscuss how to use QI data to improve your institution’s HRPP.

E20

Electronic Consent: A Discussion of the eConsent Experience, Ethical and Regulatory Considerations, and the IRB Review Process (Regulatory Balance Track)

Room 102 Basic

Faculty: J. Andy Bertolatus, J. Claire Carbary, Donna A. Messner In this session, faculty will: •R eview the use of electronic consent using iPad and computer-based interactive approaches.

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•D iscuss experience using “remote” consent, using an iPad-based consent in a pilot study and the work that was done to develop the consent, and (if available) provide preliminary data from a comparison of iPad consent and traditional paper consent.

• Examine the regulatory requirements of IRB review and consent documentation in the context of an electronic informed consent process.

• Discuss the potential ethical challenges of using electronic technology in streamlining the informed consent process.

E21

“I Agreed to What?”

Terms of Service Versus Consent (Research Involving the Internet & Social Networking Track)

Room 204 Advanced

Faculty: Elizabeth Buchanan, Tomas A. Lipinski, Laura Odwazny This session will discuss the emerging importance of terms of service (TOS) and end user license agreements (EULAs), and the ways they may influence IRB review. From Facebook to mTurk, term agreements may complicate the dual roles of being a user of an internet tool or venue and being a subject of research with that tool or venue. In this session, faculty will: • Define TOS/EULAs, and address their potential influence on IRB review.

• Review the legal standing of TOS/EULAs. • Describe common internet tools and venues.

• Provide guidance for IRBs and researchers on what to look for in TOS/EULAs that can aid in effective IRB review.

E22

Special Problems in Reviewing Student-Led Research (SBER I – Basic Track)

Room 302 Basic

Faculty: Eric Allen, Suzanne Stone This session will focus on assessing research subject risk and scientific merit in student-conducted research.

In the session, faculty will: • Discuss how to effectively respond to poorly prepared student research proposals due to substandard faculty oversight and mentorship.

• Review the data security issues that can arise when student investigators or faculty advisors separate from the institution and IRB oversight.

Saturday, November 9 • Review the issues that can arise from multiyear research requiring “protocol passing” from graduating student investigators to other student investigators, including data integrity, ownership, security, etc.

E23

Ethically Valid Consent and Assent in Persons with Diminished Cognitive Capacity (SBER II – Advanced Track)

Room 104 Advanced

E24

Comparing the Contract with the Protocol and Consent Forms When You Have Limited Access to a Contract Officer and/ or a General Counsel Office (Small Research Programs Track)

Room 303 Advanced

Faculty: Robert Bienkowski, Lynn Smith This session will be of particular interest to individuals from community hospitals. In this session, faculty will: • Discuss the common components of a clinical trial agreement (CTA), emphasizing those parts that

E25

Identifying Red Flags: Protocol Review for the Unaffiliated and Non-Scientist IRB Member (Unaffiliated and Non-Scientist IRB Members Track)

Room 110 Basic

Faculty: Michelle Feige, Amanda Hammond, Nancy A. Olson When it all sounds like Greek, how does the nonscientist IRB member know when to be concerned?

This session will address the potential red flags that non-scientist reviewers should be aware of when reviewing a study protocol. In this session, faculty will: • Identify problematic areas of protocols.

• Define specific issues for methodological consideration in IRB review.

• Provide suggestions for the unaffiliated/non-scientist IRB member when reviewing challenging protocols.

12:45-1:45 PM

Exhibit Hall D

12:45-1:45 PM

Ballroom A

Lunch

Luncheon with the Lifetime Achievement Award for Excellence in Research Ethics Recipient Joan Rachlin, JD, MPH

Join us for a luncheon with 2013 Lifetime Achievement Award for Excellence in Research Ethics Recipient, PRIM&R’s Executive Director, Joan Rachlin. This event will provide attendees the opportunity to celebrate this distinguished leader as she prepares to retire from nearly 39 years at the helm of PRIM&R.

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schedules

Faculty: Rebecca Davis, Paul Reitemeier IRB members are aware of studies showing that many research subjects are unable to accurately describe or explain the research in which they have enrolled.

This suggests that neither the enrolled subjects nor the researchers are part of an ethically valid consent process. Many researchers describe the consent process as an administrative paperwork burden rather than a dialogical process that seeks to establish, secure, and perpetuate ethically valid consent. This session will explore selected challenges and tensions in the consent process that originate from study subjects, researchers, and IRB members. In this session, faculty will: • Review the obstacles to ethically valid informed consent arising from subjects, researchers, and IRBs. • Examine innovative methods of engaging in the consent process.

• Provide a reference tool for assessing research-related risks to persons with diminished cognitive capacity.

• Use complex case studies from social and behavioral research to stimulate audience discussion about how researchers and their IRBs can protect human subjects from harm without unnecessarily restricting scientific inquiry.

bear on human subjects protections. Examples include drug, device, and physical manipulation studies, and the role of student researchers.

• Poll participants about who in their institution provides final approval for CTAs, who negotiates contract/consent language, and whether their processes are effective and secure.

• Review items that should concern a local IRB and what a central IRB expects when a protocol is reviewed.

• Discuss how to develop education programs for hospital offices that are not familiar with clinical research.

Schedule Recognition Conference Information 2:00-3:15 PM

schedules

Panel X: Giving Drugs to Drug Users and Other Ethical Quandaries in Research on Substance Use

Ballroom C

Moderator: Alan Wertheimer Panelists: Karen Leggett Dugosh, Edward Nunes, David H. Strauss Substance use disorders are highly prevalent in the United States, and efforts to identify mechanisms underlying addiction and treatments that work are ongoing. Research on substance abuse poses unique and ethical questions that challenge fundamental attitudes about voluntariness, autonomy, and privacy.

Is it reasonable to administer drugs of abuse to drug abusers? When is subject capacity to consent compromised by addiction, the availability of drugs in the research, and compensation? Under what circumstances are researchers obligated to treat substance users or report illegal activities? The panel will address these questions in both practical and theoretical terms.

2:00-3:15 PM

Panel XI: Someone to Watch Over Me: Mobile Device Research and the Sense of the Self

Ballroom B

Moderator: Ivor A. Pritchard Panelists: Stephen S. Intille, Camille Nebeker, Donna Spruijt-Metz Mobile devices are being carried by or implanted in human subjects in a wide variety of research studies.

They monitor behavior, location, and physiological functions, and they often include interventions designed to influence the carrier’s mood or behavior. Carriers get instructions to smoke or not smoke, eat or not eat, take their medicine, report what they are doing, exercise, and take steps to avoid temptations. This panel will explore the range of devices currently being studied, what devices IRBs can expect to see in trials over the coming decade, and whether such mobile devices pose any special ethical or regulatory issues.

The panel will highlight questions IRBs should expect researchers to address when designing mobile device studies and when explaining them to subjects, in the following domains: 1) Autonomy and privacy. How do mobile device interventions influence subjects’ sense of autonomy, privacy, and agency? When subjects receive communications and interventions delivered to devices

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that are constantly with them, how does this influence their ability to decide what to do? What about their sense of what is private? And, do people ill enough to merit an intervention have the capacity to consent? 2) Apprehension about new technologies. Some express the concern that these technological developments are so revolutionary that conventional approaches to the protection of human subjects in such research are wholly inadequate. This is of course not the first time society has reacted to technological innovation with alarm.

Is mobile device research genuinely so different from “conventional” research that it requires a fundamentally different oversight approach, or is it not so different after all? 3) Third parties and “secondary subjects.” Mobile device research frequently involves studying people who are alongside of, or who are connected to, the individuals who are the ostensible subjects of the study. At the regulatory and ethical levels, what obligations are owed to these “secondary subjects”?

2:00-3:15 PM

Panel XII: Is Meaningful Regulatory Change Possible?

Veterans Auditorium

Moderator: Michele Russell-Einhorn Panelists: Jeffrey R. Botkin, John D. Lantos, Tom Puglisi The scientific literature, the lay press, and the research community frequently call for change to the current requirements for IRB review and research informed consent. Many national committees and commissions have been convened over the years to author thorough and well-informed reports on significant issues involving the protection of human subjects in research and the need for regulatory change to address them.

Nevertheless, no change in the federal regulations governing research with human subjects has occurred since the publication of the “Federal Policy for the Protection of Human Subjects” in 1991, despite the publication of the ANPRM two years ago. Why is this?

What are the constraints in the regulatory process that surround the current regulations and hinder change?

Can we think outside the box and find any flexibility in the existing regulations that do not depend upon a regulatory fix? This panel will describe the barriers to meaningful regulatory change by examining the existing system, and will explore how HRPPs can address the changing needs despite regulatory stagnation by reviewing where flexibility currently exists, but is not used.

Saturday, November 9 3:15-3:30 PM

Break

Pre-Function Auditorium

Join us for coffee.

GF1

Room 310

People and Perspectives (P&P): Bring Your Story!

GF2

Affinity Group (AG) Wrap-Up Meetings

You’ve spent three days getting to know your colleagues.

So where do you go from here? Come to this wrapup session to connect with your fellow AG members.

Participate in a facilitated brainstorming session with your group leaders to determine how you would like to stay in touch after the conference, what topics you would like to see at the next AER conference, and what other activities your AG might want to undertake. Each AG will have its own wrap-up meeting.

Educators/Trainers Global Research Human Specimen/Tissue Banking Institutional Officials IRB Chairs

Room 305 Room 107 Room 301 Room 108 Room 303

Room 111 Room 109 Room 308 Room 110

GF3

Ballroom A

Human Subjects Protections Jeopardy!

Faculty: Elyse Summers You’ve learned so much at the conference, let’s put it to use! Take part in this fun and interactive Jeopardy! game to test what you’ve learned, show off for your friends, and enjoy your last hours at the PRIM&R conference!

Answer: Human Subject Protections Jeopardy. Question: What is a guaranteed good time for all!?

GF4

The Uncomfortable Conversation: Talking about Diversity

Room 302

Faculty: Dorotha Love Hall The issue of diversity is not directly addressed in the federal regulations governing human subjects research, although it is referenced in The Belmont Report.

Nevertheless, IRB professionals have opportunities to consider issues of diversity during the protocol review process, development of policies and procedures, investigator training, and the like. In this session, a member of PRIM&R’s Diversity Advisory Group will pose and address questions such as: How can you, as IRB professionals, ensure the issue of diversity is adequately addressed during protocol review? How can you develop policies and procedures that support diversity when there are no clearly defined federal regulations? How do you encourage investigators to recruit diverse subject populations when resources are short? What arguments should you use, and how are those arguments based in ethics, regulations, science, and research history? Come be part of this important conversation.

GF5

Room 312

Ask the Experts! Everything You Wanted to Know, But Were Afraid to Ask

Faculty: Janet Donnelly, Yvonne Higgins, Patrick McNeilly, Irene Stith-Coleman Are you new to the field of research ethics? Do you still have a nagging question regarding HRPPs and IRBs? Join us for this session where experienced veterans of the field will be available to answer all the questions you’ve been afraid to ask! Come with ideas,

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Faculty: Gigi McMillan, Joan Rachlin In honor of its 40th anniversary in 2014, PRIM&R has launched a new online initiative, P&P, a multimedia library that captures and catalogues stories from members of our community. We welcome contributions from anyone working in or around the field of research ethics and research protections. If you’d like to know more about P&P, please join us at this session where the site will be unveiled. Attendees will learn about the tradition of oral history and will receive tips on how to create compelling content and submit it to P&P. The last half of the session will be “open mic,” during which audience members can share a real time snapshot of their work in the research field. We thus ask those of you who would like to “go live” during the session to come with a three to five-minute story about some aspect of your professional life. This casual, fun, and friendly session will be videotaped for inclusion in P&P. Be one of the first to contribute to this archive of our community’s stories and become an early member of PRIM&R’s multimedia, digital, story-telling collection.

Content may also be submitted in a variety of formats through the website after the session. See page 9 for more information about P&P.

QA/QI Small Research Programs SBER Unaffiliated/Community Members

Schedule Recognition Conference Information questions, and concerns to share with the group and be prepared to participate in an open, interactive, and lively discussion with faculty and your peers.

GF6

Ballroom C

schedules

Film Screening: Finding Dr. Schatz: The Discovery of Streptomycin and a Life It Saved

Moderator: Elisa A. Hurley Faculty: Inge Auerbacher Join us for a screening of the riveting documentary Finding Dr. Schatz: The Discovery of Streptomycin and a Life It Saved based on the book of the same name written by Inge Auerbacher and Albert Schatz. The documentary depicts the relationship formed by Dr. Auerbacher, a child survivor of the Holocaust stricken with tuberculosis, and Dr. Schatz, the co-discoverer of Streptomycin, the drug that saved her life, 50 years after Dr. Schatz discovered the drug. The story is one of hardship, intrigue, and lack of recognition for Dr. Schatz’s contribution to one of the most important medical discoveries of modern times. The film includes testimony of principal witnesses, including Senator Bob Dole, who was saved by Streptomycin after contracting tuberculosis from an injury inflicted in World War II. Please join us for this film, as well as for commentary and a question and answer session with Dr. Auerbacher.

During the session, Dr. Auerbacher will also be selling and signing copies of her companion book, Finding Dr. Schatz.

GF7

Room 304

Connect with PRIM&R: Resources to Network, Volunteer, and Advance Your Career

Faculty: PRIM&R Staff Join the PRIM&R staff for a session that will help you learn more about PRIM&R and how our resources can benefit you after the conference. During this session, staff will review PRIM&R’s online course, E-ROC, and explain its benefits as they relate to continuing education. In addition, the PRIM&R staff will explore the Knowledge Center, an online educational resource for members that features PRIM&R program archives; workplace tools, templates and SOPs; Workload Salary Survey Reports; and more. Finally, the PRIM&R staff will highlight ways to connect with other members and the community at large through our website, social media

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channels, and the IRB Forum, as well as discuss many other networking opportunities, including our Mentoring Program, volunteer opportunities, and the Regional Connections program. Hope to see you there!

4:45-5:45 PM

Closing Reception

Boylston Hallway 3rd floor

Join us to wish each other a fond farewell and to make plans for the 2014 AER Conference! Light refreshments will be served.

Continuing Medical Education (CME) Accreditation Statement

schedules

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Posters Selected for Presentation Recognition Conference Information PRIM&R is pleased to present the Annual Poster Presentation at the 2013 AER Conference.

Thirteen posters were selected for presentation in our new “Innovations in…” series and 98 posters will be on display throughout the conference in The Conference Connection.

Many thanks are owed to the Poster Abstract Sub-Committee, including co-chairs Susan Fish and Nancy Olson, and members Jennifer Bell, Paula Bistak, Okyere Boateng, Warren Capell, Cheryl Dubenezic, Samantha Ferrante, Karen Hale, Michele Kennett, Patricia MacCubbin, Amal Matar, Nancy Ondrusek, David Resnik, Tracy Rightmer, Fabian Sandoval, Lauren Solberg, Carol Weil, and Rachel Zand for coordinating this conference event. Please note, the inclusion of posters featuring commercial products should not be considered an endorsement by PRIM&R. 1. A Comparative Study on the Effectiveness of a Preliminary Review Process in the Reduction of Study Deferrals

5. A Pre-Emptive Approach to Streamlining Review of Social and Behavioral Science Protocols During Peak Submission Seasons

2. A Descriptive Review and Analysis of the FDA Docket: Public Disclosure Material for Emergency Research Studies Conducted Under 21 CFR 50.24 (Docket ID: FDA-1995-S-0036)

6. A Protocol Navigation Training Program at the National Institutes of Health

posters

Dorean J. Flores, BS, CIP; Meredith Burcyk; Emily Chumas North Shore-Long Island Jewish Health System

Robert Silbergleit, MD; Benjamin D. Hume, BS; Erin Bengelink, MS; Deneil M. Harney, MPH, MSW University of Michigan

3. A Model for Collaborative Review Between IRBs and Ancillary Review Committees

Bruce Sachais, MD, PhD; Nicole Aqui, MD; Tracy Ziolek, MS, CIP; Benjamin Hernberg, MBE; Heather Emery University of Pennsylvania

4. A New Program to Enhance Research Coordinator Education at a Large Academic Medical Center

Jody Harland, MS, CIP; Lucy Miller, RN, BSN, CCRC; Marta Sears, BSN, CCRC; Sara Benken, CIP; Chartley Bondurant, CHRC; Brenda Dugan; Bethany Johnson, JD; Leslie Pfeffer, BS, CHP; Jennifer Weddle, CHRC; Christy Yoder, CCRP Indiana University School of Medicine

p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

Katrina Blount, PhD, CIP; Adam Schechter, PhD, CIP; Susan Bouregy, PhD, CIP Yale University

Marcia L. Vital, MS; Beverly Barham, RN, MSN, CCRC National Institutes of Health

7. A Systematic Review of Placebo/ Sham- and Lesion-Controlled Surgical Trials: Ethical Issues in Design, Conduct, and Reporting

Thomas B. Freeman, MD; Dorothy E. Vawter, PhD; Barbara Manchec; Michael Brannick, PhD Minnesota Center for Health Care Ethics

8. A Win-Win: Designing Competitive Certified IRB Professional Study Sessions for Office Staff

Cortni Romaine, BSEd, CCRC; Glen Fuhrmeister, BA; Melissa Ball, MA, CCRP, CCRA, CIP The George Washington University

9. A Workshop for IRB Chairs and Members in Japan

Masumi Ai, MD, PhD; Miwa Suzuki, RN, PhD; Naoko Nii, BN; Yuka Ozasa RN, PhD; Yasuko Abe, MD; Eiichiro Kanda, MD, PhD; Masayuki Yoshida, MD, PhD Tokyo Medical and Dental University

10. An Innovative Approach to Engage Committee Members in Educational Topics Donna Hoagland, LPN, BS, CIP, CCRC, CHRC; Swapnali Chaudhari, CIP; Paula Bistak, DMH, RN, MS, CIP, CHRC University of Medicine and Dentistry of New Jersey

11. An IRB Model for Quality Improvement Projects

June Walker, CIP, MS, MSCR; Phyllis Kennel; John Falletta, MD Duke University

12. Assessing Voluntariness Among Incarcerated Substance Abusers Participating in Research

13. Awareness and Attitude of Behavioural Scientists to Research Ethics Committee in Nigerian Universities Olufunke Arojo, BSc, MSW, MSc; Ayodele Jegede, BSc, MSc, MHSc, PhD University of Ibadan

14. Barriers Impacting the Future Use of Biospecimens in Human Research and the Value of Developing Global Patient Consent Coding Standards

Amelia Wall Warner, PharmD; Lori A. Ball, MBA BioStorage Technologies, Inc.

William Pomat, PhD; Charles H. King, MD; Joseph Gibbons, MD; Peter M. Siba, PhD; Nancy C. Erdey, PhD; Sana Loue, JD, PhD, MPH, MSSA; Deborah Marko Koeberer, MA; Suzanne Rivera, PhD, MSW; Philip A. Cola, MA; Isabel Sánchez-Cummings Case Western Reserve University

16. Case Studies for Assessing and Mitigating Risk in Social, Behavioral, and Educational Research: Creation of Educational Resources for IRB Members and Researchers

Matthew Stafford; Cynthia Monahan, MBA, CIP; Hila Bernstein, MS; Christina Booth, MS, HPM, CIPP; Ken Carson, JD; John Ennever, MD, PhD; Joanna Greene; Sara Harnish, JD; Alyssa Speier, MS, CIP; Elizabeth Witte; Barbara Bierer, MD; Sabune Winkler, JD Boston Children’s Hospital

17. Changes in Study Staff

Michael Centola, MHS, CIP; Jeffrey A. Cooper, MD, MMM University of Massachusetts Medical School

18. Collaborative Ethical and Regulatory Review of Joint Institute Research

Michael Geisser, PhD; Raymond Hutchinson, MS, MD; Yali Cong, PhD University of Michigan

19. Conduct and Oversight of Research After a Natural/ Man-Made Disaster

Holly A. Taylor, PhD, MPH Johns Hopkins Bloomberg School of Public Health

selected for “Innovations In...” series

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posters

Karen Leggett Dugosh, PhD Treatment Research Institute

15. Bioethics and Cultural Competence Education for IRBs for Jointly Reviewed Protocols at International Study Sites

Posters Selected for Presentation Recognition Conference Information 20. Continuous Quality Improvement: Closing the Feedback Loop

Susie Corl, MSW, MPH, CIP, CCRP; Eunice Yim Newbert, MPH Boston Children’s Hospital

21. Creating a Unified IRB Authorization Agreement Process for Separate Biomedical and Social/Behavioral IRBs at a Single Institution Judy Birk, JD; Lois Brako, PhD; Cindy Shindledecker, BA; Diana Miller, MS; Georgia L. Marvin, JD University of Michigan

22. Creating Collaborative Review: A Strategic Approach to the Development of Collaborative Review Mechanisms for Multi-Site Research

Francis H. Barchi, MBE, PhD; Megan K. Singleton, JD, MBE, CIP; Jon F. Merz, JD, PhD University of Pennsylvania

posters

23. Dealing with Research Participants’ Complaints: Experiences from Zimbabwe Sithembile Ruzario, MSc; Resign Gunda; Rutendo Gutsire, BSc, MPH, MSc Medical Research Council of Zimbabwe

24. Design and Implementation of a ‘Researcher User-Friendly’ Chart Review Research IRB Application Amy Gelfand, MD; John Heldens, CIP; Vanessa Jacoby, MD; Vanja Douglas, MD; Liz Tioupine, CIP; Melanie Mace, MA, CIP, CCRP; Joanne Mickalian, MA, CIP; Anita Katona, MPH, CIP University of California, San Francisco

25. Development and Pilot Testing of an Online Module for Ethics Education Based on the Nigerian National Code for Health Research Ethics Olubunmi A. Ogunrin, BSc, MBChB, MSc, FWACP; Temidayo O. Ogundiran, MBBS, MHSc, FWACS, FACS, FRCS; Clement Adebamowo, MD, ScD University of Benin

26. Development of Core Training for IRB Staff: Reimagining the Education and Training Program for New Members of IRB Staff S. Joseph Austin, JD, LLM; Diana Miller, MS; Judy Birk, JD University of Michigan Medical School

27. Differences in Policies for Paying Research Participants

Donna Peters, CIP; Rosemary Cogan, PhD, ABPP, CIP; Katherine Austin, PhD Texas Tech University

28. Discrepancies Identified Between Boxed Warnings and IRB-Approved Informed Consent Risks

Pranathi Lingam, MD; Aleksandra Florek, MD; Eileen M. Yates, MS, CIP; Heather J. Gipson, JD, MA, CIM; Beatrice Nardone, MD, PhD; Steven M. Belknap MD, FACP, FCP; Dennis P. West, PhD; Debra G. Tice, MS, CIP, CCRC Northwestern University

29. Do Client Payments Precipitate Drug Use or Coerce Participation?

David S. Festinger, PhD Treatment Research Institute

30.Does the Principal Investigator Demographic Influence the Enrollment of Minorities in Clinical Trials?

Mary Cataletto, MD; Diane Redmond, CCRA; Shahidul Islam, MPH; Robert D’Antuono, MHA; Tina Berry, CIP; Harry Staszewski, MD Winthrop University Hospital

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31. Don’t Guess When They Say Yes! Do Youth Participants Really Understand What They Are Assenting To?

37. Enhancements to Systematic Approach to Tracking Regulatory Data

32. Drawing Patients in with HIPAA in Comic Form

38. Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by a Developmental Approach

Sharon Zack, MS; Kerry Levin, PhD; Jocelyn Newsome, PhD; Alicia Norberg; Jasmine Folz, MA Westat

Leah R. Eisenberg, JD, MA; Jim Pringnitz; Linda Hasadsri, MD, PhD; W. Edward Highsmith Jr., PhD; Devin Oglesbee, PhD; Rose Anderson Mayo Clinic

33. Effective Evaluation for a Human Research Protection Education Program Sarah B. Fowler-Dixon, PhD, CIP; Martha F. Jones, MA, CIP; Michael Leary, MA, CIP; Jeanne Velders, RN, JD, CIP; Mandi Walsh, MA Washington University in St. Louis

Janice Putnam, PhD, RN, CIP; Victoria Steel, PhD; Meghan Hestand University of Central Missouri

35. Electronically Reinventing the IRB Application and Review Process at a Primarily Undergraduate Teaching Institution Megan Williams, MPA; Chad Goodrich, Jeremy Norris Salem State University

36. Empirical Analysis of Changes to Procedures for Review of Exemption Requests

Hillary A. Edwards, BA, MPH; Tamer Mohamed Said Hifnawy, MD, DrPH; Henry Silverman, MD, MA University of Maryland

39. Establishment of IRB Reciprocity in a Multicenter Translational Research Network

Junko Nishitani, PhD; Zoe H. Hammatt, JD, MPhil; John C. Smith, MSW, CIM, CIP, Brenda J. Klement, PhD; Stephen O. Sodeke, PhD, MA Charles R. Drew University of Medicine and Science

40. Ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants: The Concerns and Solutions Identified for Protecting a Highly Controversial Population

Hila Berger, MPH, CIP; Amy Krenzer, CIP; Nicole Bryan, PhD Montclair State University

41. Facilitating the Use of Alternative Models of IRB Review: Development of an Electronic Reliance Agreement Toolkit Grace G. Kelly, RN, MS; Betsey Herpin, MSN, CCRC, ACRN; Martin Michael, MBA National Institute of Allergy and Infectious Diseases

Christian P. Marks, PhD, MBA, CIP University at Buffalo

selected for “Innovations In...” series

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posters

34. E-Learning Platforms for IRB Protocol Management: A Familiar, Convenient, and Cost Effective Solution for Small Institutions

Elizabeth O’Connell, RN, BSN; Sarah Lein, MS, Pamela Schwingl, PhD, Janet Archer, MSc, Elizabeth Reeves, BSc Social & Scientific Systems, Inc.

Posters Selected for Presentation Recognition Conference Information 42. FDA Warning Letters Citing Exception from Informed Consent for Emergency Research

Valerie Stevenson; Ronald Maio, DO, MS; Erin Bengelink; Robert Silbergleit, MD University of Michigan

43. Frequently Asked Questions: A Tool for Streamlining Information Michele Antisdel, MBA, CCRP; Monika Lau, MEd, CIP; Adam Schechter, PhD, CIP Yale University

44. From GWAS to Omics and Beyond: NIH Expands its Expectations for Sharing Genomic Research Through the Draft Genomic Data Sharing Policy

Erin Luetkemeier, PhD; Rosann Wise; Alice Bailey; Laura Lyman Rodriguez, PhD; Dina N. Paltoo, PhD, MPH National Institutes of Health

posters

45. Go Team! A Winning Approach to IRB Staffing

Cathleen Montano, JD; Jean H. Larson, MBA; Ellen Bedard, MS, CIP; Amy Blakeslee, CIP, CCRP; Brandy Dionne, BS, CIP; Christine Earley, MA, CIP; Michele Antisdel, MBA, CCRP; Jennifer Reese, MS, CIP; Dawn Pedevillano, BS, CIP; Donna LaCivita, MPH Yale University

46. Harnessing Clinical Research in Kenya Through Knowledge Sharing: A Model for Enhancing Transparency and Building Trust Between Stakeholders in Clinical Research Christine Wasunna, BSc, PhD; Jayesh Pandit, MPharm; Edward Abwao, BPharm, MSc-MedStat Kenya Medical Research Institute

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47. Implementation of a Training Program to Teach Core Clinical Research Skills Mina P. Busch, MS, CCRP, CIP; Ellen Skalski, RN, BS; Dana Raab, RN, BSN Cincinnati Children’s Hospital Medical Center

48. Implementing a Community Engagement Strategy in a Busy, Multidisciplinary Research Center: Experiences in Working with Community Representatives in Kilifi, Kenya Betty Kalama; Francis Kombe, MSc; Salim Mwalukore KEMRI-Wellcome Trust Research Programme

49. Implementing a Process for Accelerating Protocol Approval Through Prospective Administrative Review Corbin Dill, CIP; Craig Carson; Kristofer Griffith MD Anderson Cancer Center

50. Improving Efficiency and Review Quality by Applying Continuous Performance Improvement Principles to the IRB Review Process Kelly Hebner, JD; Tara Polek, PhD; Joan Doherty, JD Seattle Children’s Research Institute

51. Improving the Clinical Research Informed Consent Process

Roy Cambria, BS; Ann Rodavitch, MA; Collette Houston, BA; Roger Wilson, MD Memorial Sloan-Kettering Cancer Center

52. Incorporating Research Participants’ Perspectives into Radiation Risk Statements

A. Robert Schleipman, RT, CNMT, MSc; John Fanikos, BS Pharm, MBA; Richard Nawfel, MS, DABR; Sharmila Dorbala, MBBS, MPH Brigham and Women’s Hospital

53. Informed Consent Document and Informed Consent Process: An Exploratory Analysis Barna Ganguly, MBBS, MD PS Medical College

54. Infoshorts: Educating IRB Members in Small Increments

Jean H. Larson, MBA; Cathleen Montano, JD, CIP; Sandra L. Alfano, PharmD, CIP Yale University

55. Issues to Consider and Lessons Learned When Concurrently Transferring Approved Research Projects to a New IRB (Separating from an Academic Affiliate IRB), Implementing a New IRB Program, and Implementing a New IRB Electronic Submission System Laverne Estanol, MS, CHRC, CIP, CCRP; Salvador Doria, BSCE, AA, AS; Theresa Sanchez; Jennifer Dier, CIP VA San Diego Healthcare System

Miwa Suzuki, RN, NMW, PhD; Yuka Ozasa, RN, PhD; Naoko Nii, BN; Masumi Ai, MD; Masayuki Yoshida, MD, PhD Tokyo Medical and Dental University

57. Knowledge + Action = Power: A Multi-Faceted Approach to Education and Empowerment of Your Investigators and IRB Members Jennifer Kucera, MS, CIP University of Nebraska Medical Center

58. Knowledge and Awareness of Nigerian National Code of Health Research Ethics Among Nigerian Biomedical Researchers

Felix Chukwuneke, DDS, MPH, NDP, FWACS; Mariana Kruger; Neca Egbunike University of Nigeria Teaching Hospital

60. Large Scale Prospective Updating of Informed Consent Documents to Lessen Regulatory Burden and Reduce Errors

James Berger; Craig Carson; Kristofer Griffith MD Anderson Cancer Center

61. Lessons Learned: Switching Electronic Systems

Jessica Conrad, MS, CIP; Christy Wise, BA Summa Health System

62. Managing Genomic Findings of Pediatric Clinical Research Studies: Challenges, Ethical Considerations, and Best Practices

Francesca Gould, BA, CCRP Cincinnati Children’s Hospital Medical Center

63. Not Human Subjects Research?

Not So Fast...

Andrea Saltzman, RN, CIP; Stacey Donnelly, MPA; Emily Lipscomb, BA; Janaka Fonseka Broad Institute

64. Ongoing Lessons Learned from a Clinical Research Patient Recruitment Registry at a Large Academic Health Center: Boston University Medical Center’s “Recruitment Services Program of the Clinical and Translational Science Institute (ReSPECT)” Registry Farrah Belizaire Boston University Medical Center

Olubunmi A. Ogunrin, BSc, MBChB, MSc, FWACP University of Benin

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56. Judgment of the Ethical Committee for the Molecular Genetics Predictive Test of Neurology at Tokyo Medical and Dental University in Japan

59. Knowledge and Compliance with Ethical Guidelines Among Medical Researchers in Eastern Nigeria

Posters Selected for Presentation Recognition Conference Information 65. Ousting the Outliers: An In-Depth Exploration into the Longest IRB Approval Periods

70. ProMedica’s Experience Transitioning to the Use of a Central Institutional Review Board

66. Perception of Children’s Assent in Biomedical Research Among Medical Specialists and Trainees in a LowResource Setting

71. Recovering Your HRP Program After a Natural Disaster: An IRB Perspective

Tani L. Prestage, MA, MPH, CIP; Adam McClintock, CIP; Ellen A. Patricia, MS, CIP The Ohio State University

Robinson Chukwudi Onoh, MBBS, FWACS, FMCOG, FMAS, DMAS, C-ART; Odidika Ugochukwu Joannes Umeora, MBBS, FWACS, FMCOG, FICS; Uzoma M. Agwu, MBBS, FWACS, FMCOG; Paul Olizaemeka Ezeonu, MBBS, FICS; Ekpe C. Nathan, MBBS; Toochukwu Joan Petrolina Onoh, MBBS Federal Teaching Hospital Abakaliki

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67. Perceptions of Benefits of Participating in HIV Treatment Clinical Trials

Rosemary Musesengwa, MPH, CRA; Melody E. Phiri-Shana Medical Research Council of Zimbabwe

68. Policy Interventions in Research Ethics Education and Responsible Conduct of Research for Graduate Students of the University of Ibadan, Southwest Nigeria

Kayode Omoniyi Osungbade, MBBS, MSc, FMCPH; Temidayo O. Ogundiran, MBBS, MHSc, FWACS, FACS, FRCS; Clement Adebamowo, MD, ScD University of Ibadan

69. Preparing and Training Your Workforce to Be Ready for E-Submission Systems

Helen Panageas, CIP; Paul Thompson; Andrew Hadaway; Royell Sullivan, BA New York University School of Medicine

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Roberta Redfern, PhD; Melanie Wheeler, RN, BSN, MBA, CCRC ProMedica Health System

Elan Czeisler; Helen Panageas, CIP New York University School of Medicine

72. Recruitment Experience in Clinical Trials from an Inner-City Minority Population

Jane A. Otado, PhD; John Kwagyan, PhD; Alice Ukaegbu, MSN, FNP-BC; Dasheema Jarrett, MA Howard University College of Medicine

73. Research Subjects: How Much Do They Know About Institutional Review Boards Kathleen A. Seabolt, CIM Baptist Medical Center

74. Researcher Risk Perception in Educational Research IRB Applications

Cris Wells, EdD, MBA, CCRP Arizona State University College of Nursing and Health Innovation

75. Research-Related Injury Compensation Policies of US Research Institutions David B. Resnik, JD, PhD; Efthimios Parasidis, JD, MBE; Kelly Carroll, JD, MBE; Jennifer Evans, JD; Elizabeth Pike, JD, LLM National Institute of Environmental Health Sciences

76. Risk, Reward, and the DoubleEdged Sword: Alaska Native Perspectives on Pharmacogenetic Research and Testing

Jennifer Shaw, PhD; Renee Robinson, PharmD; Helene Starks, PhD, MPH; Wylie Burke, MD, PhD; Denise Dillard, PhD Southcentral Foundation

77. Role of Community IRBs and Research Review Committees in Ensuring the Ethics and Integrity of CBPR

Mei-Ling Isaacs; Eric Wat, MA; John Cooks; Elmer Freeman, MSW; Alice Park, MPH; Lola Santos; Sarena Seifer, MD; Nancy Shore, MSW, MPH, PhD Community-Campus Partnerships for Health

82. Sustainability and Fiscal Efficiency as the IRB’s Obligation to Society

Monika Lau, MEd, CIP; Jan Hewett, BSN, RN, JD Yale University

83. Symbiotic Partnerships between the IRB and Academic Programs Emma Meagher, MD; Tracy Ziolek, MS, CIP; Megan Kasimatis Singleton, JD, MBE, CIP; Christine Davison, MBE University of Pennsylvania

84. Tailored Human Research Protections Education for CommunityEngaged Research Partners: The CIRTification Curriculum

Emily Anderson, PhD, MPH Loyola University Chicago Stritch School of Medicine

78. Scientific Misconduct: Attitudes, Perceptions, and Associated Factors in a Developing Country

85. The Effects of Consent Form Placement in Online Studies

79. Starting from Scratch: Training Medical Students to Write Understandable Consent Forms

86. The IRB Harmonization Process: How to Boost Resourcefulness

Patrick Okonta, MD, FWACS, FMCOG, MPH; Theresa Rossouw, MBChB, MPH, DPhil Delta State University

80. Streamlining the Review of Reported Incidents by Seattle Children’s Human Subjects Protection Program Tara Polek, PhD; Kelly Hebner, JD; Joan Doherty, JD Seattle Children’s Research Institute

81. Subject Protection in Surgical Innovation and Research: A Survey on Surgical Innovation Committees

Lindsay McNair, MD, MPH, MSB; Walter Biffl, MD WIRB-Copernicus Group and the Union Graduate College Bioethics Program

Cathleen Montano, JD, CIP; Monika Lau, MEd, CIP; Amy Blakeslee, CIP, CCRP Yale University

87. “The Reality Show”: An Innovative Method of Providing Responsible Conduct of Research Education Kaarkuzhali B. Krishnamurthy, MD; Nancy J. Brown, RN; Angela Lavoie, RN; Michael D’Egidio Beth Israel Deaconess Medical Center

88. The ‘SUBMIT IT’ Card: A Reference Tool for Submitting Research to the IRB Dorean J. Flores, BS, CIP; Emily Chumas; Meredith Burcyk North Shore-Long Island Jewish Health System

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Adam G. Lamm, MD/MA candidate; Nicole M. Deming, JD, MA Case Western Reserve University School of Medicine

Helen C. Harton, PhD; Danielle Stuck; Wayva Lyons, MA; Asha Ganesan; Anita Gordon, MSW University of Northern Iowa

Posters Selected for Presentation Recognition Conference Information 89. To Include or Exclude: Non-English Speakers at a Large Cardiac Clinical Research Institute Andrea Mitsch, MPH; Ross Garberich, MS, MBA; Stephanie Rutten-Ramos, DVM, PhD; Michael Claussen, BS; Joseph Cosico, MA, CRA, CCRC Minneapolis Heart Institute Foundation

90. Unanticipated Problems Involving Risk to Subjects or Others: Process Improvement

Michelle Rodriguez, CIP, CIM; Raffaella Hart, CIP; Mark Sinnett, PharmD; Michael Belotto, MPH, CCRC, CCRA; Portia Rindos, RN, CCRC, CCRA Biomedical Research Alliance of New York

91. Unifying Reviewer Checklists: How Our SBER and Biomedical IRBs Made it Work

posters

Ellen Bedard, MS, CIP; Monika Lau, Med, CIP; Carrie McDaniel, BA, CIP; Cathleen Montano, JD, CIP Yale University

92. Utilization of an Electronic Submission System for Joint IRB Review of International Studies Joseph Gibbons, MD; Charles H. King, MD; Peter M. Siba, PhD; William Pomat, PhD; Norries Pomat; Nancy C. Erdey, PhD; Meghan Kulaszewski; Philip A. Cola, MA; Karya Ottey, MA Case Western Reserve University

93. Utilizing an In-Depth Administrative Pre-Review Process: Improvement in Time to Approval, Quality of Review, and Use of IRB Member Time

Jessica Macha; Catherine Powers, CIP, MBA Ann & Robert H. Lurie Children’s Hospital of Chicago

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94. Views of Dental Professionals and Dental Patients in Jos, Nigeria Concerning the Need for Informed Consent Prior to Participation in Dental Clinical Research Olaniyi Taiwo, BDS, MPH; Raymond Panas The Regional Centre for Oral Health Research and Training Initiatives for Africa

95. Voluntariness in a Diagnostic Trial Farirai Mutenherwa, MSc, MSocSc; Theresa Rossouw, MBChB, MPH, Dphil Biomedical Research and Training Institute

96. Web-Based Investigator Training Program: Easy Access and Incentivized Training Promote Learning Kathy Ababio, BS, CHES; Marie Blake, BSN, RN, CCRC Inova Research Center

97. Welcome to the Agency!

Documenting Research Interns and Volunteers as Agents of the Institution Allison Blodgett, PhD; Michael Centola, MHS, CIP University of Massachusetts Medical School

98. What is the Value of Sharing?

Analysis of Six Years of dbGaP Usage Reveals Success of the NIH Genome Wide Association Studies Policy

Kristofor K. Langlais, PhD; Taunton Paine, MA; Erin Luetkemeier, PhD; Kimberly Tryka, PhD; Dina N. Paltoo PhD, MPH National Institutes of Health

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Posters Selected for Recognition Conference Information “Innovations in…”

Series This year, 13 exemplary posters have been selected for presentation in our new “Innovations in…” series on Thursday, November 7, from 2:00 to 3:15 PM. The “Innovations in…” series is composed of four concurrent discussions on cuttingedge topics. During these sessions, research professionals will present their work in the field of human subjects protections and provide audience members with concrete strategies designed to improve the effectiveness of their HRPPs/IRBs. The posters that will be presented during each panel are listed below, and the following pages provide an opportunity to read the submitted abstracts. These 13 posters will also be on display in The Conference Connection.

Innovations A: Innovations in Research on Controversial Topics

Innovations C: Innovations in Influences on Research Participation

POSTeR 7: A Systematic Review of Placebo/Sham- and Lesion-Controlled Surgical Trials: ethical Issues in Design, Conduct, and Reporting PReSeNTeR: Dorothy e. Vawter, PhD

POSTeR 12: Assessing

Thursday, November 7 from 2:00 to 3:15 PM, Ballroom C Moderated by Steven Joffe, MD, MPH

Conduct and Oversight of Research After a Natural/Man-Made Disaster PReSeNTeR: Holly A. Taylor, PhD, MPH

posters

POSTeR 19:

ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants: The Concerns and Solutions Identified for Protecting a Highly Controversial Population PReSeNTeR: Hila Berger, MPH, CIP POSTeR 40:

Subject Protection in Surgical Innovation and Research: A Survey on Surgical Innovation Committees PReSeNTeR: Lindsay McNair, MD, MPH, MSB POSTeR 81:

Innovations B: Innovations in Genomics and Biobanking Thursday, November 7 from 2:00 to 3:15 PM, Ballroom B Moderated by Paul S. Appelbaum, MD

From GWAS to Omics and Beyond: NIH expands its expectations for Sharing Genomic Research Through the Draft Genomic Data Sharing Policy PReSeNTeR: erin Luetkemeier, PhD POSTeR 44:

Managing Genomic Findings of Pediatric Clinical Research Studies: Challenges, ethical Considerations, and Best Practices PReSeNTeR: Francesca Gould, BA, CCRP POSTeR 62:

Risk, Reward, and the Double-edged Sword: Alaska Native Perspectives on Pharmacogenetic Research and T Testing PReSeNTeR: Jennifer Shaw, PhD POSTeR 76:

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Thursday, November 7 from 2:00 to 3:15 PM, Room 302 Moderated by Jeffrey R. Botkin, MD, MPH

Voluntariness Among Incarcerated Substance Abusers Participating in Research PReSeNTeR: Karen Leggett Dugosh, PhD Does the Principal Investigator Demographic Influence the Enrollment of Minorities in Clinical Trials?

PReSeNTeR: Mary Cataletto, MD POSTeR 30:

Perceptions of Benefits of Participating in HIV Treatment Clinical Trials PReSeNTeR: Rosemary Musesengwa, MPH, CRA POSTeR 67:

Innovations D: Innovations in Communication with Research Subjects Thursday, November 7 from 2:00 to 3:15 PM, Room 312 Moderated by Cynthia A. Gómez, PhD

Don’t Guess When They Say Yes! Do Youth Participants Really Understand What They Are Assenting To? PReSeNTeR: Sharon Zack, MS POSTeR 31:

Drawing Patients in with HIPAA in Comic Form PReSeNTeR: Leah R. eisenberg, JD, MA POSTeR 32:

Incorporating Research Participants’ Perspectives into Radiation Risk Statements PReSeNTeR: A. Robert Schleipman, RT, CNMT, MSc POSTeR 52:

Posters Selected for “Innovations in…” Series POSTeR 7

A Systematic Review of Placebo/Sham- and Lesion-Controlled Surgical Trials: Ethical Issues in Design, Conduct, and Reporting

Thomas B. Freeman, MD; Dorothy E. Vawter, PhD; Barbara Manchec; Michael Brannick, PhD Minnesota Center for Health Care Ethics

Description of the Research: We searched PubMed, Google Scholar, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials for PCSTs and LCSTs posing greater than minimal risk. We identified and systematically reviewed 79 trials reported in english between January 2000 and March 2012. These trials enrolled more than 8,000 subjects, were performed in more than 20 countries, 50% were performed in the United States (in part or in whole), were approved by hundreds of IRBs, and were funded by numerous companies, government agencies, and foundations.

The studies included novel, as well as established interventions, and ranged from early feasibility studies through phase II/III trials. They occurred most often in cardiac surgery and neurosurgery. Pre-determined assumptions about the placebo response varied widely.

The magnitude of the placebo response was frequently underestimated often resulting in underpowered trials.

Assumptions about the magnitude of the lesion effect

POSTeR 12

Assessing Voluntariness Among Incarcerated Substance Abusers Participating in Research Karen Leggett Dugosh, PhD Treatment Research Institute

Problem Statement: There are a host of reasons why individuals participate in research. While these reasons vary from person to person, the decision to participate must be informed and autonomous. A number of legal protections and doctrines have been put into place since World War II to help ensure that participation is informed and autonomous. Although a great deal of empirical research has focused on ensuring that consent is informed, researchers have only recently begun to focus on the empirical examination of the voluntariness of research participation. Voluntariness was defined in The Belmont Report as a choice that is free from undue influence or coercion. Importantly, more recent conceptualizations of voluntariness introduce the concept of subjective experience, suggesting that n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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Problem Statement: Placebo/sham-controlled surgical trials (PCSTs) are valued for the level of evidence they offer. Three well-publicized PCSTs—conducted a decade ago or more—are widely discussed in the literature. The debate, which began with whether PCSTs can ever be ethically appropriate, now concerns when and how they are appropriate. Lesion-controlled surgical trials (LCSTs)—generally more difficult to justify than PCSTs—have received little attention in the research ethics literature. Questions remain about both PCSTs and LCSTs: What are their risk/benefit profiles? What special human subjects protections issues do they pose? Are subjects willing to participate? How feasible are PCSTs and LCSTs? Surgical researchers, IRBs, regulators, funders, and prospective subjects would benefit from a more complete understanding of the ethical and methodological questions that arise in the design, conduct, and reporting of randomized surgical trials that involve placebo/sham- and lesion-controls.

The goals were to evaluate: the scope and frequency of placebo/sham- and lesion-controlled surgical and technical intervention trials; the magnitude and duration of the placebo/sham/lesion response; the risk profiles of the active vs. the placebo/sham/lesion arms; the relative risk of PCSTs vs. LCSTs; common pitfalls; and best ethical and methodological practices.

were rarely reported. More than twice as many studies used lesion controls than used placebo/sham surgery controls. The mortality rates and serious adverse event rates varied markedly both between the active and control arms and between PCSTs and LCSTs. In general, LCSTs posed higher risks and additional types of risks. We observed a pattern of risk in lesion arms that was not evident in single trials. Open-label extension studies and long-term follow-up studies were common strategies for minimizing risks and increasing benefits.

A few reports discussed special ethical considerations involving such matters as informed consent practices and deception. IRBs and regulators imposed ethical constraints on trials, some of which appeared misguided and damaged the integrity of the trial designs. In the absence of agreed upon terminology, reporting practices, and descriptors that can reliably facilitate a successful search of the medical literature for PCSTs and LCSTs, our review may not be fully representative of these trials.

Moreover, the trials in our study are disparate in design and reporting style, which may limit our conclusions. This review did not survey investigators or review consent forms and other trial materials, but relied on published reports. Our findings and recommendations will enhance the guidance available to surgical researchers, IRBs, regulators, funders, prospective subjects, and journal editors regarding the ethical design, conduct, and reporting of PCSTs and LCSTs—some of the highest risk, highest cost, and highest impact clinical research conducted. The unanticipated findings regarding LCSTs necessitate further methodological and ethical guidelines for this type of surgical research.

Posters Selected for Recognition Conference Information “Innovations in…”

Series

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voluntariness may be compromised when an individual perceives external influence. These perceptions, regardless of their accuracy, may compromise an individual’s autonomy. The Coercion Assessment Scale (CAS) measures specific sources of overt coercion and undue influence, as well as specific sources of perceived negative and positive pressures that may influence their decision to participate in research. The purpose of the current study was to use the CAS to examine the voluntariness of participation in a sample of incarcerated individuals participating in a National Institute on Drug Abuse (NIDA)-funded host study examining the impact of the interruption of methadone maintenance treatment during short-term incarceration.

Description of the Research: A total of 91 participants from the host study were recruited for participation and completed the 15-item CAS within one month of recruitment into the host study. Descriptive statistics were calculated for each item to examine the prevalence of different perceptions related to voluntariness in this sample of incarcerated substance abusers. Approximately 19% of participants agreed that they felt that the judge would like it if they entered the study and 6% agreed that they felt that entering the study would help their case. In addition, about 6% of participants felt their parole officer would like it if they entered the study. Overall, 20% of the sample endorsed at least one item. Findings indicate that a number of study participants perceived that their participation (or refusal to participate) could have important repercussions on their criminal justice status, supporting the utility of the CAS as an important tool for research. Assessing voluntariness in this manner could allow researchers to identify who is in need of enhanced consent procedures to address such perceptions, or who may be unsuitable for participation because of issues related to voluntariness. This study was conducted within the context of a single trial being conducted in a single criminal justice setting. Future research should examine the utility of the CAS in other types of studies and criminal justice settings.

POSTeR 19

Conduct and Oversight of Research After a Natural/Man-Made Disaster Holly A. Taylor, PhD, MPH Johns Hopkins Bloomberg School of Public Health

Problem Statement: I have a standing interest in the ethical quality of IRB review. I had the opportunity to

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conduct a pilot project regarding the conduct, review, and oversight of human subjects research on mental/ behavioral outcomes related to man-made and natural disasters. While there is a growing literature on the incidence and prevalence of mental and behavioral health outcomes in the wake of a natural or man-made disaster (Kelen and Sauer 2008; Smith, et al 2009), there will unfortunately be additional opportunities to advance our understanding about the effect of disasters on individuals and communities (Pfefferbaum, et al 2010). In addition, there are gaps in the current evidence base that ought to guide future research efforts to expand and deepen our understanding of post-disaster effects (Collogan, et al 2004; Pfefferbaum and North 2008). Given the priority of meeting the immediate medical and mental health needs of survivors of and witnesses to disaster, when and how to conduct mental and behavioral health research with these populations is logistically and ethically challenging (Fleishman and Wood 2002; Black 2003; Jacobsen and Landau 2003; Levine 2004; Rosenstein 2004; Pfefferbaum and North 2008). It is important for institutions and individuals considering or actively engaged in such research to be ready to review and approve the conduct of systematic data collection under these circumstances. My specific aim was to describe and consider the ethical challenges encountered by principal investigators (PIs) and IRBs conducting and reviewing post-disaster mental and behavioral health research. The overall goal of the project is to iteratively combine empirical and normative methods to identify key issues IRBs/PIs ought to consider in preparing for and reviewing proposals for the conduct of mental and behavioral health research among adults and children affected by a natural or man-made disaster. The ultimate goal of this effort is to determine whether these findings can contribute to considerations regarding the quality of the ethical review of human subjects research.

Methods: With the help of a professional librarian, a systematic review of the literature was conducted to identify research reports published between 2005 and 2012, and to identify a sample of IRBs and PIs able to be key informants. Of the 557 research reports identified, 331 were identified as reports on research conducted in the United States and involved the recruitment and direct engagement with human subjects. The majority of the publications reported on research conducted after the terrorist attacks on the World Trade Center (43%) or Hurricane Katrina (42%).

The resulting list of institutions and investigators was

sampled according to the volume of research they had conducted. In-depth interviews were then conducted with eligible and willing subjects. Eight informants affiliated with 25 of the eligible IRBs were interviewed, and nine informants among the 22 eligible investigators were sampled. All interviews were conducted over the phone, audio recorded, and transcribed. Analysis of the data focused on the identification of themes and patterns among the themes identified.

Preliminary Findings: According to the IRB informants, IRBs adopt a range of models for the conduct of their review of post-disaster research.

Primary concerns among IRBs in their approach to the review of post-disaster research include: the quality of research proposed; level of harm to which subjects may be exposed; burden on subjects; avoiding confusion between research and service; and the safety of research staff. PIs report that IRBs are concerned with quality of research and the level of harm to which subjects are exposed. PIs report a range of procedural and substantive challenges in the conduct of post-disaster research, including: identifying funding sources; access to populations; and securing appropriate referral options for subjects.

Next steps: The next step for this project (the results of which will be presented) will be to consider whether any of the findings, in combination with additional normative analysis, ought to be considered as clear recommendations for IRBs and PIs to consider when reviewing or conducting post-disaster research.

References:

• Black, R. “Ethical Codes in Humanitarian Emergencies: From Practice to Research.” Disasters. (2003) 27.2: 95-108.

• Collogan, L., Tuma, et al. “Ethical Issues Pertaining to Research in the Aftermath of Disaster.” Journal of Traumatic Stress. (2004) 17.5: 363-72.

• Fleischman, A. and E. Wood. “Ethical Issues in Research Involving Victims of Terror.” Journal of Urban Health. (2002) 79.3: 315-21.

• Jacobsen, K. and L. Landau. “The Dual Imperative in Refugee Research: Some Methodological and ethical Considerations in Social Science Research and Forced Migration.” Disasters. (2003) 27.3: 186-206.

• Kelen, G. and L. Sauer. “Trend Analysis of Disaster Health Articles in Peer-Reviewed Publications Pre and Post-9/11.” Disaster Medicine.

(2008) 3.6: 369-76.

• Levine, C. “The Concept of Vulnerability in Disaster Research.”

Journal of T Traumatic Stress. (2004) 17.5: 395-402.

POSTeR 30

Does the Principal Investigator Demographic Influence the Enrollment of Minorities in Clinical Trials?

Mary Cataletto, MD; Diane Redmond, CCRA; Shahidul Islam, MPH; Robert D’Antuono, MHA; Tina Berry, CIP; Harry Staszewski, MD Winthrop University Hospital

Problem Statement: Disparities in access and enrollment for minorities in clinical trials persist despite the enactment of the National Institutes of Health (NIH) Revitalization Act and policy guidelines of other national funding agencies conducting clinical research. Barriers and challenges have been well described for both the recruitment and retention of minority participants, including issues of trust, cultural background, and language.

Research Questions: 1. Did principal investigator (PI) demographics (minority vs. non-minority) influence minority enrollment at our institution during 2010 and 2011?

2. Analyze trends in minority enrollment by study type Methods: All submissions to the IRB at Winthrop University Hospital during the calendar years 2010 and 2011 were reviewed. PIs were queried by email regarding the assignment of race and ethnicity. Minority was defined as non-Hispanic, non-Caucasian. Studies were divided into therapeutic and non-therapeutic, and the demographics of participants in each study were recorded. Studies limited to a single race were excluded. Study enrollment in therapeutic trials was analyzed against the demographics of the PI and the demographics of the surrounding community. Trends in study type with minority participation were analyzed.

Data was analyzed using Wilcoxon rank-sum test and Fisher’s exact test. All calculations were performed using SAS 9.3 (SAS Institute, NC).

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Limitations: The primary limitation of this research is that it is pilot in nature. While informational redundancy occurred among core themes, some unique themes may have been confirmed with additional data collection.

• Pfefferbaum, B. and C. North. “Research With Children Exposed to Disasters.” International Journal of Methods in Psychiatric Research.

(2008) 17.S2: S49-S56.

• Pfefferbaum, B., Maida, et al. “Enhancing National Capacity to Conduct Child and Family Disaster Mental Health Research.” Disaster Research. (2010) 31.40: 237-41.

• Rosenstein, D. “Decision-Making Capacity and Disaster Research.”

Journal of Traumatic Stress. (2004) 17.5: 373-81.

• Smith, E, Wasiaka, J., et al. “Three Decades of Disasters: A Review of Disaster-Specific Literature From 1977-2009.” Prehospital and Disaster Medicine. (2009) 24.4: 306-11.

Posters Selected for Recognition Conference Information “Innovations in…”

Series Results: A total of 275 studies were analyzed. Fifty-two percent (n=132) were therapeutic trials and 48% were non-therapeutic trials (n=120). There were a total of 67 PIs. Conclusions: No significant correlation was identified between minority status of the PI and the demographics of the study participants in the clinical trials in this survey. Racial demographics of the minority participants were more closely correlated with county census data.

Minority enrollment was higher in non-therapeutic trials.

Next Steps: Focus groups will be held with IRB and community leaders to discuss strategies to improve recruitment and retention of minorities in clinical research. educational programs are being developed to assist clinical investigators with the preparation of proposals and progress reports that are compliant with national guidelines for the inclusion, analysis, and reporting of race in federally-funded randomized controlled trials.

POSTeR 31

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Don’t Guess When They Say Yes! Do Youth Participants Really Understand What They Are Assenting To? Sharon Zack, MS; Kerry Levin, PhD; Jocelyn Newsome, PhD; Alicia Norberg; Jasmine Folz, MA Westat

Problem Statement: Federal regulations (45 CFR 46) require researchers to ensure decisions to participate in research are well informed. evidence suggests that individuals often do not understand a study’s informed consent form (Willis, 2006). Children, in particular, are a “vulnerable” population, necessitating special consideration. In most cases, parents provide consent on behalf of the child while the child provides assent. It is difficult for researchers to ascertain whether children actually understand various required elements of consent. Cognitive interviewing uses in-depth, semistructured interviews to assess comprehension of information (Willis, 2005). Traditionally, this method has been used to evaluate survey questions, but it can also be applied to other contexts, such as the informed consent process.

Methods: An assent form for the National Institute on Drug Abuse/FDA Population Assessment of Tobacco

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and Health (PATH) Study was cognitively tested with nine youths, ages 12-17. Respondents were carefully selected to ensure a diverse mixture of youth based on gender, ethnicity, and age. Respondents were 55% female and 44% white, with an average age of 13.8 years. All cognitive interviews were conducted by experienced survey methodologists. Respondents were asked to read a section of the assent form and then probed about specific issues within that section.

The cognitive probes focused primarily on assessing respondent comprehension.

Results: Overall, the youth who participated in the interviews generally understood the key points, including the confidential nature of the study (e.g., parents and teachers would not see their results), the purpose of the study, and the fact that the study is voluntary. However, some aspects of the assent form were not clearly understood. For example, respondents: • Did not understand the duration and frequency of the study interview • Were not familiar with the term “public health records” • Were not clear about how the promise of confidentiality functioned when someone was in danger Conclusions: Cognitive testing assent documents will not only enhance compliance to ethical principles and promote safeguards for voluntary participation, but will also improve respondents’ understanding.

Limitations: Recruited youth lived in Montgomery County, an affluent section of Maryland. To ensure that the assent process is understood by a more representative youth population, additional research should be conducted across a broader geographic region, with youth with less education, and from families with lower socioeconomic status.

Next Steps: Within the field of cognitive interviewing, databases are often created to provide a repository of questions previously tested. A similar database of informed consent materials would be a valuable resource in the area of human subjects protections.

Disclaimer: The views and opinions expressed in this presentation are those of the author only and do not necessarily represent the views, official policy, or position of the United States Department of Health and Human Services or any of its affiliated institutions or agencies.

POSTeR 32

Drawing Patients in with HIPAA in Comic Form Leah R. Eisenberg, JD, MA; Jim Pringnitz; Linda Hasadsri, MD, PhD; W. Edward Highsmith Jr., PhD; Devin Oglesbee, PhD; Rose Anderson Mayo Clinic

Description of the Research: A new approach to the HIPAA Notice of Privacy Practices is needed. In recent years, there has been a rise in the use of stylized, comic-style illustrations for patient education purposes.

Graphic documents convey complex information in an engaging, accessible format. But can they work for a detailed legal document like HIPAA? Two illustrated HIPAA documents have been developed at our institution: the required Notice of Privacy Practices and an authorization to use and disclose personal health information for research purposes. The illustrated forms were developed as a multidisciplinary collaboration among design, illustration, ethics, research, and legal professionals, and they convey all the information required by the HIPAA statute. Although it is unclear

Additional Information: HIPAA forms, and even standard informed consent practices, rarely result in informed patients. However, pictures increase the likelihood that medical information will be read. We will share the process of developing, prototyping, and incorporating patient feedback for several illustrated medical forms, including a Notice of Privacy Practices and consent forms for participation.

POSTeR 40

Ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants: The Concerns and Solutions Identified for Protecting a Highly Controversial Population Hila Berger, MPH, CIP; Amy Krenzer, CIP; Nicole Bryan, PhD Montclair State University

Problem Statement: In reviewing research, the three basic tenets IRBs are expected to abide by are beneficence, justice, and respect for persons. The IRB was challenged in meeting these tenets during the course of a recent review. Given the highlycontroversial participant population of sex offenders, and the methodology initially proposed, there were a multitude of ethical challenges uncovered that required unique solutions. The protocol presented to the IRB was developed to investigate the use of networked technologies and communications for the purpose of human trafficking. To do so, the researchers proposed recruiting “Johns,” or individuals convicted of soliciting sex, and interviewing them to discover how they use the internet and networked technologies to find victims online. Ultimately, the research intends to provide technology-based tools for combating trafficking of minors. So the question for the IRB was how to go about protecting “Johns” while protecting the potential victims and meeting the criteria for approval.

Description of the Research: When working with participants who are convicted of a crime that has high

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Problem Statement: The Health Information Portability and Accountability Act (HIPAA) was enacted in 1996, in part, to provide a framework for protecting the privacy, security, and availability of patient medical information.

One section of HIPAA, the Privacy Rule, requires covered health care institutions to provide patients with a Notice of Privacy Practices. This notice must contain information about how the covered entity may use protected health information. The Privacy Rule divides uses and disclosures of personal health information into two general categories: those that require patient authorization and those that do not (there are also a few special circumstances where patient consent is not required, but objections are honored). In theory, the Notice of Privacy Practices provides crucial information to patients about who may have access to their protected health information. In practice, though, there is evidence that many HIPAA documents are written at a twelfth-grade level and above, while the average American reads at an eighth-grade level. Consequently, many patients do not understand the notices, and the availability of the forms does nothing to increase their knowledge about their privacy rights. From an ethical standpoint, it is not appropriate to consider patient authorization adequate when comprehension is in question. The goal of HIPAA is to help patients understand their rights, not to add another pro forma document to the health care experience.

whether illustrations can satisfy legal requirements to the satisfaction of the IRB, preliminary patient feedback reveals that 80% of adults presented with graphic forms preferred them to their traditional counterparts. If this patient preference correlates with a better understanding of the HIPAA privacy information, and increased retention of the materials, there is a legitimate role for graphic forms in the health care setting.

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amounts of recidivism with children as victims, there is an inherent human nature to protect the possible victims. However, the regulations require a refocus to protecting the “Johns.” The initial protocol was effective in de-identifying the data and maintaining confidentiality.

However, upon further review, we identified several areas that were lacking in protections and worked with the researcher in addressing the three major concerns: participant’s awareness of risk; legal obligations for reporting suspected child abuse; and maintaining confidentiality when a Certificate of Confidentiality (CoC) is not obtainable. Managing participant risk was the impetus for putting into place several of the protections. During the 60-90 minute interview of the “Johns,” there was the possibility that the participant would not only speak of the convicted offenses, but also of the intent to commit additional criminal activity.

To manage the risk for legal action the IRB committee agreed to the following protections: 1. Strong language in the consent that identified the risk of legal action 2. Language in the consent and interview process that encouraged hypothetical responses 3. exacting guidances on how to record data The second major issue was the legal obligation for reporting suspected child abuse in states with three different laws. The project is funded in the state of New dif Jersey, while the researchers proposed recruiting in New York and Oregon. Across the three states, the laws regarding reporting of child abuse vary significantly.

In New Jersey, it is a crime if any citizen does not report sexual abuse of a minor; while in New York, only specific professionals (teachers, social workers, etc.) are required to report under state law. The IRB agreed that the most conservative approach to reporting would be required in an effort to meet the regulations across the country and to protect potential victims. Finally, research involving drug use or sexual behavior is often protected under a CoC. This research did not meet the criteria for a CoC and thus the data and researchers would be subject to subpoenas and other legal actions.

Subsequently, the committee and legal counsel generated appropriate language for the consent that would provide the participants with all risks.

Additional Information: There was little precedent available for reviewers to refer for this type of research.

The novelty subsequently elongated the review process at our institution. On the other hand, the IRB is now prepared with the appropriate protections in place for

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additional research in this area. Other institutions may use this model for reviews with a similar population of participants at times when a CoC is unattainable.

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From GWAS to Omics and Beyond: NIH Expands its Expectations for Sharing Genomic Research Through the Draft Genomic Data Sharing Policy Erin Luetkemeier, PhD; Rosann Wise; Alice Bailey; Laura Lyman Rodriguez, PhD; Dina N. Paltoo, PhD, MPH National Institutes of Health

Problem Statement: Since 2007, the Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies (GWAS) has governed the sharing of GWAS data from human participants in research supported by NIH funding.

The GWAS Policy established the expectation that all such data be made available, with exceptions as warranted, for secondary research uses that are consistent with research participants’ informed consent.

Rapid advances in DNA sequencing and other highthroughput technologies, as well as the dramatic decline in sequencing costs, which substantially increased the research use of these technologies, led NIH to reevaluate data sharing expectations for NIH-supported genomic research. The draft NIH Genomic Data Sharing (GDS) Policy updates and expands the scope of the existing GWAS Policy and maintains the principle of maximizing public benefit by facilitating broad sharing and ensuring the responsible oversight of genomic data sharing. NIH sought public comment on the draft GDS Policy in the spring of 2013, and expects this policy to be implemented in 2014.

Description of the Research: The draft GDS Policy differs from the current GWAS Policy in the following areas: • Scope: The draft GDS Policy broadens the scope beyond human GW GWAS data to include all NIHsupported research generating large-scale human and non-human data types with broad utility for the scientific community. Initially, these data types will include GWAS data and genomic, transcriptomic, or epigenomic data produced by array-based technologies, or data obtained from high-throughput sequencing technologies, as well as data pertinent to the interpretation of these data such as phenotype data, clinical information, and metadata.

• Data Release: Under the draft GDS Policy, the release of human data for secondary use can be deferred for up to six months after data submission, with no publication embargo upon data release. Under the GWAS Policy, data are released immediately, but GW secondary analyses are subject to a publication embargo of up to 12 months.

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• Informed Consent: The draft GDS Policy states that the Institutional Certification should confirm that the submission of data and subsequent sharing for research purposes is “not inconsistent with” the original informed consent, rather than “consistent with” as in the GW GWAS Policy. The revision is intended to help clarify NIH’s expectations for retrospective studies in which the informed consent was silent on data sharing.

Background: Informed consent has been described as a foundational doctrine of medical ethics, a manifestation of respect for subjects’ autonomy, and a counterweight to physician paternalism. A key element is the enumeration and description of risks and discomforts associated with study procedures, investigational drugs, or devices. Many clinical research protocols require imaging procedures. These are used variously for: (i) screening criteria thresholds, such as disease staging; (ii) safety assessments (e.g., cardiac function compromised by study drugs); and (iii) biomarker endpoints. Risks of imaging procedures may be minimal, as in trans-thoracic echocardiography, or more substantial. Ionizing radiation presents known threshold-related deleterious effects at high doses, as well as hypothetical, stochastic risks at low doses, which include development of radiogenic cancers.

Communicating the probability and extent of these risks proves difficult in both clinical and research settings. The communication process and consent documents related to radiation risks are often not institution-specific, seldom use standardized language, may be incorrectly stated, and are often jargon-laden.

These shortcomings compromise participants’ full understanding and may diminish the integrity of the informed consent process.

Additional Information: Through notices in the Federal Register and NIH Guide and two public webinars, NIH sought public comment on all aspects of the draft GDS Policy, in addition to comments on related data management topics such as the potential benefits and harms of broadly sharing genomic research data; factors that NIH should consider in assessing how to balance the benefits of broad data sharing with the protection of research participants; and models that NIH should consider to facilitate access to large-scale controlled-access data, enhance data utility, and protect participant interests. The comments were posted for public access on the NIH GDS website after the close of the public comment period. To assist in implementation of the new policy, NIH established an implementation working group tasked with updating existing policy guidance, developing training resources and additional guidances, and conducting outreach.

A. Robert Schleipman, RT, CNMT, MSc; John Fanikos, BS Pharm, MBA; Richard Nawfel, MS, DABR; Sharmila Dorbala, MBBS, MPH Brigham and Women’s Hospital

Research Question: To determine the appropriate message to convey stochastic risks of ionizing radiation procedures to research participants and to provide a template for investigators. A heretofore missing element was the research participant’s perspective.

Our question—what do research participants want to know concerning radiation—can be further elaborated as: Would carcinogenic potential scare off participants, or would fullest disclosure be preferred, and which risk comparators would be useful to them?

Methods: This protocol was a priori deemed exempt from review by our IRB. We surveyed potential subjects from outpatients and visitors dispersed between pharmacy, radiology, and cardiology waiting areas.

Several trainees also completed the survey. The survey instrument included basic demographics, attained n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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• Risks: In considering risks associated with submitting data to NIH-designated data repositories and the subsequent sharing of such data, the draft GDS Policy separates the consideration of risks associated with groups or populations from those of individuals and their families and adds that all risks should be considered “to the extent relevant and possible,” acknowledging that not all of these risks can be anticipated.

Incorporating Research Participants’ Perspectives into Radiation Risk Statements

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education levels, and subjects’ preferences for how much information they wished to know. Five possible risk statements for a simulated protocol proposing PET/CT scans and x-rays were included. The five risk statements presented varying amounts of information, ranging from broad general statements to specific calculations of effective radiation dose and estimated incidental cancer risk. Several dose comparators (background radiation, maximum occupational limit, etc.) were included. each of the statements were validated in that they are routinely used by either our, or neighboring, institutions, all tertiary care academic medical centers with robust clinical research programs.

Likert scale ratings of the five statements were also sampled to yield quantitative data, which were entered into excel spreadsheets for statistical analysis with SPSS. Due to the complexity of some statements, the survey was only available in english.

Results: We administered the survey to approximately 180 participants, receiving 168 responses. Fifty-nine percent were female. Age classifications were: 18-24 years (17%), 25-49 years (28%), 50-64 years (33%), and 65+ (22%). Participants were well educated: 26% had an advanced degree, 37% had completed a baccalaureate degree, and 24% had attended some college. english was a second language for 7%, and 30% had previously participated in a clinical research protocol. Regarding subjects’ preferences, 131 complete responses were received. Fortyone respondents (31%) preferred a simple concise statement, two respondents (1.5%) preferred minimal information, and 85 respondents (65%) preferred either “maximum information” or “maximum information plus a cancer estimate.” The most detailed statement in terms of estimated dose and cancer risk was designated as the clearest (42%) and, paradoxically, the most worrisome statement, though by a much smaller margin (17%). Mean risk statement rating values were also used for ANOVA and other group comparisons.

Conclusions: The complexity of medical imaging protocols and uncertain risks of ionizing radiation complicates informed consent. To become full participants in clinical research, subjects’ prerogatives, needs, and limitations should be incorporated. Contrary to our assumptions, these participants preferred to receive more, rather than less, information, including cancer estimates. More detailed analyses are forthcoming. Several persons left during the survey, changed their mind, or could not understand the

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language. This project should also be repeated within other cultural contexts.

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Managing Genomic Findings of Pediatric Clinical Research Studies: Challenges, Ethical Considerations, and Best Practices Francesca Gould, BA, CCRP Cincinnati Children’s Hospital Medical Center

Problem Statement: Genetic screening and testing provides a wide range of data about the current, as well as future, health status of not only the individual tested, but also their relatives and future offspring. The ability to sequence individual genomes is leading to identification of an increasing number of risk factors for serious diseases. Sometimes researchers uncover unexpected and surprising test results, referred to as incidental findings, often of varying levels of significance.

Knowledge of these test results not only raises a series of clinical and medical questions, but also highlights a series of complex ethical and social issues as well.

New technologies and the expanding use of genetics research are causing some heated debate. It is often in question whether the researcher has a duty to inform the patient of potentially important health information that may be returned in their results. However, we wonder if the vulnerability of children participating in clinical research presents additional factors that require a more stringent review of this conflict. Research involving children raises ethical questions that are unique to this population including, but not limited to: Who will be informed of the test results? What is the threshold of suggested disclosure? Will the research require future re-consent as participants reach the age of legal majority? Should we limit the amount of information shared with the parents out of respect for the child’s autonomy? Does the frequency of provider contact have an effect on the duty to return individual results? How do we structure the informed consent in regards to all of these questions?

Description of the Research: We conducted a literature review and had discussions with multiple experts in the field—including representatives from our institutional IRB, clinical nurse specialists heavily involved in genetic research, and professors of pediatrics—in order to develop some guidelines. We believe that greater clarity of current recommendations and guidelines can be a highly effective tool for the entire research community.

Results: Genetic research offers both benefits and harms to our pediatric population. Consideration of their use as research participants requires that we pay respect to their collective best interests as well as individual rights. Risks and benefits have to be weighed against not only their present vulnerable dependence, but also over their future decades of life. While patients and families perceive their decisions to be independent and fully informed, overt gaps relating to their protection as research participants have been identified. As a result, we have developed an internal policy that better defines our ethical obligations as researchers to pediatric participants of genome studies.

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Perceptions of Benefits of Participating in HIV Treatment Clinical Trials

The study aimed to address the following objectives: a) To describe to what extent benefits of offered in a clinical trial influenced participants’ decision to participate in the research. b) To describe the types of benefits that participants expected to receive from the study. c) To investigate participants’ opinions on who should make decisions of what is offered as benefits in research and why. d) To make recommendations to the researchers and the regulating bodies about participants’ views on benefits of research so as to influence the decisionmaking purposes.

An exploratory study was carried out to answer these questions. The study used a close-ended questionnaire on participants of an anti-retroviral treatment clinical trial. The questionnaire focused on the following areas: 1. Reasons/motivations for participation in research 2. Expectations on benefits before participation 3. Perceptions of benefits received in the study 4. Decisions made on benefits

Rosemary Musesengwa, MPH, CRA; Melody E. Phiri-Shana Medical Research Council of Zimbabwe

This basic questionnaire was intended to make it clear if participants had an opinion in these issues and if they were ready to be engaged in these types of discussions.

Problem Statement: A major issue arising from the literature is that research in developing countries should not be exploitative in nature, but should provide participants with benefits. Decisions about benefits of research are normally based on international guidelines, ethics committee decisions, and rarely on participants’ views. Given the limited empirical

Methods: A questionnaire was administered to 100 participants of a clinical trial to find out their views about what type of benefits they expected to receive and which ones, if any, influenced their decision to participate.

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Conclusions: Our findings highlight the need for more targeted interventions as part of pediatric consent for genome sequence studies, decisional support for patients and their families, and education of our staff on the necessary protections of the participants involved in this type of research. Our preliminary observations reflect consistent opinion among stakeholders that researchers have a dutiful obligation to: modify the consent documents to better address the unique needs of this patient population (10 minimum consent elements have been identified), take additional precautions during the consent process when dealing with families of children with potentially fatal and/ or progressive diseases, inform patients and their families about health implications that are significant and immediately actionable, prohibit full access to these data at least until the child reaches legal age of majority, honor requests made by mature adolescents, and to hold these duties at a higher level if the general practitioner or clinician is in frequent contact with the research participants. These collective guidelines may be useful to other institutions considering or currently conducting genomic research on children.

data documenting understanding and voluntariness in international research, studies need to be carried out to determine how participants in international research define benefits and which of the benefits they consider to influence their decisions to participate. A pilot study was carried out to explore the perceptions of participants in a clinical trial on the issue of benefits in research. The study sought to answer the following questions: 1. What are the reasons for people to participate in research?

2. What types of benefits do participants expect to receive when they volunteer for research?

3. What do participants think of the benefits they receive in studies?

4. Who do participants think should make decisions on benefits of research?

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to participate in the survey was high, as indicated by a high response rate. The most influencing motivator to participate was mainly the need for healthcare-related benefits, and some were motivated to participate out of curiosity for new interventions for HIV treatment. Most participants said the healthcare benefits were the most important to them and they would worry about the loss of these benefits if they were taken away. Participants generally felt that researchers should decide on the types of benefits to be offered in a study. Other concerns the participants had were post-trial care, paediatric care for their children, and food aid. Before participants entered the study, 52% expected to receive antiretroviral drugs (ARVs), 13% did not expect anything at all, 12% expected healthcare, 9% expected money, and 7% expected health education and psychosocial support. Reasons for participating included: access to ARVs (76%), access to medical care (27%), curiosity (24%), and HIV/AIDS education and psychosocial support (13%). Participants felt decisions regarding benefits should be made by researchers (68%), the Ministry of Health (19%), and research participants (15%).

Conclusions: Participants’ perception of research benefits is that they should improve their health, and their decisions to participate are greatly influenced by the type of benefits.

The preferred form of benefits in this trial was the provision of ARVs, which are inaccessible and unaffordable in the public healthcare system. Participants have shown a willingness to be involved in making decisions on benefits of research. It is an ethical imperative to include study participants in decisions involving them.

Limitations: These study findings were limited in that they reflect the views of people in one urban area participating in one clinical trial and, as such, may not be generalizable to other groups. The questionnaire for the study was predominantly closed ended, meaning that by giving participants choices of predetermined answers, it would limit their responses and thought processes.

Next Steps: A qualitative investigation using focus group discussions and individual open-ended interviews would yield more valuable data on this subject.

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Risk, Reward, and the Double-Edged Sword: Alaska Native Perspectives on Pharmacogenetic Research and Testing

Jennifer Shaw, PhD; Renee Robinson, PharmD; Helene Starks, PhD, MPH; Wylie Burke, MD, PhD; Denise Dillard, PhD Southcentral Foundation

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Problem Statement: The promise of personalized medicine has broad appeal, and pharmacogenomics is the “golden child” of modern medical science. However, pharmacogenetic research and clinical testing (PGX) raise important concerns, especially in communities where past research has perpetrated harm and cultivated distrust of healthcare systems and providers. This study investigated perceptions among Alaska Native (AN) people of PGX, as well as its utility and acceptability in an AN-owned and operated healthcare system.

Methods: Four focus groups, held with 32 AN people in Southcentral Alaska, elicited views about PGX in general and for treatment of four conditions. Data were inductively analyzed for perceived risks and rewards of PGX using tenets of grounded theory and ATLAS.ti 9.2.

Results: Perceived risks of PGX included the potential for healthcare rationing, misuse of information, and increased stigma for AN people. Perceived rewards included the potential for decreased cost of care, improved outcomes, and community development.

Participants also discussed eight contingent conditions (i.e., if/then scenarios) that could mitigate potential risks and increase PGX acceptability, such as the direct involvement of AN people in PGX research and clinical care, and culturally-relevant informed consent.

Participants did not endorse using PGX for nicotine cessation and depression treatment as strongly as for cardiovascular disease and breast cancer.

Limitations: Study findings drawn from a small sample at a single institution have limited generalizability. Males were underrepresented and thus the findings may not represent the views of AN men about PGX. Despite these limitations, these findings may be useful in populationbased healthcare systems with limited resources.

Conclusions: PGX is recognized as a “double-edged sword,” a cutting-edge science with the power to heal as well as harm. These AN study participants’ recognition of the dual potential of PGX tells a cautionary tale for anyone working in communities where past research and clinical practices have produced a legacy of distrust. PGX must be undertaken with respect for these histories, restorative relationship, and responsiveness to the ethical concerns and contingencies of the communities in which we work. Additional research on the perceived utility and acceptability of pharmacogenetic research and testing should be conducted with historically underserved populations

with persistent health disparities. Future research should also examine how explanatory models of illness influence perceived utility of PGX for various conditions (e.g., addiction vs. cancer) and the associated implications for resource allocation in limited-resource healthcare systems.

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Subject Protection in Surgical Innovation and Research: A Survey on Surgical Innovation Committees

Lindsay McNair, MD, MPH, MSB; Walter Biffl, MD WIRB-Copernicus Group and the Union Graduate College Bioethics Program

Methods: An electronic survey was developed to assess the awareness and implementation of the task force recommendations among the surgery department chairs of academic medical centers in the United States and Canada. The brief survey was designed to determine whether an institution had created an SIC and, if so, what the SIC looked like (activity, membership). If the institution did not have an SIC, the survey assessed why and what other mechanisms within the institution were assumed to have oversight of innovative surgery. Additional non-identifying information was collected regarding institution size and characteristics. The Albany College of Pharmacy and Health Sciences IRB determined that the protocol was exempt from IRB review.

Conclusions: Most respondents reported surgical innovation was an institutional strength, but only 23% have created an SIC to provide formal oversight.

Although most of the respondents were from highvolume surgery centers, the existing SICs reviewed surprisingly few procedures. This raises concerns about whether the SICs are being recognized and, since part of their role is to ensure that surgical research is identified and directed to the IRB, if surgical research is occurring that is not recognized as such.

Limitations: Although the response rate was good, since only 23% of institutions (n=14) have an SIC, it is difficult to make conclusions about the SIC role and function. There was no assessment of the perceived effectiveness or value of the SICs. Next Steps: Results will be reported in the surgical literature/conferences, with the intention of promoting additional discussion among surgeons. A follow-up survey may be considered to assess, at institutions that do have an SIC, why the reported use is so low, and what the institutional education and training has been about the role of the SIC.

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Background: A continual challenge in the field of surgery has been the distinction between surgical practice, surgical innovation, and true surgical research (which requires IRB review). In this area, more so than in many other types of biomedical research, it may be difficult to differentiate between a surgeon’s use of an innovative procedure, and evaluation of a new procedure as a research study intended to contribute to generalizable knowledge. Therefore, the possibility that activities that should truly be categorized as research may not be recognized as such remains a concern. In 2008, a task force of the Society of University Surgeons (SUS) issued recommendations that academic institutions create Surgical Innovation Committees (SIC) to review proposed procedures that were considered to be innovative. The SIC’s role would be to determine whether the activity constituted research that required IRB review, or, if the activity was considered innovation, whether additional elements of informed consent might be required above the usual practice standard.

Results: The survey was distributed to 140 persons.

Sixty-five completed surveys were returned (46% response). eighty-four percent reported that their institution promoted innovative surgery as an institutional strength, but 56% of respondents were unaware of the SUS recommendations. Twenty-three percent reported that their institution has an SIC, and 20% more said their institution has discussed or plans an SIC. existing SICs have a median of 10 members.

Ninety-three percent of the SICs had reviewed fewer than 10 procedures in the prior year, and 57% reviewed three or fewer. Most reported alternative mechanisms of oversight (morbidity/mortality conferences (88%), peer review (77%), and outcomes registries (51%)) for innovative surgery.

2013 AER Conference Faculty List* Melissa E. Abraham, PhD, MS Chairperson, Partners Human Research Committee; Assistant Clinical Professor, Harvard Medical School Session: B13

Jaime Arango, EdD, CIP Associate Director of Education Collaborative Institutional Training Initiative (CITI) Program University of Miami Session: C6

Clement Adebamowo, MD, ScD Director, Office of Strategic Information, Research, and Training, Institute of Human Virology, Nigeria; Chairman, National Health Research Ethics Committee of Nigeria; Associate Professor, Epidemiology, University of Maryland, Baltimore Session: Panel IV

Lester J. Arnold, JD Senior Corporate Counsel Pfizer, Inc. Session: B9, D9

Philip M. Alberti, PhD Senior Director Health Equity Research and Policy Association of American Medical Colleges (AAMC) Session: C7

Chris Asmann-Finch, DMH, MS Program Development Specialist and Medical Humanist Human Subjects Protection Program Rutgers University Session: E4

Albert J. Allen, MD, PhD Senior Medical Fellow Bioethics and Pediatric Capabilities Eli Lilly and Company Session: A14, D14, E5

Inge Auerbacher Holocaust Survivor, Author, and Inspirational Speaker Session: GF6

Eric Allen, CIP, CPIA Associate Director of Consulting Services HRP Consulting Group, Inc. Session: D22, E22 Emily E. Anderson, PhD, MPH Assistant Professor of Bioethics Loyola University Chicago Session: E18, GF2 Paul S. Appelbaum, MD Dollard Professor of Psychiatry, Medicine, and Law; Director, Division of Law, Ethics, and Psychiatry; Director, Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics, Department of Psychiatry Columbia University College of Physicians and Surgeons Session: A7, Innovations B, Keynote Address (Nov. 8), Paul S. Appelbaum Luncheon (Nov. 8)

Maria Arnold, CIP IRB Clinical Research Manager South Florida Baptist Hospital Session: D24

A. Cornelius Baker Senior Policy Advisor, National Black Gay Men’s Advocacy Coalition; Technical Advisor, Center on AIDS and Community Health, FHI 360 Session: Pre-Con V John Y. Baker, PhD Research Associate st The 21 Century Partnership for STEM Education Session: Panel IX Elizabeth Bankert, MA Assistant Provost and Interim IRB Director Dartmouth College Session: Pre-Con VII, B10, D20

Marinna Banks-Shields, PhD, LICSW, BCD Captain United States Public Health Service Commissioned Corps Office for Human Research Protections (OHRP) Session: B10, D19 Joni K. Barnard, PhD, CIP Quality Improvement Specialist Social/Behavioral Science Education and Outreach The Ohio State University Session: A6 Mark Barnes, JD, LLM Partner Ropes & Gray Law Firm Session: Panel VII, B9, C11, The Drama of DNA, D18, E9 Edward Bartlett, PhD International Human Research Liaison Office for Human Research Protections (OHRP) Session: A23, E9 John R. Baumann, PhD Executive Director Human Research Protection Program Indiana University Session: B3 Thomas L. Beauchamp, PhD Professor of Philosophy The Kennedy Institute of Ethics Georgetown University Session: Panel III Barry B. Bercu, MD Affiliate Professor of Molecular Pharmacology and Physiology; Professor Emeritus of Pediatrics, University of South Florida Morsani College of Medicine; Biomedical Consultant, Institutional and Global Services Schulman Associates IRB Session: C5 Hila Berger, MPH, CIP Compliance Administrator Montclair State University Session: Innovations A

*This list is current as of 10/31/2013.

Scott Berry, PhD President and Senior Statistical Scientist Berry Consultants Session: C14 J. Andy Bertolatus, MD IRB Co-Chair, Research Services Administration, University of Iowa; Associate Professor of Internal Medicine, University of Iowa Carver College of Medicine Session: E20 Laura M. Beskow, MPH, PhD Associate Professor of Genome Ethics, Law, and Policy Duke Clinical Research Institute Session: A10 Robert Bienkowski, PhD, CIP Consultant RSB Consulting Session: E24 Barbara E. Bierer, MD Senior Vice President for Research Brigham and Women's Hospital Session: The Drama of DNA, D11

Walter Bockting, PhD Professor of Medical Psychology; Co-Director, LGBT Health Initiative, Division of Gender, Sexuality, and Health; Professor, Medical Psychology (in Psychiatry and Nursing); Research Scientist Columbia University/New York State Psychiatric Institute Session: Panel I Marguarette M. Bolton-Blatt, BA, CIP IRB Administrator New York University Session: GF2 Ann C. Bonham, PhD Chief Scientific Officer Association of American Medical Colleges (AAMC) Session: D6 Christina Booth, MS, HPM, CIPP Administrative Chair and Managing Director of IRB Operations, Systems, and Human Research Compliance McLean Hospital Session: C20, D17

Sara Lavinia Brair, MBBS, MD, IMFE Fellow Associate Professor; Deputy Director of Quality and Educational Development Center; Head of the Community Medicine Department Al Neelain University Session: Panel IV Lois Brako, PhD Assistant Vice President for Research University of Michigan Session: A20, D3 Troy Brinkman, JD, MA, CIP Manager of Consulting Services Western Institutional Review Board Session: Pre-Con IX Laura Ruse Brosch, RN, PhD Director Office of Research Protections United States Army Medical Research and Materiel Command Session: B1 Celia Brown Regional Advocacy Specialist New York State Office of Mental Health Session: E17

Greg Biggers Chief Investigator and CEO, Genomera; EIR, Genetic Alliance Session: Panel VIII

David A. Borasky, MPH, CIP Deputy Director Office of Human Research Ethics University of North Carolina at Chapel Hill Session: A23, C9

Michelle Biros, MD Chief of Service Department of Emergency Medicine Hennepin County Medical Center; Professor, University of Minnesota Session: C8

Kristina C. Borror, PhD Director Division of Compliance Oversight Office for Human Research Protections (OHRP) Session: A1, C25, D18

Paula Bistak, DMH, CIP, MS, RN Executive Director Human Subjects Protection Program Rutgers University Session: E4

Robert F. Boruch, PhD, BE Co-Director Center for Research and Evaluation in Social Policy (CRESP) University of Pennsylvania Session: Panel IX

Donna Buckley, MEd, CCRP Senior Clinical Research Coordinator Cincinnati Children's Hospital Medical Center Session: B6

Jeffrey R. Botkin, MD, MPH Professor of Pediatrics and Medical Ethics; Associate Vice President for Research Integrity University of Utah Session: Innovations C, The Drama of DNA, Panel XII, E1

Mina Busch, MS, CCRP, CIP Education Consultant Office of Research Compliance and Regulatory Affairs Cincinnati Children's Hospital Medical Center Session: A10, B6, GF2

Jeffrey P. Braff, DrPH, MBA, CIP Director, Human Research Protections, Kaiser Foundation Research Institute, Kaiser Permanente, Oakland; Institutional Official, Kaiser Permanente Session: GF2

Lynn W. Bush, PhD, MS, MA Faculty, Pediatric Clinical Genetics; Faculty Associate, Center for Bioethics Columbia University Medical Center Session: The Drama of DNA

Marianna J. Bledsoe, MA Independent Research Professional/Consultant Marianna J. Bledsoe Consulting, LLC Session: Pre-Con IV, A16, E16, GF2 Jeremy Block, PhD, MPP Senior IRB Manager, Icahn School of Medicine at Mount Sinai; Adjunct Professor of Public Affairs, Baruch College Session: B17, D5

Elizabeth Buchanan, PhD Endowed Chair in Ethics; Director, Center for Applied Ethics University of Wisconsin Stout Session: Pre-Con X, B21, E21 Lisa Buchanan, MAOM, CIP Public Health Analyst Office for Human Research Protections (OHRP) Session: C10, E6

Wesley Byerly, PharmD Research Compliance Officer University of Texas System Session: A3, E11

Sara Calvert, PharmD Senior Clinical Project Manager Clinical Trials Transformation Initiative (CTTI) Duke Translational Medicine Institute Session: B14 Jessica Candia, CIV, DAF Program Manager Research Oversight and Compliance Division United States Air Force Session: B1 Alexander M. Capron, LLB University Professor; Scott H. Bice Chair in Healthcare Law, Policy, and Ethics; Co-Director, Pacific Center for Health Policy and Ethics University of Southern California Session: Panel III J. Claire Carbary, JD, CIP Regulatory Attorney Quorum Review IRB Session: E20 Mary Cataletto, MD IRB Vice Chair Winthrop University Hospital Session: Innovations C Andrew Chase Vice President of Research Management and Research Finance Partners HealthCare Session: Pre-Con II Paul Christopher, MD Assistant Professor Department of Psychiatry and Human Behavior Alpert Medical School at Brown University Session: A7, B12 Jeffrey M. Cohen, PhD, CIP Chief Executive Officer HRP Consulting Group, Inc. Session: Panel II, B22, D17 Charlotte Coley, MACT, CIP Director IRB Educational Programs Duke University Health System Session: B18, E6, GF2 Jeffrey A. Cooper, MD, MMM Vice President Global Consulting WIRB-Copernicus Group Session: Pre-Con IX, B10, D14 Jeremy Corsmo, MPH, CIP Director

ORCRA Cincinnati Children's Hospital Medical Center Session: C3

Associate Chair of Academic Affairs Department of Pediatrics Connecticut Children's Medical Center Session: A6, E3

Kellina M. Craig-Henderson, PhD Deputy Division Director and Human Subjects Protections Officer National Science Foundation (NSF) Session: A2

Janet Donnelly, RAC, CIP Policy Analyst Office of Good Clinical Practice Office of the Commissioner Food and Drug Administration (FDA) Session: Pre-Con VI, GF5

Brenda Curtis, PhD Health Communication Research Scientist Treatment Research Institute Session: C21 Rebecca Dahl, PhD, CIP Director Human Subjects Protection Program Children’s Hospital Los Angeles Session: C19 Susan Callery D'Amico Vice President R&D Quality Assurance AbbVie, Inc. Session: A5 Rebecca Davis, PhD, RN Associate Professor of Nursing Grand Valley State University Session: E23 Liza Dawson, PhD Team Leader Research Ethics Team Basic Sciences Program Division of AIDS National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Session: A26 Susan Delano, CIP Deputy Managing Director Research Foundation for Mental Hygiene, Inc. Session: B17 George D. Demetri, MD Director, Ludwig Center at DanaFarber/Harvard Cancer Center and Center for Sarcoma and Bone Oncology; Senior Vice President for Experimental Therapeutics, Dana-Farber Cancer Institute Session: Keynote Address (Nov. 7) Neal Dickert, MD, PhD Assistant Professor Division of Cardiology and Department of Epidemiology Emory University School of Medicine and Rollins School of Public Health Session: Pre-Con I, Panel VI, C8 Francis DiMario, MD, MA, CIP

Stacey Donnelly, MPA Director Sponsored Research Broad Institute Session: B16 Kelly Dornin-Koss, MPPM, RN, CIP Director Education and Compliance Office for Human Subject Research University of Pittsburgh Session: A19 James DuBois, PhD, DSc Director, Bander Center for Medical Business Ethics; Hubert Maeder Professor of Health Care Ethics Saint Louis University Session: E18 Esther Duflo, PhD Abdul Latif Jameel Professor of Poverty Alleviation and Development Economics; Director, Abdul Latif Jameel Poverty Action Lab (J-PAL) Massachusetts Institute of Technology Session: Keynote Address (Nov. 8) Karen Leggett Dugosh, PhD Research Scientist Treatment Research Institute Session: Innovations C, Panel X Linda Ehler, RN, MN Senior Nurse Consultant National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Session: E2 Susan Ehringhaus, JD Office of Interaction with Industry Partners HealthCare Session: Pre-Con II Leah R. Eisenberg, JD, MA Instructor of Medical Humanities University of Arkansas for Medical Sciences Session: Innovations D

Melissa Epstein, PhD, CIP IRB Administrator Albert Einstein College of Medicine of Yeshiva University Session: C13

Megan Frame Membership Coordinator Public Responsibility in Medicine and Research (PRIM&R) Session: GF7

Ruth R. Faden, PhD, MPH Director and Philip Franklin Wagley Professor of Biomedical Ethics Berman Institute of Bioethics The Johns Hopkins University Session: Panel III

Elizabeth Frank, EdM Patient Advocate Dana-Farber Cancer Institute Session: Pre-Con IV, A16

Owen Faris, PhD Deputy Director Division of Cardiovascular Devices Center for Devices and Radiological Health Food and Drug Administration (FDA) Session: A8, C1, D8 Michelle Feige, MSW, LCSW-C Acting Director Division of Education and Development Office for Human Research Protections (OHRP) Session: A22, B17, E25 Ruth L. Fischbach, PhD, MPE Director Center for Bioethics Columbia University Session: The Drama of DNA Susan S. Fish, PharmD, MPH, MA Professor of Biostatistics and Epidemiology, Boston University School of Public Health; Director of the MA in Clinical Investigation Program, Boston University School of Medicine Session: B25, D25 Celia B. Fisher, PhD Director Center for Ethics Education Fordham University Session: C21 Emily C. Fogler, Esq. Senior Legal Counsel Office of the General Counsel Partners HealthCare Session: Pre-Con II, A15 David G. Forster, JD, MA, CIP Chief Compliance Officer WIRB-Copernicus Group Session: A5, C3, E1

Elmer Freeman, MSW, PhD(c) Executive Director, Center for Community Health Education Research and Service, Inc.; Adjunct Assistant Professor and Director, Urban Health Programs and Policy, Bouvé College of Health Sciences, Northeastern University Session: B18 William Freeman, MD, MPH, CIP Director of Tribal Community Health Programs; Human Protections Administrator Northwest Indian College Session: C17 Sharon Freitag Director Research Ethics Office St. Michael's Hospital Session: D12 Robert W. Frenck, MD Professor of Pediatrics Cincinnati Children's Hospital Medical Center Session: Pre-Con XI, C10 Dean R. Gallant Retired--Assistant Dean and IRB Executive Officer Harvard University Session: Pre-Con VII, B22, Panel IX Samual Garner Bioethicist Henry M. Jackson Foundation for the Advancement of Military Medicine National Institutes of Health (NIH) Session: A26 George Gasparis, CIP President The PEER Consulting Group Session: C4, D18

Atul Gawande, MD, MPH Director, Ariadne Labs; General and Endocrine Surgeon, Brigham and Women’s Hospital; Professor of Surgery, Harvard Medical School; Professor, Department of Health Policy and Management, Harvard School of Public Health Session: Keynote Address (Nov. 7) Leonard Glantz, JD Professor of Health Law, Bioethics, and Human Rights Boston University School of Public Health Session: Panel V Alexandra K. Glazier, JD, MPH Vice President and General Counsel, New England Organ Bank; Lecturer in Law, Boston University School of Law Session: B26 Rachel Glennerster, PhD Executive Director Abdul Latif Jameel Poverty Action Lab (J-PAL) Massachusetts Institute of Technology Session: Panel IX Sara F. Goldkind, MD, MA Senior Bioethicist Office of Good Clinical Practice Food and Drug Administration (FDA) Session: C8 Cynthia A. Gómez, PhD Director Health Equity Institute for Research, Practice, and Policy San Francisco State University Session: Innovations D Bruce Gordon, MD Executive Chairman, IRB; Professor, Pediatrics University of Nebraska Medical Center Session: Pre-Con VII, D5, E6, GF2 Valery M. Gordon, PhD, MPH Acting Director Clinical Research Policy Office of Clinical Research and Bioethics Policy Office of Science Policy National Institutes of Health (NIH) Session: A26, D1 Julia Gorey, JD Public Health Analyst Office for Human Research Protections (OHRP) Session: A12, B12, D16, E1 Francesca Gould, BA, CCRP

Regulatory Affairs Specialist Cincinnati Children's Hospital Medical Center Session: Innovations B Kristen Grace MD, PhD Senior Scientist-Investigator Office of Research Integrity Division of Investigative Oversight United States Department of Health and Human Services (DHHS) Session: D18

Dorotha Love Hall, PhD, MPA, CIP Acting Country Director—Angola Centers for Disease Control and Prevention (CDC) Session: GF4

Robert Hendersen, PhD Chair Department of Psychology Grand Valley State University Session: C23

Amanda Hammond, JD Senior Director Research Protections Administration City of Hope Session: Pre-Con IX, E25

Julia Hesse, JD, M. Bioethics Partner Choate, Hall & Stewart LLP Session: C15

Christine Grady, RN, PhD Chief Department of Bioethics Clinical Center National Institutes of Health (NIH) Session: The Drama of DNA, D1

Susie A. Han, MA, MA Deputy Director and Principal Policy Analyst New York State Task Force on Life and the Law New York State Department of Health Session: B15

Jonathan M. Green, MD Associate Dean and Executive Chair of the IRB Washington University School of Medicine Session: Pre-Con IX

Karen Hansen Director Institutional Review Office Fred Hutchinson Cancer Research Center Session: Pre-Con V, GF2

Laurence Greenhill, MD Ruane Professor of Psychiatry New York State Psychiatric Institute Session: E5

Ann Hardy, DrPH Extramural Human Research Protection Officer National Institutes of Health (NIH) Session: A26, C15

William Grizzle, MD, PhD Professor of Pathology The University of Alabama at Birmingham Session: Pre-Con IV

Deneil Harney, MPH, MSW Human Subjects Protection Specialist University of Michigan Medical School Session: C8

Michelle Groman, JD Associate Director Presidential Commission for the Study of Bioethical Issues Session: A17, B2

Shannon Harr, CIM, EdD Director Research Integrity and Compliance Morehead State University Session: A24, C24

Felix A. Khin-Maung-Gyi, PharmD, MBA,CIP, RAC, FRAPS Chief Executive Officer Chesapeake IRB Session: B24

Carl Hart, PhD Associate Professor of Psychology Columbia University Session: Panel I

Cynthia Hahn Research Compliance Officer North Shore-LIJ Health System Session: B14 Karen Hale, RPh, MPH, CIP Director Office of Responsible Research Practices The Ohio State University Session: Pre-Con VIII, B5, C12

Kate Gallin Heffernan, JD Counsel Verrill Dana LLP Session: A15, B26, D11, E15 Christina Heide, JD Senior Health Information Privacy Policy Specialist United States Department of Health and Human Services (DHHS) Session: A15

Yvonne Higgins, CIP Vice President Quality Management Copernicus Group IRB Session: D13, GF5 Susie Hoffman, RN, BSN, CIP Director IRB for Health Sciences Research University of Virginia Session: D20 Elizabeth Hohmann, MD Chair and Physician Director Partners Human Research Committees Partners HealthCare Massachusetts General Hospital and Brigham and Women's Hospital Session: Pre-Con II, B13, Panel VII Scarlett Hopkins, MA, RN Director Community Engagement and Clinical Support Core Center for Alaska Native Health Research University of Alaska Fairbanks Session: C17 Leslie Howes, MPH, CIP Director Quality Improvement Program Harvard School of Public Health Session: B19 Elisa A. Hurley, PhD Education Director Public Responsibility in Medicine and Research (PRIM&R) Session: The Drama of DNA, GF6 Stephen S. Intille, PhD, SM, BSE Associate Professor of Computer and Information Science and Health Sciences Northeastern University Session: Panel XI Gwynne L. Jenkins, PhD, MPH Senior Policy Advisor to the Director Office of Clinical Research and Bioethics Policy Office of Science Policy National Institutes of Health (NIH) Session: D1

Steven Joffe, MD, MPH Emanuel and Robert Hart Associate Professor Perelman School of Medicine University of Pennsylvania Session: Pre-Con XI, Innovations A, C10, The Drama of DNA, D16 Dahron Johnson, BA Chaplain and IRB Community Member Tennessee Valley Healthcare System Session: A25, GF2 L. Andrew Jones, PhD, SPHR, CIP Deputy Director Research Protections Division Office of Naval Research Session: B1 Martha Jones, MA, CIP Executive Director Human Research Protection Office Washington University in St. Louis Session: D3 Julie Kaneshiro, MA Policy Team Leader Office for Human Research Protections (OHRP) Session: Pre-Con II, A1, B16, C18, E16 Nancy E. Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health Berman Institute of Bioethics The Johns Hopkins University Session: Panel III, The Drama of DNA Hallie Kassan, MS, CIP Director Human Research Protection Program North Shore-LIJ Health System Session: D12 Moira Keane, MA, CIP Retired--Executive Director Human Research Protection Program University of Minnesota Session: Pre-Con III, D7 Marianne Kearney Clinical Research Program Project Manager Partners HealthCare Session: Pre-Con II Sarah Kiskaddon, JD, CIP Director of Business Development, Communications, and Public Relations Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) Session: D3

Caroline Kithinji, BS, MS Research Officer Kenya Medical Research Institute Session: Pre-Con V, C9 Richard Klein HIV/AIDS Program Director Office of Special Health Issues Food and Drug Administration (FDA) Session: A8 Valerie Gutmann Koch, JD Visiting Assistant Professor of Law Illinois Institute of Technology ChicagoKent College of Law; Lecturer in Law, Medicine, and Ethics, University of Chicago MacLean Center for Clinical Medical Ethics Session: B15 Joseph A. Konstan, PhD Professor; Distinguished McKnight University Professor and Distinguished University Teaching Professor of Computer Science and Engineering University of Minnesota Session: Pre-Con X, Panel II, C22 Susan Z. Kornetsky, MPH Director Clinical Research Compliance Boston Children's Hospital Session: Pre-Con VIII, B7, Panel VIII, The Drama of DNA Edward “Greg” Koski, PhD, MD President and Co-Founder Alliance for Clinical Research Excellence and Safety (ACRES) Session: Pre-Con V, D6 Kaarkuzhali Babu Krishnamurthy, MD Director Human Subjects Protection Office Beth Israel Deaconess Medical Center; Assistant Professor of Neurology, Harvard Medical School Session: E12 Jennifer Kulynych, JD, PhD Senior Counsel; IRB Counsel Legal Department The Johns Hopkins Hospital and Health System Session: C11 Dario Kuzmanovic, BA, CRA, MHSc Research Ethics Manager and Analyst University of Toronto Session: C25 Pramod M. Lad, PhD, MBA, MS, CIP Senior Quality Assurance and Education Specialist Children’s Hospital Los Angeles Session: C19

John D. Lantos, MD Director, Children's Mercy Bioethics Center; Professor of Pediatrics, University of Missouri-Kansas City Session: Panel XII Emily Largent, RN Research Fellow National Institutes of Health (NIH) Session: Pre-Con I Lisa M. Lee, MS, PhD Executive Director Presidential Commission for the Study of Bioethical Issues Session: A17, B2 Joanne Less, PhD Director Office of Good Clinical Practice Food and Drug Administration (FDA) Session: C1 Robert J. Levine, MD Professor of Medicine and Lecturer in Pharmacology Yale University Session: Pre-Con V, Panel III Eifaang Li, DVM, MPH, CIP Director Research Compliance and Quality Improvement Cedars-Sinai Medical Center Session: B3 Rebecca Li, PhD Executive Director Multi-Regional Clinical Trials (MRCT) Center Harvard University Session: Pre-Con V, A5, E9 Gregorio Lim, CIP Human Subjects Protection Program Administrator The Boeing Company Session: C6 Kim Lincoln Senior Project Specialist Office of Interactions with Industry Partners HealthCare Session: Pre-Con II Tomas A. Lipinski, JD, LLM, PhD Director and Professor School of Library and Information Science Kent State University Session: E21 Scott Lipkin, DPM, CIP Chief Network Office of Research and Innovation Lehigh Valley Health Network Session: B24, E3

Ernest D. Litwack, PhD Staff Fellow Food and Drug Administration (FDA) Session: E8 Bebe Loff, PhD Head of Human Rights and Bioethics Department of Epidemiology and Preventive Medicine Monash University, Melbourne Session: Pre-Con V Sana Loue, PhD, JD, MPH, MSSA Professor, Department of Bioethics; Vice Dean, Faculty Development and Diversity Case Western Reserve University School of Medicine Session: Pre-Con V, Panel IV

Ellen Marakowitz, PhD Interim IRB Co-Chair; Advisor, Master’s Program in Anthropology Columbia University Session: B23, C15 Monika S. Markowitz, PhD, MA, MSN, RN Director Office of Research Integrity and Ethics Virginia Commonwealth University Session: D23 Patricia A. Marshall, PhD Professor of Bioethics Case Western Reserve University School of Medicine Session: Panel VI

Kimberly Hensle Lowrance, EdM, PHR Managing Director Public Responsibility in Medicine and Research (PRIM&R) Session: GF7

Justin McCarthy, JD Senior Vice President; Associate General Counsel Pfizer, Inc. Session: Panel VII

Erin Luetkemeier, PhD Health Science Policy Analyst Office of Science Policy National Institutes of Health (NIH) Session: Innovations B

Gianna McMillan, BA Founder We Can, Pediatric Brain Tumor Network Session: GF1

Maeve Luthin, JD Professional Development Manager Public Responsibility in Medicine and Research (PRIM&R) Session: A5, GF7

Lindsay McNair, MD, MPH, MSB Chief Clinical Research Officer WIRB-Copernicus Group Session: Innovations A, B4, D25, E14

Patricia MacCubbin, MS President and CEO Research Ethics Group Session: A24 Diane M. Maloney, JD Associate Director for Policy Food and Drug Administration (FDA) Session: B8, C1 Amulya Mandava, BA Research Fellow National Institutes of Health (NIH) Session: Pre-Con I Barry Mangum, PharmD Associate Professor, Clinical Pharmacology; Assistant Clinical Professor, Pediatrics Duke University Medical Center Session: A14 Greg E. Manship, MDiv, DBe(c), CIM, CIP IRB Coordinator and Human Protections Administrator University of Indianapolis Session: GF2

Patrick McNeilly, PhD, CIP Senior Health Policy Analyst Food and Drug Administration (FDA) Session: A12, GF5 Eric M. Meslin, PhD Director, Indiana University Center for Bioethics; Professor of Bioethics and Associate Dean, Indiana University School of Medicine Session: Panel IV Donna A. Messner, PhD Research Director Center for Medical Technology Policy Session: E20 William J. Meurer, MD, MS Assistant Professor Department of Emergency Medicine University of Michigan Session: C14 Franklin G. Miller, PhD Bioethicist National Institutes of Health (NIH) Session: Panel VI

Jonathan Miller, MPPA, CIP IRB Director The University of Alabama at Birmingham Session: D22 Susan M. Miller, MD, MPH Associate Professor Weill Medical College and Cornell University Session: Pre-Con V Joseph Millum, PhD Staff Scientist Clinical Center Department of Bioethics & Fogarty International Center National Institutes of Health (NIH) Session: Pre-Con I, Pre-Con V, A26 Celia Molvin, MSW, CIP Senior HRPP Lead Research Compliance Office Stanford University Session: GF2 Cynthia J. Monahan, MBA Director Charles River Campus IRB Boston University Session: D23 Tara Moore QA Specialist Wellspan Health York Hospital Session: D13 Lindsay Motz, CIM Human Subjects Research Database Manager United States Department of Energy (DOE) Oak Ridge Associated Universities Session: D2 F. Lisa Murtha, Esq., CHC, CHRC Partner Dentons US LLP Session: Pre-Con VI, A11, E11 Rosemary Musesengwa, MPH, CRA National Coordinator Medical Research Council of Zimbabwe Session: Pre-Con V, Innovations C, GF2 Camille Nebeker, MS, EdD IRB Member and Assistant Professor University of California San Diego Session: Panel XI Daniel K. Nelson, MSc, CIP Director, Office of Human Research Ethics; Professor of Social Medicine; Adjunct Professor of Pediatrics University of North Carolina at Chapel Hill Session: Pre-Con III, A18, B5, E1

Robert “Skip” Nelson, MD, PhD Deputy Director and Senior Pediatric Ethicist Office of Pediatric Therapeutics Food and Drug Administration (FDA) Session: Pre-Con XI, B7, The Drama of DNA

Betto Ortiz, MS, PMP, CIPM Contractor Clinical Research Implementation SME OPCRO-Division of AIDS National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Session: E2

Eunice Yim Newbert, MPH Manager Education and Quality Improvement Program Boston Children's Hospital Session: D19

Dina N. Paltoo, PhD, MPH Director Genetics, Health, and Society Program Office of Science Policy National Institutes of Health (NIH) Session: C16, D1

Edward Nunes, MD Professor of Clinical Psychiatry Columbia University College of Physicians and Surgeons/New York State Psychiatric Institute Session: Panel X

Helen Panageas, CIP Associate Director of the IRB New York University Langone Medical Center Session: A13

Kelley O'Donoghue, MPH, CIP Executive Director of the IRB University of Rochester Session: C6, E13 Kathleen O’Hara, MSW PhD Candidate Columbia University School of Social Work Session: E17 P. Pearl O'Rourke, MD Director Human Research Affairs Partners HealthCare Session: Pre-Con II, Panel VIII, The Drama of DNA Laura Odwazny, JD, MA Senior Attorney Office of the General Counsel United States Department of Health and Human Services (DHHS) Session: Pre-Con X, Panel II, B15, C2, D21, E21 Nancy A. Olson, JD Director Human Research Office and Institutional Review Boards University of Mississippi Medical Center Session: E25 Nancy Ondrusek, PhD Research Ethics Officer Public Health Ontario Session: A4

Sangeeta Panicker, PhD Director Research Ethics American Psychological Association Session: C23 Catherine Parker, RN, BSN Team Lead Human Subject Protection Branch Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration (FDA) Session: C1 Wayne Patterson, PhD Associate Vice President for Research University of Texas at Austin Session: B11 Cynthia Pearson, PhD Director of Research Policy and Methods, Indigenous Wellness Research Institute; Assistant Professor, School of Social Work, University of Washington Session: C17 Cheri Pettey, MA, CIP Quality Improvement Specialist Regulatory and Exempt Determinations The Ohio State University Session: C20 Sean Philpott, PhD, MSBioethics Director Center for Bioethics and Clinical Leadership Union Graduate College Session: B4, C4

Jan Piasecki, PhD, MA Asssistant Professor Jagiellonian University Medical College Session: Pre-Con V Richard Platt, MD, MSc Professor and Chair, Department of Population Medicine, Harvard Medical School; Executive Director, Harvard Pilgrim Health Care Institute Session: D4 Ernest D. Prentice, PhD Associate Vice Chancellor, Academic Affairs; Professor, Genetics, Cell Biology, and Anatomy University of Nebraska Medical Center Session: C5 Ivor A. Pritchard, PhD Senior Advisor to the Director Office for Human Research Protections (OHRP) Session: Pre-Con VI, Panel XI Tom Puglisi, PhD Chief Officer Office of Research Oversight Department of Veterans Affairs Session: Panel XII Joan Rachlin, JD, MPH Executive Director Public Responsibility in Medicine and Research (PRIM&R) Session: Keynote Address (Nov. 9), Joan Rachlin Luncheon (Nov.9), GF1 Jessica Randall-Aprea, MA, CIP Manager Compliance Oversight Team Institutional Review Board Columbia University Medical Center Session: D19, GF2 Kari Babski Reeves, PhD, CPE Associate Professor Department of Industrial and Systems Engineering Mississippi State University Session: GF2 Paul J. Reitemeier, PhD Chair Human Research Review Committee Grand Valley State University Session: D24, E23 Josiah D. Rich, MD, MPH Professor of Medicine and Community Health Brown University Session: B12

James Riddle, MCSE, CNE, CIP, CPIA Assistant Director Institutional Review Office Fred Hutchinson Cancer Research Center Session: E13 Suzanne M. Rivera, PhD, MSW Associate Vice President for Research Case Western Reserve University Session: A13 Laura Lyman Rodriguez, PhD Director Division of Policy, Communications, and Education National Human Genome Research Institute (NHGRI) National Institutes of Health (NIH) Session: B16, C16, The Drama of DNA Lori Roesch, CIM, CIP Manager and Human Protections Administrator Research Subject Protection Program Aurora Health Care, Inc. Session: C24 Kristen B. Rosati, JD Shareholder and President American Health Lawyers Association Session: Pre-Con IV Susan L. Rose, PhD Executive Director Office for Protection of Research Subjects University of Southern California Session: A25 B. R. Simon Rosser, PhD, MPH, LP Professor; Director, HIPS Program University of Minnesota Session: Panel II Karen H. Rothenberg, JD, MPA Senior Advisor to the Director on Genomics and Society National Human Genome (NHGRI) Research Institute National Institutes of Health (NIH) Session: The Drama of DNA Rebecca Rousselle, CIP Director of the IRB Emory University Session: Pre-Con VI Brenda Ruotolo, CIP Interim Executive Director of the IRB Columbia University Session: D12 Andrew Rusczek, JD, M.Bioethics Counsel Verrill Dana LLP Session: C18, D15

Michele Russell-Einhorn, JD Senior Director Office for Human Research Studies Dana-Farber Cancer Institute Session: Pre-Con IV, A16. Panel XII Carla Saenz, PhD Bioethics Regional Advisor Pan American Health Organization Session: Pre-Con V Cheryl Savini, CIP Principal and COO HRP Consulting Group, Inc. Session: C13 A. Robert Schleipman, RT, CNMT, MSc Health Physics Educator Brigham and Women's Hospital Session: Innovations D Melissa Schlenker, MS, CCRC, CIP IRB and Clinical Trials Manager Wellspan Health - York Hospital Session: D13 Sebastian Schneeweiss, MD Vice Chief Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Session: D4 Ada Sue Selwitz, MA Director, Office of Research Integrity; Adjunct Associate Professor, Department of Behavioral Science University of Kentucky College of Medicine Session: Pre-Con VII, A12, E16 Elizabeth Senft, MDiv, MLS Research Community Liason Cincinnati Children's Hospital Medical Center Session: A10 Seema Shah, JD Bioethicist and Faculty Member National Institutes of Health (NIH) Session: Pre-Con I Robyn S. Shapiro, JD Partner Health Law Drinker Biddle & Reath LLP Session: A11, B11 Jennifer Shaw, PhD Researcher Southcentral Foundation Session: Innovations B

Cynthia Shindledecker Director Health Sciences and Behavioral Sciences IRB University of Michigan Session: A20 Nicole Sieffert, BA, CCRC Program Director Biorepository Regulatory Support MD Anderson Cancer Center Session: Pre-Con IV, A16, GF2 Julie Simpson, PhD Director Research Integrity Services University of New Hampshire Session: B23 Megan Kasimatis Singleton, JD, MBE, CIP Associate Director Human Research Protections University of Pennsylvania Session: D15 Lynn E. Smith, JD, CIP Director Huron Consulting Group Session: E24 Samantha Smith, PhD Public Health Analyst Office for Human Research Protections (OHRP) Session: B22, C20, E12 Lauren B. Solberg, JD, MTS Assistant Professor Program in Bioethics, Law, and Medical Professionalism University of Florida Session: C22, D10 Donna Spruijt-Metz, PhD Director Mobile and Connected Health Program Dornsife Center for Economic and Social Research University of Southern California Session: B21, D21, Panel XI Sujatha Sridhar, MBBS, MCE Executive Director Research Compliance, Education, and Support Services The University of Texas Health Science Center at Houston Session: A3 Matthew Stafford, BA IRB Manager Office of Clinical Investigation Boston Children's Hospital Session: C25

Irene Stith-Coleman, PhD Director Division of Policy and Assurances Office for Human Research Protections (OHRP) Session: A1, B20, D5, GF5 Suzanne Stone, MA, CIP Consultant Session: A22, E22 Walter L. Straus, MD, MPH Global Director for Scientific Affairs-Vaccines Merck Co., Inc. Session: A4, B8, D4 David H. Strauss, MD Deputy Director for Research, New York State Psychiatric Institute; Associate Clinical Professor of Psychiatry, Columbia University; Vice Chairman for Research Administration, Ethics and Policy , Department of Psychiatry, Columbia University College of Physicians and Surgeons Session: Panel I, E5, Panel X Jeremy M. Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine The Johns Hopkins University Session: A17, Panel V, B9 Elyse I. Summers, JD President and CEO Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) Session: A3, B3, C12, D3, E3, GF3 Karen Szala-Meneok, PhD Senior Ethics Advisor McMaster University Session: B23 Adrienne Tanner, CIP IRB Administrator Office for the Protection of Human Subjects University of California Berkeley Session: A21 Erica Tauriello, CIP Manager Human Research Program Wentworth Douglass Hospital Session: GF2 Holly A. Taylor, PhD, MPH Associate Professor Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health Session: Innovations A, A26

Sharon F. Terry, MA President and CEO Genetic Alliance Session: Pre-Con IV, Panel VII, Panel VIII Hugh Tilson, MD, MPH, DrPH Adjunct Professor and Senior Advisor University of North Carolina at Chapel Hill School of Public Health Session: A4, D4 Susan Brown Trinidad, MA Research Scientist University of Washington Session: Panel I Robert D. Truog, MD Professor, Medical Ethics, Anesthesiology, and Pediatrics; Director, Clinical Ethics, Harvard Medical School; Executive Director, Institute for Professionalism and Ethical Practice; Senior Associate in Critical Care Medicine, Boston Children's Hospital Session: Panel V Min-Fu Tsan, MD, PhD Deputy Chief Officer Department of Veterans Affairs Session: E19 Peter Vasilenko, PhD Program Director Alion HRPP Accreditation Program Alion Science and Technology Session: Pre-Con VI, C2 Dorothy E. Vawter, PhD Associate Director Minnesota Center for Health Care Ethics Session: Innovations A Kenneth A. von Kluck, JD Attorney Howard & Howard PLLC Session: GF2 Steven Wakefield Director External Relations HIV Vaccine Trials Network Fred Hutchinson Cancer Research Center Session: Pre-Con V, A9 Marcin Waligora, PhD Assistant Professor Jagiellonian University Medical College Session: Pre-Con V Amelia Wall Warner, PharmD, RPh Founder and CEO, Global Specimen Solutions, Inc.; President, Gentris Corporation Session: D9

James Warner, PhD Assistant General Counsel R&R Legal Pfizer, Inc. Session: E14 Carol Weil, JD Regulatory Affairs Advisor Office of Biorepositories and Biopecimen Research National Cancer Institute (NCI) National Institutes of Health (NIH) Session: D16 Janice Weinberg, ScD Professor Department of Biostatistics Boston University School of Public Health Session: B25 Alan Wertheimer, PhD Professor Emeritus of Political Science University of Vermont Session: Pre-Con I, Panel VI, Panel X, E7 Elizabeth White, MBA, MPH, CIP Program Manager United States Department of Energy (DOE) Session: D2 Sarah White, MPH, CIP Director Human Research Quality Improvement Program Partners HealthCare Session: A19, GF2 Ilene F. Wilets, PhD, CIP Executive Director of the IRB, New York State Psychiatric Institute; Assistant Clinical Professor of Medical Psychology (in Psychiatry), Columbia University Session: E10 Delia Wolf, MD, JD, MSCI, CIP Assistant Dean, Regulatory Affairs and Research Compliance; Assistant Professor of Radiology Harvard Medical School Session: B19 Wendy Wolf, PhD Executive Director of Biorepositories Boston Children’s Hospital Session: Pre-Con IV Leon Wong, CISSP Information Security Analyst University of California Berkeley Session: A21

Emily Wood, JD Deputy General Counsel-Research Beth Israel Deaconess Medical Center, Inc. Session: E15 David L. Wynes, PhD Vice President for Research Administration Emory University Session: Pre-Con VI Masayuki Yoshida, MD Director Life Science and Bioethics Research Center Tokyo Medical and Dental University Session: Panel IV Laura Youngblood, MPH, CIP Human Subjects Advisor National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention (CDC) Session: A4, B20 Sharon L. Zack, MS IRB Administrator Westat Session: Innovations D Tracy Ziolek, MS, CIP Director Human Research Protections University of Pennsylvania Session: B20

faculty

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

Plenary Biographies Conference Information Clement Adebamowo, MD, ScD, is director of the

Columbia College, received his medical degree from Harvard Medical School, and completed his residency in psychiatry at the Massachusetts Mental Health Center/ Harvard Medical School in Boston, MA.

Office of Strategic Information, Research, and Training at the Institute of Human Virology, Nigeria; chairman of the National Health Research Ethics Committee of Nigeria; and associate professor of epidemiology at the University of Maryland, Baltimore. Dr. Adebamowo is principal investigator of the NIH-funded West African Bioethics Training Program (WAB), which provides up to master’s degree-level training in bioethics at the University of Ibadan, as well as short and medium-term training in research ethics for biomedical investigators in West Africa. The strategic focus of WAB is the ethics of genomics research in Africa. Members actively participate in the Wellcome Trust and NIH-funded Human Heredity and Health in Africa Initiative to expand genomics research across the continent.

John Y. Baker, PhD, is a research associate with the 21st Century Partnership for STEM Education. Since joining the partnership, Dr. Baker has worked on several projects supporting and investigating evidence-based science and mathematics professional development in schools. Over the past three years, Dr. Baker has been involved with a large clinical research trial that includes 180 schools and tens of thousands of students across four cities. For the past 10 years, Dr. Baker has worked on conducting, and supporting others conducting, research in education. Dr. Baker completed his PhD at the Graduate School of Education at the University of Pennsylvania in 2011. His research interests include the learning and use of mathematics in out-of-school time.

faculty

Paul S. Appelbaum, MD, is the Elizabeth K. Dollard

Professor of Psychiatry, Medicine, and Law and director of the Division of Psychiatry, Law, and Ethics in the Department of Psychiatry at the College of Physicians and Surgeons of Columbia University. He is also a research psychiatrist at the New York State Psychiatric Institute, and an affiliated faculty member at Columbia Law School. An expert on informed consent, decisional capacity, and related issues, Dr. Appelbaum has written widely on research ethics and was the first to identify the “therapeutic misconception.” He now directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics. Dr. Appelbaum is past president of the American Psychiatric Association and the American Academy of Psychiatry and the Law, and has been elected to the IOM. Dr. Appelbaum is a graduate of

Mark Barnes, JD, LLM, practices law as a partner at Ropes & Gray LLP, where he represents academic institutions and industry in matters related to research with humans and animals, clinical trials, research grants and contracts, and fabrication of research data.

Mr. Barnes formerly served as the associate provost and senior research officer for Harvard University, and continues to teach health care law and research law as a faculty member at Harvard Law School. He also serves as faculty co-chair of the MRCT Center at Harvard, which works to improve the planning, conduct, and oversight of clinical trials in emerging economies.

Mr. Barnes has served as executive vice president and chief administrative officer for St. Jude Children’s

Common Orgainzational Name Abbreviations AAAS American Association for the Advancement of Science AAHRPP Association for the Accreditation of Human Research Protection Programs, Inc. ARENA Applied Research Ethics National Association, PRIM&R’s former membership division CCPC Core Conference Planning Committee CDC Centers for Disease Control and Prevention DHHS Department of Health and Human Services FDA US Food and Drug Administration HIPAA Health Insurance Portability and Accountability Act IOM Institute of Medicine

IRB Institutional Review Board MRCT Multi-Regional Clinical Trials NCI National Cancer Institute NIH National Institutes of Health NSF National Science Foundation OHRP Office for Human Research Protections ORI Office of Research Integrity PHS US Public Health Service SACHRP Secretary’s Advisory Committee on Human Research Protections VA US Department of Veterans Affairs WHO World Health Organization

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Research Hospital, has held senior appointed positions in the New York City and New York State departments of health, and was the founding executive director of Harvard’s AIDS treatment programs in Nigeria, Tanzania, and Botswana, which received funding from the United States President’s Emergency Plan for AIDS Relief.

Thomas L. Beauchamp, PhD, is professor

Hila Berger, MPH, CIP, is the compliance

administrator at Montclair State University. She functions as the institution’s policy expert and officer, ensuring compliance with the IRB, institutional animal care and use committee (IACUC), PHS, financial conflict of interest, Medicare, and HIPAA regulations. Ms. Berger is responsible for outreach and educational activities for faculty and students conducting human subjects research, including giving frequent lectures in graduate research methods courses. She provides expertise and guidance in the conduct of inquiries and investigations

Greg Biggers, is chief instigator and CEO at Genomera, a Mountain View, California–based company that helps people share genomic and phenotypic information, and provides an intuitive platform for conducting sophisticated research analyses. Genomera, which Mr. Biggers founded in 2010, aims to provide patients the opportunity to drive their own agendas and engage with one another to grow evidence more quickly than the traditional bottlenecks allow. Mr. Biggers hopes that, ultimately, projects stemming from the company’s platform will yield clinically useful studies, conducted with sufficient rigor to be published in major scientific journals. Mr. Biggers also serves on the Council for Genetic Alliance, a leading nonprofit health advocacy organization committed to transforming health through genetics.

Walter Bockting, PhD, is a professor of medical

psychology (in psychiatry and nursing) and co-director of the Lesbian, Gay, Bisexual, and Transgender (LGBT) Health Initiative at the New York State Psychiatric Institute/Columbia Psychiatry with the Columbia University School of Nursing. He received his PhD from the Vrije Universiteit, Amsterdam, and prior to joining the faculty at Columbia, directed transgender health services at the University of Minnesota Medical School. Dr. Bockting’s research interests include gender and sexual development, LGBT health, internet research methods, HIV prevention, and the promotion of sexual health. He recently completed an NIHfunded randomized controlled trial of an internet-based transgender health promotion intervention. Dr. Bockting has published widely on research with stigmatized sexual, gender, and ethnic/racial minority populations.

He served on the IOM committee that produced an IOM report on LGBT health. He is editor of the International Journal of Transgenderism, past president of the World Professional Association for Transgender Health, and a fellow and past president of the Society for the Scientific Study of Sexuality.

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of philosophy and senior research scholar at the Kennedy Institute of Ethics, Georgetown University.

His research interests include the ethics of human subjects research, the ethics of animal research and human uses of animals, the place of universal principles and rights in biomedical ethics, methods of bioethics, Hume and the history of modern philosophy, and business ethics. His publications include Principles of Biomedical Ethics (with James Childress, 7th edition, 2012), A History and Theory of Informed Consent (with Ruth Faden, 1986), and The Human Use of Animals (with Barbara Orlans, John Gluck, Rebecca Dresser, and David Morton, 2008). In early 2010, many of his scholarly articles were collected and republished by the Oxford University Press under the title Standing on Principles: Collected Works. Dr. Beauchamp recently co-edited (with R. G. Frey) The Oxford Handbook of Animal Ethics—a comprehensive, state-of-the-art presentation of the field—and has also co-edited (with George G. Brenkert) The Oxford Handbook of Business Ethics. In 2011, Dr. Beauchamp received, with Ruth R. Faden, PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics. In 2010, he was presented the Henry Beecher Award of The Hastings Center for a lifetime of contributions to research ethics and other areas of bioethics. In 2004, he received the Lifetime Achievement Award of the American Society of Bioethics and Humanities in recognition of outstanding contributions and significant publications in bioethics and the humanities.

into the ethical conduct of research. She also volunteers as a committee member on the Rutgers University IRB. In previous positions, Ms. Berger served as compliance manager for several multi-site high-risk clinical trials among vulnerable populations and, prior to that, as a researcher in tobacco control and policy evaluation. Ms. Berger received her Master of Public Health degree from Rutgers University, formerly the University of Medicine and Dentistry of New Jersey-School of Public Health.

Plenary Biographies Conference Information Robert F. Boruch, PhD, BE, is co-director of the Center for Research and Evaluation in Social Policy at the University of Pennsylvania. He has served on the Board of Trustees for the W. T. Grant Foundation and the Board of Advisors for the NSF Education and Human Resources Division. He currently serves on the Board of Directors for the American Institutes for Research, and has previously served on advisory committees for the United States Department of Education, NIH, and other federal agencies. Dr. Boruch is an elected fellow of the American Academy of Arts and Sciences, the Academy for Experimental Criminology, the American Educational Research Association, and the American Statistical Association. He has been a senior fellow at the Center for Advanced Studies in the Behavioral Sciences (Stanford University) and at the Rockefeller Foundation’s Bellagio Study Center, and a visiting fellow at research centers in Berlin, Mannheim, and Munich. He has also received awards for his work from the American Educational Research Association, the Policy Sciences Organization, the American Evaluation Association, and The Campbell Collaboration. The Campbell Collaboration has named an award in his honor for individuals who contribute to the use of better evidence in policy making.

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Jeffrey R. Botkin, MD, MPH, is professor of

pediatrics and adjunct professor of human genetics at the University of Utah. He is chief of the division of medical ethics and humanities, and serves as the associate vice president for research integrity. His research is focused on the ethical, legal, and social implications of genetic technology with a particular emphasis on research ethics, genetic testing for cancer susceptibility, biobanking, newborn screening, and prenatal diagnosis. Dr. Botkin is the current chair of SACHRP and is a member of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. He is a member of the FDA’s Pediatric Ethics Subcommitee of the Pediatric Advisory Committee and he chairs the NIH’s Working Group for Human Embryonic Stem Cell Eligibility Review. Dr. Botkin is also an elected fellow of The Hastings Center.

Sara Lavinia Brair, MBBS, is an associate professor

of community medicine at Al Neelain University in Khartoum, Sudan. She received her bachelor’s degree in medicine and surgery from Juba University, and specialized in community medicine at the Sudan Medical Specialization Board. After becoming interested in health professions education and completing a fellowship

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at the Foundation for Advancement of International Medical Education and Research in South Africa, Dr. Brair earned a spot as head of the Community Medicine Department at Al Neelain University. She also serves as deputy director of the Quality and Educational Development Centre at Al Neelain University. Dr. Brair’s work focuses on health professions research projects and research ethics. She was trained in ethics at Middle East Research Ethics Training Initiative, which is hosted by the University of Maryland School of Medicine. She is now member of the Al Neelain IRB, the State Ministry of Health IRB, and the National Continuous Professional Development Centre.

Alexander M. Capron, LLB, works on national

and international issues in public health law, bioethics, and research policy. He is a university professor and occupant of the Scott H. Bice Chair in Healthcare Law, Policy, and Ethics at the University of Southern California (USC). An honors graduate of Swarthmore College and Yale Law School, he previously taught at Georgetown University, the University of Pennsylvania, and Yale University. Professor Capron was the executive director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a congressionally chartered body that prepared 14 reports on subjects ranging from equitable health care access to human genetic engineering, and whose recommendations led to the creation of the “Common Rule.” From 2002 to 2006, he served as the first director of ethics, trade, human rights, and health law at the WHO in Geneva. Professor Capron is an elected member of the IOM and of the American Law Institute, as well as a fellow of the AAAS. He is also a founding fellow of The Hasting Center. He has served as president of the International Association of Bioethics, president of the American Society of Law, Medicine, and Ethics, and vice president of the Council for International Organizations of Medical Sciences. He is currently chair of PRIM&R’s Board of Directors and is a member of the 2013 AER Conference CCPC.

Mary Cataletto, MD, completed her fellowship

training in pulmonary physiology and critical care pediatrics at the Albert Einstein School of Medicine. She has been actively involved in the investigational device review process, with a particular interest in the assent process for pediatric studies. She currently serves as vice chair for the IRB at Winthrop University Hospital in Mineola, NY.

Jeffrey M. Cohen, PhD, CIP, is the CEO of HRP Consulting Group. For 20 years, Dr. Cohen served as the associate director for research compliance and information management in the Office for Research at the University at Albany, State University of New York. In this role, Dr. Cohen was responsible for the administration of the IRB, as well as the IACUC. He then served as director of the Division of Education and Development at OHRP. Following his service at OHRP, Dr. Cohen served as associate dean for responsible conduct of research at Weill Medical College of Cornell University. Since leaving Cornell, Dr. Cohen has been an independent consultant. Dr. Cohen has been an active contributor to national discussions of human subjects research issues since 1979, is a highly visible participant at national meetings such as those sponsored

by PRIM&R, and is a past president of ARENA, PRIM&R’s former membership division. In 2009, he was the recipient of the ARENA Legacy Award for his contribution to human research protections.

Esther Duflo, PhD, is the Abdul Latif Jameel

Professor of Poverty Alleviation and Development Economics in the department of economics at the Massachusetts Institute of Technology, and a founder and director of the Jameel Poverty Action Lab. Her research focuses on microeconomic issues in developing countries, including household behavior, education, access to finance, health, and policy evaluation. Professor Duflo has received numerous academic honors and prizes, including the Financial Times and Goldman Sachs Business Book of the Year Award (with Abhijit Banerjee) for Poor Economics: A Radical Rethinking of the Way to Fight Global Poverty (2011); the David N. Kershaw Award from the Association for Public Policy Analysis and Management (2011); a John Bates Clark Medal for the best economist under 40 (2010); a MacArthur Fellowship (2009); and the American Economic Association’s Elaine Bennett Prize for Research (2003). Professor Duflo is a research associate for the National Bureau of Economic Research, serves on the board of the Bureau for Research and Economic Analysis of Development, is director of the Center of Economic Policy Research’s Development Economics Program, and is a member of the President’s Global Development Council. She serves as the founding editor of the American Economic Journal: Applied Economics.

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George D. Demetri, MD, is director of the Ludwig Center at the Dana-Farber/Harvard Cancer Center and of the Dana-Farber Cancer Institute’s Center for Sarcoma and Bone Oncology. He was a pioneer in the development of the anti-cancer pill Gleevec and, subsequently, his work led to FDA and worldwide regulatory approval of several other “smart drugs,” including Sutent and Stivarga for gastrointerstinal stromal tumor, and Votrient for other sarcomas. Dr. Demetri has been instrumental in raising awareness of issues related to sarcoma, serving as chair of the Medical Advisory Board of the Sarcoma Foundation of America, and as a member of the board of the Hope Funds for Cancer Research. He is also the co-principal investigator for the country’s only multi-institutional Specialized Programs of Research Excellence grant awarded to the Sarcoma Alliance for Research through Collaboration by NCI. After receiving his undergraduate degree in biochemistry from Harvard College and a medical degree from Stanford University School of Medicine, Dr. Demetri completed his internal medicine residency and chief residency at the University of Washington Hospitals in Seattle, WA. He completed a fellowship in medical oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and has served as a member of the IRB for the Dana-Farber Cancer Institute since 1994.

Neal Dickert, MD, PhD, is assistant professor in the division of cardiology at the Emory University School of Medicine and the department of epidemiology at the Rollins School of Public Health. Dr. Dickert conducts research focusing largely on ethics in clinical research, particularly in the setting of acute, emergent illness. He has served as principal investigator and co-principal investigator of several funded research projects investigating the views and experiences of patients enrolled in research conducted using the exception from informed consent for research in emergency settings, and the community consultation process required for this type of research. He has also published work and has ongoing projects related to optimizing approaches to consent in the context of acute care research that does not meet requirements for the exception from consent.

Other areas of interest and scholarship include the use of incentives in clinical research, the conduct of research in the developing world, and the process of shared decision-making in cardiovascular disease. Dr. Dickert is a former fellow in the Department of Bioethics at NIH, the 2009 recipient of the Pillars of PRIM&R Award, and a current Greenwall Foundation Faculty Scholar.

Plenary Biographies Conference Information Karen Leggett Dugosh, PhD, is a research scientist

faculty

in the Section on Law and Ethics at the Treatment Research Institute. Dr. Dugosh holds a Master of Science and PhD in experimental psychology from the University of Texas at Arlington. She conducts research examining the ethical issues surrounding research participation, and much of this research has focused on the doubly vulnerable population of substanceabusing offenders. Dr. Dugosh is currently the principal investigator on a grant funded by the National Institute on Drug Abuse (NIDA) to develop and evaluate a measure of perceived coercion to participate in research that is specially tailored to criminally involved individuals who have substance use disorders. Her prior NIDAfunded research has examined ethical issues related to remuneration of research participants who have substance use disorders and the development of novel strategies to improve recall of consent information in this population.

Leah R. Eisenberg, JD, MA, recently started a faculty position in medical humanities at the University of Arkansas for Medical Sciences after spending five years at the Mayo Clinic. She completed a fellowship in bioethics research at the Mayo Clinic after earning a master’s degree in bioethics from Case Western Reserve University and a JD from the University of Wisconsin. Ms. Eisenberg’s education and experience give her unique insight into problems that arise at the intersection of law, medicine, and ethics. One of her particular interests is developing forms and processes that help individuals understand medical and legal documents. As someone trained in bioethics, she is concerned about the fact that many people sign consent forms without understanding them and, as a lawyer, she is dismayed that legal regulations are often cited as the reason such forms are incomprehensible.

She knows complex jargon is not necessary to meet the requirements for legal documents. Utilizing plain language, she drafted a significant portion of the patient materials used for biobanking at the Mayo Clinic. To further increase participant engagement and understanding, she has collaborated with the Mayo Clinic Center for Innovation and Center for Individualized Medicine to produce and evaluate graphic versions of these documents.

Ruth R. Faden, PhD, MPH, is the Philip Franklin Wagley Professor of Biomedical Ethics and founding director of the Johns Hopkins Berman Institute of Bioethics. She is the author and editor of many books

and articles on biomedical ethics and health policy including Social Justice: The Moral Foundations of Public Health and Health Policy (with Madison Powers, 2006) and A History and Theory of Informed Consent (with Thomas L. Beauchamp, 1986). Dr. Faden is a member of the IOM, and a fellow of The Hastings Center and the American Psychological Association. She has served on numerous national advisory committees and commissions, including President Clinton’s Advisory Committee on Human Radiation Experiments, which she chaired. Dr. Faden is a co-founder of the Hinxton Group, a global community committed to exploring ethical and policy challenges in stem cell science, and the Second Wave project, an effort to ensure the health interests of pregnant women are fairly represented in biomedical research and drug and device policies. In 2011, Dr. Faden received a Lifetime Achievement Award from the American Society of Bioethics and Humanities and a Lifetime Achievement Award for Excellence in Research Ethics, with Thomas L. Beauchamp, from PRIM&R. Her current research focuses on justice theory, national and global challenges in learning healthcare systems, health systems design and priority setting, and access to the benefits of global investments in biomedical research. Dr. Faden also works on ethical challenges in biomedical science and in women’s health.

Dean R. Gallant retired this spring as assistant dean for research policy and administration in the Faculty of Arts and Sciences at Harvard University. In that capacity, he was responsible for the oversight of human subjects and animal research, professional conduct, and general issues of research policy. Mr. Gallant has a background in social psychology and worked at the Alcohol and Drug Abuse Research Center at McLean Hospital, where he studied the behavioral effects of marijuana use, before moving to the Center for Behavioral Sciences at Harvard University, where he long served as assistant director.

He was director of the Harvard University Science Center for 10 years and, for 35 years, Mr. Gallant was a member of Harvard University’s Committee on the Use of Human Subjects in Research, where he served as executive officer. He is an active member of PRIM&R, with frequent service on annual conference planning committees, and has spoken and written on human subjects research issues for many years. He also serves as a member of the SACHRP Subcommittee on Harmonization. Mr. Gallant is a member of the 2013 AER Conference CCPC.

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Atul Gawande, MD, MPH, practices general and endocrine surgery at Brigham and Women’s Hospital in Boston, MA, and is a professor of surgery at Harvard Medical School and a professor at the Harvard School of Public Health. Dr. Gawande is also head of Ariadne Labs, a joint center for health systems innovation created with Brigham and Women’s Hospital and the Harvard School of Public Health. He serves as lead advisor for the WHO’s Safe Surgery Saves Lives program, and is the founding chairman of Lifebox Foundation, an international not-for-profit implementing systems and technologies to reduce surgical deaths globally. Dr. Gawande is known for his influential articles, two of which won him the National Magazine Award. His books, Complications, Better Better, and The Checklist Manifesto, have been highly praised, and TIME Magazine named him one of the world’s 100 most influential thinkers. He is a MacArthur Fellowship winner, a New Yorker staff writer, and an author, but, most of all, he is a physician, with a practitioner’s grasp of the everyday challenges of healthcare delivery. Dr. Gawande is one of Foreign Policy’s top 100 Global Thinkers, and winner of AcademyHealth’s Heath Services Research Impact Award. His work is centrally concerned with questions such as: What does an effective healthcare system look like in the 21st century, and how can we improve quality, manage risk, and measure performance more effectively?

Rachel Glennerster, PhD, is executive director of

Leonard Glantz, JD, is a professor of health law,

Equity Institute at San Francisco State University.

She previously served as co-director of the Center for AIDS Prevention Studies at the University of California, San Francisco, and has been a leading scientist in HIV prevention research since 1991. Her work has focused primarily on gender, culture, and sexual health; the development of prevention interventions; and the translation of science to community practice. Dr. Gómez earned a master’s degree from Harvard University and a PhD in clinical psychology from Boston University. Prior to her work in HIV prevention research, Dr. Gómez spent 12 years working in community health settings, including five years as director of a child and family mental health center in Boston, MA. She was an appointed member to the Presidential Advisory Council on HIV/AIDS under both the Clinton and G.W. Bush administrations. In 2007, she was appointed by Governor Schwarzenegger to the first California Public Health Advisory Council.

Dr. Gómez has served on several national committees including the CDC’s HIV and STD Advisory Council, the Substance Abuse and Mental Health Services Administration’s Committee on Women, and the

Cynthia A. Gómez, PhD, is the director of the Health

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bioethics, and human rights at the Boston University School of Public Health. He is also a faculty member in the Schools of Medicine and Law. Professor Glantz has spent much of his career examining issues related to the protection of human subjects. He is the author of numerous books, articles, reports, and appellate briefs on medico-legal issues. He is the author or editor of two books, Informed Consent to Human Experimentation: The Subject’s Dilemma, with George Annas and Barbara Katz (1977), and Children as Research Subjects: Science, Ethics and Law, co-edited with Michael Grodin (1994). He has been an IRB member for more than 30 years. His current research interests include reproductive rights, rights of the terminally ill, regulation of research with human subjects, children’s rights, and the constitutional limits of public health regulation. Mr. Glantz is a member of PRIM&R’s Board of Directors, previously serving as chair. He is also a member of the 2013 AER Conference CCPC.

the Abdul Latif Jameel Poverty Action Lab (J-PAL). Her research includes randomized evaluations of community driven development, the adoption of new agricultural technologies, and improving the accountability of politicians in Sierra Leone; empowerment of adolescent girls in Bangladesh; the behavioral economics of complying with tuberculosis medication in Pakistan; and health, governance, education, and microfinance programs in India. She serves as scientific director for J-PAL Africa, co-chair of J-PAL’s Agriculture Program, and is a board member of the Agricultural Technology Adoption Initiative. She is lead academic for Sierra Leone for the International Growth Center.

Between 2007 and 2010, she served on the United Kingdom’s Department for International Development’s Independent Advisory Committee on Development Impact. Dr. Glennerster helped establish and serves as a board member for Deworm the World, which has helped deworm 23 million children worldwide. Before joining J-PAL, she worked at the International Monetary Fund and Her Majesty’s Treasury. She has a PhD in economics from Birkbeck, University of London. She is co-author of Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases, and Running Randomized Evaluations, which will be released this fall.

Plenary Biographies Conference Information IOM’s Committee on Prisoners and Research. She currently serves as chair of PRIM&R’s Executive Director Search Committee, and is a member of PRIM&R’s Board of Directors.

Francesca Gould, BA, CCRP, is a regulatory affairs

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specialist at Cincinnati Children’s Hospital Medical Center, serving the departments of bone marrow transplantation and immunology. She has over seven years in the field, and has held multiple positions of increasing responsibility. Some of her previous clients include Pfizer, Eli Lilly, Aventis, Wyeth, Novartis, General Electric, Novo Nordisk, Sanofi, Merck, Roche, GlaxoSmithKline, Astra Zeneca, and Amgen. Ms. Gould is the recipient of multiple Pfizer Fish awards, and is a two-time recipient of a Real Leader award (given by her co-workers and managers at INC Research). Ms. Gould holds a bachelor’s degree from Xavier University, where she graduated with honors. She is nearing completion of an MBA from Xavier University and expects, again, to, graduate with honors. Furthermore, she has recently begun studies towards her Master of Science in Health Sciences in clinical research administration at George Washington University. Ms. Gould is an active member of PRIM&R, the Society of Clinical Research Associates, the Association of Clinical Research Professionals, the University of Cincinnati Center for Clinical and Translational Science and Training, and Xavier University’s Women of Excellence. She looks forward to a lifelong career in human subjects protections, and is on a mission to help stop childhood cancer.

Carl Hart, PhD, is an associate professor in the departments of psychology and psychiatry at Columbia University. He is also a research scientist in the Division of Substance Abuse at the New York State Psychiatric Institute.

A major focus of Dr. Hart’s research is understanding complex interactions between drugs of abuse and the neurobiology and environmental factors that mediate human behavior and physiology. Dr. Hart is a member of the National Advisory Council on Drug Abuse and sits on the Board of Directors of the College on Problems of Drug Dependence and the Drug Policy Alliance. His new book, High Price: A Neuroscientist’s Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society is a complex story of scientific achievement in the face of overwhelming odds; it also argues that the United States’ drugs policy is misguided and needs to change.

Elizabeth Hohmann, MD, is IRB chair and physician director of the Partners HealthCare Human Research Committees covering Massachusetts General Hospital

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(MGH) and Brigham and Women’s Hospital, two of the major teaching hospitals of Harvard Medical School in Boston, MA. She is an associate professor of medicine in the Infectious Disease Division at MGH, and has research interests in “first in human” translational research and live attenuated bacterial vaccines.

Stephen S. Intille, PhD, SM, BSE, is an associate professor in the College of Computer and Information Science and Bouvé College of Health Sciences at Northeastern University. His research focuses on the development of novel healthcare technologies that incorporate ideas from ubiquitous computing, user-interface design, pattern recognition, behavioral science, and preventive medicine. His areas of special interest include technologies for measuring and motivating health-related behaviors, technologies that support healthy aging and well-being in the home setting, and mobile technologies that permit longitudinal measurement of health behaviors for research, especially the type, duration, intensity, and location of physical activity. Professor Intille received his PhD from the Massachusetts Institute of Technology (MIT) in 1999, working on computational vision at the MIT Media Laboratory, a master’s degree from MIT in 1994, and a BSE degree in computer science and engineering from the University of Pennsylvania in 1992.

He has published research on computational stereo depth recovery, real-time and multi-agent tracking, activity recognition, perceptually based interactive environments, and technology for healthcare. In 2012, after 10 years as technology director of the House_n Research Consortium at MIT, he joined Northeastern University to help establish a new transdisciplinary PhD program in personal health informatics.

Steven Joffe, MD, MPH, is the Emanuel and Robert

Hart Associate Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine. Dr. Joffe attended Harvard College, received his medical degree from University of California, San Francisco (UCSF), and received his Master of Public Health from the University of California, Berkeley. He trained in pediatrics at UCSF and undertook fellowship training in pediatric hematology/ oncology at the Dana-Farber Cancer Institute and Boston Children’s Hospital. His clinical work is in the area of stem cell transplantation in children. His research addresses the many ethical challenges that arise in the conduct of clinical and translational investigation, both in pediatric oncology and other areas of medicine and science. He is the principal investigator (PI) of studies

that examine the roles and responsibilities of PIs in multicenter randomized trials, accountability in the clinical research enterprise, return of individual genetic results to participants in epidemiologic cohort studies, and integration of genomic sequencing technologies into the clinical care of cancer patients. He currently serves as chair of the Children’s Oncology Group Bioethics Committee and as a member of the FDA’s Pediatrics Ethics Subcommittee. In addition, he recently completed a term as a member of SACHRP.

Joseph A. Konstan, PhD, is Distinguished McKnight University Professor, Distinguished University Teaching Professor, and associate department head of the department of computer science and engineering at the University of Minnesota. His research addresses a variety of human-computer interaction issues, including personalization (particularly through recommender systems), eliciting online participation, and designing computer systems to improve public health. He is best known for his work in collaborative filtering recommenders (the GroupLens project, which recently won the Association for Computing Machinery (ACM) Software System Award), and for his work in online HIV prevention. It is through that latter work that he became involved in issues of human subjects research ethics

Susan Z. Kornetsky, MPH, is the director of clinical research compliance at Boston Children’s Hospital.

Her responsibilities have included: directing an IRB administrative office, educating principal investigators, assisting investigators with protocol development, assuring institutional compliance with regulations pertaining to human research, establishing appropriate policies and procedures, and overseeing a quality improvement program. In May of 2010, she completed a medical ethics fellowship at Harvard Medical School. Ms. Kornetsky is a past appointed member of the SACHRP Subcommittee on Research Involving Children, and currently serves on the SACHRP Subpart A Subcommittee. She is a past board member and site visitor for AAHRPP, as well as a former member of the IOM’s Committee on Clinical Research Involving Children. She currently serves on the Scientific and Research Advisory Committee for the Massachusetts Down Syndrome Congress. Ms. Kornetsky has also served as a consultant for federal agencies. She teaches internationally as part of a Fogarty International Center grant in addition to other international teaching activities. She is faculty for multiple clinical research courses offered through Harvard Medical School and the Harvard Clinical and Translational Science Award grant.

Ms. Kornetsky has been a member of PRIM&R’s Board of Directors since 2001, and currently serves as vice chair. Previous Board roles include chair of PRIM&R’s Education Committee (2002-2009). In 2003, Ms. Kornetsky received PRIM&R’s Distinguished Service Award. She lectures at many national meetings, in addition to PRIM&R’s conferences and educational programs, and is co-chair of PRIM&R’s 2013 AER Conference CCPC. John D. Lantos, MD, is a general pediatrician and director of the Bioethics Center at Children’s Mercy Hospital in Kansas City, MO. He is a national leader in bioethics, having served as president of the American n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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Nancy E. Kass, ScD, is the Phoebe R. Berman Professor of Bioethics and Public Health in the Berman Institute of Bioethics, and professor in the department of health policy and management at the Johns Hopkins Bloomberg School of Public Health. She is also a fellow of The Hastings Center. She received her bachelor’s degree from Stanford University, doctoral training from the Bloomberg School of Public Health, and was awarded a National Research Service Award to complete a postdoctoral fellowship at the Kennedy Institute of Ethics at Georgetown University. Dr. Kass conducts empirical work in bioethics and health policy.

She served as a member of the IOM’s Committee on Perinatal Transmission of HIV and as a consultant to the National Bioethics Advisory Commission to examine American investigators’ experiences working in developing countries. Her current research projects examine ethics and learning healthcare systems, informed consent, obesity and public health ethics, and ethics issues in international health research. Dr. Kass teaches or has taught courses on HIV/AIDS policy, research ethics, and international research ethics. She also directs the Johns Hopkins PhD in Bioethics and Health Policy program and the Johns Hopkins-Fogarty African Bioethics Training Program.

and practices for online research, a subject on which he has lectured at a variety of conferences and universities.

Professor Konstan received his PhD from the University of California, Berkeley in 1993. He is a fellow of the ACM, a past president of the 4500-member ACM Special Interest Group on Computer-Human Interaction (SIGCHI), and a member of the Computer Human Interaction Academy (a group of researchers honored

by SIGCHI). He has also served as vice chair of the Federal Demonstration Partnership where he worked to document and reduce faculty burden associated with administration of federal research grants.

Plenary Biographies Conference Information

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Society of Law, Medicine, and Ethics, as well as the American Society of Bioethics and Humanities. Dr. Lantos edits a regular column on ethics for the journal Pediatrics, and is on the executive committee of the American Academy of Pediatrics Section on Bioethics. At Children’s Mercy, he works closely with clinicians and administrators to analyze dilemmas in clinical and organizational ethics. His recent projects include analyses of immunization mandates for healthcare workers, treatment decisions for premature babies at the borderline of viability, and emerging problems in biobanking and personalized medicine. He has written over 200 peer-reviewed articles and book chapters, and written or edited six books, including Do We Still Need Doctors? (Routledge, 1997), The Last Physician: Walker Percy and the Moral Life of Medicine (Duke, 1999), and The Lazarus Case: Life-and-Death Issues in Neonatal Intensive Care (Johns Hopkins, 2003). His newest book, Controversial Bodies, about plastination of bodies for display in science museums, was released in 2011.

Robert J. Levine, MD, is professor of medicine, lecturer in pharmacology, and chair of the executive committee of the Interdisciplinary Center for Bioethics at Yale University. He is a fellow of The Hastings Center and the American College of Physicians, past president of the American Society of Law, Medicine, and Ethics, and serves on PRIM&R’s Board of Directors. Dr. Levine was chair of the IRB at Yale-New Haven Medical Center (1969-2000), and founding editor of IRB: A Review of Human Subjects Research (now IRB: Ethics and Human Research). He has served several agencies involved in policy development for human subjects protections, including the Council of International Organizations of Medical Sciences Steering Committee for the 1993 and 2002 revisions of International Ethical Guidelines for Biomedical Research Involving Human Subjects (chairperson); the World Medical Association Working Group to Propose a Revision to the Declaration of Helsinki (chairperson); and, currently, the National Research Council Committee on Proposed Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences.

Dr. Levine was a coauthor of The Belmont Report. He received PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in 2005 and is a member of the 2013 AER Conference CCPC. Sana Loue, PhD, JD, MPH, MSSA, is a professor in the department of bioethics and serves as the vice dean for faculty development and diversity at Case Western Reserve University School of Medicine in

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Cleveland, OH. She has secondary appointments in the departments of epidemiology and biostatistics, psychiatry, and global health, as well as at the Mandel School of Applied Social Sciences. Dr. Loue holds graduate degrees in law, epidemiology, medical anthropology, social work, and secondary education.

She is also ordained as an interfaith minister. Dr. Loue’s primary research focus is on HIV risk and prevention and family violence in marginalized communities, such as non-English speakers, immigrants, sexual/ethnic/ racial minorities, and persons with severe mental illness.

Other research interests include forensic epidemiology, severe mental illness, and ethical issues in the conduct of research with vulnerable persons. She has authored more than 90 peer-reviewed articles and 70 book chapters, and has authored and/or edited 33 books.

Erin Luetkemeier, PhD, works in the Office of the Director at NIH. She performs background research and analysis, develops reports and policies, and identifies and interprets policy issues being considered by the Office of Science Policy, with specific focus on research using human stem cells, genomic data sharing, dualuse research, and gene transfer and recombinant DNA techniques. She was an AAAS science and technology fellow in the NIH Office of Biotechnology Activities. Dr. Luetkemeier was funded by an agriculture genomic sciences and public policy fellowship from the University of Illinois where she earned her PhD. Following graduate school, she held a postdoctoral fellowship position at NIH in the National Human Genome Research Institute (NHGRI). Her research at NHGRI focused on human congenital defects and disorders. In addition to her postdoctoral position, Dr. Luetkemeier worked in the Public Policy Office at the American Institute of Biological Sciences. She has authored articles in the areas of genetics and immunology and has presented and lectured on topics in those fields.

Patricia A. Marshall, PhD, is professor of bioethics and anthropology, and co-director of the Center for Genetic Research Ethics and Law, at Case Western Reserve University in Cleveland, OH. Her research focuses on cultural diversity and bioethics practices, particularly in the area of research ethics, genetic research, and informed consent. Dr. Marshall has served on the executive boards of the American Society of Bioethics and Humanities, the Society for Medical Anthropology, and the Fogarty International Center at NIH, and she is a fellow of The Hastings Center. Dr. Marshall was a consultant to the President’s National

Bioethics Advisory Commission on its initiative to examine ethical issues in international health research (1998-2000). In 1999, she consulted on revisions to the International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council of International Organizations of Medical Sciences in collaboration with the WHO, specifically on the sections addressing challenges in the informed consent process.

In 2001, she was appointed to the National Academy of Sciences’ Study Panel on IRBs, Surveys, and Social Science Research. More recently, she served on SACHRP, and she is a member of the H3Africa Ethics and Regulatory Working Group for building capacity for genome science on the continent of Africa.

administrative positions include directing bioethics research for the Ethical, Legal, and Social Implications program of the Human Genome Project, and serving as executive director of the National Bioethics Advisory Commission established by President Clinton. Dr. Meslin has been a member of several boards and committees including the recent IOM Committee on the Ethical and Scientific Issues in Studying the Safety of Approved Drugs, and the Board of Directors of Genome Canada.

He is a current member of the Ethics Subcommittee of the Advisory Committee to the Director at CDC. In 2007, he was appointed a Chevalier de L’Order Nationale du Mérite (Knight of the National Order of Merit) by the French Ambassador to the United States.

Lindsay McNair, MD, MPH, MSB, is the chief clinical research officer for the WIRB-Copernicus Group (WCG). Dr. McNair has extensive experience in the pharmaceutical industry working in clinical research and drug development. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair is adjunct faculty at Boston University and teaches graduate-level courses on the scientific design of clinical research studies and the development of clinical study protocols. Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master of Public Health degree at Boston University concentrating in biostatistics/epidemiology, and her Master of Science degree in bioethics with a concentration on research ethics at Union Graduate College. She was a member of the IRB at Boston University Medical Center, and founded and chaired the human subject protections committee at Vertex Pharmaceuticals. Dr. McNair serves on committees including Bioethics International’s World Council for Ethical Standards, and contributes to the MRCT Center at Harvard.

Franklin G. Miller, PhD, is a member of the senior

Indiana University (IU) Center for Bioethics, and associate dean for bioethics in the IU School of Medicine. He also directs the IU-Moi University Academic Research Ethics Partnership, an NIH-funded bioethics training program in Eldoret, Kenya. Born in Canada, Dr. Meslin received his bachelor’s degree in philosophy from York University in Toronto, and his master’s degree and PhD from the Kennedy Institute of Ethics at Georgetown University. His previous

Rosemary Musesengwa, MPH, CRA, is the

national coordinator for the Medical Research Council of Zimbabwe. As such, she is responsible for the ethical and regulatory oversight of all human subjects research, including clinical trials, in Zimbabwe. In this role, Ms. Musesengwa also works to set up and accredit IRBs in tertiary institutions and major teaching hospitals. Ms. Musesengwa graduated with a Bachelor of Science, honors, in microbiology and genetics from the University of Zimbabwe. She was awarded a scholarship by the South African Research Ethics Training Initiative, which enabled her to obtain a Master of Public Health degree specializing in research ethics from the University of Pretoria. She also has a Clinical Research Associate Certificate from Kendle INC Research, and has undergone extensive training from the WHO in clinical trial monitoring through the Global Training Network on Vaccine Quality.

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Eric M. Meslin, PhD, is founding director of the

faculty in the Department of Bioethics at NIH. His current principal research interests are ethical issues in clinical research, death and dying, and the placebo effect. Dr. Miller has written two books, The Ethical Challenges of Human Research: Selected Essays and Death, Dying, and Organ Transplantation (co-authored with Robert Truog), both published by Oxford University Press; edited six books; and written numerous published articles in medical and bioethics journals on the ethics of clinical research, ethical issues concerning death and dying, professional integrity, health policy, pragmatism and bioethics, and the placebo effect. Dr. Miller is a fellow of The Hastings Center, a faculty affiliate at the Kennedy Institute of Ethics at Georgetown University, and a professor of public health in the division of medical ethics at Weill Medical College.

Plenary Biographies Conference Information Camille Nebeker, MS, EdD, received her master’s

degree and EdD from San Diego State University (SDSU) and is presently working on research ethicsrelated projects at SDSU and the University of California, San Diego. Dr. Nebeker has been involved in advancing human research ethics and responsible research practices through her roles in academic research leadership, IRB service, and as an educator involved with designing research ethics curricula to train students, faculty, and paraprofessional research staff. Since 2002, Dr. Nebeker has received federal support from NIH, NSF, and ORI to foster research ethics education. These projects have produced training materials designed to build research capacity among academic trainees and non-academic paraprofessional research staff (e.g., community health workers, case managers, etc.) to conduct ethical and responsible research. Dr. Nebeker’s experiences as an IRB member, research administrator, and principal investigator have presented opportunities to consider applied human research ethics from different perspectives, including those of the research subject. Presently, Dr. Nebeker is working with faculty, IRB members, and research participants to better understand the ethical dimensions of mobile technologies that are used to monitor, track, and intervene in health behaviors.

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Edward Nunes, MD, is a professor of clinical

psychiatry at Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, where he has spent his career conducting research on the development of behavioral and pharmacological treatments for cocaine and opioiddependent patients and on the evaluation and treatment of co-occurring psychiatric disorders among substancedependent patients. He has published over 150 peerreviewed articles and chapters. Dr. Nunes has been a principal investigator since 2000 in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (Greater New York Node), through which he has become deeply involved in the translation and dissemination of evidence-based treatments and the design of treatment research in community-based treatment settings.

He is also extensively involved in mentoring junior investigators, particularly physicians and other clinicians, towards careers in research on substance use disorders.

He has been a regular participant in NIH peer review, and served a term as chair of the treatment research review committee at NIDA. Currently, he serves as chairman of the New York State Psychiatric Institute IRB.

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P. Pearl O’Rourke, MD, is the director of human research affairs at Partners HealthCare in Boston, MA, and is an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also chair of the Partners HealthCare Embryonic Stem Cell Research Oversight Committee. Dr. O’Rourke has worked as a pediatric critical care physician at Boston Children’s Hospital and at Seattle Children’s Hospital, where she was the director of the Pediatric Intensive Care Unit. She was active in clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation.

From 1995 to 1996, Dr. O’Rourke completed a Robert Wood Johnson Foundation Health Policy Fellowship working for Senator Edward Kennedy. She then became the deputy director of the Office of Science Policy in the Office of the Director at NIH, where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Dr. O’Rourke is a member of PRIM&R’s Board of Directors, having previously served as Board chair. She is also a member of the 2013 AER Conference CCPC. Laura Odwazny, JD, MA, is a senior attorney

with the Office of the General Counsel, DHHS. Ms. Odwazny’s primary client is OHRP, which interprets and enforces the DHHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the Presidential Commission for the Study of Bioethical Issues, the DHHS Office on Women’s Health, and the DHHS Office of Global Affairs.

Throughout her 13 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within DHHS, including the Office of the Assistant Secretary for Health, the Program Support Center Division of Freedom of Information Act Services, the Health Resources and Services Administration, the Substance Abuse and Mental Health Administration, and the ORI. Prior to her employment with DHHS, Ms. Odwazny served as a law clerk to the Superior Court of Pennsylvania and the Supreme Court of Pennsylvania. Ms. Odwazny is a graduate of the University of Chicago and the University of Pittsburgh School of Law, and received a master’s degree in bioethics through the History and Philosophy of Science Department at the University of Pittsburgh. She is a member of PRIM&R’s 2013 AER Conference CCPC.

Ivor A. Pritchard, PhD, is the senior advisor to the

director of OHRP. He came to OHRP in 2004 from the Institute of Education Sciences at the US Department of Education, where he was a senior research analyst.

He joined the US Department of Education in 1986.

He has a PhD in philosophy from Boston University.

Dr. Pritchard has authored or co-authored several publications, including: “How Do IRB Members Make Decisions? A Review and Research Agenda” (Journal of Empirical Research on Human Research Ethics, 2011); “Searching for ‘Research Involving Human Subjects’: What is Examined? What is Exempt? What is Exasperating?” (IRB: Ethics & Human Research, 2001); “Travelers and Trolls: Practitioner Research and Institutional Review Boards” (Educational Researcher, 2002); Ethical Standards of the American Educational Research Association: Cases and Commentary (Strike et. al., 2002); “Students as Research Subjects” (with Greg Koski, MD, PhD, in The Encyclopedia of Bioethics, 2004); and “Power, Truth and Justice in Youth Participatory Action Research: Ethical Questions” (Practicing Anthropology: A Career-Oriented Publication of the Society for Applied Anthropology, 2004). His professional interests include research ethics and federal policy, moral and civic education research and practice, and education policy. Dr. Pritchard is a member of the 2013 AER Conference CCPC.

Tom Puglisi, PhD, is chief officer (director) of the

B. R. Simon Rosser, PhD, MPH, LP, is professor

and director of the HIV/STI Intervention and Prevention Studies Program in the Division of Epidemiology and Community Health at the the University of Minnesota.

He received his master’s degree, with honors, in psychology from the University of Auckland, and his PhD in behavioral medicine from Flinders University of South Australia. Professor Rosser earned his Master of Public Health in epidemiology from the University of Minnesota. He also has a postdoctoral specialization in sexology from the University of Minnesota. His research focuses on the design and testing of “next generation” HIV prevention interventions for high-risk populations, especially men who have sex with men, persons living with HIV, and structural levels studies of the impact of the internet and laws and policies related to homosexuality on gay communities and alcohol-related HIV risk behavior.

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Office of Research Oversight in the Department of Veterans Health Administration (VHA) at the VA, where he serves as the principal advisor to the Under Secretary for Health, and ensures regulatory compliance related to the protection of human subjects, laboratory animal welfare, research safety, research laboratory security, research information security and privacy, research misconduct, and government wide debarment for impropriety in VA research. He is also responsible for education for VA’s facility-based research compliance officers. Dr. Puglisi joined the VA with more than 20 years of experience in research compliance, 10 years as a funded research investigator, and five years as a consultant in the private sector. His previous positions include director of human subject protections at OHRP; tenured associate professor of psychology at the University of North Carolina at Charlotte, where he chaired the human subjects IRB; and congressional science fellow with the Select Committee on Aging in the United States House of Representatives. Dr. Puglisi received his PhD in the psychology of aging and life span development from The Ohio State University in 1978. He is a fellow of the American Psychological Association.

Joan Rachlin, JD, MPH, has been the executive director of PRIM&R since 1975. During those almost four decades, she has worked with the staff, board, and the wider subject protections community to create the premier educational organization for those conducting and reviewing human subjects and animal research both in the United States and internationally. Ms. Rachlin has contributed to the development of more than 200 conferences, short courses, webinars, and e-learning platforms; the creation of AAHRPP; the establishment of PRIM&R’s certification initiatives—CIP® and CPIA®—and the newly launched People & Perspectives, PRIM&R’s archive of stories from and about those working in the field. Among her proudest accomplishments is the growth of PRIM&R’s membership community, which numbers more than 4,000 research professionals from around the world. A health lawyer by training, Ms. Rachlin holds a JD from the Suffolk University School of Law and an MPH from the Harvard School of Public Health. As a practicing lawyer, she worked on cases involving women’s health and criminal defense. Ms. Rachlin has also taught and lectured extensively at Boston-area universities on research ethics, women’s health, and health law. Ms. Rachlin will step down from her post in April of 2014 and pursue a second career as an oral historian. Ms. Rachlin is the recipient of PRIM&R’s 2013 Lifetime Achievement Award for Excellence in Research Ethics, which will be presented on November 9 at 8:00 AM.

Plenary Biographies Conference Information Michele Russell-Einhorn, JD, is the senior director

of the Office for Human Research Studies at the DanaFarber Cancer Institute. She is responsible for the management and support of scientific and IRB review, as well as other regulatory matters regarding cancer-related research involving human subjects at the five clinical institutions under the Dana-Farber/Harvard Cancer Center umbrella. Trained as a lawyer, Ms. RussellEinhorn has more than 30 years of professional expertise, including service as the conflicts of interest attorney for NIH; director of regulatory affairs for the DHHS Office for the Protection from Research Risks, and its successor OHRP; director in the global pharmaceuticals practice at PricewaterhouseCoopers; and associate general counsel for the J. Craig Venter Institute. She is a member of the SACHRP Subpart A Subcommittee, and a member of the Vanderbilt University steering committee for a NIH grant on alternative IRB models. Ms. Russell-Einhorn is one of the leaders of the IRB Directors Forum of the National Comprehensive Cancer Network. She is also a speaker at numerous conferences on topics related to human subjects research, and is adjunct faculty in the Northeastern University Master of Science in Regulatory Affairs Program. Ms. Russell-Einhorn has served on the CCPC for PRIM&R’s AER Conference since 2008, specifically as co-chair from 2009 to 2011.

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A. Robert Schleipman, RT, CNMT, MSc, works

with staff and patients undergoing radionuclide therapy in the Health Physics and Radiopharmacology Department of Brigham and Women’s Hospital in Boston, MA. He also provides educational and scientific support to medical imaging personnel, trainees, and investigators using ionizing radiation in their clinical research. An additional focus includes training medical students and others on communicating radiation risks to patients and research subjects. Mr. Schleipman’s undergraduate training includes biology and nuclear medicine technology, and he holds separate graduate degrees in healthcare administration (Webster University) and clinical investigation (Massachusetts General Hospital [MGH] Institute of Health Professions). He has been an adjunct faculty member of the Massachusetts College of Pharmacy and Health Sciences and the MGH Institute of Health Professions. Mr. Schleipman serves as a scientific member of a Partners HealthCare IRB panel, and on the committee on human studies at Harvard Medical School. He is currently a PhD candidate in the Law and Public Policy Program at Northeastern University, and is specializing in health policy.

Mr. Schleipman’s current research interests explore the intersections of bioethics and law.

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Jennifer Shaw, PhD, is a medical anthropologist and health services researcher at Southcentral Foundation (SCF), a tribally-owned and operated healthcare system serving more than 60,000 American Indian and Alaska Native people in Alaska. She received her bachelor’s degree at Mount Holyoke College, master’s degree at the University of Kansas, and a doctorate at Case Western Reserve University. She specializes in the social and cultural dimensions of health, healthcare delivery and access in rural and underserved populations, and cross-cultural child and adolescent well-being. After moving to Alaska in 2003, Dr. Shaw lived and worked for several years in “the bush,” where she completed her dissertation research on the role of cultural activities in the well-being of Dena’ina Athabascan youths. Since joining the SCF Research Department in 2010, she has worked with the Northwest-Alaska Pharmacogenomics Research Network on a qualitative study to identify potential barriers and facilitators for use of pharmacogenomics in healthcare. The Network is the first pharmacogenomics program that addresses the needs of populations of the Pacific Northwest and Alaska.

Mildred Z. Solomon, EdD, is president and chief

executive officer of The Hastings Center, a renowned bioethics institute that focuses on ethical issues in medicine, health care, life sciences research, and the environment. The Hastings Center publishes two journals in the field of bioethics, has nine scholars on its staff doing normative and empirical research, maintains an active visiting scholars program that brings scores of scholars from around the world each year to the Center’s campus in Garrison, NY, and collaborates with a worldwide network of nearly 200 Hastings Center fellows, distinguished scholars who have made extraordinary contributions to areas central to the Center’s mission. In addition to her role at The Hastings Center, Dr. Solomon is a clinical professor of anaesthesia at Harvard Medical School, where she directs the school’s fellowship in medical ethics, a program aimed at building the bioethics capacity of Harvard-affiliated hospitals. Prior to her leadership of The Hastings Center, she was senior director for implementation science at the Association of American Medical Colleges, where she was responsible for encouraging the development of comparative effectiveness research and implementation science within the nation’s teaching hospitals and medical schools.

Jeremy M. Sugarman, MD, MPH, MA, is the Harvey M. Meyerhoff Professor of Bioethics and Medicine and deputy director for medicine of the Berman Institute of Bioethics at the Johns Hopkins University. He is an internationally recognized leader in the field of biomedical ethics with particular expertise in the application of empirical methods and evidencebased standards for the evaluation and analysis of bioethical issues. Dr. Sugarman is the author of more than 200 articles, reviews, and book chapters.

He has also edited or co-edited four books. He has worked with the White House Advisory Committee on Human Radiation Experiments, the National Bioethics Advisory Commission, the Presidential Commission for the Study of Bioethical Issues, and the Maryland Stem Cell Research Commission. Dr. Sugarman is currently a member of PRIM&R’s Board of Directors. In addition, he chairs the Ethics Working Group of the HIV Prevention Trials Network and is the ethics officer for the Resuscitation Outcomes Consortium. Dr. Sugarman has been elected as a member of the American Society for Clinical Investigation, the Association of American Physicians, and the IOM. He is also a fellow of the AAAS and The Hastings Center.

David H. Strauss, MD, is deputy director for research

Holly A. Taylor, PhD, MPH, is currently an associate professor in the department of health policy and management at the Johns Hopkins Bloomberg School of Public Health, and is a core faculty member and associate director for empirical research of the Johns Hopkins Berman Institute of Bioethics. She received her bachelor’s degree from Stanford University, her Master of Public Health degree from the School of Public Health at the University of Michigan, and her PhD in health policy with a concentration in bioethics from the Bloomberg School of Public Health. In 1999, Dr. Taylor received a Mentored Scientist Development Award to pursue theoretical and practical aspects of justice in human subjects research. Dr. Taylor has served on the IRB of the Bloomberg School of Public Health and the Johns Hopkins School of Medicine. Her primary interests are research ethics, local translation of federal policy relevant to human subjects research, HIV/AIDS policy, and qualitative research methods.

of the new Mobile and Connected Health Program at the University of Southern California Dornsife Center for Economic and Social Research. She also holds an adjunct associate professor of preventive medicine position in University of Southern California’s Keck School of Medicine. She is director of responsible conduct of research for the Keck School of Medicine, a long-standing member of the USC IRB, and associate editor for Pediatric Obesity. Dr. Spruijt-Metz’s work focuses on childhood obesity and mobile health technologies. Dr. Spruijt-Metz’s research meshes 21st century technologies with transdisciplinary metabolic, behavioral, and environmental research in order to facilitate the development of dynamic, personalized, and contextualized behavioral interventions that can be adapted on the fly. She has a deep interest in harnessing mobile health and new media modalities to bring researchers and researched systems into interaction, to engage people in their own data, and to bring about lasting change in obesity through changes in societal norms, built and perceived environments, and behavior. Dr. Spruijt-Metz has published over 150 peerreviewed articles.

at the New York State Psychiatric Institute (NYSPI) and vice chair for research administration, ethics, and policy in the Columbia University Department of Psychiatry. He oversees NYSPI’s 23 research divisions and 10 research centers, its core imaging facilities, animal care, and research oversight functions. From 2000 until 2010, Dr. Strauss chaired the NYSPI IRB and directed the Office of Human Subjects Research. He co-chairs Columbia University’s Standing Committee on the Conduct of Research, and previously served as co-director of the Ethics, Public Policy, and Human Rights Core of the current HIV Center for Clinical and Behavioral Studies.

Dr. Strauss is a past recipient of two NIH grants on research ethics training and the enhancement of human subjects oversight for psychiatric research. He is a former member of SACHRP and completed work as co-chair of its Subcommittee on the Inclusion of Individuals with Impaired Decision-Making in Research. He currently serves on a SACHRP subcommittee charged with developing recommendations to enhance Subpart A or the “Common Rule.” Dr. Strauss practices psychiatry, psychotherapy, and psychopharmacology, and lectures and consults widely on research and professional ethics. Dr. Strauss is co-chair of PRIM&R’s 2013 AER Conference CCPC.

Sharon F. Terry, MA, is president and CEO of Genetic Alliance, a network of more than 10,000 organizations that enables individuals to reclaim their health and become full participants in research and services. She is the founding CEO of PXE International, a research advocacy organization for the genetic n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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Donna Spruijt-Metz, MFA, PhD, is the director

Plenary Biographies Conference Information condition pseudoxanthoma elasticum (PXE), and is codiscoverer of the gene associated with PXE. Ms. Terry is also a co-founder of the Genetic Alliance Registry and Biobank. She is the author of more than 100 peer-reviewed articles, and is on the editorial boards of several journals. Ms. Terry serves in a leadership role on many major organizations, including the IOM Science and Policy Board, the IOM Roundtable on Translating Genomic-Based Research for Health, and the International Rare Disease Research Consortium Interim Executive Committee. She has received numerous awards, including the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. In 2013, she was named one of FDA’s “30 Heroes for the 13th Anniversary of the Orphan Drug Act.” Ms. Terry is also an Ashoka Fellow.

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Susan Brown Trinidad, MA, is a research scientist

in the department of bioethics and humanities at the University of Washington. She has contributed to several NIH-funded studies aimed at improving understanding of the ethical, legal, and social implications of genomic research, including the New Exome Technology Medicine Study, the electronic Medical Records and Genomics Network, and the Center for Genomics and Healthcare Disparities. Other research interests include communication and decision making in healthcare settings; health equity; narrative ethics; discourse analysis; and community-based participatory research approaches. Ms. Trinidad is a member of the University of Washington IRB. Previously, she was a product development executive for companies specializing in telephone nurse triage, patient education, and behaviorchange counseling services for chronically ill patients.

She holds a master’s degree in health and humanities.

Robert D. Truog, MD, is professor of medical ethics, anaesthesia, and pediatrics at Harvard Medical School.

He has practiced pediatric intensive care medicine at Boston Children’s Hospital for more than 25 years, including serving as chief of the division for more than a decade. Dr. Truog is director of clinical ethics at Harvard Medical School, where he has a leadership role in creating and teaching an ethics curriculum from the undergraduate level to postgraduate continuing medical education. As executive director of the Institute for Professionalism and Ethical Practice, he creates and teaches highly interactive seminars to enhance the relational and communication skills of clinicians across a variety of topics, including breaking bad news, discussing organ donation with families, and

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disclosure of adverse events and medical error. Dr. Truog has published more than 200 articles and books in bioethics and related disciplines. His recent books include Talking with Patients and Families about Medical Error: A Guide for Education and Practice (2010, Johns Hopkins University Press), and Death, Dying, and Organ Transplantation (2012, Oxford). In 2013, he was awarded the Shubin-Weil Master Clinician/Teacher: Excellence in Bedside Teaching Award from the Society of Critical Care Medicine and was honored with the Spinoza Chair at the University of Amsterdam.

Dorothy E. Vawter, PhD, is the associate director

of the Minnesota Center for Health Care Ethics and the lead ethics consultant for Fairview Health Services.

She completed her doctoral studies in philosophy at Georgetown University and the Kennedy Institute of Ethics. She served on the staff of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research and the President’s Commission on Ethical Problems in Medicine and Biomedical and Behavioral Research.

Dr. Vawter was the principal investigator of a five-year, NIH-funded project on ethical and policy issues in the study, use, and financing of deep brain stimulation for Parkinson’s disease. She has been chair, staff ethicist, and community member on seven IRBs for academic medical centers, device manufacturers, non-academic nonprofit institutions, and a State Department of Human Services. Her interests in research ethics include implantable device research; placebo and lesioncontrolled surgical research; research involving persons with serious progressive diseases (e.g., Parkinson’s disease); and special protections for participants in complex high-risk studies. Other areas of scholarship include rationing healthcare resources; cross-cultural healthcare ethics; organizational ethics; dementiaspecific advance care planning; and organ/tissue donation and transplantation.

Alan Wertheimer, PhD, is senior research scholar in the Department of Bioethics at the NIH. He is also professor emeritus of political science at the University of Vermont, where he taught from 1968 to 2005.

Dr. Wertheimer is the author of Coercion (Princeton University Press, 1987), Exploitation (Princeton University Press, 1996), Consent to Sexual Relations (Cambridge University Press, 2003), and Rethinking the Ethics of Clinical Research (Oxford University Press, 2011). He has served as visiting professor of public policy at the John F. Kennedy School of Government

at Harvard University, professor of law at the University of San Diego, and professor of political science at the University of Vermont. He has held fellowships at the Institute for Advanced Study at Princeton University, and the Program in Ethics and the Professions at Harvard University. Prior to joining NIH, Dr. Wertheimer’s work focused on political philosophy and philosophy of law.

His work now focuses on issues in research ethics. He is a member of the 2013 AER Conference CCPC.

Masayuki Yoshida, MD, is director of the Life Science and Bioethics Research Center at Tokyo Medical and Dental University (TMDU). As a physician and scientist, he focuses on vascular biology, cardiology, and genetics. Dr. Yoshida graduated from TMDU in 1988, and completed a residency in internal medicine and cardiology at TMDU hospital. After his post-doctoral research fellowship in the department of pathology at Harvard Medical School, he returned to TMDU to work as an instructor in molecular medicine and was then promoted to associate professor in medical biochemistry and vascular medicine. Dr. Yoshida also directs the Medical English Course at TMDU, and is involved with IRB management and medical education.

Sharon Zack, MS, is the IRB administrator at Westat,

faculty

a Maryland-based survey research organization. She has directed the IRB office for the past six years and is the lead contact on all operational and regulatory matters involving the rights and welfare of human subjects. Ms. Zack’s responsibilities include managing the IRB office staff, pre-reviewing all nonexempt and exempt research protocols, providing educational training to investigators, developing and revising IRB policies and procedures, and assuring institutional compliance with all federal and state regulations. In order to streamline the review and approval process, as well as to maintain an IRB document repository, she is also managing the development and enhancement of an electronic IRB submission system. Additionally, she contributes to policies on handling research misconduct and HIPAA. Earlier in her career, Ms. Zack conducted research on tobacco use, prevention, and intervention with teens and adults, and co-authored a multi-faceted smoking cessation intervention for people ages 18 or younger. She has presented on numerous topics at PRIM&R’s AER Conferences, including “Minimizing IRB Burden on Investigators” and “Response to IRB Conditions Following a Convened Meeting.” Ms. Zack has more than 20 years of experience designing, conducting, and reviewing research with human subjects.

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maps

Maps

p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

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n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

maps

Maps

p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

maps

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

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p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

Notes

notes

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

notes

Notes

p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e

Notes

notes

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

notes

Notes

p rim& r’ s 20 1 3 adv anci ng e th i cal r e s e a rc h c on f e r e n c e