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PRIM&R’s 2012 Advancing Ethical Research Conference

December 4-6

San Diego, CA


Thank you to all our Planning Committee members who made this conference possible! CORE CONFERENCE PLANNING COMMITTEE CO-CHAIRS Susan Kornetsky, MPH Director, Clinical Research Compliance Boston Children’s Hospital David Strauss, MD Deputy Director for Research New York State Psychiatric Institute

MEMBERS Tracy Smart Arwood, MS Research Integrity Officer; Director, Office of Research Compliance Clemson University

A. Cornelius Baker Senior Communications Advisor, FHI 360 Center on AIDS and Community Health

Dean Gallant Assistant Dean for Research Policy and Administration Harvard University

Bronwyn Blackwood, MPH, CIP Director, IRB for the Social and Behavioral Sciences University of Virginia

Leonard Glantz, JD Associate Dean Emeritus, Academic Affairs; Professor of Health Law, Bioethics, and Human Rights Boston University School of Public Health

Alexander Capron, LLB University Professor; Vice Dean for Faculty and Academic Affairs; Scott H. Bice Chair in Healthcare Law, Policy and Ethics; Co-Director, Pacific Center for Health Policy and Ethics University of Southern California

Robert Levine, MD Professor of Medicine; Lecturer in Pharmacology; Senior Fellow in Bioethics Interdisciplinary Center for Bioethics Yale University

Daniel Nelson, MSc, CIP Director, Office of Human Research Ethics; Professor, Social Medicine and Pediatrics University of North Carolina at Chapel Hill P. Pearl O'Rourke, MD Director, Human Research Affairs Partners HealthCare System, Inc. Sangeeta Panicker, PhD Director, Research Ethics American Psychological Association

Michele Russell-Einhorn, JD Senior Director Office for Human Research Studies Dana-Farber Cancer Institute Alan Wertheimer, PhD Senior Research Scholar Department of Bioethics National Institutes of Health Ex-officio: Ada Sue Selwitz, MA Director, Office of Research Integrity; Adjunct Associate Professor University of Kentucky

Ivor Pritchard, PhD Senior Advisor to the Director Office for Human Research Protections

WORKSHOP AND DIDACTIC SUB-COMMITTEE CO-CHAIRS

MEMBERS

Susie Hoffman, RN, BSN, CIP Director IRB for Health Sciences Research University of Virginia

Tracy Smart Arwood, MS Research Integrity Officer; Director, Office of Research Compliance Clemson University

Elyse Summers, JD Director, Division of Education and Development Office for Human Research Protections

Robert S. Bienkowski, PhD Executive Director Baptist Clinical Research Institute Baptist Memorial Hospital Memphis

Elizabeth Buchanan, PhD Endowed Chair in Ethics; Director, Center for Applied Ethics University of Wisconsin Stout Charlotte Coley, MACT, CIP Director, IRB Educational Programs Duke University Health System, Inc.

Sharon Freitag Director, Research Ethics Office St. Michael's Hospital Yvonne Higgins, CIP Director, Quality Management Copernicus Group Institutional Review Board

Janet Donnelly, RAC, CIP Acting Human Subjects Protection Branch Team Lead Division of Safety Compliance Food and Drug Administration

G. Levering Keely, BSN, MPA Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health Food and Drug Administration

Lane Fischer, PhD Associate Professor in Counseling Psychology and Special Education; IRB Chair Brigham Young University

Patricia MacCubbin, MS President and CEO Research Ethics Group

Scott Lipkin, DPM, CIP Chief, Network Office of Research and Innovation Lehigh Valley Health Network Helen Panageas, CIP Associate Director Institutional Review Board NYU Langone Medical Center Sangeeta Panicker, PhD Director, Research Ethics American Psychological Association

POSTER ABSTRACT SUB-COMMITTEE CO-CHAIRS David Borasky, MPH Deputy Director, Office of Human Research Ethics University of North Carolina at Chapel Hill Susan S. Fish, PharmD, MPH Professor Biostatistics and Epidemiology Boston University School of Public Health

MEMBERS Paula Bistak, DMH, RN, MS, CIP, CHRC Human Subjects Protection Program Executive Director University of Medicine and Dentistry of New Jersey

Okyere "Boat" Boateng, MSc, MHSc IRB Administrator, Epidemiology Department Noguchi Memorial Institute for Medical Research Warren Capell, MD Assistant Professor of Medicine University of Colorado – Denver

George Gasparis, CIP Assistant Vice President and Senior Assistant Dean for Research Ethics Columbia University Medical Center

Cheryl Dubenezic, RN, CIM, CIP IRB Manager Hackensack University Medical Center

Karen Hale, RPh, MPH, CIP Office of Responsible Research Practices Interim Director The Ohio State University

Samantha Ferrante, MS, CIP IRB Analyst II The Children’s Hospital of Philadelphia

Michele Kennett, JD, MSN, LLM Human Research Protections Director University of Missouri – Columbia

David Resnick, JD, PhD Bioethicist National Institute of Environmental Health Science

Amal Matar, MB, BCh Coordinator Middle East Research Ethics Training Initiative American University in Cairo

Tracy Rightmer, JD, CIP Research Compliance Officer Yale University School of Medicine

Nancy Olson, JD Institutional Review Board Director University of Mississippi Medical Center

Carol Weil, JD Senior Advisor for Ethical and Regulatory Affairs Office of Biorepositories and Biospecimen Research National Cancer Institute

Nancy Ondrusek Research Ethics Officer Public Health Ontario Christine Philput, PhD President and CEO Applied Human Research Protections, Inc

Sharon Zack, MS IRB Administrator Westat


RECOGNITION Thanks to Those Who Made This Conference Possible Thank You to Our Volunteers CIP® Board of Directors ARENA Legacy Award Distinguished Service Award Community Member Recognition Pillars of PRIM&R In Memoriam

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POSTERS Posters Selected for Presentation Posters Selected for Panel Presentation Posters Selected for Moderated Discussion

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FACULTY Faculty List Plenary Biographies

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MAPS

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CERTIFICATE Certificate of Attendance

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Notepaper

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SCHEDULES Schedule: December 3 Your Guide to the 2012 AER Conference Program Your Guide to the Tracks Schedule: December 4-6 Continuing Medical Education

faculty

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posters

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SUPPORTERS & EXHIBITORS Supporters Exhibitors Map of The Conference Connection

recognition

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supporters & exhibitors

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CONFERENCE INFORMATION Welcome to the Conference from PRIM&R’s Executive Director Welcome from the Conference Co-Chairs Announcements & Reminders Blog Squad Affinity Groups Special Events Support the San Diego Community Special Commemoration of the 40th Anniversary of the End of the United States Public Health Service Syphilis Study at Tuskegee Continuing Education Supporting the Growth of Research Ethics Evaluation Guide

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Contents

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Welcome from PRIM&R’s Executive Director

“In all things that are purely social we can be as separate as the fingers, yet one as the hand in all things essential to mutual progress.” - Booker T. Washington

Dear Friends, Welcome, and thank you for joining us! We are looking forward to sharing information, inspiration, strategies, and all manner of other professional lifelines over the coming days. I am so proud of this community and so grateful to be part of it. In an age of hyper-individualism, PRIM&R is a happy holdout against that trend. Every healthy community has a strong center, and ours is the shared purpose of advancing ethical research. I am consistently struck by the energy generated when individuals with a commonality of purpose come together, but in order for this combustion to take place, we need your full-throated and full-hearted participation. One reason I am encouraging your active engagement is because this is your conference and your community; thus your commitment to maximizing the benefits of each will be selffulfilling. Your experience at the 2012 Advancing Ethical Research (AER) Conference will be determined by the investment you make in each session and in each corridor conversation. If you commit to connecting, I can guarantee that you will reap innumerable benefits from being part of an intentional community with a shared purpose, shared challenges, and often, shared solutions. I therefore ask that you go “all in” during your days onsite, as doing so will fuel you in both tangible and intangible ways. The “tangibles” include burnishing your job skills, and the “intangibles” include being happier, healthier, and more successful, as research has shown that those who work on problems and face challenges together reap these and other benefits.

One of the obligations of belonging to a community is the responsibility of remembering: I thus ask you to join me in commemorating the end of one of our most tragic historical antecedents—the United States Public Health Service Study at Tuskegee (USPHSS)—as it, along with the Nazi atrocities, gave birth to our field. A gifted artist named Tony Hooker has documented parts of the USPHSS in a photography exhibit titled The Greater Good. This year marks the 40th anniversary of the Study’s end, and we are humbled and pleased to share excerpts from Mr. Hooker’s collection in commemoration of that horrific chapter in our field’s history. Please schedule time to visit this exhibit, which can be found in The Conference Connection in the Sails Pavilion. In addition, many of us remember the courageous, brilliant, ferocious, and ultimately game-changing activism of ACT-UP (AIDS Coalition to Unleash Power) and TAG (Treatment Action Group), two groups that changed the face of HIV/AIDS research during the early years of the pandemic. A new documentary about these groups, How to Survive a Plague, will be shown during Session C27 on December 5, and during Grand Finale 4 on December 6. I am certain that both the The Greater Good and How to Survive a Plague will leave you with a renewed commitment to your crucial task of tending the research ethics flame. We believe that by remembering the past, we replenish the wells of our

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determination and renew our motivation to ensure that ethical research and the Belmont principles are always kept front and center. On to other meeting highlights! Bragging rights for this extraordinary program belong to a talented and dedicated group of planners. I would like to thank the Planning Committee members, led by Co-Chairs Susan Kornetsky and David Strauss; Workshop/ Didactic Sub-Committee Co-Chairs Susie Hoffman and Elyse Summers; and Poster Abstract Sub-Committee Co-Chairs David Borasky and Susan Fish, for putting together a comprehensive and innovative program. A full listing of the members of the Planning Committees can be found on the interior cover of this Guide. Many, many thanks are also due to the faculty, which brings the Planning Committees’ vision to life. In addition to their respected status as subject matter experts, those on the faculty were selected because they share a principled commitment to the advancement of ethical research. I thus thank them for their leadership in this field, as well as on this program, and for their commitment to fostering an environment where ethics matter. I am confident that, given the breadth of their knowledge and experience, you’ll leave San Diego armed with finely tuned antennae and other instruments designed to navigate the complexities of human research protection programs. We are fortunate to have a program of such depth, thanks to the Planning Committees and faculty, and we also have great breadth! You are about to immerse yourself in a program that includes 14 plenary sessions on a wide range of topics, and more than 130 workshops and didactic sessions, and seven Grand Finale sessions. For those interested in meeting colleagues and networking in a more structured format, we are proud to once again offer affinity groups in seven areas of professional activity. Please see pages 10-11 of this Guide in order to learn more about these “birds of a feather” flocking spots.

you saw, heard, and learned, so please tell us via our electronic evaluation. The link for the evaluation will be sent to your inbox after the conference, so keep an eye out since our staff is as committed to quality improvement as you and yours, but we need your impressions and observations in order to do better. Please let us know if there is anything we can do to make your onsite experience more comfortable, more pleasant, and more productive. We’re happy you’re here, and so very grateful to be part of this “goodfor-what-ails-you” community. Although we’ve only just said “hello,” I want to make sure that your 2013 calendars include our next AER gathering, which will be held November 7-9 (with pre-conference programs on November 6) in Boston, MA. We’ll be rolling out the red carpet in our hometown and can’t wait to welcome you to our corner of the world. Please help us make it another rich gathering by sharing your ideas for topics, faculty, and even extracurricular activities on this year’s evaluation forms or via email at info@primr. org. Thank you for helping us plan another terrific meeting, as you deserve no less. During our time together, though, “be here now,” and make the most of this educational feast. Once the conference is over, it will be on to the winter holidays! We hope that yours are all that you want them to be, and my colleagues and I wish you happiness and good health always. Thanks again for joining us, and thank you for your important work. Warmly,

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

If we don’t say so ourselves, this is an extraordinarily strong and relevant program, so don’t miss a minute! And we’d like to know what you thought of everything

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Welcome from the Co-Chairs

Welcome to the 2012 Advancing Ethical Research (AER) Conference: Guided by Principles in an Era of Change. As your conference Co-Chairs, we are delighted to welcome you to San Diego and are eager to share with you the exciting program developed by our Planning Committees. PRIM&R strives to create a forum at our AER Conference and pre-conference programs in which research professionals can come together to exchange ideas, discuss best practices, and grapple with the complex ethical issues raised by research with human subjects. We are confident that, over the next several days, the keynote addresses will provide you with insight and inspiration, the panels and debates will challenge and inform you, and the didactic sessions and hands-on workshops will offer you concrete tools to strengthen your knowledge and skills.

close to 30 CSP sessions. We strongly encourage everyone to consider submitting a session proposal or a poster abstract for the 2013 AER Conference! Please visit www.primr.org/aer13 for details.

The crafting of this year’s conference program involved the time, expertise, and dedication of nearly 50 volunteers across three Planning Committees. This energetic group was responsible for selecting our four keynote speakers; designing 14 plenary sessions; planning 130 workshops and didactic sessions; identifying over 250 faculty members best suited to bring the content to life; and vetting the poster presentations. It was truly a vast undertaking, and we believe it has paid off in a program that is as timely and content rich as they come. Our hope is that you will not only enjoy the conference, but will return to your home institutions with innovative strategies that you can use to enhance your research programs.

Warmly,

Thank you so much for joining us. We hope you will make the most of this stimulating environment and the unique opportunities for dialogue, hard work and fun offered in the 2012 program. So, welcome, once again, to San Diego and to the 2012 AER Conference. We are so glad you’re here!

Susan Kornetsky, MPH Director, Clinical Research Compliance Boston Children’s Hospital David H. Strauss, MD Deputy Director for Research New York State Psychiatric Institute

This year we received more than 115 excellent suggestions in response to our Call for Session Proposals (CSP), and more than 125 exemplary abstracts for the poster presentations, and we would like to thank all those who contributed their ideas to this year’s conference. We rely on our community for fresh ideas and perspectives, and this year’s program is without a doubt stronger for including p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


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 the PRIM&R booth in The Conference Connection in the Sails Pavilion, or you may connect wirelessly from anywhere in the Convention Center. To access the wireless internet, please select the wireless device (SSID) called AER2012 from your wireless browser list. The password for this meeting is: sandiego2012. Please note the username and password are case sensitive. Please log off the wireless internet when you are not using it, and please refrain from downloading large files and/or videos, which tend to use a lot of bandwidth. Please also note the system will time out after being idle for 10 minutes. If you lose your connection, please log back on using the aforementioned SSID and password. If you have questions, please see a PRIM&R staffer at the Help Desk.

Registration and More

Conference check-in and the Help Desk are located in Lobby 20 on the upper level of the Convention Center, and will be open as follows: Sunday, December 2: 4:00-7:00 PM Monday, December 3: 7:00 AM-6:00 PM Tuesday, December 4: 7:00 AM-6:00 PM Wednesday, December 5: 7:00 AM-5:30 PM Thursday, December 6: 7:00 AM-3:00 PM

The Conference Connection

Join us in The Conference Connection, which is home to all attendee meals and breaks, two receptions, the supporters and exhibitors, the poster abstracts, the Internet Café, The Greater Good, and the PRIM&R Booth. The Conference Connection will be open as follows:

Questions?

Please stop by the Help Desk located in the Registration area in Lobby 20. A PRIM&R staff member will be happy to assist you.

Courtesy 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.

Lead Retrieval at the 2012 AER Conference

In an effort to help facilitate connections between our attendees and supporters and exhibitors, as well as to help PRIM&R better plan for future conferences, we will be employing lead retrieval during this year’s event. Included on your name badge is a bar 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, those 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 by a supporter or exhibitor. PRIM&R will scan the badges of those registered to attend a special breakfast or lunch. However, we will only use this information for planning purposes; it will not be distributed to a third party. Please visit the Help Desk in Lobby 20 if you have questions.

Name Badges and Agendas

Please wear your name badge at all times. Please note that your personalized agenda included with your name badge may not reflect the most recent schedule changes or cancellations, so please double check your agenda with the current schedule in this Guide, as well as the daily schedules at the Help Desk.

Tuesday, December 4: 7:00 AM-6:30 PM Wednesday, December 5: 7:00 AM-5:30 PM* Thursday, December 6: 7:00 AM-1:45 PM *Please note the supporters and exhibitors will not be at their booths until 10:30 AM.

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Announcements & Reminders


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Announcements & Reminders

PRIM&R’s Green Initiatives

We’re doing our best to make the 2012 AER Conference another “green” PRIM&R meeting, and hope that you’ll join us in our efforts! PRIM&R has taken the following steps, and more: • We’re using our online Conference Passport. • We’re using an electronic evaluation for the meeting. • We’re providing a reusable tote bag onsite. • We’re using soy-based ink in the printing of this Guide. The San Diego Convention Center is pleased to announce that its highly successful conservation and recycling efforts has earned it a LEED Silver Certification from the U.S. Green Building Council. The Center’s wide-ranging policies and practices include, but are not limited to: • Mixed recyclables (paper, plastic, aluminum, glass) are collected daily in clearly marked bins throughout the Center, and this diverts approximately 45% of the Center’s total waste. • Copper wire is recycled after every show, averaging five tons annually. • Cooking oil is recycled into bio-diesel fuel. • Energy-management software and energyefficient lighting saves 734,000 kWh annually. • The Center has installed low flow automatic sinks and toilets in all restrooms. • The Center’s outdoor landscaping uses drip irrigation, drought-tolerant plants, and mulch to reduce watering. • A food composting program diverts nearly 150 tons of food waste annually. • Products made with biodegradable, recycled materials, including copy paper, legal pads, envelopes, toilet paper, facial tissue, and paper towels are purchased. • Environmentally responsible cleaning products are purchased for carpets, floors, kitchens, and bathrooms. • Catering purchases fruits, vegetables, olive oils, and seafood from local farms and suppliers that are within a 100 mile radius, as supply and season allow. • The Center works with clients to ensure excess food is donated following events. Approximately 100 tons of food is donated to local charities annually.

Help us be Green!

Recycle your name badge holder and/ or lanyard in the Registration area at the conclusion of the conference and receive not only the knowledge that you’ve done something good for the environment, but a special thank you gift from PRIM&R!

Message Board

Looking for a colleague? Please post messages to the bulletin board in the Registration area. 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 these name badge ribbons and more in the Registration area! These ribbons are designed to enhance community building, and help you connect with colleagues who share similar professional experiences.

First-Time Attendees

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

Session Locations

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 in the back of this Guide, and our staff is ready to help with directions or with any questions you might have.

Session Selections

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.

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Session Q&A

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, and the didactic sessions less.

Special Meals

If you ordered a special meal, please alert a server to your needs before you are seated. Please see a PRIM&R staff member with questions or concerns.

Luggage Storage

On the morning of your departure, we recommend that you check your luggage at the bell stand of your respective hotel and plan to return there prior to your departure, as the 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 December 6, please bring your personal items with you and check them at the luggage stand in Lobby 20 at the Convention Center. Please note the fee to check bags is $2 per item, and luggage check will be open from 7:00 AM to 6:00 PM on December 6.

In Case of Emergency

If friends or family need to contact you and cannot reach you directly, they should call San Diego Convention Center Security at 619.525.5490. In case of an emergency, please dial 5911 from any house phone and ask for security. You may also see a PRIM&R staffer at the Help Desk for assistance in case of an emergency.

Onsite services include automated external defibrillator in the event of cardiac arrest; a wide variety of over-the-counter medications including aspirin, Tylenol, ibuprofen, and antacids; additional first aid materials to treat minor cuts, bruises, and/or sprains; and a cot.

Bookstore

We are excited to offer again our very own version of the “corner bookstore” – except this Bookstore has been stocked with your professional interests in mind. Spotlighting books and other reference materials on human subjects protection, research ethics, and IRB management, the Bookstore will offer the latest resources to help guide you in your work. The Bookstore is located in Lobby 20 and will be open: Tuesday, December 4: 7:00 AM-6:00 PM Wednesday, December 5: 7:00 AM-5:30 PM Thursday, December 6: 7:00 AM-3:00 PM

Shipping, Fax, and Photocopy Services The Center’s business center, FedEx Office, offers shipping, mailing, faxing, and photocopying services. FedEx Office is conveniently located in the Exhibit Hall D lobby, and is open Saturday and Sunday from 9:00 AM to 5:00 PM, and Monday through Friday from 8:00 AM to 5:00 PM.

First Aid Station

If you have a first aid emergency or situation while onsite at the conference, we encourage you to visit the First Aid Station located in The Conference Connection in the Sails Pavilion on the upper level of the Convention Center. An emergency medical technician will be available as follows: Monday, December 3: 7:00 AM-6:30 PM Tuesday, December 4: 7:00 AM-6:30 PM Wednesday, December 5: 7:00 AM-5:30 PM Thursday, December 6: 7:00 AM-5:45 PM

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Announcements & Reminders

Say Cheese!

Please be ready to say “cheese” for our conference photographer and videographer! 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 or videotaped. Thank you for understanding our desire to both capture these exciting moments and, at the same time, respect your right to refuse to participate.

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 take a few minutes to complete the evaluations, which will be emailed to you at the conclusion of the conference. Thank you for your feedback.

Conference Passport

The Conference Passport includes select session handouts, links to the program and attendee list, keynote and plenary biographies, venue details, and information about PRIM&R. After the conference, audiovisual components for select presentations will be added to the Conference Passport. Materials are now available for your use and reference. To access them, please follow these instructions: 1. Open your internet browser. 2. Go to http://www.conferencepassport. com/primr.asp. 3. Enter the access key found on the back of your name badge (this was also emailed to you prior to the conference). 4. Select “Login.” 5. Select “Launch” next to the 2012 AER Conference image. 6. Using the left-hand navigation titled “Program Content,” select one of the available search options to locate a specific session. 7. If materials are available for a session, a button will be visible for each resource. Select the appropriate button to access the corresponding resource. 8. Download the materials to your computer for personal use. 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 Center’s business center, FedEx Office, located in the Exhibit Hall D lobby. If you have questions about the Conference Passport, please email us at info@primr.org or call 617.423.4112.

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Affinity Groups

To help those attending the 2012 AER Conference connect with colleagues who have shared professional responsibilities and interests, PRIM&R is pleased once again to host Affinity Groups during this year’s meeting! Affinity Groups are composed of people who share areas of specialized professional interest. They are designed to enhance the conference experience by fostering networking and community building before, during, and after the conference. PRIM&R is hosting the following seven Affinity Groups (listed with group co-facilitators): • Global Research: Karen Hansen, Rosemary Musesengwa, Jan Piasecki, and Marcin Waligora • Institutional Officials (IOs): Elizabeth Bankert and Jeff Braff • IRB Chairs: Dwight Hare and Paul Reitemeier • Quality Assurance/Quality Improvement (QA/QI): Jessica Randall, Terry VandenBosch, and Sarah White • Small Institutions: Greg Manship and Erica Tauriello • Social, Behavioral, and Educational Research (SBER): Emily Anderson, Tora Bikson, and Claire Dunne • Unaffiliated/Community Members: Robert Ferguson, Gigi McMillan, and Ken von Kluck Those who signed up for an Affinity Group at the 2012 AER Conference have access to: • Color-coded networking ribbons to help identify other Affinity Group members • A pre-conference networking reception from 4:00 to 6:00 PM on Monday, December 3 in Room 28ABCD • A special networking breakfast from 7:00 to 8:00 AM on Tuesday, December 4 in Room 25B • Breakfast and lunches with Affinity Groups. Tables will be reserved for each affinity group at all general meals taking place in the Sails Pavilion after the Affinity Group breakfast on Tuesday, December 4. Look for signs designating each group’s tables. • An Affinity Group Meeting Spot in The Conference Connection where members can browse resources, leave business cards, host meetings, chat informally with peers, or just relax • “Office hours” with Affinity Group facilitators in Affinity Group Meeting Spots • A dedicated message board in The Conference Connection • A designated LinkedIn Group for each Affinity Group to promote connecting with others before and after the conference • A dedicated Grand Finale session from 3:30 to 4:45 PM on Thursday, December 6 to determine how each group would like to stay connected after the conference For the most up-to-date information about Affinity Group activities, including facilitator office hours and chances to meet up with your group at particular conference sessions, keep your eye on the daily schedules (available each day in the Registration area) and the looping slides that play before each keynote and plenary session. Didn’t register for an Affinity Group? You still can! Visit the Help Desk, or email registration@primr.org, and a staff member will happily sign you up.

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Throughout the conference, Affinity Group members may be interested in attending or meeting up at the following sessions and tracks:

Members of the following Affinity Group:

May be especially interested in the following sessions and tracks:

• Track 11: International Research Global Research

• Living Room Conversation: Whose Ethics Matter? Conducting Responsible Research in the Global Arena, on Tuesday, December 4, from 2:00 to 3:15 PM, Ballroom 20CD

Institutional Officials (IOs)

• Track 10: IOs • Track 22: Responsible Conduct of Research

IRB Chairs

• Track 5: Advanced Forum for IRB Professionals • Track 13: IRB Operations and Toolkit

Quality Assurance/Quality

• Track 19: QA/QI and Post-Approval Monitoring

Improvement (QA/QI)

Small Institutions

• Track 25: Small Research Programs

Social, Behavioral, and Educational

• Tracks 23 and 24: SBER I and II

Research (SBER)

• Track 26: Unaffiliated and Non-Scientist IRB Members Unaffiliated/Community Members

• Lunch with Melinda Hurst, Pioneering “Community Member,” Thursday, December 6 from 12:45 to 1:45 PM, in Room 25B

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Special Special Events Events

Monday, December 3, 2012

Pre-Conference Program & Affinity Group Networking Reception 4:00-6:00 PM, Room 28ABCD

All those registered to attend a pre-conference program on December 3, or who signed up to participate in one of our Affinity Groups, are welcome to join us for a networking reception. Light refreshments will be served.

Tuesday, December 4, 2012

First-Time Attendee Breakfast

7:00-8:00 AM, Room 28ABCD

Is this your first time at the AER Conference? We hope you’ll have a terrific time! To get you started, please join us for this continental breakfast, during which we’ll answer the top 10 most frequently asked questions about the conference and give you an opportunity to connect and network with colleagues.

Affinity Group Networking Breakfast 7:00-8:00 AM, Room 25B

If you have signed up for an Affinity Group, you are invited to join us for this continental breakfast where you can connect and network with your fellow group members.

Common Ground Networking Luncheon

affiliations, and we will have tables available for those for those wishing to “just lunch.” The Supporter and Exhibitor booths will be open during this time, and the posters will be available for viewing.

Research Ethics Book Group Lunch with Jonathan Haidt, PhD 12:00-1:00 PM, Room 28ABCD

Participate in a vibrant discussion of The Righteous Mind: Why Good People Are Divided by Politics and Religion, the newest title from 2011 AER Conference keynote speaker Jonathan Haidt. Attendees will have the opportunity to discuss the book with their peers and with the author, who will be joining the discussion via live video feed. Professor Haidt’s book may be purchased onsite at the conference Bookstore.

Lunch with Keynote Speaker John P. A. Ioannidis, MD, PhD 12:00-1:00 PM, Room 26AB

Join us for a luncheon with keynote speaker John Ioannidis. 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.

Lunch with Plenary Speaker Robert Bartlett, MD 12:00-1:00 PM, Room 25B

Join us for a luncheon with plenary speaker Robert Bartlett. This event will provide attendees the opportunity to talk with and ask questions of this distinguished researcher and medical pioneer in an intimate and informal environment.

12:00-1:00 PM, Sails Pavilion

Time to connect…over lunch! Meet peers for conversation and networking. The tables will be divided by Affinity Groups and professional

Icon Key

pre-registration was required

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Meet and Greet the Conference Supporters and Exhibitors and Poster Presenters 1:00-1:45 PM, Sails Pavilion

Visit The Conference Connection to network with this year’s conference Supporters and Exhibitors and to meet the poster presenters during or after lunch.

Demonstration of PRIM&R’s Online Course and Knowledge Center 1:15-1:45 PM, Sails Pavilion

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections.

Conference Welcome Reception 5:00-6:30 PM, Sails Pavilion

Join us in The Conference Connection to kick off the 2012 AER Conference, meet and greet our Supporters and Exhibitors, view this year’s posters, and receive a complimentary mini-massages! Light refreshments will be served.

PRIM&R’s Mentoring Program

5:00-6:30 PM, PRIM&R Booth in The Conference Connection, Sails Pavilion

PRIM&R’s Mentoring Program is one of our most celebrated member benefits. Join Megan Frame, membership coordinator, in the PRIM&R Booth to learn more about this valuable networking resource. Already a participant in our Mentoring Program? Come and share your experiences with other members of the program, and the research ethics community at large.

Wednesday, December 5, 2012

CIP® Breakfast

7:00-8:00 AM, Room 28ABCD

Interested in earning your Certified IRB Professional (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.

Demonstration of PRIM&R’s Online Course and Knowledge Center 12:45-1:15 PM, Sails Pavilion

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections.

Lunch with Keynote Speaker James R. Gavin III, MD, PhD

12:45-2:00 PM, Room 26A

Join us for a luncheon with keynote speaker James Gavin. This event will provide attendees the opportunity to talk with and ask questions of this distinguished leader of the nation’s efforts to address health disparities and research inequalities in an intimate and informal environment.

Young Professionals Networking Reception

8:00-10:00 PM, Fox Sports Grill, Hilton San Diego Bayfront Hotel Meet and network with other young professionals.

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Special Special Events Events

Lunch and Book Signing with Panelist Henry S. Richardson, JD, PhD 12:45-2:00 PM, Room 26B

Join us for this informal luncheon with Panel IV speaker Henry Richardson, and participate in a timely discussion of ancillary-care obligations in research. This event will provide attendees an opportunity to talk with and ask questions of this distinguished ethicist and author of the new book, Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers. Professor Richardson’s book may be purchased onsite at the conference Bookstore, and Professor Richardson will be available to sign books during this lunch.

Research Ethics Book Group Lunch and Book Signing with Laura Stark, PhD

Networking Reception in The Conference Connection 3:30-5:30 PM, Sails Pavilion

Light refreshments will be served.

• Meet and Greet our Supporters and Exhibitors

Please see Supporters and Exhibitors section of this Guide for details.

• Commemoration of the 40th Anniversary of the End of the United States Public Health Service Syphilis Study at Tuskegee Please see page 25 for details.

• PRIM&R’s Mentoring Program

PRIM&R’s Mentoring Program is one of our most celebrated member benefits. Join Megan Frame, membership coordinator, in the PRIM&R Booth to learn more about this valuable networking resource. Already a participant in our Mentoring Program? Come and share your experiences with other members of the program, and the research ethics community at large.

12:45-2:00 PM, Room 28ABCD

Participate in a vibrant discussion of Behind Closed Doors: IRBs and the Making of Ethical Research, by Laura Stark. Attendees will have the opportunity to discuss the book with their peers and the author. Professor Stark’s book may be purchased onsite at the conference Bookstore, and Professor Stark will be available to sign books during this lunch.

• Speed Mentoring

3:45-5:00 PM 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 personalized answers to your regulatory, ethical, and/or operational questions. Light refreshments will be served.

• Moderated Poster Discussions

Join us for an informal opportunity to learn about how your colleagues are supporting the advancement of ethical research. Attend one of four discussions with the authors of select posters. Each discussion promises to provide important and original ideas in a relaxed and interactive environment.

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Thursday, December 6, 2012

PRIM&R Online Connections & Resources Continental Breakfast 7:00-8:00 AM, Room 28ABCD

Interested in learning more about PRIM&R’s array of online resources? From The Ethical Oversight of Human Subjects Research Course and our new Knowledge Center, to the IRB Forum and our groups on Facebook and LinkedIn, PRIM&R has many ways for you to connect, learn, and grow professionally from the convenience of your home or office. Attend this breakfast to learn more about PRIM&R’s offerings and to speak with/ask questions of the PRIM&R staff. If you are interested and did not pre-register, please inquire about space availability at the Help Desk.

Book Signing with Author and Pillars of PRIM&R Lecturer Elyn Saks, JD, PhD 10:45-11:15 AM, Registration Area, Lobby 20 Join us in the Registration area after the morning plenary sessions for a book signing with Pillars of PRIM&R Lecturer Elyn Saks. Professor Saks’ book may be purchased onsite at the conference Bookstore.

Lunch and Book Signing with Author and Pillars of PRIM&R Lecturer Elyn Saks, JD, PhD 12:30-1:45 PM, Room 26AB

Join us for a luncheon with Pillars of PRIM&R lecturer Elyn Saks, author of The Center Cannot Hold: My Journey Through Madness. This event will provide attendees the opportunity to talk with and ask questions of this distinguished author and professor in an informal environment. Her book may be purchased onsite at the conference Bookstore, and Professor Saks will be available to sign books during this lunch.

Lunch with Melinda Hurst, Pioneering “Community Member” 12:45-1:45 PM, Room 25B

Please join us for a luncheon to talk with Melinda Hurst, a woman who has volunteered as an unaffiliated, non-scientific IRB member for over 30 years. As an advocate for research subjects, Ms. Hurst embodies the values, ethics, and commitment to protection that human subjects who participate in research deserve.

What’s New at the CITI Program? Lunch

12:45-1:45 PM, Room 28ABCD

Staff members from the CITI Program 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.

Demonstration of PRIM&R’s Online Course and Knowledge Center 1:15-1:45 PM, Sails Pavilion

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections.

Closing Reception

4:45-5:45 PM, Room 28ABCD

Join us to wish each other a fond farewell and to make plans for the 2013 AER Conference! Light refreshments will be served.

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Support the San Diego Community

In the spirit of the holiday season, and in keeping with the PRIM&R community’s commitment to helping others, we are partnering with the Ronald McDonald House Charities (RMHC) during this year’s conference. For 30 years, San Diego’s RMHC has provided lodging, support, and comfort to more than 14,000 families whose children face life-threatening illnesses or injuries, and are receiving treatment at area hospitals. In addition to these vital services, RMHC provides toiletries, clothing, games, activities, welcome bags, and more to its guests. We hope you will join us in making a difference in the lives of families dealing with life-threatening illness or injury by contributing to the San Diego RMHC. Please consider donating one or more of the following items: • • • • • • • • • • • • • • • • • • •

Travel size toothpaste, toothbrushes, and floss Soap Deodorant Shampoo and conditioner Lotion Hand sanitizer Hair bands and hair brushes Small journals with pens and/or pencils Disposable cameras Crayons, markers, or colored pencils Board games or electronic games Stuffed animals Craft projects Puzzles Coloring or activity books Portable DVD players Baby blankets, shampoo, and wipes Children’s pants, sweatshirts, and jackets Umbrellas

In addition, RMHC contribution boxes will be located in the Registration area for those who would also like to donate money to support the RMHC’s School Away From School program, meals, outdoor play equipment, and lodging services. RMHC of San Diego is a nonprofit organization that receives 10 percent of its funding from McDonald’s and local McDonald’s Restaurant owners and operators. The remaining funds needed to operate the House and provide other services are raised through private donations. Thank you for considering this request, and for opening your heart and/or pocketbook for these families in crisis.

A collection bin will be set up in the Registration area December 3-6.

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“Those who cannot remember the past are condemned to repeat it.” - George Santayana In commemoration of the end of the 40th anniversary of the end of the United States Public Health Service Syphilis Study at Tuskegee (USPHSS), PRIM&R has mounted an exhibit by photographer Tony Hooker, titled The Greater Good: An Artist’s Contemporary View of the Tuskegee Syphilis Experiment. This exhibit will be on display in The Conference Connection in the Sails Pavilion December 4 through December 6. We believe that it will be one of the most important stops you make in your days onsite. Please take time to not just look at these powerful images, but to see them, take them in, reflect on them, and to remember that these men and their families suffered deeply in both physical and dignitary ways. Their suffering was one of the drivers for the creation of the research ethics field, and we honor them posthumously by remembering their sacrifice, as well as by doing the work we do. In an attempt to recapture the study and its implications on society and research more broadly, Mr. Hooker has combined historic photographs taken during the study with his own contemporary images. We encourage you to not only “see” his photographs, but to also read the quotes from some of those involved in the study. The photographs and accompanying words powerfully evoke a small sliver of this heartbreaking episode, and remind us of the responsibilities that lie with each of those presently involved with the conduct and review of human subjects research. According to Mr. Hooker, the exhibit tells the story of “[g]ood intentions gone awry. Of small lies. Of deceit. Of suffering and heartbreak. Of questionable ethics. Of entanglements small and large. Of racism. And, perhaps, most importantly, loss of trust among people, their community, and their government.” Thank you for visiting the exhibit, and we hope that you will find meaning in these moving photos and captions. PRIM&R is extremely grateful to Mr. Hooker for creating and sharing this powerful work, and we join him in his commitment to remembering this seminal event in research ethics.

About the USPHSS For those of you who would like to know more about the Study, we have included the below short summary, courtesy of Mr. Hooker: “From 1932 to 1972, the United States PHS conducted a study of syphilis in AfricanAmerican men in rural Macon County, Alabama. Some 412 men who tested positive for syphilis and a control group of 200 healthy men were enrolled in the study with the promise of minor medical treatment and physical examinations (which generally were not available to them at the time), hot meals, free rides into town, and a ‘decent and free burial,’ an important consideration in the culture of the day. During the study, approximately 28 participants died directly from the ravages of an untreated disease and, in all likelihood, many others died of related illnesses. Tragically, poor record keeping and various complications cloud the cause of death in many of the other cases, and much of the suffering and emotional turmoil surrounding this experiment, its participants, and their families remain unrecorded. Overall, 13 medical papers were published from the study; many a stepping stone for the advancement of their authors in the PHS. Widely disseminated in the medical community, the records hold only one letter from one doctor questioning the ethics of the study in the 40 years of its duration. Exposed in 1972, this study has become a shameful landmark in the history of medical research, and President Clinton issued an official government apology to the African-American community in 1997.”

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Special Commemoration


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Continuing Continuing Education Education

A Certificate of Attendance for the 2012 AER Conference, December 4-6, is included in the back of this Guide. Certificates for the preconference education programs on December 3 are included in the individual course materials. Such certificates are useful for obtaining continuing education 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 professional association representative for information as to if, and how many, credits from PRIM&R’s conference may be used. A maximum of 18 continuing education credit hours are available for the 2012 AER Conference. Credit hours for the pre-conference educational programs vary depending upon the duration of the course.

Missing a Certificate of Attendance from a previous PRIM&R conference? If you need a copy of a Certificate of Attendance from a previous PRIM&R conference, please email info@primr.org with the following information: name, contact information, conference name and date(s), and dates and hours of attendance. Certificates will be delivered via email within two weeks.

CIP® Recertification

Continuing Education credits from the 2012 AER Conference may be used by Certified IRB Professionals (CIPs) who are eligible to recertify by continuing education if the sessions attended are beyond the basic or fundamental level. Sessions that meet CIP recertification requirements are designated

with a icon on the conference schedule. Additional information on qualifying continuing education activities for CIP recertification purposes can be found in the recertification materials on PRIM&R’s website, www.primr.org, or by contacting certification@primr.org.

Continuing Medical Education (CME)

CME credits are available for designated sessions and workshops. CME-eligible sessions are noted by a icon on the conference program. A maximum of 16.75 CME credit hours are available for the 2012 AER Conference. CME applications will be available online and may be accessed on www.surveymonkey. com/s/PRIMR12. Attendees must complete the online claim for credit and evaluation form within four weeks to receive a CME certificate. Once the online claim for credit and the evaluation form are completed, a certificate will be issued by Boston University School of Medicine, the CME provider for this conference. For more information about CME credits, please visit the Help Desk in the Registration area. Please note that we do not offer specific credits for nurses, pharmacists, and members of other professions. You are welcome to apply for such credits on your own using the Certificate of Attendance that is included in your conference materials, as noted above.

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PRIM&R’s three scholarship programs have brought nearly 300 individuals to Advancing Ethical Research Conferences since 2006. International Scholarship Program

PRIM&R is dedicated to improving communication among research ethics committees (RECs), researchers, and others 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 human research protection programs (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 with those involved in research globally.

Institutional Capacity Building Scholarship Program

Many small, underfunded institutions of higher education in the United States need, but do not have, fully functioning IRBs or HRPPs. Many of these 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. Almost all such institutions have significantly fewer resources than their larger peer institutions. 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/ Non-Scientific) IRB Member Scholarship Program

The Community (Unaffiliated/Non-Scientific) IRB Member Scholarship Program was developed in response to feedback from advocates and IRB community members. The program’s goal is to ensure that community members and unaffiliated IRB members receive the same educational opportunities as their colleagues so as to develop and progress in their IRB service. The program strives to extend educational and development opportunities to interested community members committed to advancing ethical research practices and to provide a networking base among collegial practitioners and peers.

PRIM&R is grateful to the Collaborative International Training Initiative (CITI) Program for partially underwriting the 2012 International Scholarship Program. Thanks also go to John Isidor and Sandy Kaltman for their generous donation to the Program, which was made in memory of Roma Kaltman and Sidney Rachlin.

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Supporting Supporting the the Growth Growth Research Ethics Ethics ofofResearch


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Evaluation Guide

Since the Conference Evaluation will be electronic (you’ll find it in your email inbox!), we’ve included these pages to help you jot down your contemporaneous impressions of the sessions you attend. Please refer to the notes you record here when you complete your evaluation. And, thank you! Your feedback means everything to us – we look forward to reading your comments!

Tuesday, December 4

Keynote Address: John P.A. Ioannidis, MD, PhD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Plenary Address: Robert H. Bartlett, MD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session A___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel I: “The Common Rule:” How Did We Get Here, and Where Should We Go? ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel II: An Introduction to Flexible Adaptive Clinical Trial Designs: Implications for IRB Review and Informed Consent ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Living Room Conversation: Whose Ethics Matter? Conducting Responsible Research in the Global Arena ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

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Session B___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Wednesday, December 5

Keynote James R. Gavin III, MD, PhD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel III: Hot Off the Presses: Selected Posters on Innovative Programs and Research on Research Ethics ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel IV: Do Investigators Have Ethical Responsibilities to Their Subjects Outside the Scope of Research, and If So, What are They? ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Panel V: Ethical Implications of Novel Methodologies and Technologies in Social and Behavioral Research ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session C___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ A Great Debate: Be It Resolved That Large-Scale Genomic Research Poses Special Privacy Risks to Research Subjects ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

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Evaluation Guide

Panel VI: Should Society Treat Research Differently From Other Risky Activities? ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Session D___ Presenters_______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Thursday, December 6

Pillars of PRIM&R Lecture: Elyn R. Saks, JD, PhD ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Panel VII: IRB Review of Research on Mental Illness: Are Additional Protections Always Appropriate Protections? ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Panel VIII: Ethical Design and Conduct of Cluster Randomized Trials ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel IX: To Return or Not To Return: Individual Research Results and the Role of Biobanks ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Session E___ Presenters________________________________________________________________________ _______ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

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Panel X: Protecting Privacy and Confidentiality: Exploring Persistent Limitations, Novel Challenges, and Whether it is Time for a New Approach ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ _______________________________________________________________________________________ Panel XI: The Single IRB of Record Proposal: Appraising the Balance of Risks and Benefits ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Panel XII: Compensation for Research-Related Injury: Is It Finally Time for a Nationalized System? ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Grand Finale: ___ Presenters____________________________________________________________________ ___________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________

Connect with PRIM&R—and each other! Use your mobile device to scan the QR codes below to get started.

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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 the Sails Pavilion on the upper level of the San Diego Convention Center, as follows: Tuesday, December 4: 7:00 AM-6:30 PM Wednesday, December 5: 10:30 AM-5:30 PM Thursday, December 6: 7:00 AM-1:45 PM

The 2012 AER Conference Supporter and Exhibitor Treasure Hunt

Who holds the key to the conference treasure chest filled with information to help with day-to-day operations in the field of subject protections? Our Supporters and Exhibitors do! While onsite, participate in our Supporter and Exhibitor Treasure Hunt program to learn more about the field of human subject protections and the services available to assist with your responsibilities; network and meet others in the field; help to create a community that will help guide the future of research ethics; and have fun! Review the questions on the Treasure Hunt Map included in your conference tote bag. Determine which vendors and organizations have the answers by visiting with and talking to their staff. Once you’ve obtained the correct answers for all 10 questions, place the completed form in the Treasure Chest located in the PRIM&R booth in The Conference Connection by 4:00 PM on December 5. We will then draw names of the prize winners between 4:00 and 5:00 PM during the reception on December 5 in the Sails Pavilion!

Vendors participating in this program have a

next to their name.

Platinum Supporter

The Collaborative Institutional Training Initiative (CITI) Program 305.243.2388 • www.citiprogram.org Booths: 37 and 48 The CITI Program at the University of Miami offers customized web-based 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. Thank you to CITI for its support of the Conference’s International Scholarship Program. p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


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Silver Supporters Huron Life Sciences 503.601.4120 • www.huronconsultinggroup.com Booths: 35 and 36 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 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, COI, and other research compliance processes. Thank you to Huron for its support of breakfast on December 4.

InfoEd Global 518.713.4200 • www.infoedglobal.com Booths: 19 and 58, 61 InfoEd Global provides research institutions worldwide with superior technology to reduce cost, 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 fullyintegrated InfoEd eRA Suite includes Solutions for Grants and Contracts, IRB and IACUC Submissions, COI, Clinical Trials, Animal Facilities, Technology Transfer, and Research Outputs. Thank you to infoEd Global for its support of breakfast on December 5.

WIRB-Copernicus Group 360.252.2485 • www.wcgirb.org Booths: 49 and 60 The two leading independent institutional review boards (IRBs) are now united to provide a comprehensive ethical review solution to Sponsors, CROs and Institutions. WIRB and Copernicus Group IRB have more than 60 years of combined experience reviewing research protocols and studyrelated information to ensure that subjects’ rights and welfare are protected. Together, they’re transforming ethical review. d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a


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Supporters & Exhibitors

Bronze Supporters

COI-SMART from Health Care Compliance Strategies, Inc. (HCCS) 516.478.4100 • www.coismart.com, www.hccs.com Booths: 27 and 34 The HCCS COI-SMART system provides comprehensive tools for tracking and managing conflict of interest disclosures. COI-SMART provides for the development of multilevel questionnaires, assignment of reviewers, the development of COI management plans, and data mining tools for auditing, tracking, and reporting on potential conflicts of interest. HCCS also provides COI and research online compliance training courses. Thank you to HCCS for its support of the Networking Reception on December 5.

Consilience International LLC and the Ideate Framework 646.502.8062 • www.ideate.com Booths: 13 and 24 Consilience International 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 Consilience team has 100 years collective experience working with leading research organizations worldwide. For information, email info@ideate.com. Ideate is Research 2.0™. Thank you to Consilience International LLC and the Ideate Framework for supporting the morning break on December 6.

HRP Consulting Group 347.862.9321 • www.thehrpconsultinggroup.com Booths: 38 and 39 HRP Consulting Group focuses solely on human research protections. We provide expert advice both internationally and domestically to research-driven universities, hospitals, government, and military organizations. HRP 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; and retention plans. Thank you to the HRP Consulting Group for its support of the morning break on December 5.

iMedRIS 951.520.9164 • www.imedris.com Booths: 40 and 41 At iMedRIS we provide state-of-the-art Electronic Research Administration software. Welcome to iRIS (“Integrated Research Information System”), the premier integrated research management system designed to reduce redundancy of data input while providing maximum data availability to all those who need it. iRIS™ modules include: IRB Assistant™, IACUC Assistant™, COI Assistant™, PreAward Assistant™, Grants & Contracts, and Site Assistant™. To see details of iRIS Modules or to schedule a demo, please visit our website. Thank you to iMedRIS for its support of the afternoon break on December 4.

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IRBNet 617.758.4202 • www.irbnet.org Booths: 31, 32, and 33 IRBNet offers the most widely used electronic research compliance solution, with more than 1,700 large, medium, and small research institutions, boards, and research sites registered on the National Research Network®. Integrated modules enable institutions to seamlessly manage conflict of interest, IRB, IACUC, biosafety, R&D, sponsored programs, and other critical research oversight activities while integrating with your institution’s 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. Thank you to IRBNet for its support of the Conference ROCK program.

Quorum Review IRB 206.448.4082 • www.quorumreview.com Booths: 25 and 26 Quorum Review IRB is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection Programs. Our primary focus is to safeguard the rights and well-being of research participants. We provide sponsors, CROs, institutions, and sites with reliable, responsive services that ensure efficient study start-up and management. Email clientrelations@quorumreview.com with questions. Thank you to Quorum for its support of the morning break on December 4.

Alion Science and Technology 202.756.3817 • www.alionscience.com Booth: 50 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 protection programs.

Arizona State University College of Nursing and Health Innovation 602.496.0703 • www.nursingandhealth.asu.edu Booth: 59 The College of Nursing and Health Innovation is an inclusive, world class enterprise of discovery that prepares innovative, evidence-based health care providers, educators, leaders, and researchers to optimize health in a culturally diverse global community. Large enough to offer multiple health career tracks, but small enough to offer individualized student learning and intensive mentored experiences, the college educates professional nurses and selected trans-disciplinary health care professionals at the baccalaureate, graduate, doctoral, and post-doctoral levels.

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supporters conference & exhibitors info

Exhibitors


supporters conference & exhibitors info

Supporters & Exhibitors

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) 202.783.1112 • www.aahrpp.org Booth: 23 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 U.S. federal requirements. The accreditation program uses a voluntary, peer-driven, educational model.

Association of Clinical Research Professionals (ACRP)/ Academy of Physicians in Clinical Research (APCR) 703.253.6270 • www.acrpnet.org, www.apcrnet.org Booth: 14 ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, and those in hospital, academic medical centers, and physician office settings. ACRP was founded in 1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 35 years later, ACRP is a global association comprised of more than 18,000 individuals in over 70 countries dedicated to clinical research and development.

and academic physicians and physician investigators. We make the case for clinical research to the government, media, and the public at-large. APCR is the leading professional organization, exclusive to physicians, that supports and addresses the unique issues and challenges of physicians in clinical research.

The Bioethics Program of Union Graduate College and Mount Sinai School of Medicine 518.631.9860 • www.bioethics.union.edu Booth: 42 The Bioethics Program of Union Graduate College and Mount Sinai School of Medicine offers a 12-course competency-based Masters of Science in Research Ethics. A four-course 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, and on-site seminar, practica, and capstone assessment courses.

Chesapeake IRB 443.283.1515 • www.chesapeakeirb.com Booth: 44 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 11 compliant, electronic IRB platform (CIRBI), which streamlines protocol submissions and decreases investigator review turnaround times resulting in faster subject enrollment.

APCR encourages the highest standards of integrity and the ethical conduct of clinical research by knowledgeable professionals. Our dedication to quality ensures that patients benefit from evidencebased therapeutics, supported by pharmaceutical p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Compass IRB 480.832.7373 • www.compassirb.com Booth: 21 Compass IRB is a central IRB located in Mesa, Arizona with full AAHRPP accreditation. Compass IRB is dedicated to outstanding customer service and protecting human subjects through strict adherence to federal regulations. Compass IRB utilizes a customized online system, THE ANCHOR™, for online submissions, access and distribution of all IRB documents, and providing 24/7 “real time” tracking of all IRB documents.

Department of Veterans Affairs (VA) – Office of Research Oversight (ORO) 708.202.7266 • www.va.gov/oro Booth: 9 ORO was established by Public Law to ensure research compliance within the VA. ORO exercises oversight in all matters of research compliance in human subject protections, laboratory animal welfare, laboratory safety and security, and research information security. Additionally, ORO investigates allegations of research misconduct and impropriety within VA research.

The Health Care Compliance Association (HCCA) 952.933.3803 • www.hcca-info.org Booth: 30 The 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.

Health Equity Institute (HEI) at San Francisco State University 415.746.9914 • www.healthequity.sfsu.edu Booth: 53 The mission of HEI is to create an intellectual environment that encourages diversity of perspectives, challenges conventional approaches, and produces innovative action-oriented research in the biomedical and behavioral sciences in order to improve health, eliminate health disparities, and establish equity in health.

Ethics CORE 217.265.5292 • www.nationalethicscenter.org Booth: 29 Ethics CORE is a Collaborative Online Resource Environment funded the National Science Foundation and created by the National Center on Professional and Research Ethics at the University of Illinois. d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

supporters conference & exhibitors info

Ethics CORE gathers, curates, preserves, and provides comprehensive access to resources related to professional and research ethics for instruction, students, researchers, administrators, scholars, and persons with questions or interests in these areas.


supporters conference & exhibitors info

Supporters & Exhibitors

Committed to the Protection of Research Subjects

IntegReview IRB 512.326.3001 • www.integreview.com Booth: 28 IntegReview IRB, AAHRPP accredited, provides six weekly meetings, including Canadian review, same day site review, thorough, prompt, and knowledgeable IRB review along with consulting, available, responsive staff, quality assurance and quality control, electronic submissions, and web portal access to study documents within one to two days of board review.

IRBManager 516.627.3800 • www.irbmanager.com Booth: 51 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!

Iritzi 866.410.4427, x114 • www.iritzi.com Booth: 17 and 18 At Iritzi IRB Management Software, we have 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 the most common headaches and manages studies from inception, the IRB decision process, and the life of the study.

Key Solutions 510.456.4502 • www.keyusa.com Booth: 43 Key Solutions, Inc. provides web-based Integrated Research Compliance and Administration Software for human subjects (IRB), biosafety (IBC), stem cell (SCRO), radiation safety (RSC), chemical safety (CSC), animal subjects (IACUC), controlled substance (CS), post-approval monitoring (PAM), animal facility management (LARS), Census RFID, animal health records (LAHS), pre and postaward grants management (eGrants), system-tosystem (S2S), conflict of interest (eCOI), material transfer agreement (MTA), and sponsored project administration (SPA).

Kuali Coeus Consortium 617.253.8048 • www.kuali.org/kc Booth: 47 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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supporters conference & exhibitors info

National Cancer Institute Central IRB Initiative

Mentor IRB by Axiom Education 203.242.3070 • www.axiomeducation.com/irb Booth: 57 From social science to clinical research, the Mentor paperless IRB system 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. Contact us at sales@axiomeducation.com.

Medical College of Wisconsin Center for Bioethics and Medical Humanities 414.955.4299 • www.mcw.edu/ bioethicsandmedhumanities.htm Booth: 46 The Medical College of Wisconsin’s Center for Bioethics and Medical Humanities offers a graduatelevel Certificate Program in Research Ethics. This engaging online educational program builds a solid foundation in human subjects research regulation, examines the historical and philosophical foundations of these regulations, and broadly surveys current topics in research ethics.

National Cancer Institute Central IRB Initiative (NCI CIRB) 888.657.3711 • www.ncicirb.org Booth: 10 The NCI CIRB is designed to reduce administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. Using the NCI CIRB enables Principal Investigators to open studies and enroll study participants into selected Cooperative Group clinical trials significantly faster.

National Coordinating Center (NCC) and the Newborn Screening Translational Research Network (NBSTRN) 301.718.9603 • www.nbstrn.org Booth: 11 The Health Resources and Services Administration/ Maternal and Child Health Bureau-funded NCC, National Genetics Education and Consumer Network, and the seven Regional Genetic and Newborn Screening Service Collaboratives (RCs) work together to improve access to local genetic and newborn screening services, and provide information and resources for individuals and families with heritable disorders. The NICHD awarded the American College of Medical Genetics a five-year contract to develop the NBSTRN. The NBSTRN seeks to improve the health outcomes of newborns with genetic or congenital disorders through an infrastructure that provides the research community access to robust newborn screening resources.

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supporters conference & exhibitors info

Supporters & Exhibitors

Office for Human Research Protections (OHRP) 240.453.8127 • www.hhsgov/ohrp Booth: 7 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 education resources.

Office of Research Integrity (ORI) 240.453.8400 • www.ori.hhs.gov Booth: 8 ORI oversees and directs Public Health Service research integrity activities on behalf of the Secretary of the Department of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.

ProIRB® 731.421.4622 • www.proirb.com Booth: 16 ProIRB® Compliance Assurance Software for the IRB professional provides tools for tracking protocols, planning meeting agendas, generating customized notification letters, and action follow-up. CyberIRB® for Electronic Submission features customized forms, making transition painless by duplicating your current paper documents and process. Our two part system grows as your IRB grows!

Schulman Associates IRB 513.794.5757 • www.sairb.com Booth: 52 Schulman Associates IRB has been a leading provider of review services in the U.S. and Canada since 1983. Schulman is AAHRPP accredited and has an unparalleled Food and Drug Administration audit history. Through our industry-leading suite of e-tools and reputation for quality, we’ve helped define the expectations. Now we’re redefining the experience.

Society of Research Administrators (SRA) International 703.741.0140 • www.srainternational.org Booth: 20 SRA International is a professional society of over 4,000 research administrators of all levels—from those new to the field of research administration to vice presidents of research and everything in-between. Our focus is to provide information, education, and networking opportunities to advance your institution and your career. Collaboration of research administrators from multiple settings including universities, nonprofits, hospitals, government agencies, and commercial businesses sets SRA International apart in enriching your experience and network base.

Taylor & Francis 212.216.7800 • www.taylorandfrancis.com Booth: 56 For two centuries, Taylor & Francis has been fully committed to the publication of scholarly information. We publish a wide variety of books and journals in the field of bioethics and other related fields. Be sure to stop by our booth to view our products and to pick up FREE sample copies of our journals!

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supporters conference & exhibitors info

TOPAZ Technologies 512.249.8080 • www.topazti.com Booth: 45 TOPAZ Technologies is the leading provider of integrated enterprise software solutions and services to the medical research community, providing automated, regulatory compliant solutions for online protocol submission, review, and approval, as well as applications for clinical veterinary information, animal ordering/receiving, accounting, training, census, breeding, and facility management. Doing business for over 30 years, TOPAZ has been developing and implementing some of the most highly regarded software applications in the industry.

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The 2012& Advancing Supporters Exhibitors Ethical Research

supporters conference & exhibitors info

Conference (AER) is jointly sponsored by

In collaboration with

Discover the CITI Program’s fully customizable, web-based, research ethics training options at

Booth #37-48.

E-mail citisales@med.miami.edu to arrange a time to meet with a CITI Program representative at the 2012 AER Conference.

www.citiprogram.org p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Is your organization prepared to meet the new NIH Conflict of Interest regulations? Your PHS funding may be at risk.

Manage, Track and Report on Conflict of Interest Disclosures Booth # 27 • www.coismart.com • (877) 933-4227


Your Enterprise Portal. IRBNet offers the most widely used electronic solution for managing research compliance for institutions of any size, with more than 1,700 sites registered on the National Research Network. 速

IRB, IBC, IACUC, COI, Grants, VA R&D... and more

Flexible, Intuitive, Easy to Use

Trusted by Hundreds of Institutions

www.irbnet.org | info@irbnet.org Booth 31, 32, 33


When Performance Matters — choose

Quorum Review IRB

Visit us at Booth 25 at the 2012 PRIM&R Conference! • AAHRPP Accredited

• 100% Quality Control

• Privately-held Central IRB

• Oncology Board based in Cambridge, MA

• 13 Board Meetings per week

• U.S. & Canadian Review

• 24-Hour Site Start-Up

• Smart Forms

• 36-Hour Amendment Review

• Study Support Available 8AM-8PM ET

• Secure Portal

for IRB resources, news and events, visit QuorumReview.com

• Same-day Site Changes

877-472-9883

Full AAHRPP Accreditation since 2006

The 9 Most Important Questions To Ask When Choosing Your IRB Solution 1. Does this require expensive consultants or developers to install, customize or maintain? 2. Can the vendor show me how to quickly and easily customize and configure the solution? 3. Does the application have built-in reporting or do you have to rely on custom reports created by the vendor or 3rd party software? 4. Does the framework promise everything, but start with practically nothing? 5. Is this solution a resonsible way to spend your money? Be aware of sequestration. 6. Will the software be updated automatically as regulations and compliance needs change? 7. Can the solution be customized and maintained by staff you already have? 8. Will I customize myself out of compliance? 9. Is this an Open Source solution? If so, you will be choosing to be in the software business rather than growing and managing your research programs. Implement Your IRB Process Without 3rd Party Costs +1.800.727.6427 www.InfoEdGlobal.com


If you’re serious about quality, you should be AAHRPP accredited. AAHRPP accreditation is the “gold standard” for research protections and research quality. When you earn the AAHRPP seal, you earn the respect of your colleagues and the confidence of clients and research participants. You strengthen your organization and your position in the marketplace.

For more information: www.aahrpp.org | accredit@aahrpp.org | 202-783-1112.


Graduate Certificate Program in

RESEARCH ETHICS

www.mcw.edu/bioethics

It’s the experience. Experience matters when choosing the right graduate program. The Medical College of Wisconsin’s Center for Bioethics and Medical Humanities has been a pioneer in bioethics and research ethics education and remains a leader in these fields, with a proven record of excellence. It’s our experience that makes a difference in yours.

Program Objectives

Program Description

Program Courses

Designed to provide an understanding of human subjects research regulations and the historical and philosophical foundations underlying the regulations, as well as an opportunity to pursue a broad-based survey of current topics in research ethics.

The Certificate Program in Research Ethics consists of four courses delivered in an online format. The technical requirements are minimal. Participants earn a Certificate in Research Ethics from the Medical College of Wisconsin’s Graduate School of Biomedical Science.

Introduction to Research Ethics (3 credits) Regulatory Issues in Human Subjects Research (3 credits) Current Topics in Research Ethics (3 credits) Elective course (3 credits)

“Students will be hard pressed to find another program that offers intensive research ethics training and education.”

Amy Bovi, MA, CIM, Research Compliance Analyst and Educator, Aurora Health Care, Milwaukee, WI; and 2000 graduate of the MCW Bioethics MA program

C EN T ER FOR B I OE T HIC S A N D M E D IC A L H U M A N IT I ES Thomas May, PhD, Graduate Program Director, 414-955-8498, tmay@mcw.edu Kristen Tym, MA, Graduate Program Manager, 414-955-4299, ktym@mcw.edu


Visit us in Booth 51

• • • • • • •

Complete Clinical Trial Financial Management Solution Enrollment and Visit Tracking Budget Development Sponsor Billing Holdback Reconciliation Investigator and Sponsor Matching Visit www.SmartResearchManagement.com

To learn more about our solutions visit us www.techsoftinc.com or call 516-627-3800 d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

conference info

• Leading Ethics Oversight Management Solution • Electronic Submissions/Reviews/Meetings • Supports Biomedical, Behavioral/Social, Commercial, Institutional and Governmental • Highly Client-Configurable, No Limits • Automated Reminders for Researchers and Staff • Visit www.IRBManager.com


Thanks to Those Who Made This Conference Possible

Thank you to all those who contributed their time, effort, and energy

recognition

We can never fully express our gratitude to the conference Planning Committees and Subcommittees for their important work to develop this conference. Please see the inside front cover of this Guide for a complete listing of these hardworking volunteers. We are ever grateful for their guidance, energy, leadership, and dedication in bringing this conference to life.

schedules

Our thanks also go out to our entire faculty for bringing the conference content to life. Each faculty member has made essential and inspired contributions to this conference and to the field of research ethics more broadly, and we could not provide worthwhile educational opportunities without their input and dedication.

posters

to this meeting!

Among PRIM&R’s most cherished partners are the Federal agency representatives here with us today. Our field is blessed with a cadre of caring, accessible, highly principled, and helpful individuals. We thank them for their input and participation in this shared educational venture. We would also like to offer a big “thank you” to those who submitted abstracts for the Poster Presentations. This program has been greatly enriched by their contributions, and we appreciate the effort and initiative that went into their submissions. Make sure to take a look at the important work being demonstrated

in these posters, as they are filled with helpful strategies, creative ideas, and useful information regarding research protections and HRPP operations. Speaking of posters, we’re sure that you’ve got ideas of your own, so please share what you know and consider submitting an abstract next year! Visit www. primr.org/aer13 for details. We asked, and you answered! We’d like to extend a special thanks to everyone who submitted a session idea through our Call for Session Proposals, especially to those whose recommendations were selected for the final program: Elizabeth Bankert, Marianna Bledsoe, Jeremy Block, Jeffrey Cohen, Pierre Deschamps, Teresa Doksum, James Dubois, Elizabeth Hohmann, Greg Manship, William Meurer, Mitchell Parrish, Mary Ott, Paul Reitemeier, James Riddle, Shirley Roach, Nicholas Slack, Lauren Solberg, Adrienne Tanner, Marc Teitelbaum, Louise Tipton, Malia Villegas, Wendy Visscher, Kay Warner, Carol Weil, Charles Weijer, and Deborah Zarin. 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 Session Proposals are marked with a star on the program, which is included in this Guide.

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Thank You to Our Volunteers

PRIM&R’s success is a direct result of the dedication and support of our many volunteers. We’d like to take a moment to thank them for their many hours of research ethics. Here, we list those who volunteered with PRIM&R between September 2011 and September 2012. From conference greeters to Ampersand bloggers to conference faculty, we are very appreciative of their efforts. Thank you! Danielle Abram Oluyemisi Akinwande Anne Alberhasky Tim Allen Patricia Alt Rob Anderson Joe Andrews Michelle Aparicio Maria Arnold George Babcock Janiine Babcock Lorraine Babeu Matthew Bailey Linda Balk Ron Banks Szczepan Baran Mary Barnhart Kathryn Bayne Scott Beardsley Wilfred Bengnwi Taylor Bennett Lynn Bevan-Watson Carol Bienstock Natasha Blakeney Gary Borkowski Susan Bouregy Joe Breault Candice Brotchie-Fine Linda Brovarney Marcy Brown Marilyn Brown Pat Brown

Melinda Bruns John A. Bryan Caryn Burgess Julie Burgess Mina Busch Heather Butts Eileen Callahan Jennifer Camacho David Cannon Lauren Cantamessa Warren Capell Andrew Cardon Liz Carroll Samuel Cartner Jerry Castellano Cheryl Cheney Michelle Christiano Shana Clark Carol Clarke Michael Clayman Paula Clifford J.G. Collins Laura Conour Alicia Cook Kathleen Cornely Miriam Cotler Dawnmarie DeFazio Monica DeFeo Jennifer Delgado Dawn Diehl Regina Drake Nicole Duffee

Donna Eaton Marianne Elliott Ruth Faden Michael Fallon Tom Fey Cameron Fletcher Elizabeth Ford Valerie Fratus William Freeman Sharon Freitag Bonnie Frisard Deborah Frolicher Barbara Garibaldi David Gary Jon Geller Barbara Gibson Bobette Godding Paul Goebel Sylvia Gografe Betty Goldentyer Jaimie Graff Judith Grant Robert Green Molly Greene William Greer Bambi Grilley Teryl Grosz Cyndi Hahn Troy Hallman Estela Hamblen F. Claire Hankenson James Harper

Susan Harper Shannon Harr Joseph Haywood Hope He Tracy Heenan Dorothy Hilpmann Gene Hines Elizabeth Hodge Charles “Robin” Hogen Deborah Holland Kathryn Holthaus Cindy Hoorn Marilyn Horn Amanda Howard Germaine Hughes Melissa Hunsley Mary Lou James Donna Jarrell Sandra Jensen Ann Jernigan Tania Johnson Julie Jones Susan Kallay Alicia Karas Nancy Kass Hallie Kassan Lev Keely Debbie Kemper Loreene Kemperman Bruce Kennedy Julia Kennedy William King

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recognition

hard work, for their expertise, and for their ongoing commitment to


posters

schedules

recognition

Thank You to Our Volunteers

Sharron Kirchain Mandy Kozlowski Kaarkuzhali Krishnamurthy Lee Krulisch Arthur Lage Stewart Laidlaw Margaret Landi Emily Largent Janet Leary-Prowse Anna Marie Lee Sara Levin Linda Lewicki Sally Light Danielle Littee Barbara LoDico Susan Loess-Perez Mark Long Dorotha Love Hall Jayne Mackta Monika Markowitz Georgia Mason Amal Matar Monte Matthews Natalie Mays Suzanne McCaffrey Kathy McClelland Michael McDonald Holly McEntee

Ross McKinney Justin McNulty Sandra Meadows Leticia Medina Anna Michonski Mitchell Glendon Miller Farah Moluvi Tara Moore Carol Murgo Camille Nebeker Karl Nelson Teresa Neubauer Chris Newcomer Steve Niemi Gwenn Oki Leanne Olson Dennis Orgill Julie Ozier Valerie Parkison Emily Patterson-Kane Deb Paxton Jennifer Perkins Cindy Peterson Madeline Peyton Alison Pohl Stacy Pritt Donna Pulkrabek Mindy Reeter

Paul Reitemeier Lori Roesch Bernard Rollin Cynthia Rosenblatt Andrew Rowan Chris Samek Kathryn Schulz Miriam Schwartz Walt Senterfitt Mary Jo Shepherd Charlotte Shupert Joan Sieber Robert Sikes Susan Silk Henry Silverman Julie Simpson Elaine Skinner-Ntiri Elizabeth Small Michael Smith Lisa Snider Matt Stafford Suzanne Stone Kacey Strickland Shannon Stutler Catherine Sutherland LaWanda Thompson Steve Tinge Sarah Trautz

Samuel Varghese Joan Volin Kenneth von Kluck Dan Voss Julie Washington Dawnett Watkins Amanda Watts Casey Webster Sally Westlake Mark Whary William White Ilene Wilets Sandy Wilkins Dorinda Williams Wendy Williams Christina Winnicker Vinita Witanachchi Chris Witwer Delia Wolf Brenda Wright Dorothy Wright John Wright Noreen Wynn Mike Wyss Laura Zanewicz Steven Ziemba Joanne Zurlo

Thank you also to our Board of Directors (pages 38-39), 2012 AER Conference Planning Committees (please see the inside cover), and our 2012 AER Conference faculty (please see page Faculty section of this Guide). This list was generated on October 1, 2012. We apologize for any errors or omissions.

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In the more than 10 years since PRIM&R established the Certified Institutional Review Board (IRB) Professional (CIPÂŽ) program, more than 2,100 individuals have earned the credential. The CIP designation is for individuals whose primary job responsibilities include substantial participation in overseeing, administering, or performing the daily activities of an IRB office. The credential was developed to promote ethical research practices and programs by ensuring that those charged with their administration have demonstrated an appropriate level of knowledge, understanding, and relevant experience. The success of the CIP program is reflected in the growing number of job advertisements that either ask for CIP certification or commitment to obtain certification within a specified time frame. It is also reflected in personal stories of growth and recognition associated with the preparation for and successful attainment of certification. The Council for Certification of IRB Professionals (CCIP), the group responsible for developing and maintaining the program and its examinations, has a diverse membership, representing various types of IRBs, institutions, organizations, and areas of expertise. PRIM&R would like to thank the following members of the 2012 CCIP for their dedication to the program:

Front row: Bambi Grilley, Erica Heath (vice chair), Barbara LoDico, Sallyann Henry (PTC), Greg Lim (chair) Back row: David Forster, Kathy Schulz, Gary Chadwick, Dan Voss, Paul Goebel, Jerry Castellano Not pictured: Lynn Bevan-Watson, Heather Butts Examinations are conducted during two periods of two weeks each in the spring and fall. The 2013 testing periods are as follows:

Complete information about the CIP program, including the code of ethics, eligibility information, application procedures, and the Body of Knowledge that is covered in the test can be found on PRIM&R’s website at www.primr.org. For more information, please stop by the PRIM&R Booth in The Conference Connection or email certification@primr.org.


Board of Directors

recognition

Officers

Members

Walter Straus

A. Cornelius Baker

Joseph J. Byrne

Chair

FHI 360

Tufts University

posters

schedules

Merck Vaccine Division

Cynthia A. Gómez

Susan S. Fish

Leonard Glantz

Vice Chair

Boston University

Boston University

San Francisco State University

Alexander Capron

Tanise L. Jackson

Moira Keane

Secretary

Florida Agricultural and

University of Minnesota (retired)

University of Southern California

Mechanical University

David A. Borasky Treasurer

Susan Z. Kornetsky

Robert J. Levine

University of North Carolina at Chapel Hill

Boston Children’s Hospital

Yale University

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P. Pearl O’Rourke

Marky E. Pitts

Partners HealthCare System

IACUC Consultant

Harry Rozmiarek

Ada Sue Selwitz

Barbara Stanley

University of Pennsylvania

University of Kentucky

Columbia University

Jeremy M. Sugarman

Hugh Tilson

Joan Rachlin

Johns Hopkins University

University of North Carolina

Executive Director

at Chapel Hill

PRIM&R Ex-officio

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recognition

Judy Norsigian Our Bodies, Ourselves


posters

schedules

recognition

ARENA Legacy Award

PRIM&R is honored to present the 2012 ARENA Legacy Award to Susan J. Delano, CIP.

The 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.

As noted in the award nomination submitted by a PRIM&R member: “In the six years that she chaired the Certified IRB Professional (CIP®) Council, the CIP credential evolved into the gold standard for the certification of IRB professionals. It is now a sought after credential for those in the human subjects protections community, and the number of certified IRB professionals exceeds 2,100 individuals. Susan has been the steady, guiding influence that has allowed the CIP credential to achieve its current level of success. She has devoted countless volunteer hours to improving the quality of the exam content, making presentations on the CIP credential in many fora, and promoting the ethical conduct of human subjects research more widely.”

This award was developed to honor not only the recipient, but also the living legacy created by the Applied Research Ethics National Association (ARENA), which was the membership division of PRIM&R from 1986 to 2005. We are thrilled to announce that Susan J. Delano, CIP, has been selected as the 2012 recipient of the ARENA Legacy Award. She will receive this award on Wednesday, December 5 at 8:00 AM in Exhibit Hall D. Susan is a highly respected, longstanding, and tireless advocate for ethical research, and for the education needed to reach that end. She long ago came to understand that raising the professionalism of those charged with protecting human subjects was an important step for our field, and she has served as a core member of the group that founded and then nurtured the credentialing program for institutional review board administrators.

The commendation above is just one of many comments we receive about Ms. Delano’s important work that has so greatly benefitted the PRIM&R community, the CIP community, and the research community more widely. To meet Susan Delano is to be impressed by Susan Delano, and she is respected and appreciated by all who know and work with her.

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Ms. Delano is a regular presenter at PRIM&R meetings on a range of topics, including the CIP program, issues relating to vulnerable populations, those who are decisionally impaired, and informed consent. Her commitment to advancing ethical research is longstanding and deep, having first become involved with research protections in 1980 when she was hired as the IRB staff person at the State University of New York at Stony Brook. Two years later, she joined the Research Foundation for Mental Hygiene, Inc. (RFMH), a not-for-profit corporation affiliated with the New York State Department of Mental Hygiene located in Albany, NY. Ms. Delano has been the deputy managing director of RFMH since 2001.

and Policy, 1998), “Uninformed Decision Making: The Case of Surrogate Research Consent” (The Hastings Center Report, 1997), “Protecting Mental Health Research Subjects Without Prohibiting Progress” (Hospital & Community Psychiatry, 1994), and “Protection of Persons with Mental Disorders from Research Risk: A Response to the Report of the National Bioethics Advisory Commission,” (Archives of General Psychiatry, 1999). Ms. Delano received her bachelor’s degree at the level IIA (the equivalent of an American master’s degree) in sociology, psychology, and research methodology from the Australian National University. Ms. Delano has left an indelible mark on the PRIM&R community and on the wider research ethics field as well. It is thus with tremendous gratitude for her valuable and unique contributions that we present her with the 2012 ARENA Legacy Award.

In addition to being a superb teacher, leader, and administrator, Ms. Delano is an active author. Her publications include chapters on “Research Involving Adults with Decisional Impairment” and “Certification of IRB Professionals” (with E. Bankert and R. Amdur, in Institutional Review Board Management and Function, 2006), articles in journals such as “Regulating Research With Vulnerable Populations: Litigation Gone Awry” (Journal of Health Care Law

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Ms. Delano has been a PRIM&R member for more than 18 years, and her devotion to the organization is evident in many aspects, but, as noted above, none more so than in the development of the CIP program. PRIM&R is thus especially grateful to Ms. Delano for her seminal role in spearheading the creation and maintenance of this credential for IRB professionals. She was there from the beginning when, in 1999, she participated in small meetings that led to the creation of the CIP program. She became a founding member of the Council for Certification of IRB Professionals and then became Chair of the Council in 2005, a position she held until her term ended in December 2011.


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Distinguished Service Award

PRIM&R is proud to present the 2012 Distinguished Service Award to Mary Jo “MJ” Shepherd, DVM, CPIA.

The Distinguished Service Award recognizes a PRIM&R member who has made a valuable and unique contribution to the field of research ethics, and who has attained distinction in promoting PRIM&R’s purpose and ideals through writing, teaching, or research.

in the reams of positive evaluations she receives each time she teaches, speaks, or writes, since, in addition to these considerable professional skills, it is Dr. Shepherd’s generous spirit, personal warmth, and easy humor that make her a beloved colleague to all who know her.

We are thrilled to announce that Mary Jo “MJ” Shepherd, DVM, CPIA, has been selected as the 2012 recipient of this year’s Distinguished Service Award.

As noted by one of those who nominated Dr. Shepherd:

A self-proclaimed institutional animal care and use committee (IACUC) “geek,” Dr. Shepherd has been a tireless and effective advocate for her fellow IACUC administrators/coordinators and the critical role they play in ensuring quality animal care and use programs. She has actively promoted and participated in the education of all those who have expressed an interest in learning more about IACUCs, and that is but one of the many reasons why she is so deserving of this Award. Dr. Shepherd is also a generous and talented volunteer for a number of organizations working in the laboratory animal field. In fact, one can only wonder how she manages to maintain her “day job,” given the unending extracurricular activities in which Dr. Shepherd participates. The answers can be found

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“Dr. Shepherd has promoted animal welfare through her multifaceted promotion and support of IACUCs, and she has also worked through a variety of avenues to educate the public on the importance and value of animal research…She has been an advocate for the people who do this important work, through the Certified Professional IACUC Administrator (CPIA®) program, the mentoring and training she has provided, and by always speaking up for them with pride and understanding. MJ’s hard work and impact on the CPIA program alone merit recognition by PRIM&R and the laboratory animal community more widely. Considered alongside her many other careerlong efforts on behalf of animal welfare, IACUCs, and those who care for laboratory animals, I can think of no one more deserving of PRIM&R’s Distinguished Service Award.”


This is but one of the many testaments we received saluting Dr. Shepherd’s leadership, her significant contributions to the field, and her unwavering dedication to her colleagues.

Dr. Shepherd has also volunteered for the American Association for Laboratory Animal Science at the local and national levels as a Trustee, member of the editorial review board, and branch president, to name just a few of her many roles there. For more than 10 years, she has been actively involved in the planning of the New Jersey Association for Biomedical Research’s annual IACUC seminar. Dr. Shepherd was also on the Board of Directors of Americans for Medical Progress for five years, and she has been a member of the Pennsylvania Society for Biomedical Research since 2008.

It is thus a privilege and honor to present Dr. Shepherd with the 2012 Distinguished Service Award. She will receive this award at PRIM&R’s 2013 IACUC Conference in Baltimore in March, but we wanted our wider community to join us in acknowledging her achievements during the 2012 AER Conference.

Dr. Shepherd has written numerous articles for magazines and journals, including Advances in Ocular Toxicology, Contemporary Topics in Laboratory Animal Science, Lab Animal, ILAR Journal, and Medical Device and Diagnostic Industries. Given all of these remarkable achievements, it should come as no surprise that Dr. Shepherd has been a dynamo within the PRIM&R community as well. Since 2001, she has chaired multiple Planning Committees for our annual IACUC Conferences, served as a faculty member at each of these

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As the Director of the Office of the IACUC at Columbia University, Dr. Shepherd administers two IACUCs for one of the largest animal care and use programs in the country. She has worked in the field of laboratory animal medicine since early 1988, when she first became an IACUC member. Since that time, she has served as instructor, clinical veterinarian, attending veterinarian, IACUC member, consultant, scientist, and finally, as the professional administrator/director of several well-respected IACUCs, including at Pfizer, Merck, the University of Pennsylvania, and now Columbia.

meetings, and also been a central member of the pre-conference program faculties for the IACUC 101 and Essentials of IACUC Administration courses. In addition, she is currently a member of PRIM&R’s Certification Committee, and was a founding member of, and has served as the chair of, the Council for Certified Professional IACUC Administrators (CCPIA) since its inception. As chair of the CCPIA, she has worked hard to provide those in the profession with a highly visible and highly credible way to advance their knowledge and perform their duties in a professional manner. Largely through her dedication and the sheer force of her passion, Dr. Shepherd has been a key driver and sustainer of the CPIA credential.


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Community Member Recognition

Spotlight on an Unsung Shero: Melinda Hurst

We hope you’ll join us on Thursday, December 6 at 8:00 AM, when PRIM&R will recognize the exemplary contributions of Melinda Hurst, an individual who has demonstrated an outstanding commitment to research ethics through advocacy and education. For over 30 years, Ms. Hurst has served as a unaffiliated, non-scientific member of several institutional review boards (IRBs) including the ethics committee and IRB of Cedars-Sinai Medical Center, California’s Human Subjects Protection Committee, and the Los Angeles County/University of Southern California IRB. Ms. Hurst was a fixture on PRIM&R’s conference faculties throughout the 80s and 90s, and quickly became a leader in the effort to educate unaffiliated, non-scientific members about their roles. She deserves significant credit for enhancing the visibility and credibility of unaffiliated, non-scientific IRB members and for educating institutions about the need to treat these members as more than mere tokens. The amount of time, creativity, and energy Ms. Hurst has spent supporting other “community members” of IRBs is incalculable. She has organized educational and networking events, advocated for more institutional support and greater involvement of “community members” in the IRB process, and served as a particularly valued mentor to countless new and/or less experienced IRB members. Ms. Hurst has written many bioethics articles and presented a paper at the Fifth World Conference of Bioethics in London in 2000 in which she stated:

“The value of difference is crucial because human subject[s] research involves people in many different roles. Appreciating these differences is central to the successful functioning of the committee… I believe that ‘nonaffiliates’ can best fulfill their role when ethical review of human research is viewed as essential. I am optimistic that the increasingly visible activity of ‘nonaffilitates’ is a major step in this direction.” Throughout her distinguished service, Ms. Hurst has advocated to raise awareness of and promote the ethical principles underlying human subjects protections. Her work has inspired IRB “community members” nationwide to better understand their role on the IRB and to feel empowered to express their perspectives on the rights and welfare of human subjects. Ms. Hurst’s advocacy embodies the values, ethics, and commitment to protection that human subjects who participate in research deserve. It is with enormous gratitude for her service to both PRIM&R and the community at large that we recognize Ms. Hurst for her dedication and commitment to research ethics. We look forward to celebrating Ms. Hurst’s accomplishments on Thursday, December 6 at both 8:00 AM before the start of the keynote presentation and during a luncheon in her honor from 12:45 to 1:45 PM, in Room 25B. If you did not sign up in advance for this lunch, please stop by the Help Desk to inquire about availability. Congratulations and thank you, Melinda Hurst…our unsung shero!

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Second Annual Pillars of PRIM&R Lecture

PRIM&R has been blessed with visionary, wise, hard-working, and highly principled leaders since its founding in 1974. In 2006, the Board of Directors established the annual Pillars of PRIM&R members Louis Lasagna, MD; Herman Wigodsky, MD, PhD; and Sanford Chodosh, MD. Those creating this award felt that the best way to honor their colleagues was by identifying and supporting early-career professionals whose scholarship in the field of research ethics reflects PRIM&R’s mission and core values. Past Pillars of PRIM&R awardees have also demonstrated exceptional potential for leadership in advancing ethical research. In recognition of those accomplishments, awardees receive small grants to be used to further their professional development. As a companion to this award process, in 2011, PRIM&R established an annual Pillars of PRIM&R Lecture. The speaker chosen to present this lecture is selected based on their scholarship, principles, values, and professional accomplishments, as well as on their ability to educate and inspire our audience members. The remarks of the Pillars of PRIM&R lecturer serve as a reminder of the importance of keeping ethics at the center of our individual and shared work. They also serve to reflect the values embodied by Drs. Lasagna, Wigodsky, and Chodosh, as well as PRIM&R’s mission of advancing the highest ethical standards in research and its core values of excellence, community, diversity, integrity, knowledge, respect, creativity, and social responsibility. The second annual Pillars of PRIM&R Lecture will be held at this conference, and we are proud and privileged to announce that it will be delivered by Elyn R. Saks, JD, PhD. Professor Saks is the Orrin B. Evans Professor of Law, Psychology, and Psychiatry and the Behavioral Sciences at the University of Southern California Gould School of Law (USC Law), and a specialist in the fields of mental health law, criminal law, and children

and the law. Her scholarship, much of which focuses on the dignity, autonomy, and rights of the mentally ill, highlights the ethical dimensions of psychiatric research and forced treatment of the mentally ill. Professor Saks’ talk, titled My Journey Through Madness: Elyn R. Saks, JD, PhD Schizophrenia and Research Ethics, will be held on Thursday, December 6, 8:30-9:15 AM, in Exhibit Hall D. Professor Saks teaches Mental Health Law, Mental Health Law and the Criminal Justice System, and Advanced Family Law: The Rights and Interests of Children at USC Law. In addition, she served as USC Law’s associate dean for research from 2005 to 2010 and teaches at the Institute of Psychiatry and the Law at the Keck School of Medicine at USC. She is an adjunct professor of psychiatry at the University of California, San Diego. In 2009, Professor Saks was a recipient of a MacArthur Foundation fellowship. She used the funds from the “genius grant” to create the Saks Institute for Mental Health Law, Policy, and Ethics. The Institute spotlights one important mental health issue per academic year and is a collaborative effort that includes faculty from seven USC departments: law, psychiatry, psychology, social work, gerontology, philosophy, and engineering.

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Award as a meaningful and enduring memorial to deceased Board


Second Annual Pillars of PRIM&R Lecture

Professor Saks has demonstrated integrity and courage through her Louis Lasagna, MD Herman Wigodsky, MD, PhD Sanford Chodosh, MD writings about her own experience with schizophrenia, and she has In 2007, Professor Saks published The Center shown great commitment to ethics and social justice Cannot Hold: My Journey Through Madness, a through her scholarly work on the dignity, autonomy, memoir about her struggles and successes with and rights of the mentally ill in both the clinical and schizophrenia and acute psychosis. The Center research contexts. As a research subject herself, her Cannot Hold paints a vivid, terrifying, and very remarks promise to shed important new light on the human portrait of a life lived with schizophrenia, while little-discussed domain of research with the mentally serving to remind readers that mental illness is not ill. We are honored to have Professor Saks present equivalent to decisional incapacity. the second annual Pillars of PRIM&R Lecture, and simply put, we cannot imagine a more powerful Other publications include Refusing Care: Forced exemplar of character, authenticity, and principle. Treatment and the Rights of the Mentally Ill (University of Chicago Press, 2002), Interpreting

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Interpretation: The Limits of Hermeneutic Psychoanalysis (Yale University Press, 1999), and Jekyll on Trial: Multiple Personality Disorder and Criminal Law (with Stephen H. Behnke, New York University Press, 1997).

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In Memoriam

Mr. Bernhardt’s long, devoted, and distinguished service to the ARENA Council included serving as its third president, a chair of the bylaws committee, and a member of the nominations and elections committee. In 1992, Mr. Bernhardt edited the first ARENA/ OPRR (Office for Protection from Research Risks) IACUC Guidebook, and in 1993, he wrote a history of ARENA, which became the definitive record of those early years. Even after his formal retirement from the ARENA Council in 1998, Mr. Bernhardt remained in close contact with the organization and was one of PRIM&R’s most ardent advocates until just weeks before he died. After travel to PRIM&R conferences became impossible due to mobility problems, Mr. Bernhardt looked forward to reading the programs and receiving reports from the PRIM&R staff about the highlights of each meeting.

Mr. Bernhardt also kept abreast of PRIM&R’s activities and members by faithfully reading the PRIM&R Newsletter every month. Mr. Bernhardt was much loved by his many PRIM&R/ ARENA friends, and he loved them back. He once wrote that “membership in, and the opportunity to help with the creation and development of, ARENA have enriched me in two ways: introducing me to colleagues and leaders in the field who have taught me much— and continue to do so—and keeping me on the cutting edge of the field.” Those words demonstrate his humility as well as his unflagging intellectual and professional curiosity and commitment. David Bernhardt enriched our community in countless ways, and has left us an inspiring legacy that challenges us to continue to be committed to our mission and our members, as he surely was to both.

When the news of his passing spread to some of those who had worked with Mr. Bernhardt in PRIM&R’s early years, warm reminiscences poured in: David was an inspiration to us all, as well

David was SUCH a lovely man, indeed... and

always have a place in my heart and mind as

as a terrific role model and mentor for many

FEISTY too. I will remember him always with

an early leader.

of us. He will be missed.

the greatest affection!

- Gwenn Oki, Van Andel Institute

- Karen Hansen, Fred Hutchinson

- Natalie Reatig, retired, formerly of the

Cancer Center

National Institute of Mental Health

I always had a soft spot for David—such a

Hearing of David’s passing was a reminder of

of the contributions he made to PRIM&R and

thoughtful person and a gentle man.

how things were when PRIM&R and ARENA

human subjects protections, is the fact that

- Helen McGough, retired, formerly of the

were small and just beginning to blossom...

he was, in the best sense, a gentleman and a

University of Washington

So many milestones, so many growing pains,

gentle man.

so much fun and camaraderie... David will

- Jere Boyer, Clinical Research Management, Inc.

What I remember most about David, after all

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David Bernhardt, a long-standing and cherished leader of the PRIM&R community, passed away on June 20, 2012 at the age of 93. Mr. Bernhardt was a member of the steering committee that created the Applied Research Ethics National Association (ARENA), PRIM&R’s former membership division.


Schedule: Monday 12.3

PRIM&R’s Pre-Conference Educational Programs will be held on Monday, December 3, 2012. As registration for these programs is now closed, only those attendees who pre-registered are able to participate.

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A continental breakfast will be served from 7:00 to 8:30 AM in Ballroom 20AB. Boxed lunches will be provided for all sessions, also in Ballroom 20AB. Please review your program’s agenda, as lunch times differ for each course. At the conclusion of the Pre-Conference Educational 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.

ABCs of Tissue Banking

8:30 AM-5:00 PM 24ABC Faculty: Marianna Bledsoe, MA; Helen Panageas, CIP

Advanced Research Ethics

8:30 AM-4:30 PM 33AB Faculty: Amulya Mandava, BA; Franklin G. Miller, PhD; Elizabeth Pike, JD, LLM; Seema Shah, JD; Sumeeta Varma, MD; Alan Wertheimer, PhD

Centralized Institutional Review Board (IRB) Review

8:30 AM-4:30 PM 32B Faculty: Emily Chi Fogler, Esq.; Elizabeth Hohmann, MD; Julie Kaneshiro, MA; P. Pearl O’Rourke, MD; Panelists: K. Lynn Cates, MD; Jacquelyn L. Goldberg, JD

Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent

8:30 AM-4:30 PM 32A Faculty: Moira Keane, MA, CIP; Daniel K. Nelson, MSc, CIP

Hot Topics for Institutional Officials

IRB 101sm

8:30 AM-4:15 PM 29BC Faculty: Bruce Gordon, MD; Ada Sue Selwitz, MA; Elizabeth Bankert, MA; Dean Gallant

IRB 201: An In-Depth Analysis of the Criteria for Review 8:30 AM-4:30 PM Faculty: Karen Hale, RPh, MPH, CIP; Susan Kornetsky, MPH

26AB

IRB 301: Review and Application of the Regulatory Criteria for Approval

8:30 AM-4:45 PM 29D Faculty: Jeffrey A. Cooper, MD, MMM; J. Michael Oakes, PhD; Charlotte Coley, MACT, CIP; Michele Russell-Einhorn, JD

Quality Assurance/Quality Improvement 101: Fundamentals and Application

8:30 AM-4:15 PM 27AB Faculty: Eunice Yim Newbert, MPH; Terry VandenBosch, PhD, RN, CIP, CCPC; Delia Wolf, MD, JD, MSCI, CIP

Regulatory, Ethical, and Technical Challenges in Internet Research

8:30 AM-5:00 PM 23AB Faculty: Elizabeth Buchanan, PhD; Joseph A. Konstan, PhD; Laura Odwazny, JD, MA

Research Involving Children: Framing and Applying Additional Protections

8:30 AM-4:00 PM 33C Faculty: Deborah Barnard, MS; Steven Joffe, MD, MPH; Robert “Skip” Nelson, MD, PhD

8:30 AM-4:30 PM 23C Faculty: Janet Donnelly, RAC, CIP; Felix KhinMaung-Gyi, PharmD, MBA, CIP, RAC; Scott Lipkin, DPM, CIP; F. Lisa Murtha, Esq.; Ivor Pritchard, PhD; Robyn S. Shapiro, JD; David Wynes, PhD p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

Pre-Conference Program & Affinity Group Networking Reception 4:00-6:00 PM

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Your Guide to the Conference Program

The 2012 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 26 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 each track, there are three types of breakout sessions: workshops (interactive), didactic sessions session that are twice as long as the regular breakout sessions). Since there are so many choices, we advise you to use the descriptors that follow to identify the breakout sessions that are the most relevant to your needs and interests. As you consult these descriptions, please also note the following:

Icon Key Indicates a didactic session (presentation-based) Indicates a workshop (interactive)

1

2 3

Double sessions are held over lunch and include a box meal (provided prior to the start of the session). Pre-registration is required to ensure meal availability. If you pre-registered for a double session and are unable to attend, please let a staff member at the Help Desk know so that another person may attend in your place. Please note that not every topic is a perfect fit for one of the 26 tracks. We request your indulgence if you come across an occasional round peg in a square hole. The tracks are not meant to be exclusive, and any person can go to 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 Institutional Officials (IO) Track even if you’re not an IO.

Indicates session will be recorded for conference proceedings. Qualifies for Continuing Medical Education credit Qualifies for CIP® Continuing Education (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 December 5. 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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(presentation-based), and double sessions (hybrid workshop/didactic


Your Guide to the Tracks TRACKS DESCRIPTORS 1&2

3

A Dialogue with

Tracks 1 and 2 will provide attendees with an opportunity to hear from and ask questions of federal agency

the Feds I and II

representatives.

Accreditation of

This track will focus on strategies for achieving and maintaining accreditation. Topics to be covered include

HRPPs

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

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5

6

7

Activities Along

This track will explore the definitional, ethical, and jurisdictional issues that arise in a range of health-related

the Boundaries

activities that are often said to occur along the imprecisely drawn borders of human subjects research. Each of these

Between Research

workshops will dig into questions specific to a particular activity while also highlighting issues that are common to a

and Practice

range of activities that PRIM&R is exploring in its ongoing “Boundaries of Research” Project.

Advanced

This track will provide experienced IRB professionals with a series of sessions covering both “hot button” issues

Forum for IRB

and everyday aspects of their jobs. Sessions in this track may be of particular interest to members of the IRB

Professionals

Chairs Affinity Group.

Clinical Research

This track will provide those conducting clinical research studies—investigators, research nurses, research staff,

Professionals

CRO employees—with sessions addressing operational and regulatory challenges.

Ethical Issues

This track will explore the underlying ethical principles of human subject research and issues for HRPPs/IRBs as they are translated from the theoretical to the human research setting. This track will provide attendees with an opportunity to learn about and discuss regulations and guidance pertaining

8

FDA Regulations

to FDA-regulated clinical investigations with representatives from FDA’s Office of Good Clinical Practice (OGCP), Center for Drugs (CDER), Center for Biologics (CBER), Center for Devices and Radiological Health (CDRH), and the Center for Tobacco Products (CTP). This track will cover both basic and advanced topics.

9

Informed Consent

This track will provide information on how to design and implement an optimal consent process, and how to write a fair, accurate, and comprehensible form.

10

Institutional

This track will provide a meeting ground where institutional officials (IOs) and others with oversight responsibilities

Officials

can discuss shared concerns, problems, strategies, best practices, and other useful innovations. Sessions in this track may be of particular interest to members of the IOs Affinity Group.

11

International

This track is designed for non-US-based research professionals and US-based professionals working outside North

Research

America. Sessions will cover issues relating to the conduct of ethical research across geographic and cultural borders. Sessions in this track may be of particular interest to members of the Global Research Affinity Group. This track is designed for those new to the field of human subjects protections and IRB review and management. As

12

IRB Bootcamp

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

This track is designed to provide a forum where IRB professionals can come together to acquire and augment the

and Toolkit

strategies and skills needed to do their jobs well and efficiently. Sessions in this track may be of particular interest to members of the IRB Chairs Affinity Group.

14

Issues for

This track will provide representatives from HRPPs and drug, device, and biotechnology industries with an

Pharma/Biotech

opportunity to discuss topics of mutual interest, including the role of pharmaceutical and biotechnology companies in unanticipated findings, informed consent, the globalization of clinical research, and more.

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TRACKS DESCRIPTORS This track will cover legal, legislative, and compliance issues. Methods for effective communication and 15

16

Legal

collaboration among legal counsel, sponsors, HRPP professionals, and other stakeholders will also be discussed.

Out-of-Body

This track will explore the complex evolving ethical and regulatory issues for the collection and banking of biological

Experiences:

specimens for both clinical and genetic research.

Research Involving Tissue and Data

17

Populations

This track will explore issues related to vulnerable populations, including regulations, guidance, and ethical

Requiring

principles. This track will include both basic and advanced sessions, and will also address vulnerable populations

Additional

beyond those recognized in the federal regulations.

Protections This track includes a variety of sessions that are current and complex, late-breaking, or involve important topics that Potpourri

did not fit easily into another track.

This track will address current topics and issues Quality Assurance/Quality Improvement (QA/QI) programs face 19

20

QA/QI and

when implementing and conducting post-IRB approval monitoring, also known across organizations by various

Post-Approval

names such as not-for-cause study reviews; and with follow-up after monitoring/review visits (e.g. reports, corrective

Monitoring

action, and education). Sessions in this track may be of particular interest to members of the QA/QI Affinity Group.

Regulatory

This track will explore potential models for streamlining IRB processes through an examination of existing regulatory

Balance

flexibility, alternative review models, and best practices.

Research 21

Involving the

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

Internet and Social Networking

22

Responsible

This track will focus on ways the research community can promote integrity. Sessions will introduce components

Conduct of

necessary for responsible conduct of research (RCR) programs, including the regulations. Topics covered in this

Research

track will also include ways to handle alleged research misconduct, strategies for negotiating differences in difficult situations, responding to wrongdoing in research, and more. Tracks 23 and 24 will cover issues related to the conduct and review of social, behavioral, and educational research

23&24

25

SBER I and II

(SBER). Sessions in these tracks may be of particular interest to members of the SBER Affinity Group.

Small Research

This track is geared toward small research programs including, but not limited to, community hospitals, colleges, and

Programs

research institutions. The sessions will address the special challenges faced by these entities. Sessions in this track may be of particular interest to members of the Small Institutions Affinity Group.

26

Unaffiliated and

This track will introduce unaffiliated and non-scientist IRB members and staff to essential, basic scientific topics and

Non-Scientist IRB

foundational strategies for IRB review. Following the conference, a “Certificate of Core Competency� will be awarded

Members

to those who attend at least four of the five sessions in this track. Sessions in this track may be of particular interest to members of the Unaffiliated/Community Members Affinity Group.

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Schedule Tuesday, December 4 7:00-8:00 AM

Continental Breakfast

10:30–11:45 AM

7:00-8:00 AM

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Continental Breakfast to Welcome our First-Time Attendees 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

25B

Affinity Group Networking Breakfast

Those who signed up for an affinity group are invited to join us for this continental breakfast where they can connect and network with their fellow group members. 8:00-8:30 AM

EXHIBIT HALL D

Welcome and Conference Overview 8:30-9:15 AM

EXHIBIT HALL D John P. A. Ioannidis, MD, PhD C.F. Rehnborg Professor in Disease Prevention and Director, Stanford Prevention Research Center Professor of Medicine and Health Research and Policy, Stanford University School of Medicine 9:15-10:00 AM EXHIBIT HALL D Plenary Address Robert H. Bartlett, MD Professor of Surgery, Emeritus, University of Michigan

Keynote Address

10:00-10:30 AM

SAILS PAVILION

Break

Icon Key

didactic session

Didactic Sessions and Workshops Series A

SAILS PAVILION

A1 25A

A Dialogue with the National Institutes of Health (NIH) (A Dialogue with the Feds I Track)

Faculty: Jacquelyn Goldberg, Valery Gordon, Dina Paltoo, Maria Stagnitto Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to: • Hear from representatives of the NIH Office of Science Policy, the NIH Office of Extramural 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 A2

A Dialogue with the Office for Human Research Protections (OHRP) (A Dialogue with the Feds II Track)

30D

Faculty: Kristina Borror, Julie Kaneshiro, Irene StithColeman, Elyse Summers Attendees are encouraged to come with questions that will be of interest to all. This session will provide attendees with an opportunity to: • 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.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

A3

Preparing for a Successful AAHRPP Site Visit (Accreditation of HRPPs Track)

29A

Faculty: Anastasia Doherty, Sujatha Sridhar This session will provide attendees with an opportunity to: • Consider the process of organization-wide education in preparation for a site visit. • Share experiences of and develop strategies for preparing for a site visit. • Discuss practical tips for organizing the visit. • Examine common problems found during site visits.

Comparative Effectiveness Research: What Bioethicists Need to Know (Activities Along the Boundaries Between Research and Practice Track)

30C

Faculty: Newell McElwee, Walter Straus, Steven Teutsch, Hugh Tilson Comparative Effectiveness Research (CER) incorporates a multidisciplinary approach, drawing upon both biomedical and social scientific disciplines. The purpose of CER is to provide information on the safety and effectiveness of different approaches to addressing health care issues and inform health care decision making. CER can involve reviewing existing data (observational research), as well as conducting innovative prospective research to compare drugs, diagnostics and medical devices, surgical interventions, or behavioral methods and other approaches. In this session, faculty will: • Familiarize attendees with CER so that they are equipped to assess CER proposals. • Explore the increasing attention to this field, given the recent designation of $1 billion in federal funds addressing high-priority issues via CER. • Discuss the importance of CER to the bioethics community, given the expectation that non-conventional research proposals will need to be reviewed.

receives CIP credit

pre-registration was required

30AB

Perfection is the Enemy of the Good: How IRBs Can Harm a Study by Trying to Make it Better (Advanced Forum for IRB Professionals Track)

Faculty: Susan Fish, Lindsay McNair IRBs may require changes to research protocols under review for the benefit of subjects in that study. However, when those changes are implemented, the resultant research question may become irrelevant, the results may become less generalizable, or the study may become unfeasible to conduct. This session will provide attendees with an opportunity to: • Use real cases to discuss the reasons IRBs might require protocol changes, as well as the scientific impact of those changes on the study and its results. • Identify unintended consequences of IRBrequired changes to research protocols. • Discuss how improving subject benefits can result in irrelevant study questions. • Learn how to work with investigators in order to maximize the subject benefit and scientific merit of studies. A6

The PI’s Responsibility: The Rubber-Meets-theRoad Relationship (Clinical Research Professionals Track)

24A

Faculty: Charlotte Coley, Karena Cooper, Bruce Gordon In this session, faculty will: • Review the nine statements investigators commit to when signing Form FDA 1572. • Explore the implications of signing the form and how doing so affects the conduct of research and FDA inspections and audits. • Analyze the implications of FDA warning letters to investigators.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

A4

A5 Advanced


Schedule

A7

schedules

Ethical Issues Involving Third Parties and Secondary Subjects in Research (Ethical Issues Track)

33B

Faculty: Sara Goldkind, Robert Levine, Mitchell Parrish In this session, faculty will: • Identify when pregnant partners, caregivers, and other third parties are research subjects under DHHS and FDA regulations and guidelines. • Understand how the IRB interprets protocol and consent form language considerations that implicate third parties or secondary subjects. • Identify confidentiality, Health Insurance Portability and Accountability Act (HIPAA), and informed consent considerations for third parties. A8 Advanced

Nontraditional Access to Investigational Drugs and Devices: Single-Patient Investigational New Drugs (INDs), Expanded Access, and Humanitarian Uses (FDA Regulations Track)

31C

Faculty: Lynn Henley, Richard Klein, Joanne Less In this session, faculty will: • Review the FDA requirements related to nontraditional uses of FDA-regulated test articles. • Discuss the similarities and differences in the expanded access provisions for investigational drugs, biologics, and medical devices. • Explore Humanitarian Device Exemptions (HDEs) and Humanitarian Use Devices (HUDs) and the IRB’s role in their review. A9 Advanced

31B

To Waive or not to Waive? That Is the Question (Informed Consent Track) Faculty: Jeffrey Cooper

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didactic session

In this session, faculty will: • Discuss the appropriate use of waivers. • Review the regulatory applicability of waivers. • Explore a variety of cases in which a waiver would add more protections and help facilitate research. A10 Basic

Supporting Your Institutional Official (IO), Protecting Your Organization, and Enhancing Human Subjects Protections (Institutional Officials Track)

23C

Faculty: Scott Lipkin, Ivor Pritchard, David Wynes IOs must assure that human subjects research is conducted in accordance with the Office for Human Research Protections (OHRP) Terms of Assurance, regulatory requirements, and institutional policy. In this session, faculty will: • Help attendees understand the responsibilities of the IO. • Discuss ways that administrators educate IOs and keep them informed about organizational issues. • Explore ways to maintain open channels of communication between administrators and IOs. A11 Advanced

32B

Issues When Conducting Research in the Midst of Social Injustice (International Research Track)

Faculty: Liza Dawson, Jeanita Richardson, Jerome Singh In this session, faculty will: • Discuss the ethical issues presented when research is proposed in settings where there is social injustice. • Explore whether the conduct of research in such settings can be perceived as an endorsement of the injustice. • Explain how research can be designed to anticipate and address such ethical challenges. • Review considerations of additional protections for research participants who are also the target of the injustice in areas such as informed consent, privacy, and confidentiality.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

A13

A15 Advanced

33A

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

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

24C

Faculty: Helen Panageas, Suzanne Rivera This interactive session will use studies, concrete examples, and role-playing exercises to provide attendees with an opportunity to: • Learn techniques for delivering bad news to investigators clearly and with grace. • Acquire specific strategies for using the medium of email more effectively for transmitting IRB findings and stipulations. • Practice skills for diffusing anger and resolving conflicts in a professional manner. A14 Advanced 28E

New HITECH/HIPAA Developments and Strategies for Success (Legal Track)

31A

Faculty: Susan McAndrew, Susan Stayn In this session, faculty will: • Review regulatory requirements, the Office for Civil Rights’ new enforcement tools (such as breach and audit), and practical compliance strategies in the research environment. • Discuss research-related aspects of the new rules and guidance under the Health Information Technology for Economic and Clinical Health

Private Sector Concerns Regarding Biorepositories and Tissue Banking (Issues for Pharma/ Biotech Track) Faculty: Amelia Warner

receives CIP credit

pre-registration was required

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Julia Gorey, Cheryl Savini, Jean Toth-Allen In this session, faculty 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.

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: • Reveal 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 the academic setting and commercial companies, given that the latter do not maintain ongoing relationships with patients participating in clinical trial specimen collection and storage. • Review how changes in global regulations are driving discussions about how commercial companies will structure specimen collection procedures in the future.

A12 Basic


Schedule

(HITECH) Act and the Health Insurance Portability and Accountability Act (HIPAA). A16

30E

schedules

“Front-Door” Consent for Biospecimens: Making It Work (Out-of-Body Experiences: Research Involving Tissue and Data Track)

Faculty: Marianna Bledsoe, Ty Hoover, Paula Kim, Michele Russell-Einhorn, Nicole Sieffert The explosion of new technology and the need for high-quality research specimens has led to increasing interest in obtaining “front-door” consent for specimens obtained during the course of routine care. In this session, faculty will: • Discuss when such mechanisms are feasible and what makes “front-door” consent work. • Review the practical implementation challenges and benefits of an institution-wide biospecimen banking initiative. • Address the ethical and regulatory responsibilities of the institution using “frontdoor” consent and of its researchers. • Provide attendees with a practical approach to evaluating barriers, risks, and benefits for implementing “front door” consent at their own institutions. Participant perspectives, as expressed by a patient advocate, will also be presented. A17 Advanced

Protection and Inclusion: Considerations for Participants with Disabilities (Populations Requiring Additional Protections Track)

23A

Faculty: Jeremy Block, Jenny Kiratli Studying populations that include disabled participants requires additional considerations. What does “disability” mean in the legal sense and to the participant? What protections are provided under law and what protections are ethically mandated? How do we ensure inclusion of this group as

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didactic session

participants? This session will provide attendees with an opportunity to: • Examine this topic from the perspectives of the IRB member, researcher, and participant. • Learn to distinguish when the research is studying a disabled population, and how to identify what types of additional protections might be necessary. • Develop an understanding of the different models of disability and how they contribute to our understanding of participation in research by individuals with disabilities. • Learn about the various laws, rules, and policies at all levels (institutional, state, federal, international) pertaining to individuals with disabilities, and how these laws, rules, and policies interact with the human subjects research enterprise. A18

23B

Rewriting the National Cancer Institute (NCI) Informed Consent Template (Potpourri Track)

Faculty: Jeanne Adler The NCI has recently completed a two-year effort to revise the NCI Informed Consent Template to result in shorter and more concise informed consent documents. In this session, faculty will: • Present the finalized template with the hope of obtaining an evaluation as well as comments for incorporation into the next version. • Discuss the concerns that prompted the NCI to revise the template. • Explore the benefits and beneficiaries of the revisions of the template. • Describe the federal regulations pertaining to the informed consent form and how the

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

and Social Networking Track)

NCI Informed Consent Template achieves compliance for each. A19

Nuts and Bolts of Not-forCause Study Reviews (QA/QI and Post-Approval Monitoring Track)

33C

Faculty: Kelly Dornin-Koss, Sarah White In this session, faculty will: • Review points to consider when developing a QA/QI program. • Review basic auditing concepts. • Discuss how to determine a sample size for audits. • Discuss advantages of a standard observations.

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

24B

Faculty: Lois Brako, Laura Odwazny, Cindy Shindledecker In this session, faculty will: • Provide attendees with a basic overview of the multiple opportunities to find flexibility in the regulations. • Help attendees discover the pros and cons of “unchecking the box.” • Discuss basic ways to utilize regulatory flexibility throughout the HRPP. • Help attendees learn about applying the criteria for exemptions and expedited review. A21 Basic

Internet Research with Minors (Research Involving the Internet

receives CIP credit

pre-registration was required

A22

Building Best Practices in Clinical Research (Responsible Conduct of Research Track)

29C

Faculty: George Gasparis Building best practices in clinical research requires focus by both researchers and institutions. In this session, faculty will: • Review what can go wrong in clinical research that could compromise results. • Discuss what can be learned from cases of clinical research misconduct to prevent it in the future. • Explore how a university can become more involved in promoting high-quality clinical research, and what researchers can do to prevent errors. • Discuss areas of clinical trials that are most likely to experience problems, and answer the

29B

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

A20 Basic

Faculty: John Santelli In this session, faculty will: • Review the basic ethical and regulatory elements of research with minors. • Discuss unique issues in internet research involving minors, including specific online research procedures and age verification. • Provide suggestions to researchers and IRBs for preparing and executing informed consent and assent with minors in internet settings.


Schedule

question of whether all research should be subject to audits. A23 Basic

29D

schedules

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

Faculty: Pierre Deschamps, Michelle Feige, Ada Sue Selwitz In this session, faculty will: • Explore the concept of informed consent and underlying ethical principles. • Review when informed consent is mandatory and when it can be altered or waived. • Discuss how to implement an alteration or a waiver of documentation of consent. • Examine the challenging issues of “passive consent,” minor assent, and short forms. A24 Advanced

A26

Faculty: TBA In this session, faculty will: • Discuss a framework for reviewing international SBER. • Review guidance and best practices when such international SBER is conducted by students. • Raise awareness about issues that may be specific to different cultures, countries, and populations. A25

Networking: A Necessity for Those Working at Institutions with Small Research Programs (Small Research Programs Track)

27B

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

32A

International Social, Behavioral, and Educational Research (SBER) (SBER II Track)

attendees will interact with everyone in the session at least once. This session is intended for individuals from institutions with small research programs. Please bring business cards. This session will provide attendees with an opportunity to: • Learn new skills related to developing a professional network. • Use these skills to begin to develop a professional network among attendees from institutions with small research programs.

27A

Faculty: Argelis Ortiz, Susan Rose, Elizabeth White As key members of the IRB, unaffiliated/non-scientist members join with the other IRB members in shaping the culture and conduct of research within their institutions. In this session, faculty will: • Review the relevant regulatory provisions governing IRB membership and recent academic articles about the perceptions of the role of the unaffiliated/non-scientist member. • Examine the ethical and regulatory responsibilities of the unaffiliated/non-scientist IRB member. • Discuss the responsibilities and challenges of lay review in a variety of IRB scenarios. 12:00-1:00 PM

25B

Lunch with Plenary Speaker Robert Bartlett, MD

Join us for a luncheon with plenary speaker Robert Bartlett. This event will provide attendees the opportunity to talk with and ask questions of this

Faculty: Eric Allen, Erica Tauriello This session will start with a 15-minute didactic presentation on tools to develop your network with others in the field. The remainder of the session will take the shape of “speed networking,” in which

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didactic session

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

distinguished researcher and medical pioneer in an intimate and informal environment.

Network in The Conference Connection during or after lunch!

12:00-1:00 PM 26AB

1:15-1:45 PM

Join us for a luncheon with Keynote Speaker John Ioannidis. 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.

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections.

Lunch with Keynote Speaker John P. A. Ioannidis, MD, PhD

12:00-1:00 PM 28ABCD

2:00-3:15 PM

Participate in a vibrant discussion of The Righteous Mind: Why Good People Are Divided by Politics and Religion, the newest title from 2011 AER Conference keynote speaker Jonathan Haidt. Attendees will have the opportunity to discuss the book with their peers and with the author, who will be joining the discussion via live video feed. Copies of Dr. Haidt’s book are available at the onsite Bookstore. 12:00-1:00 PM

SAILS PAVILION

Common Ground Networking Lunch

Time to connect… over lunch! The tables will be divided by affinity groups and professional affiliations so that you can find and meet your peers for conversation and networking. Tables will also be available for those for those wishing to “just lunch.” The Conference Connection will be open during this time, and the posters will be available for viewing. 1:00-1:45 PM

SAILS PAVILION

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

receives CIP credit

pre-registration was required

EXHIBIT HALL D

Plenary: Panel I – “The Common Rule:” How Did We Get Here, and Where Should We Go?

Moderator: Alexander Capron Panelists: Barbara Bierer, Ivor Pritchard, Jeremy Sugarman This panel will discuss what kinds of changes to the Common Rule are needed, and which of those changes might realistically be achieved, given the historical, political, and cultural forces that drive such development. The panel will begin by looking at the trends of the last two decades, from the highly sensationalized research-related events of the late 1990s, which resulted in a new focus on compliance and inadequacies in the IRB system, increased funding of IRBs, and the growth of the IRB professional community; to the more recent backlash against IRBs and the ensuing call for reform from an empowered scientific community more aligned with the regulators than ever before. The panel will then discuss proposed changes to the regulations, as well

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Research Ethics Book Group Lunch with Jonathan Haidt, PhD

SAILS PAVILION

Demonstration of PRIM&R’s Online Course and Knowledge Center


Schedule

as where those changes should originate, who should be involved, and how success should be measured. 2:00-3:15 PM

BALLROOM 20AB

schedules

Plenary: Panel II – An Introduction to Flexible Adaptive Clinical Trial Designs: Implications for IRB Review and Informed Consent

Moderator: Michele Russell-Einhorn Panelists: Donald Berry, Roger Lewis, William Meurer The Critical Path Initiative was launched by the FDA in 2004 in recognition of the need for more flexibility in scientific design and enhanced collaboration and cooperation to drive innovation in scientific processes. One of the central innovations the Critical Path Initiative encourages is the use of adaptive trial designs. This panel will review different types of adaptive trial designs and consider such issues as: why and how adaptive designs differ from standard designs and the regulatory implications of those differences; whether adaptive trial design can make research more ethical; how subject safety may be improved by these flexible designs; and obstacles to the implementation of adaptive designs. The goals of the Critical Path Initiative, as implemented by encouragement of adaptive trial designs, include: (a) improved efficiency of the trial design; (b) improved drug efficacy; (c) improved effectiveness of the trial; d) reduction in the time of drug development; and (e) reduction of all the associated costs. 2:00-3:15 PM

BALLROOM 20CD

Plenary: Living Room Conversation – Whose Ethics Matter? Conducting Responsible Research in the Global Arena

to locations such as India, China, and Eastern Europe. This story has served to reinforce the public perception that the pharmaceutical industry is more likely than other research funders to take advantage of certain global realities, including favorable regulatory environments and the ready availability of willing study subjects. This session will use the Dateline report as a jumping off point to explore the roles that all stakeholders in the global research enterprise, from CROs and the pharmaceutical industry to public health agencies and research ethics committees, play in fostering and conducting ethically responsible international research. 3:15-3:45 PM

SAILS PAVILION

Break

3:45-5:00 PM

Didactic Sessions and Workshops Series B B1

31B

A Dialogue with the Food and Drug Administration (FDA) (A Dialogue with the Feds I Track)

Faculty: Karena Cooper, Joanne Less, Diane Maloney, Kevin Prohaska, James Saviola Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to: • Hear from representatives of the FDA about new and evolving issues, initiatives, regulations, and guidance.

Moderator: David Borasky Panelists: Albert J. Allen, Anant Bhan, Cassandra Kennedy, Linda Nielsen A recent Dateline NBC story reported flaws in the oversight of US pharmaceutical industry-sponsored clinical research that is increasingly being outsourced

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didactic session

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

• Participate in an open discussion about topics relevant to FDA stakeholders. • Ask questions about evolving issues at the FDA. B2

Cancelled: A Dialogue with the Department of Defense (DOD)

B5

Registrants should feel free to attend another session or visit the Help Desk for more information. B3

29A

Faculty: Gary Cseko, David Forster In this session, faculty will: • Discuss how to use 2011 metrics collected and posted by AAHRPP to inform your HRPP quality improvement program. • Provide examples of benchmarking metrics and illustrate how data has been measured and analyzed across multiple organizations. • Offer suggestions for selecting categories and measuring HRPP performance data at attendees’ home institutions.

Community Engagement and Participation in Research (Activities Along the Boundaries Between Research and Practice Track)

33A

Faculty: James Edwards, Harry McGee, Meredith Minkler In this session, faculty will: • Discuss the ethical tensions inherent in community-based participatory research (CBPR). • Explain the purpose and process of specific projects relating to CBPR.

receives CIP credit

pre-registration was required

30C

VOICE: The Valid Optimized Informed Consent Education Program (Advanced Forum for IRB Professionals Track)

Faculty: Elizabeth Bankert, Dianne Ferris While commonly recognized that review of the consent form is necessary, little attention has been paid to the conduct of the consent process. In addition, FDA audits have identified “obtaining informed consent” as an investigator responsibility that is often inappropriately delegated. The VOICE project team at Dartmouth focuses on the “teach back” method in an educational program developed for individuals obtaining consent. This session will provide attendees with an opportunity to: • Discuss the pilot project that was used to develop the educational program. • Receive a description of the educational program. • Learn how to implement the program at their home institutions. B6

Ensuring Study Data Integrity: Standards, Chain of Custody Documentation, Transfer of Data Agreements, and Audit Trails (Clinical Research Professionals Track)

23C

Faculty: Michelle Stickler In this session, faculty will: • Present the standards for the proper securing and handling of study data.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Collecting and Analyzing Metrics for Quality Improvement (Accreditation of HRPPs Track)

B4

• Explore the role the IRB plays in these projects in assuring compliance with federal regulations and adherence to high ethical standards for human subjects research.


Schedule

• Explain the Family Smoking Prevention Tobacco Control Act (TCA) and the public health standard for evaluating the risk of tobacco products in both users and non-users. • Describe the ethical and regulatory considerations in the review of different pathways of tobacco products to market. • Discuss how CTP’s regulations impact IRB review of tobacco product research. • Explore considerations for IRBs in evaluating tobacco product clinical trials to ensure adequate human subjects protections.

• Address chain of custody documentation and audit trails. • Discuss transfer of data agreements regarding data and specimen repositories. B7

33B

schedules

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

Faculty: Philip Alberti, Heather Pierce In this session, faculty will help attendees to: • Learn how a clinical trial conducted entirely within the RCR guidelines with review, approval, and oversight from an IRB might still fall short of our ethical responsibilities in the broader social contract of research. • Understand how the conduct of research fits into a continuum from concept and funding through the dissemination of results, and what other entities bear responsibility for ensuring that the results of research reach those populations that could benefit most. • Understand the ethical imperatives of understanding health disparities and the populations affected by the conditions being studied throughout the full scope of research, from basic science through implementation research. B8

Introduction to the FDA’s Center for Tobacco Products (CTP) and Ensuring Human Subjects Protections in Clinical Tobacco Trials (FDA Regulations Track)

23B

Faculty: Lester Jao Lacorte, Susan Rudy In this session, faculty will: • Describe CTP’s mission and role in regulating tobacco products.

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didactic session

B9 Basic

29C

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

Faculty: 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 disagreement between children and their parents or legal guardians about research participation. B10 Advanced

29D

Centers for Medicare and Medicaid Services’ (CMS) Proposed “Sunshine” Regulations: Implications for Research and Human Subjects Protections (Institutional Officials Track)

Faculty: Mark Barnes, Robyn Shapiro In this session, faculty will: • Provide background information about the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

• Provide an update on the status of the new rule. • Discuss ways for institutions to ensure they comply with PPACA requirements.

B12 Basic

B14

B11

24B

It Takes a Village… Models for Working with the Community in International Research (International Research Track)

Is it Human Research? Is it Exempt? Determining When an Activity Must Undergo IRB Review (IRB Bootcamp Track)

30D

Faculty: Jeffrey Cooper, Julie Kaneshiro, Patrick McNeilly, Ada Sue Selwitz, Jean Toth-Allen This session will provide attendees with an opportunity to: • Become familiar with the two distinct definitions of human subjects research found in the DHHS and FDA regulations. • Review the federally mandated exemption categories. • Discuss the differences between DHHS and FDA regulations regarding exempt research categories. B13

How to Develop Effective IRB Forms to Keep You in Compliance and Keep Investigators Happy (IRB Operations and Toolkit Track) Faculty: Kelley O’Donoghue, James Riddle

receives CIP credit

pre-registration was required

30E

Globalization of Clinical Research: Emerging Issues for Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), and IRBs (Issues for Pharma/Biotech Track)

24C

Faculty: Nicholas Slack, Walter Straus Clinical research funded in North America is increasingly being conducted abroad, and in particular in emerging economies. The offshoring of clinical trials, and the fact that many of these trials are being conducted by CROs, and not pharmaceutical and biotechnology companies, raises important ethical questions. This session will provide attendees with an opportunity to: • Discuss IRBs’ levels of awareness about the extent to which CROs are responsible for such research, and whether IRBs are equipped to ask the right questions. • Explore the ability and commitment of CROs to conduct research ethically and appropriately.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Steven Wakefield In this session, faculty will: • Review models for community engagement in international settings. • Discuss mechanisms for training community members on research and research ethics. • Present considerations for the ongoing maintenance of a community advisory group.

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 paperbased form to an online submission system and for improving the use of an online submission system once implemented. • Share case studies from two institutions showing how they improved the effectiveness of their forms. • Facilitate the sharing of ideas about best practices.


Schedule

• Discuss issues of jurisdiction, including the level of oversight CROs receive, who is responsible for that oversight, and the role of centralized review. • Discuss strategies that pharmaceutical or biotechnology companies and CROs can use to a) gather data about the practical implications that ethical considerations have on pharmaceutical research done abroad, b) assess the quality of that data, and c) ensure the presence of infrastructure needed to conduct trials ethically.

schedules

B15 Basic

32B

Genetic Privacy: How to Keep Up with the Expansion of Federal and State Legal Requirements (Legal Track) Faculty: Rachel Nosowsky In this session, faculty will: • Review the laws and rules that an IRB may need to consider in research involving genetic information. • Discuss federal requirements such as HIPAA and the Genetic Information Non-Discrimination Act (GINA). • Explore the proliferation of state laws and proposed legislation with broad reach. B16

Genome-Wide Association Studies (GWAS): The Impact of NIH’s Data Sharing Policy on the IRB’s Role in Reviewing Genetic Research (Out-of-Body Experiences: Research Involving Tissue and Data Track)

31C

Faculty: Laura Lyman Rodriguez, Pearl O’Rourke In this session, faculty will: • Explore the ethical and regulatory issues raised by NIH’s data sharing policy.

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didactic session

• Help attendees gain an understanding of the IRB’s role in the review of GWAS. • Define best practices and standards for review of GWAS. B17 Advanced

The Nexus of Vulnerability and Minimization of Risk (Populations Requiring Additional Protections Track)

33C

Faculty: Andre Ivanoff, Alan Wertheimer In this session, faculty will: • Review the definition and taxonomy of vulnerability. • Discuss general approaches to minimizing risk, with an emphasis on particular at-risk populations. • Explore the tension between justice and beneficence, and the consequences of overprotection. • Discuss groups and populations as vulnerable subjects, and discuss concepts relating to group harm and examples of such. B18 Advanced

Ethical Guidelines for Information and Communication Technology Research: “The Menlo Report” (Potpourri Track)

25A

Faculty: David Dittrich, Erin Kenneally, Wendy Visscher This session will review novel ethical challenges in information and communication technology research (ICTR), through a discussion of “The Menlo Report: Ethical Principles Guiding Information and Communication Technology Research” from the Department of Homeland Security. In this session, faculty will: • Explain the purpose of and motivations for the Menlo Report and how IRBs can use it to evaluate ICTR. • Explore the risks and benefits of ICTR and discuss when it is important to focus on whether

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Tuesday 12.4

research is potentially “human harming,” rather than whether a “human subject” is involved. • Review risks of ICTR beyond privacy, and discuss why the Menlo Report can help identify and analyze these risks. B19

Delivering Bad News: Play and Practice (QA/QI and PostApproval Monitoring Track)

23A

B20 Advanced

Finding Flexibilities in the Federal Regulations: Advanced Considerations and Applications (Regulatory Balance Track)

30AB

receives CIP credit

pre-registration was required

Faculty: Lauren Solberg, Latanya Sweeney In this session, faculty will: • Define and describe data mining on social networking sites as a method of data collection for research. • Analyze whether data mined from social networking sites is private information as defined in the regulations governing human subjects research at 45 CFR 46. • Use this privacy analysis to evaluate the ethical and regulatory implications of data mining on social networking sites under 45 CFR 46; issues to be considered include whether research involving data mining on social networking sites is considered research with human subjects. B22

Faculty: Lois Brako, Moira Keane, Irene Stith-Coleman This advanced session, designed for experienced IRB staff, administrators, and chairs, will explore implemented procedures that incorporate flexibility within the regulations while providing equivalent protections to participants. In this session, faculty will help attendees to: • Discover ways to utilize flexibility in IRB authorization agreements. • Learn about applying the criteria for exemptions and expedited review. • Discover ways to utilize flexibility when applying subparts B, C, and D. • Explore ways to customize informed consent to fit a study.

31A

Privacy in the Information Age: The Ethical and Regulatory Implications of Data Mining on Social Networking Sites (Research Involving the Internet and Social Networking Track)

Train the Trainer: When Can We Stop Teaching About Research Misconduct? (Responsible Conduct of Research Track)

27A

Faculty: Mike Kalichman This session will provide attendees with an opportunity to: • Discuss at least three reasons why a focus on research misconduct is a sub-optimal strategy for teaching research ethics. • Examine at least three examples of responsible conduct that are likely to have failed if research misconduct occurred. • Explore the idea that effectively teaching about responsible conduct of research will create an environment in which it is necessarily more difficult for research misconduct to occur.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Bertha deLanda, Terry VandenBosch Bring a sense of humor! This session will provide attendees with an opportunity to: • Use a scenario involving “bad news” audit observations to role-play ways to provide constructive, supportive, and effective feedback to a principal investigator. • Share ideas and observations with fellow attendees and faculty.

B21 Advanced


Schedule

B23 Basic

schedules

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

29B

Faculty: Sharon Freitag, Joseph Konstan In this session, faculty will: • Discuss the question of public vs. private behavior, including what counts as a reasonable expectation of privacy. • Review identifiable vs. anonymous participation and data. • Discuss the tension between public recognition of research participation and de-identification of results to ensure participants are not individually identifiable. • Examine the adequacy of confidentiality protections and procedures designed to avoid or minimize privacy invasion. B24 Advanced

Reviewing Qualitative Research (SBER II Track)

32A

Faculty: Cynthia Gómez, Laura Stark This session will address ethical and regulatory issues that arise in qualitative research, and will provide attendees with an opportunity to: • Discuss potential harms associated with oral history, ethnography, and other qualitative methodologies. • Review qualitative data collection methods such as PhotoVoice. • Share best practices for reviewing such research. B25 Basic

24A

Developing and Implementing an Education Program at an Institution With a Small Research Program (Small Research Programs Track)

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didactic session

Faculty: Eric Allen, Michelle Feige In this session, faculty will: • Focus on how to develop and implement an education program for a small biomedical or social behavioral institution with no staff members that are specifically designated for education. • Discuss various methods for providing education. • Review tips for how to leverage current staff time to get the most out of your education program. • Examine options for funding an education program. B26 Basic

27B

Scientific Aspects of Clinical Study Design: A Primer for Non-Scientists (Unaffiliated and Non-Scientist IRB Members Track)

Faculty: Susan Fish, Lindsay McNair In this session faculty will: • Discuss how to identify the components of a research question. • Review the main types of observational and interventional study designs. • Explain the basic concepts of bias and confounding, and the most common ways these issues are addressed in study designs. 5:00-6:30 PM

2012 AER Conference Welcome Reception

SAILS PAVILION

Join us in The Conference Connection to kick off the 2012 AER Conference, meet and greet with our supporters and exhibitors, view this year’s poster presentations, and receive a complimentary minimassage! Light refreshments will be served. 

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5 Wednesday, December 5 7:00-8:00 AM

SAILS PAVILION

7:00-8:00 AM

28ABCD

Continental Breakfast CIP® Breakfast

Interested in earning your Certified IRB Professional (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. EXHIBIT HALL D

Welcome and Award Presentation Presentation of the ARENA Legacy Award to Susan Delano 8:30-9:15 AM

Keynote Address

9:30-10:45 AM

EXHIBIT HALL D

James R. Gavin III, MD, PhD Executive Vice President and Chief Medical Officer, Healing Our Village Clinical Professor of Medicine, Emory University School of Medicine 9:15-9:30 AM

Break

9:30-10:45 AM

BALLROOM 20AB

Plenary: Panel III – Hot Off the Presses: Selected Posters on Innovative Programs and Research on Research Ethics

During this panel, research professionals will present empirical research on research ethics and will provide audience members with concrete tools and strategies designed to improve the effectiveness of their HRPPs/IRBs.

receives CIP credit

pre-registration was required

BALLROOM 20CD

Plenary: Panel IV – Do Investigators Have Ethical Responsibilities to Their Subjects Outside the Scope of Research, and If So, What are They?

Moderator: Ivor Pritchard Panelists: Patricia Marshall, Henry Richardson, Jeanita Richardson Investigators conducting research may find themselves in a position to help their subjects in ways that go beyond obligations deriving from the ethical requirements of the research itself. Are investigators just like any other person in such a position, or does the investigator-subject relationship create special ethical obligations? If investigators know at the outset that subjects are in need of particular assistance, should they plan to provide it? Does this lend support to the claim that researchers should return incidental findings? If the provision of assistance will compromise the research itself, should the investigator ignore the opportunity to intervene? This panel will explore these and other questions.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

8:00-8:30 AM

Moderators: Susan Fish, David Borasky Topics: 1. Can we facilitate research by maximizing data and biosample utility while complying with subject’s consent? Panelist: Maria Adela Grando 2. Incentivized Corrected Feedback: A combined remedial and motivational approach for improving recall of consent information Panelist: David Festinger 3. “No Man is an Island”: Cancer patients’ experience of autonomy related to their decisionmaking process about clinical trial participation Panelist: Jennifer Bell 4. Strategies for Helping Researchers Do the Unthinkable: Destroy Their Data Panelist: Teresa Doksum


Schedule

9:30-10:45 AM EXHIBIT HALL D

• Hear from and ask questions of PRIDE staff about the VA’s human subjects protections policy. • Hear ORO representatives discuss compliance oversight activities of the VA. • Participate in an open discussion about issues relevant to VA stakeholders.

schedules

Plenary: Panel V – Ethical Implications of Novel Methodologies and Technologies in Social and Behavioral Research

Moderator: Dean Gallant Panelists: Richard Gilbert, Ian Kerr, Meredith Minkler We are currently seeing an explosion in the use of sophisticated, electronically based methodologies and technologies as tools for data collection, storage, and sharing. This panel will look at a sampling of these developments in social and behavioral research— including PhotoVoice, the use of wearable devices for data tracking, and digital anthropology/ethnography in virtual worlds such as Second Life—and discuss their implications for human subjects protections. 10:45-11:15 AM

SAILS PAVILION

Break

11:15 AM-12:30 PM

Didactic Sessions and Workshops Series C C1

A Dialogue with the Department of Veterans Affairs (VA) Program for Research Integrity Development & Education (PRIDE) and Office for Research Oversight (ORO) (A Dialogue with the Feds I Track)

31A

Faculty: Robert Brooks, Lynn Cates [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to:

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didactic session

C2

Staff Update from the Presidential Commission for the Study of Bioethical Issues (PCSBI): Creating Instructional Materials for Ethics Education (A Dialogue with the Feds II Track)

32B

Faculty: Paul Lombardo In October 2012, PCSBI released A Study Guide to “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948, based on its investigation into the unethical U.S. Public Health Service STD experiments conducted in Guatemala in the 1940s. This Study Guide will be freely available for downloading and printing on www.bioethics.gov, and is designed for university students and all other interested members of the public. This session will provide attendees an opportunity to: • Understand why the Guatemala STD studies are a critical element in research ethics education. • Hear from a Commission representative about the development of the Study Guide, including the decision to base the Study Guide on accessible case studies from the research in Guatemala and thereby promote guided ethics discussion based on real world examples. • Discuss with Commission staff the tension between the need for more ethics education and the fact that not all institutions have ethics departments or access to ethics curricula, and explore how the development of pedagogical materials to accompany Commission reports, in particular, can enrich contemporary ethics education.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

C3

29B

The Association for the Accreditation of Human Research Protection Programs, Inc.’s (AAHRPP’s) Top 10 Findings in Step One Applications and Draft Site Visit Reports (Accreditation of HRPPs Track)

C4

Models for Ethics Review of Public Health Projects: Experiences From Canada and the United States (Activities Along the Boundaries Between Research and Practice Track)

31B

Faculty: Melody Lin, Nancy Ondrusek, Raphael Saginur, Donald Willison [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] This session will bring together representatives from Canada and the United States to identify common interests and challenges around governance of public health research activities, with a view toward building

receives CIP credit

pre-registration was required

C5 Advanced

Using Metrics to Monitor, Manage, and Improve IRB Operations (Advanced Forum for IRB Professionals Track)

30AB

Faculty: Gary Cseko, Dan Nelson [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will: • Explore how metrics and monitoring can be used to assess the workload, staffing, and performance of IRB operations. • Discuss how to apply elements of a quality management system to support continuous IRB operations improvement. • Review how to identify and manage unexpected and nonconforming events in the IRB process and use them for quality improvement.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Sarah Kiskaddon In this session, faculty will: • Discuss common findings in step one • application reviews. • Present common site visitor observations and areas of concern. • Review the evaluation instrument and draft site visit report findings. • Explore strategies for avoiding common pitfalls. • Share concrete examples and solutions to common problems encountered during the accreditation process.

long-term relationships and collaborations. In this session, faculty and attendees will: • Explore challenges surrounding ethics review of public health projects and strategies for addressing those challenges. • Discuss development of tools at Public Health Ontario 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. • Provide the OHRP perspective on how proposed changes to the Common Rule will impact the review of public health projects. • Reflect on developments and discuss other challenges and approaches with attendees and the panel of presenters.


Schedule

C6

27A

Train the Trainer: One Way to Get Good Clinical Practice (GCP) Training to Your Principal Investigator Clinical Research Professionals Track

schedules

Faculty: Shirley Roach In this session, faculty will: • Define GCP. • Share their experiences developing a GCP education program. • Outline the features of a successful interactive program geared toward adult learners. • Present an example “train-the-trainer” program on GCP for investigators. C7 Advanced

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

24A

Faculty: Robert “Skip” Nelson, Susan Kornetsky [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration is required to attend and a lunch ticket will be included on your name badge.] 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 component analysis in review of pediatric studies.

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didactic session

C8 Basic

The End of Your Search for Information on FDA’s Investigational New Drug (IND) and Investigational Device Exemption (IDE) Regulations (FDA Regulations Track)

30E

Faculty: Christine Drabick, Owen Faris [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration is required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will: • Examine the federal regulations for INDs (21 CFR 312) and IDEs (21 CFR 812). • Discuss FDA guidance on INDs and IDEs that may further IRBs’ understanding of the regulatory platform for the studies they review. • Review example scenarios and discuss the application of IND and IDE regulations. C9

30D

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

Faculty: Marc Teitelbaum Most PIs, funders, regulators, and IRB members would probably say that informed consent is the process most closely associated with the IRB, and the “stamped” informed consent form (ICF) is the most visible evidence of the IRB’s labors. Yet, despite the best of intentions and evidence that reform is necessary, ICFs continue to grow in size, and unnecessarily challenge subject comprehension and readability. Investigators, coordinators, and study sponsors, afraid to run afoul of the IRB, put in information they don’t need, and leave out information they need, but can’t comfortably explain in lay terms. In this session, faculty and attendees will explore several novel approaches and models

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

C10

Understanding the Elements of a Strong Compliance Program (Institutional Officials Track)

33B

Faculty: Lisa Murtha, Ernest Prentice 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 performance metrics.

receives CIP credit

pre-registration was required

C11 Advanced

Clearing Customs: Addressing Cultural Competency in International Research (International Research Track)

29A

Faculty: Kathleen MacQueen When conducting research outside the researcher’s cultural experience, whether international or domestic, merely translating or adapting consent forms and survey instruments is not sufficient. Researchers need to take into consideration a number of issues including the relevance of constructs being studied to that particular population. In addition, they must learn to navigate different cultural norms, regulatory requirements, and social issues outside of research, e.g. the impact of research participation not just on individuals but the group as well. In this session, faculty will: • Discuss the use of interpreter services. • Explore the factors important for recruitment and retention, such as involving family and/or community members. • Discuss the challenges around cultural immersion. • Review administrative and organizational accommodations. C12 Basic

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

24C

Faculty: Julia Gorey, Robert Levine, Sara Goldkind In this session, faculty will: • Review the DHHS regulations governing research with children, pregnant women and fetuses, and prisoners, i.e. 45 CFR 46 subparts B, C, and D). • Present FDA regulations governing human subjects research at 21 CFR 50 and 56, and

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

to informed consent that attempt to address these well known problems. Specifically, this session will present attendees with an opportunity to: • Explore 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? • Discuss general strategies to adjust for reading level, translation, and overall readability. • Review an innovative sample set of recommendations for the development and formatting of easy-to-read and easyto-comprehend ICFs and examine a novel informed consent template that incorporates these recommendations as a generalizable ICF model. • Learn a second novel approach to reading, writing, and editing informed consent language that is rooted in thinking about popular fiction. By identifying what a good book and a good consent form have in common, and by interactively learning to apply the rules of good fiction to the serious rules and mission of informed consent, participants will take home a skill that will not only make consent writing more pleasant and less stressful, but will also decrease unnecessary words, improve reading level, and enhance understanding, without sacrificing regulatory compliance and relevance • Learn how to resolve informed consent battles by adapting an agreed-upon rule set.


Schedule

how they apply to children, pregnant women and fetuses, and prisoners. • Outline best practices for research with these populations and discuss other relevant guidance. C13 Advanced

29C

schedules

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

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 from two long-serving chairs. C14

Informed Consent: Enhancing the Industry Approach with Subjects in Mind (Issues for Pharma/Biotech Track)

28E

Faculty: Ellen Kelso, Anita Nelsen, Amelia Warner This session will provide attendees with an opportunity to: • Explore new industry approaches to the consent process, including steps to enhance patient involvement and the information provided to potential clinical trial participants. • Hear faculty members from across industry share their experiences of introducing patientfriendly models of consent. Examples will be

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didactic session

used to illustrate the changes that have been introduced and how these have been received. • Engage in an open dialogue with members of industry about best practices and ongoing challenges around informed consent. C15 Basic

23B

Challenges in Securing Coverage for ResearchRelated Injury (Legal Track)

Faculty: Karen Moe, Marc Francis Research sites and pharmaceutical and biotechnology companies often negotiate heavily over consent and contract language covering research-related injury. In this session, faculty will: • Address the challenges arising from this language, including practical difficulties in terms of when an injury is, in fact, covered under the language; when a participant’s own insurance must be billed first; and how a research site can reach some resolution expeditiously to help protect the injured participant. • Suggest strategies for handling these challenges. C16

30C

Tissue Issues: Ethical, Regulatory, and Practical Issues in Banking Biological Specimens for Research Out of Body Experiences: Research (Involving Tissue and Data Track)

Faculty: Marianna Bledsoe, Julie Kaneshiro, Nicole Sieffert [Please note: This is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will:

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

• Identify the ethical and regulatory principles that guide biobanking for research purposes. • Outline how different types of biobanks operate. • Explore practical challenges biobankers face in implementing regulations and policies related to biobanking. • Discuss research use of tissue collected for routine purposes. • Review informed consent and waivers for the use of tissue for research purposes. C17 Basic

25A

Faculty: Elizabeth LeQuesne, David Strauss This session will provide attendees with an opportunity to: • Discuss regulatory requirements when a subject is considered cognitively impaired. • Review federal regulations related to legally authorized representatives and explore examples of state rules. • Identify the ethical issues around consent, permission, and assent. • Explore the concept of substituted judgment of risk. C18 Advanced

Recommendations of the National Cancer Institute (NCI) Think Tank on Identifiability of Biospecimens and Genomic Data (Potpourri Track)

29D

Faculty: Nicole Lockhart, Carol Weil This session will provide attendees with an opportunity to: • Review the regulatory and ethical issues surrounding the identifiability of DNA and genomic data with respect to the twin but conflicting goals of optimizing data security

receives CIP credit

pre-registration was required

C19

Auditing International Studies (QA/QI and Post-Approval Monitoring Track)

23A

Faculty: Stanley Estime In this session, faculty will: • Describe human research compliance risks and issues arising from rapidly increasing globalization in clinical research. • Examine methods to select higher-risk international studies for auditing. • Outline audit processes for centralized remote monitoring and practical issues in conducting audits at the international site. C20 Advanced

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

32A

Faculty: Ivor Pritchard, Nancy Olson In this session, faculty will: • Review the definitions for human subjects research and clinical investigation found in the DHHS and FDA regulations, respectively. • Outline a process and set of criteria for determining whether an activity is research involving human subjects. • Describe how and when to apply the definitions of “research” and “human subject.”

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Research with Cognitively Impaired Subjects (Populations Requiring Additional Protections Track)

for research participants and maximizing data sharing among researchers. • Explore various legislative, regulatory, and institutional policy alternatives for protecting privacy and promoting genomic research. • Identify recommendations developed by the NCI Think Tank on Identifiability of Biospecimens and Genomic Research on June 11-12, 2012.


Schedule

C21

33A

• Explore and understand the frequency, variety, and hypothesized causes of wrongdoing in research. • Identify when a researcher’s wrongdoing can be addressed adequately using traditional means, and when more specialized interventions are required. • Outline the kinds of interventions that research data indicates may be most effective in reducing recidivism rates.

schedules

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

Faculty: Emily Anderson, Elizabeth Buchanan, Laura Odwazny [Please note this is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will: • Identify the unique settings and conditions for consent in internet research. • Discuss how to apply the federal regulatory requirements for informed consent to internet research. • Highlight regulatory flexibilities that are applicable to consent in internet research. • Discuss parental consent and child assent in internet research involving minors. • Share sample language on data security and confidentiality of research-related information for informed consent documents for internet research. C22

Understanding and Responding to Wrongdoing in Research (Responsible Conduct of Research Track)

33C

didactic session

23C

Speed it Up: Exempt… Expedite… Relax! (SBER I Track)

Faculty: Dean Gallant, Lorna Hicks, Irene Stith-Coleman [Please note this is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will: • Use case-based scenarios to explore regulatory flexibilities while assuring that research is conducted ethically. • Discuss the process for determining when behavioral, educational, and social research must undergo review by the full IRB, when it qualifies for expedited review, when it is exempt, and when it does not constitute research involving human subjects. C24

Faculty: James DuBois [Please note this is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will:

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C23 Basic

31C

50 Shades of Risqué Research (SBER II Track)

Faculty: Patricia MacCubbin, Susan Miller Often, IRBs are confronted with reviewing a proposal to study a socially or politically sensitive issue. Even if the proposed study has the potential to generate valuable information, pressures from inside and outside the institution might make the review and

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

approval of such studies difficult. Through the use of case studies, this session will provide attendees with an opportunity to: • Evaluate issues that could potentially hinder approval of a research proposal. • Develop regulatory rationales in support of the sample proposals that will equip attendees with tools to use when reviewing sensitive research. C25

27B

Faculty: Wilma Acosta, Ofer Amit This session will focus on the challenges of developing and maintaining an effective HRPP at a small institution. The interactive format will help attendees explore structural and operational aspects common in small HRPPs and identify solutions that can work effectively in the unique small HRPP environment. Faculty and attendees will: • Discuss and explore together what makes small HRPPs unique: What are the minimal requirements? What should you do first? Who else should be involved and how can you gain their support? (You may be a one-person IRB office, but there is no such thing as a oneperson HRPP!) • Outline how to establish and maintain a small HRPP: How do you maintain organizational support? When, where, and how can you receive outside help? What is the best way to look for and find a other HRPP colleagues? C26 Basic

PRIM&R’s Primer for the “Newbie” Reviewer (Unaffiliated and Non-Scientist IRB Members Track) Faculty: Janet Donnelly, Robert Ferguson, Gigi McMillan

receives CIP credit

pre-registration was required

24B

C27

BALLROOM 20AB

Film Screening and Discussion: How to Survive a Plague

Faculty: A. Cornelius Baker [Please note this is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration was required to attend and a lunch ticket will be included on your name badge.] This session will comprise a screening followed by a facilitated discussion of the critically acclaimed, feature-length documentary How to Survive a Plague, a powerful look at the role of early AIDS activists in expediting the development of HIV/AIDS drugs. From the film’s website: “How to Survive a Plague is a story about two coalitions whose activism and innovation turned AIDS from a death sentence into a manageable condition. Despite having no scientific training, these self-made activists infiltrated the pharmaceutical industry and helped identify promising new drugs, moving them from experimental trials to patients in record time. With unfettered access to a treasure trove of neverbefore-seen archival footage from the 1980s and ‘90s, filmmaker David France puts the viewer smack in the middle of the controversial actions, the heated meetings, the heartbreaking failures, and the exultant breakthroughs of heroes in the making.”

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Developing a Human Research Protections Program (HRPP) at an Institution with a Small Research Portfolio (Small Research Programs Track)

[Please note this is a double session and will end at 1:45 PM. Please pick up your boxed lunch before proceeding to the session room. Pre-registration is required to attend and a lunch ticket will be included on your name badge.] In this session, faculty and attendees will: • Review the basics of phase I, II, and III trials. • Discuss ethical and regulatory concepts including coercion, therapeutic misconception, minimal risk, assent, conflicts of interest, and recruitment standards. • Share a glossary of common terms and acronyms used in the human subjects protections field.


Schedule

12:45-1:15 PM

SAILS PAVILION

Demonstration of PRIM&R’s Online Course and Knowledge Center

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections. 12:45-2:00 PM

SAILS PAVILION

Lunch schedules

12:45-2:00 PM

Lunch with Keynote Speaker James R. Gavin III, MD, PhD

26A

This event will provide attendees the opportunity to talk with and ask questions of this distinguished leader of the nation’s efforts to address health disparities and research inequalities in an intimate and informal environment. 12:45-2:00 PM

Lunch and Book Signing with Panelist Henry S. Richardson, JD, PhD

26B

Join us for this informal luncheon with Panel IV speaker Henry Richardson and participate in a timely discussion of ancillary-care obligations in research. This event will provide attendees an opportunity to talk with and ask questions of this distinguished ethicist and author of the new book, Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers. Professor Richardson’s book may be purchased onsite at the Bookstore. Professor Richardson will be available to sign books during this lunch.

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didactic session

12:45-2:00 PM

Research Ethics Book Group Lunch and Book Signing with Laura Stark, PhD

28ABCD

Participate in a vibrant discussion of Behind Closed Doors: IRBs and the Making of Ethical Research, by Laura Stark. Attendees will have the opportunity to discuss the book with their peers and the author. Copies of Dr. Stark’s book are available at the onsite Bookstore, and she will be available to sign books during this lunch. 2:15-3:30 PM

EXHIBIT HALL D

Plenary: A Great Debate – Be it Resolved That Large-Scale Genomic Research Poses Special Privacy Risks to Research Subjects

Moderator: Susan Kornetsky Panelists: Jeffrey Botkin, Latanya Sweeney This debate will explore the ethical issues and privacy concerns related to genetic information learned through research such as large-scale genome sequence data. Some take the position that people need to protect themselves from the risks to their privacy inherent in the use of genetic databases and genomic research more broadly. Many on this side argue that genetic material cannot be deidentified and can be very dangerous in the wrong hands. Others take the position that genetic data is only useful if there is a reference that can be used to identify a sample or piece of data, and researchers typically do not have access to the reference. In fact, provisions can be made so that researchers do not obtain reference material information about subjects. In addition, this side argues that our society is moving toward the increased use of genetic information in personalized medicine. It will therefore become as useful as other medical information and should be protected in a similar manner. The controversy about just how risky, and how threatening to our welfare, large-scale genomic research is has implications for

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

one of the core sections of the recent Department of Health and Human Services’ Advance Notice of Proposed Rulemaking (ANPRM) on the protection of human subjects. 2:15-3:30 PM

BALLROOM 20AB

Plenary: Panel VI – Should Society Treat Research Differently From Other Risky Activities?

D2

2:15-3:30 PM

Didactic Sessions and Workshops Series D D1

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

24A

Faculty: Kellina Craig-Henderson Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to:

pre-registration was required

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

24B

Faculty: Betsy Ellis, Lindsay Motz, John Ordaz, Elizabeth White Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to: • Learn about DOE’s Human Subjects • Research Database. • Participate in an open discussion of issues relevant to DOE stakeholders. D3

Getting Smaller HRPPs Accredited: Resources and Other Challenges (Accreditation of HRPPs Track)

29D

Faculty: Francis DiMario, Scott Lipkin This session will provide attendees with an opportunity to: • Discuss the special challenges faced by smaller organizations in preparing for accreditation. • Examine strategies that are especially effective in small organizations. • Explore the primary issues relevant to the decision to begin accreditation. • Review the process of accreditation and provide strategies for achieving each step. • Receive guidance from faculty who have experience with the accreditation process and serving as site visitors.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Moderator/Panelist: Alan Wertheimer Panelists: Alexander Capron, Holly Fernandez Lynch The purpose of this panel is to examine what is sometimes referred to as “research exceptionalism.” The regulation of research is both more stringent and more lenient than the approach that we take toward many other activities that also involve risk and consent, e.g. employment. On the one hand, many activities expose individuals to risks for the benefit of others, yet are not subject to extensive regulation or oversight and do not require comprehensive disclosure of information and elaborate procedures for obtaining consent. On the other hand, research participants are not regularly afforded some protections that are afforded to workers, such as compensation for injury. This panel will seek to clarify whether we should treat research participants in much the same way as we treat workers.

receives CIP credit

• Hear from NSF representatives about evolving issues at NSF. • Participate in an open discussion of topics relevant to NSF stakeholders. • Ask questions about new and ongoing initiatives at NSF.


Schedule

D4

schedules

Defining the Status of the Research Subject in Resuscitation Research (Activities Along the Boundaries Between Research and Practice Track)

23B

Faculty: Sara Goldkind, Korin Hudson, Ryan Spellecy, Jeremy Sugarman Cardiac arrest resuscitation research necessarily involves dead people, raising unique regulatory and ethical issues. In this session, faculty will: • Address questions such as: What regulations apply in such cases? What should the IRB do in reviewing this type of research? How should researchers plan to approach informed consent? • Explore how IRBs, investigators, and research sponsors have approached this challenging topic. D5 Advanced

Making Subpart Determinations when Reviewing Research Involving Vulnerable Populations: Case Studies (Advanced Forum for IRB Professionals Track)

25A

Faculty: Jeremy Block, Bruce Gordon This session will provide attendees with an opportunity to: • Use case studies to examine research protections for vulnerable populations in clinical and behavioral studies. • Examine the protections that must be in place in order to include vulnerable population groups in research. • Review the ethical and regulatory guidelines for including these groups in research.

D6

Data Safety Monitoring Plans and Data and Safety Monitoring Boards: What Does an IRB Need to Know? (Clinical Research Professionals Track)

Faculty: Adrianna Brigatti, Susan Ellenberg In this session, faculty will: • Compare various approaches to ensuring subject safety and meeting regulatory requirements when monitoring the data collected. • Outline a model for developing standard operating procedures for data safety monitoring. • Share policies, procedures, training and educational materials, as well as logistical and communications support strategies around data safety monitoring. D7 Advanced

33A

Risk Tolerance and Risk Recalibration: Are You Overdoing It? (Ethical Issues Track)

Faculty: Moira Keane This session will provide attendees with an opportunity to: • Learn 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 Basic

FDA Expectations of IRBs When Making the Significant and NonSignificant Risk Determination in Device Investigations (FDA Regulations Track) Faculty: Erica Heath, James Saviola

Icon Key

didactic session

33B

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit

30C


Wednesday 12.5

In this session, faculty will: • Examine the regulatory requirements for risk determination of medical devices. • Discuss the FDA guidance on making risk determinations for device studies. • Explore a practical approach to evaluating medical device risk determination and discuss expectations for written procedures. D9

32B

Faculty: Rebecca Armstrong This session will provide attendees with an opportunity to: • Discuss the informed consent process from the perspective of research subjects. • Learn specific strategies for improving informed consent forms using a web-based tool called Consent Builder. • Understand the importance of gaining support from the institution and from researchers to develop such resources and use them appropriately. D10

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

24C

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

23A

Faculty: Terry Elliott, Kathleen MacQueen In this session, faculty will: • Review the international standards for informed consent and documentation of consent. • Describe practical challenges, 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. D12 Basic

How to Grow Your IRB Career: Professional Development and Networking (IRB Bootcamp Track)

30AB

Faculty: Charlotte Coley, Karen Hansen, Yvonne Higgins In this session, faculty will: • Offer practical advice about education and mentoring opportunities for IRB professionals. • Discuss creative solutions for developing a network of trusted advisors within the IRB community. • Discuss the important role of the IRB professional in serving the HRPP community on a local, regional, and national level.

Faculty: Mark Barnes, Heather Pierce In this session, faculty will: • Discuss how to create and maintain an organizational culture that understands, acknowledges, and addresses potential conflicts of interest. • Review how to handle institutional conflicts of interest, including when institutional officials don’t follow HRPP/IRB policies.

receives CIP credit

pre-registration was required

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Laying the Foundation for Better Consent: Guidelines, Templates, and an Online Tool Called Consent Builder (Informed Consent Track)

D11


Schedule

D13 Basic

30D

• Review legal requirements for ensuring data security in research. • Discuss best practices, including the respective roles of the IRB, compliance, and privacy or security offices in oversight efforts. • Explore challenging domains such as multiinstitutional studies and waiver studies. • Evaluate case studies of data security breaches.

Writing Stellar Standard Operating Procedures (SOPs) (IRB Operations and Toolkit Track)

Faculty: Karen Hale, Elyse Summers This session will provide attendees with an opportunity to: • Discuss the components of comprehensive and effective HRPP/IRB SOPs. • Understand the resources, input, and/or approvals needed to develop specific SOPs. • Draft a new or revise an existing template for HRPP/IRB SOPs.

schedules

D14 Advanced

Pharma/Biotech Responsibilities in Unanticipated Problems and Adverse Event Reporting (Issues for Pharma/Biotech Track)

31A

Faculty: Albert J. Allen, Kevin Prohaska, Glenn Veit In this session, faculty will: • Review existing guidance governing pharmaceutical and biotechnology companies’ responsibilities for adverse event and unanticipated problem reporting. • Outline the March 2011 FDA regulations on adverse event reporting. • Discuss and clarify the responsibilities of investigational new drug (IND) sponsors, as laid out in the FDA regulations, with respect to the reporting and analysis of serious, unexpected events suspected to be caused by the study drug. D15 Basic

Securing Data in Research: Legal Requirements, Consequences, and Best Practices (Legal Track)

32A

Faculty: Elizabeth Hohmann, Susan McAndrew This session will provide attendees with an opportunity to:

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didactic session

D16 Advanced

30E

Regulatory and Ethical Issues Surrounding the Consent of Pediatric Donors of Biological Specimens Who Have Reached the Age of Majority (Out-of-Body Experiences: Research Involving Tissue and Data Track) Faculty: Irene Stith-Coleman, Carol Weil In this session, faculty will: • Explore the specific regulatory and ethical issues that surround this group. • Discuss a framework for assessing whether consent should be sought in these instances. D17 Advanced

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

31B

Faculty: Jeffrey Cohen, Susan Delano This session will address populations not explicitly addressed in federal regulations, but who are nonetheless vulnerable because of homelessness, substance abuse, or other circumstances. This session will provide attendees with an opportunity to: • Review the special considerations to be addressed by study teams when designing a study with these populations.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

• Examine the special considerations for IRBs when they are reviewing these studies, such as payment and undue influence. • Discuss how to ensure confidentiality and balance criminal liability with the need for individual assistance and protection from harm. • Explore how to recruit and maintain contact with subjects during the study. D18

The Certified IRB Professional (CIP®) Credential: What’s it all About? (Potpourri Track)

29A

pre-registration was required

Faculty: Judith Birk, Susan Rose In this session, faculty will: • Discuss how to create and implement a federal demonstration project. • Examine issues specific to non-federally funded research, such as the lengthened continuing review period of two years. 31C

IRBs and InternetBased Research: Navigating the Realities of Human Subjects Protections in the Digital Age (Research Involving the Internet and Social Networking Track)

28E

Faculty: David Rickaby In this session, faculty will: • Discuss the national VA not-for-cause auditing standards and processes. • Explore a compilation of audit observations and metrics across the VA system.

receives CIP credit

27A

Faculty: Diana Holt, Laura Odwazny, Adrienne Tanner This session will provide attendees with an opportunity to: • Identify additional IRB review challenges pertaining to internet-based research, such as public vs. private domain, subject selection and recruitment, privacy and confidentiality, and informed consent. • Learn about tips, tools, and resources for enhancing the dialogue on these topics within the IRB. • Develop internet-based research guidance documents and training approaches that are designed to elicit more complete and accurate IRB applications, as well as lead to increased IRB review efficiency.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Post IRB Approval Auditing: Department of Veterans Affairs (VA) Standards and Metrics (QA/QI and Post-Approval Monitoring Track)

Roadmap for Change: You, Too, Can Implement a Demonstration Project (Regulatory Balance Track)

D21 Basic

Faculty: Jaime Arango, Gregorio Lim, Kelley O’Donoghue This session will provide attendees with an opportunity to: • Discuss the CIP credential and the steps involved in pursuing it. • Review eligibility and recertification requirements. • Discuss the types of questions on the CIP exam. • Share exam preparation strategies. D19

D20 Advanced


Schedule

D22

schedules

Navigating the Overlapping Roles of Human Subjects Protection and Research Misconduct: Issues for IRBs and Research Integrity Officers (RIOs) (Responsible Conduct of Research Track )

23C

Faculty: Kristina Borror, David Wright In this session, faculty will: • Help attendees to develop more awareness regarding areas of joint responsibilities between IRB chairs and research integrity officers (RIOs) and how they need to work together and determine priorities. • Understand and be sensitized to identify how clinical data can have both human subjects violations and possible research misconduct. • Address attendees’ questions to representatives from the Office of Human Research Protections (OHRP) and the Office for Research Integrity (ORI). D23 Basic

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

29B

Faculty: Claire Dunne, Jeffery Rodamar This session will provide attendees with an opportunity to: • Discuss consent, assent, and parental permission. • Explore the problem of undue influence, specifically in the classroom setting. • Use case studies to examine when the ‘Common Rule,’ Family Educational Rights and Privacy Act (FERPA), and Protection of Pupil Rights Amendment (PPRA) regulations apply to particular research studies conducted in a public school setting.

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didactic session

D24 Advanced

33C

Incomplete Disclosures and Outright Deceptions (SBER II Track)

Faculty: Greg Manship, Michael Tai, Jacqueline Wall This session will explore complications that arise during research involving deception. Using case studies, this session will provide attendees with an opportunity to: • Discuss how to approach research in which subjects are intentionally misled about the nature of the research. • Review how to approach research in which the researchers do not disclose to the subjects that they are conducting research. • Discuss whether research subjects should be allowed to withdraw data about themselves when they are debriefed. D25

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)

27B

Faculty: Robert Bienkowski, Lynn Smith In this session, faculty will use examples to: • Describe the common components of a clinical trial agreement (CTA), emphasizing those parts that bear on human subjects research. • Poll participants about who in their institution gives the final approval for a CTA, and who negotiates the CTA/consent document language. • Review the CTA 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.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Wednesday 12.5

D26

29C

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

Faculty: Susan Fish In this session, faculty will: • Explain the most intimidating statistical words and their usages. • Describe the basic concepts of testing. • Explore the concept of statistical power. • Discuss the relationship between statistics and ethics. • Review circumstances in which it is important to consult a statistician.

• Speed Mentoring

3:45-5:00 PM 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 personalized answers to your regulatory, ethical, and/or operational questions. Light refreshments will be served.

• Moderated Poster Discussions

3:30-5:30 PM, Sails Pavilion

Light refreshments will be served.

• Meet and Greet our Supporters and Exhibitors

Please see Supporters and Exhibitors section of this Guide for details.

• Commemoration of the 40th Anniversary of the End of the United States Public Health Service Syphilis Study at Tuskegee Please see page 25 for details.

• PRIM&R’s Mentoring Program

PRIM&R’s Mentoring Program is one of our most celebrated member benefits. Join Megan Frame, membership coordinator, in the PRIM&R Booth to learn more about this valuable networking resource. Already a participant in our Mentoring Program? Come and share your experiences with other members of the program, and the research ethics community at large.

receives CIP credit

pre-registration was required

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Networking Reception in The Conference Connection

Join us for an informal opportunity to learn about how your colleagues are supporting the advancement of ethical research. Attend one of four discussions with the authors of select posters. Each discussion promises to provide important and original ideas in a relaxed and interactive environment.


Schedule

Thursday, December 6

9:15-9:30 AM

Break

7:00-8:00 AM

SAILS PAVILION

7:00-8:00 AM

28ABCD

Continental Breakfast

schedules

PRIM&R Online Connections & Resources Continental Breakfast

Interested in learning more about PRIM&R’s array of online resources? From our Ethical Oversight of Human Subjects Research Course and our new Knowledge Center to the IRB Forum and our groups on Facebook and LinkedIn, PRIM&R has many ways for you to connect, learn, and grow professionally from the convenience of your home and office. Attend this breakfast to learn more about PRIM&R’s offerings and to speak with/ask questions of the PRIM&R staff. 8:00-8:30 AM

EXHIBIT HALL D

Welcome and Recognition of Melinda Hurst, Pioneering “Community Member”

Please join us in recognizing the exemplary contributions of Melinda Hurst, a woman who has volunteered as an unaffiliated, non-scientific IRB member for over 30 years. As an advocate for research subjects, Ms. Hurst embodies the values, ethics, and commitment to protection that human subjects who participate in research deserve, and PRIM&R is thus proud to honor her at this year’s conference. 8:30-9:15 AM

EXHIBIT HALL D

Pillars of PRIM&R Lecture: My Journey Through Madness: Schizophrenia and Research Ethics

Elyn R. Saks, JD, PhD Orrin B. Evans Professor of Law, Psychology, and Psychiatry and the Behavioral Sciences, University of Southern California Gould School of Law

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didactic session

9:30-10:45 AM

BALLROOM 20AB

Plenary: Panel VII – IRB Review of Research on Mental Illness: Are Additional Protections Always Appropriate Protections?

Moderator: David Strauss Panelists: Michael Caligiuri, Lisa Dixon, Anne Donahue “Mental Illness” encompasses a diverse group of highly prevalent disorders that are often poorly understood by practitioners outside the mental health community and by the public at large. Sound IRB review of research involving mental disorders requires an appreciation of the characteristics of mental illness as they relate to a range of research methodologies and the regulatory notions of vulnerability and susceptibility to risk. This panel will consider, from a range of perspectives, when subjects with mental illness require additional protections and when additional protections hinder research or have an inappropriate impact on autonomy or access to care. 9:30-10:45 AM

Plenary: Panel VIII – Ethical Design and Conduct of Cluster Randomized Trials

BALLROOM 20CD

Moderator/Panelist: Charles Weijer Panelists: James Feldman, Catarina Kiefe Cluster randomized trials (CRTs) are an increasingly important design for the evaluation of interventions across the spectrum of health research. In CRTs, groups or “clusters” of individuals—rather than the constituent individuals themselves—are randomly allocated to study arms (e.g. medical practices, hospital wards, schools, or communities). Study interventions in CRTs may be delivered at the cluster level (e.g. a community-wide advertising campaign to promote smoking cessation), or at the individual

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

level (e.g. vitamin supplements or leaflets distributed to patients); interventions may also be delivered to health professionals or other individuals at the head of a cluster with the aim to improve patient care or service delivery. CRTs raise complex ethical and methodological challenges to researchers and IRBs reviewing these trials. For example, in a single CRT, the units of randomization (e.g. medical practices), experimentation (e.g. health professionals), and observation (e.g. patients) may differ. Absence of specific ethics guidelines has led to considerable variation and uncertainty as to what practices are permissible in CRTs. This panel will explore the ethical, practical, and methodological issues around the design, conduct, and ethical review of CRTs.

Plenary: Panel IX – To Return or Not To Return: Individual Research Results and the Role of Biobanks

pre-registration was required

10:45-11:15 AM

LOBBY 20

Book Signing with Author and Pillars of PRIM&R Lecturer Elyn Saks, JD, PhD Join us in the Registration Area after the morning plenary sessions for a book signing with Pillars of PRIM&R Lecturer Elyn Saks, JD, PhD. Copies of the books are available at the onsite Bookstore.

11:15 AM-12:30 PM

Didactic Sessions and Workshops Series E E1

SACHRP Considerations on Internet Research (A Dialogue with the Feds I Track)

Moderator: Pearl O’Rourke Panelists: Susan Wolf, Laura Beskow, Edward Quigley There has been much discussion in recent years about returning research results to individual participants from single stand-alone studies; yet, given the many complexities around genetics and genomics research, reaching a consensus has been difficult. The discussion of returning individual results has now expanded in scope to include return of results from studies using data and samples in biobanks. A recently published proposal suggests that responsibilities for the return of research results should be shared among the players in a biobank research system, including the primary research or collection site, the biobank itself, and secondary researchers accessing the data and samples. This panel will explore the ethical justification for, as well as the logistical, regulatory, and ethical challenges of, this proposal for biobanks, researchers, and IRBs.

receives CIP credit

SAILS PAVILION

Break

31A

Faculty: Barbara Bierer, Elizabeth Buchanan, Dean Gallant Formal guidance around IRB review of internet research has not been issued, and many IRBs and researchers are asking complex questions about all aspects of Internet research, from what is exempt, to what is public information, to how we ensure informed consent. This session will provide attendees with an opportunity to: • Review with representatives of SACHRP its work to date around IRB review of Internet research. • Discuss and explore current examples and best practices currently under consideration by SACHRP. • Ask questions of and discuss Internet research issues with faculty members and other attendees.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

9:30-10:45 AM EXHIBIT HALL D

10:45-11:15 AM


Schedule

E2

schedules

A Dialogue with the Department of Education (A Dialogue with the Feds II Track)

32B

Faculty: Jeffery Rodamar Attendees are encouraged to come with questions. This session will provide attendees with an opportunity to: • Hear from Department of Education representatives about evolving issues at the Department of Education. • Identify new initiatives related to ongoing research by the Department of Education. • Participate in an open discussion about topics relevant to Department of Education stakeholders. E3

Breaking Down the Rumors About Accreditation Standards (Accreditation of HRPPs Track)

27A

Faculty: Gary Chadwick, Moira Keane In this session, faculty will: • Present rumors that have circulated about AAHRPP accreditation, and separate the mythical components from the truth. • Discuss and explore speculations that attendees may have heard. E4 Advanced

QA/QI/Program Evaluation: Is it or is it Not “Research?” (Activities Along the Boundaries Between Research and Practice Track)

30AB

didactic session

E5 Advanced

29C

HRPPs and IRBs in Tough Economic Times (Advanced Forum for IRB Professionals Track)

Faculty: Jan Hewett, Michele Russell-Einhorn The downturn in the overall economy and shrinking budgets for research will have an effect on all components of an HRPP. IRBs, researchers, and administrators may be asked to maintain or exceed their productivity with fewer people and smaller budgets. In this session, faculty will: • Discuss the implications of turning to industry as a primary source of support for the research enterprise. • Explore the vulnerability of the research infrastructure, including IRBs, given the promised cuts in federal research funding. • Address how HRPPs can plan for a coming economic hit. E6

Faculty: George Gasparis, Ivor Pritchard This session will use case studies to highlight distinctions between QA/QI/program evaluation and research. This session will provide attendees with an opportunity to:

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• Address the question of whether an activity is human subjects research, including a discussion about generalizability. • Discuss an investigator’s involvement in another institution’s QA/QI research. • Explore whether the home institution is engaged in research, for instance, if investigators from a graduate school of education are recruited to evaluate a program conducted at another school.

30E

What Investigators and IRBs Need to Know About Investigational Device Exemptions (IDEs) and Investigational New Drugs (INDs) (Clinical Research Professionals Track)

Faculty: Christine Drabick, Amanda Hammond, David Wallach In this session, faculty will:

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

• Examine institutional and investigator responsibilities and liabilities around IDEs and INDs. • Outline what safeguards, such as education, oversight, and monitoring, the IRB should require.

E9 Advanced

E7

Faculty: Joy Jurnack, Jody Power This session will provide attendees with an opportunity to: • Evaluate a protocol to determine the topics that will need to be included in the ICF. • Learn how to take information from a protocol and translate it to an appropriate reading level for the ICF.

The Ethics of Paying Research Subjects (Ethical Issues Track)

30C

E8 Advanced

29D

In Vitro Diagnostic (IVD) Devices Used as Integral Parts of Therapeutic Clinical Trials and Companion Devices: IRB Issues and Significant Risk Determinations (FDA Regulations Track)

Faculty: J. Milburn Jessup, Elizabeth Mansfield, Mya Thomae In this session, faculty will: • Examine issues that IRBs should consider related to IVD devices used as an integral part of therapeutic clinical trials. • Discuss draft guidance on IVD devices related to IRB review and oversight, and discuss some initiatives developed by the National Cancer Institute (NCI) and the FDA to manage use of investigational tests in clinical investigations of drugs. • Discuss considerations for distinguishing significant risk from non-significant risk IVD investigations.

receives CIP credit

pre-registration was required

E10 Advanced

Operationalizing the New Public Health Service (PHS) Financial Conflicts of Interest (FCOI) Rule (Institutional Officials Track)

24A

schedules

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 some guidance as to which worries merit the attention of IRB members and which do not.

23A

How to Translate a Protocol into an Informed Consent Form (ICF) (Informed Consent Track)

Faculty: Jeffrey Botkin, Lisa Murtha In this session, faculty will: • Review the changes to the new PHS FCOI rule. • Discuss ways in which universities and hospitals have implemented the new requirements, including disclosure and training. • Address difficulties that institutions have had with implementing the new requirements. E11 Basic

The (Research Ethics) World is Flat: Identifying and Working with Local IRBs in International Research (International Research Track)

29B

Faculty: David Borasky, Yali Cong In this session, faculty will: • Review US regulatory requirements and their applicability to international research. • Describe mechanisms for identifying local IRBs and ethics consultants and engaging in a useful dialogue. • Discuss the limitations of some local ethics committees in low-resource settings.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a


Schedule

E12 Basic

31C

schedules

What Happens After the Protocol is Approved: Amendments, Continuing Review, Modifications, Incident Reports, Unanticipated Problems, and Adverse Events (IRB Bootcamp Track) Faculty: Julia Gorey, Karen Hale, Kevin Prohaska In this session, faculty will: • Describe the respective responsibilities and obligations of researchers and IRBs in the postapproval phase of research. • Discuss how modifications are made through protocol amendments. • Review expectations for managing and reporting of adverse events, unanticipated problems involving risks to subjects, and other deviations from the original protocol. E13 Basic

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

30D

Faculty: Jeffrey Cohen, Melissa Epstein This session will provide attendees with an opportunity to: • Familiarize themselves with 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. • Learn ways to improve operations and streamline processes, including using a computer-based recordkeeping system, maximizing staff efficiency, using flexibilities in the regulations, and adopting written standard operating procedures. • Bring and share solutions that have worked at their respective institutions.

Icon Key

didactic session

E14 Basic

24B

Ethical and Regulatory Issues in Clinical Trials’ Websites and Social Media (Issues for Pharma/Biotech Track)

Faculty: Kristina Borror, J. Michael Warner In this session, faculty will: • Discuss the growing use of subject-driven social media sites (such as PatientsLikeMe) during preenrollment to enhance recruitment by matching volunteers with clinical trials. • Learn about the growing importance of and uses for clinical trial registration and results reporting, in the context of advancing ethical research. • Discuss the increasing use of social media sites for post-enrollment communication among study subjects, in order to, for instance, compare side effects and determine who is taking the active drug and who is taking the placebo. • Explore perspectives on evolving secondgeneration issues in trial registration and results reporting. E15 Basic

23B

Cooks in the Kitchen: The Roles of Various Entities in Human Subjects Research (Legal Track)

Faculty: Lisa Leiden, Monica Neuman Different elements of research involving human subjects are overseen by IRBs, DSMBs, tumor boards, conflict of interest committees, and hospital compliance departments, among others. This session will provide attendees with an opportunity to: • Address the overall approach to research ethics and compliance within an organization. • Understand the roles of each to ensure that there is clear and transparent communication so that nothing is overlooked.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

E16

Emerging Issues in Whole Genome Sequencing: Informed Consent and Beyond (Out-of-Body Experiences: Research Involving Tissue and Data Track)

33A

E17 Advanced

Challenges of Research with Adolescent Populations (Populations Requiring Additional Protections Track)

24C

Faculty: Mary Ott, John Santelli This session will provide attendees with an opportunity to: • Familiarize themselves with best practice guidelines for research with adolescents from the Society for Adolescent Health and Medicine (SAHM). • Consider ways in which adolescents are vulnerable, and how research can address those vulnerabilities.

receives CIP credit

pre-registration was required

Suicidality in Research: Asking Questions About Suicidal Thoughts, Enrolling Suicidal Individuals, and Other Ethical Issues (Potpourri Track)

28E

Faculty: Elizabeth Small, Barbara Stanley In this session, faculty will: • Address ethical concerns around screening for suicidality in both general and vulnerable populations. • Delineate ethical issues regarding enrolling suicidal individuals in trials and basic research. • Discuss when it is appropriate to enroll suicidal individuals in research. • Describe procedures that enhance safety and decrease risk when enrolling suicidal individuals in trials. E19

25A

Study Reviews Before Anything Goes Wrong (QA/QI and Post-Approval Monitoring Track)

Faculty: Cynthia Kern, Eunice Newbert This session will provide attendees with an opportunity to: • Learn how to do preventive study reviews. • Discover how to review and become educated about study materials before the first subject is enrolled. E20 Advanced

Collaborative Multi-site IRB Agreements: Lessons Learned and Best Practices (Regulatory Balance Track)

31B

Faculty: Valerie Bonham, Melissa Frumin In this session, faculty will: • Review the regulatory requirements of collaborative IRB agreements. • Discuss the respective responsibilities of the institution and the IRB. • Describe best practices and lessons learned.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Sharron Docherty, Laura Lyman Rodriguez In this session, faculty will: • Discuss the most up-to-date set of issues IRBs should consider when reviewing whole genome sequencing proposals. • Share resources and best practices regarding informed consent and other protocol considerations for whole genome sequencing. • Facilitate an open discussion with representatives from the National Human Genome Research Institute (NHGRI) to determine IRB-relevant needs as they pertain to whole genome sequencing.

E18


Schedule

E21

32A

schedules

Not Lost in Translation: Transforming Data Security Requirements Into Language Understandable to IRBs and Researchers (Research Involving the Internet and Social Networking Track)

E23 Basic

Faculty: Teresa Doksum, Carter Epstein, Sean Owen In this session, faculty will: • Help attendees understand basic security procedures based on regulations such as the Health Insurance Portability and Accountability Act (HIPAA), the Family Educational Rights and Privacy Act (FERPA), and the Federal Information Security Management Act (FISMA), which researchers need to follow in order to protect confidentiality and minimize risk of a security incident. • Use an analysis of over 200 agreements for data governed by HIPAA, FERPA, and other federal and state laws to help attendees understand common requirements found in data agreements and strategies for ensuring researchers adhere to these requirements. • Explore the shared responsibility of IRBs, researchers, data analysts, and data archivists in minimizing the risk of disclosure around deidentified datasets, and provide a preliminary set of recommendations. E22

33C

A “Premiere” Showing of The Clinic – The Successor to the Office of Research Integrity (ORI)’s Popular Interactive Video, The Lab (Responsible Conduct of Research Track) Faculty: Elyse Summers, Sandra Titus In The Clinic, the watcher becomes the lead character in an interactive movie and must make decisions about human subject protection

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didactic session

and research integrity that can have longterm consequences. The simulation addresses responsible conduct of research topics such as avoiding research misconduct, management of data to ensure integrity, interacting with the IRB, and fully informing subjects when obtaining consent. 33B

Lay Down Your Burden! Streamlining the Process of Reviewing Student Research (SBER I Track)

Faculty: Eric Allen In this session, faculty will: • Review the instances when student research should be reviewed by the IRB. • Discuss how the review of student research can be improved both in terms of efficiency and effectiveness. • Explore alternative models of review for student research. • Examine the role of institutional culture in approaches to reviewing student research. • Discuss ways to improve communication and build better relations with faculty who teach research courses. E24 Advanced

29A

Tribal Participatory Research: Unique Aspects of Working in American Indian and Alaska Native Contexts (SBER II Track)

Faculty: William Freeman In this session, faculty will: • Explore lessons from the native context about community consent, secondary use of data, data sharing agreements, and the role of translation and dissemination. • Discuss how insights gleaned from tribal participatory research methods can offer general ethical lessons for the field and inform the development of ethical research policy more broadly.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

E25 Advanced

23C

Managing a Small Research Operation in a Large, Growing, Multi-Component Healthcare System (Small Research Programs Track)

E26 Basic

27B

Review a Protocol! Regulatory Considerations in the Approval Process (Unaffiliated and Non-Scientist IRB Members Track) Faculty: Michelle Feige, Susie Hoffman This session will provide attendees with an opportunity to: • Review the federal regulatory criteria for approval. • Discuss strategies and tools used to facilitate protocol review. • Systematically review sample protocols.

receives CIP credit

pre-registration was required

Lunch

SAILS PAVILION

12:45-1:45 PM 25B

Lunch with Melinda Hurst, Pioneering “Community Member”

Please join us to recognize the exemplary contributions of Melinda Hurst, a woman who has volunteered as a unaffiliated, non-scientific IRB member for over 30 years. As an advocate for research subjects, Ms. Hurst embodies the values, ethics, and commitment to protection that human subjects who participate in research deserve, and PRIM&R is thus proud to honor her at this year’s conference. 12:45-1:45 PM

Lunch and Book Signing with Author and Pillars of PRIM&R Lecturer Elyn Saks, JD, PhD

26AB

Join us for a luncheon with Pillars of PRIM&R Lecturer Elyn Saks, author of The Center Cannot Hold: My Journey Through Madness. This event will provide attendees the opportunity to talk with and ask questions of this distinguished author and professor in an informal environment. Copies of Dr. Saks’ book are available at the onsite Bookstore, and she will be available to sign books during this lunch. 12:45-1:45 PM

What’s New at the CITI Program? Lunch

28ABCD

Staff members from CITI 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.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

Faculty: Robert Bienkowski In this session, faculty will use examples to: • Discuss developing and enforcing conflict of interest policies for employed and non-employed physicians. • Describe strategies for explaining and enforcing compliance with physician-investigators and getting their support. • Provide guidance for developing comprehensive, uniform policies and procedures for IRB oversight education, review, and communication standards. • Illustrate how to establish a research culture using research compliance as a tool for integration. • Evaluate different ways to develop and implement a financial interest reporting system that complies with new NIH regulations in an institution with limited NIH funding.

12:45-1:45 PM


Schedule

1:15-1:45 PM

SAILS PAVILION

Demonstration of PRIM&R’s Online Course and Knowledge Center

Join us in the PRIM&R Booth for a demonstration of two of our interactive online resources—The Ethical Oversight of Human Subjects Research Course and PRIM&R’s Knowledge Center. A 15-minute presentation on each resource will provide you with an introduction to utilizing these tools to strengthen your understanding of human subjects protections. 1:45-2:00 PM

Break schedules

2:00-3:15 PM

BALLROOM 20AB

Plenary: Panel X – Protecting Privacy and Confidentiality: Exploring Persistent Limitations, Novel Challenges, and Whether it is Time for a New Approach

Moderator: Cynthia Gómez Panelists: Nancy Kass, Rachel Nosowsky, Lauren Solberg This panel will discuss the ongoing challenge of protecting research subjects’ privacy and confidentiality and the special concerns raised by new online technologies. Issues to be discussed include the differences between confidentiality and privacy; current technical approaches to data privacy and their limitations; the actuality of privacy risks in the biomedical and the social behavioral settings; and whether IRBs can meaningfully contribute to protecting subjects from these risks. The panel will close by exploring whether, given the apparent limitations of our current regulatory and technical approaches to protecting privacy and information, we need a new framework, and what such a framework might look like.

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didactic session

2:00-3:15 PM

EXHIBIT HALL D

Plenary: Panel XI – The Single IRB of Record Proposal: Appraising the Balance of Risks and Benefits

Moderator/Panelist: Robert Levine Panelists: Albert J. Allen, Barry Mangum, Pearl O’Rourke In recent years support has been growing for having multi-site research reviewed by a single IRB of record, culminating with a proposed requirement in the recent Department of Health and Human Services’ Advance Notice of Proposed Rulemaking (ANPRM). This panel will explore the advantages and concerns surrounding such a system. The moderator is an academic bioethicist who will give a brief description of the single IRB model including comments on its efficiencies as compared with review by multiple IRBs, the current prevailing custom. A pharmaceutical corporation representative will discuss advantages from a study sponsor’s perspective of using a single IRB and then address the oft-heard concern that companies would press for single IRBs that produce rapid, pro forma reviews. An academic who stands at the intersection of academia and the pharmaceutical industry will speak about how his academic institution has changed its paradigm of ethics and regulatory review by successfully integrating university medical center research activities with a freestanding IRB, and will also address the concern that independent, commercial IRBs would attempt to corner the market for single IRBs of record. Finally, a university HRPP leader will discuss disadvantages of immediate implementation of the single IRB model without first having taken into account the facts that IRBs are just one component of larger HRPPs, and that oversight and protection policies vary substantially from one institution to another. Attendees will leave the panel much better informed about the issues in the controversy even if they are not yet sure whether it would be wise to adopt a policy mandating single IRBs of record.

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

2:00-3:15 PM

Break

pre-registration was required

Ask the Experts! Everything You Wanted to Know, But Were Afraid to Ask

Faculty: Charlotte Coley, Yvonne Higgins, Julie Kaneshiro, Irene Stith-Coleman, Jean Toth-Allen Are you new to the field of research ethics? Still have a nagging question regarding HRPPs and IRBs? Join us for this session where experienced veterans of the field and seasoned PRIM&R pros will be available to answer all the questions you’ve been afraid to ask! Come with ideas, 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. GF2 33ABC

Connecting Through PRIM&R: Mentoring, Regional Connections, Volunteer Opportunities, and More

Faculty: Megan Frame, Kimberly Hensle Lowrance In addition to the knowledge members gain from attending PRIM&R conferences and regional programs, a major benefit is networking, which allows newcomers and those with years of experience to share common problems and solutions. PRIM&R has a number of initiatives that foster such connections, including a mentoring program, a range of volunteer opportunities, social media groups, the IRB Forum, and a long-standing Regional Connections program that provides support to members to hold a local networking and/or educational events. Come and learn tips on how to find a mentor or mentee, start planning a Regional Connections program, and more.

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

schedules

3:15-3:30 PM

Grand Finale Sessions GF1 30ABCD

Moderator: Daniel Nelson Panelists: Karen Moe, Efthimios Parasidis, Elizabeth Pike For 30 years, national bioethics commissions have been calling for those who conduct research to provide treatment for subjects who may be harmed through participation, arguing that we have an ethical obligation to care for those who bear the risk. Most recently, the Presidential Commission for the Study of Bioethical Issues recommended that this issue be studied anew, and that the federal government should explain publicly why the status quo of having no nationalized system or federal requirements for compensation should be maintained or changed. Many developed countries have instituted policies that require treatment or compensation for research-related injuries, and some US agencies and institutions have independently established self-insurance programs. This panel will explore the current landscape, including the calls for a nationalized system that would mandate compensation or treatment for research-related injury.

receives CIP credit

3:30-4:45 PM

BALLROOM 20CD

Plenary: Panel XII – Compensation for Research-Related Injury: Is it Finally Time for a Nationalized System?


Schedule

GF3

Affinity Groups

You’ve spent three days getting to know your colleagues. So where do you go from here? Come to this wrap-up session to connect with your fellow affinity group members one last time. 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 Affinity Group might want to undertake. Each affinity group will have its own session:

schedules

Global Research (gold)

28E

Institutional Officials (IOs) (black)

27A

IRB Chairs (teal)

27B

puts the viewer smack in the middle of the controversial actions, the heated meetings, the heartbreaking failures, and the exultant breakthroughs of heroes in the making.” - from www.surviveaplague.com GF5

29ABC

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: HSP Jeopardy. Question: What is a guaranteed good time for all!?

Quality Assurance/Quality Improvement (QA/QI) (navy) 23A Small Institutions (neon green)

23B

Social, Behavioral, and Educational Research (SBER) (violet)

23C

Unaffiliated/Community Members (peach) 24A

GF4

BALLROOM 20AB

Film Screening: How to Survive a Plague

(Please note that in order to show the film in its entirely, this Grand Finale session will run from 3:30 to 5:30 PM) Join us for a screening of the critically acclaimed, feature-length documentary How to Survive a Plague, a powerful look at the role of early AIDS activists in expediting the development of HIV/AIDS drugs. “How to Survive a Plague is a story about two coalitions whose activism and innovation turned AIDS from a death sentence into a manageable condition. Despite having no scientific training, these self-made activists infiltrated the pharmaceutical industry and helped identify promising new drugs, moving them from experimental trials to patients in record time. With unfettered access to a treasure trove of never-before-seen archival footage from the 1980s and ‘90s, filmmaker David France

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didactic session

GF6

The Evolution of Research Ethics: Bring Your Story!

32A

Faculty: Gigi McMillan, Joan Rachlin Celebrate the rich texture of PRIM&R’s history as members of the community share meaningful tales describing their journeys in the world of ethical research. In this Grand Finale session, learn about the tradition of oral history and strategies for capturing vibrant, educational accounts. PRIM&R will describe its latest endeavor: the development of an interactive multi-media project that captures and organizes meaningful stories related to research ethics. This website, People & Perspectives, will present multiple topics in a variety of formats; listeners can contribute their own stories, download their favorites and link to similar speakers or subjects. The last half of this Grand Finale session will be an “open mic” format with pre-booked orators as well as opportunities for the audience to take the podium. This casual, fun, and friendly session will be

interactive workshop

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

recorded session

receives CME credit


Thursday 12.6

videotaped for inclusion in People & Perspectives. Be one of the first to contribute to this ground-up body of knowledge and become part of the People & Perspectives oral history collection! GF7

The Uncomfortable Conversation: Talking about Diversity

31AB

4:45-5:45 PM

Closing Reception

schedules

Faculty: Melissa Epstein, Eric Mah 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, members 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. 28ABCD

Join us to wish each other a fond farewell and to make plans for the 2013 AER Conference! Light refreshments will be served.

receives CIP credit

pre-registration was required

call for session proposal

double session

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a


Continuing Medical Education (CME) Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Boston University School of Medicine and PRIM&R. Boston University School of Medicine is accredited by the ACCME to provide CME for physicians.

schedules

Boston University School of Medicine designates this live activity for a maximum of 16.75 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This program meets the criteria of the Massachusetts Board of Registration in Medicine for 16.75 hours of risk management study. Course director: Leonard Glantz, JD, Associate Dean Emeritus, Academic Affairs; Professor, Health Law, Bioethics, and Human Rights Target audience: The target audience of this activity includes Human Research Protection Program/ Institutional Review Board (HRPP/IRB) chairs, members, and administrators; researchers and research staff; institutional officials; regulatory officials; compliance officers; those charged with overseeing “responsible conduct of research” programs; hospital/university attorneys; patient advocates; representatives of voluntary health organizations; industry and biotechnology representatives; and those involved with science policy. Educational objectives: Upon completion of this activity, participants should be able to: (1) Explain the principles listed in the various research ethics reports (Belmont Report, Nuremberg Report, Declaration of Helsinki) and apply them in their day to day work; (2) Identify the core federal regulations governing human subjects research, and recognize which aspects of their work put those regulations into practice; (3) Develop strategies for managing successful HRPPs/IRBs; (4) Assess how their HRPP/IRB policies and procedures compare with the best practices in the field; (5) Communicate effectively with those involved in various aspects of the research enterprise to ensure adherence to federal regulations and that human subjects are properly protected before, during, and after a research study; and (6) Define a “vulnerable population” and demonstrate how ethical principles and federal regulations apply to these groups during research.

Needs addressed statement: In order to successfully implement HRPPs, professionals involved with IRBs need access to current and accurate information on the laws, regulations, policies, and guidance documents governing human subject research ethics and compliance. How this information and policies are implemented varies. Past participants have rated highly the opportunity to discuss these principles with experts in the field and their peers. This conference enables participants to exchange best practices and other creative strategies that institutions around the country are employing to maximize protection of research participants, while at the same time streamlining administrative procedures influence the implementation of policies. Faculty disclosure statement: Boston University School of Medicine asks all individuals involved in the development and presentation of CME activities to disclose all relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve any apparent conflicts of interest. In addition, faculty members are asked to disclose when any unapproved use of pharmaceuticals and devices is being discussed. A detailed copy of the disclosure statement will be available in the Conference Guide, and also at the Help Desk located onsite at the San Diego Convention Center. Disclaimer: THESE MATERIALS AND ALL OTHER MATERIALS PROVIDED IN CONJUNCTION WITH CONTINUING MEDICAL EDUCATION ACTIVITIES ARE INTENDED SOLELY FOR PURPOSES OF SUPPLEMENTING CONTINUING MEDICAL EDUCATION PROGRAMS FOR QUALIFIED HEALTH CARE PROFESSIONALS. ANYONE USING THE MATERIALS ASSUMES FULL RESPONSIBILITY AND ALL RISK FOR THEIR APPROPRIATE USE. TRUSTEES OF BOSTON UNIVERSITY MAKES NO WARRANTIES OR REPRESENTATIONS WHATSOEVER REGARDING THE ACCURACY, COMPLETENESS, CURRENTNESS, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE MATERIALS. IN NO EVENT WILL TRUSTEES OF BOSTON UNIVERSITY BE LIABLE TO ANYONE FOR ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THE MATERIALS. IN NO EVENT SHOULD THE INFORMATION IN THE MATERIALS BE USED AS A SUBSTITUTE FOR PROFESSIONAL CARE.

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Posters Selected for Presentation PRIM&R is pleased to present the Annual Poster Presentation at the 2012 AER Conference. Four posters were selected for special panel presentations; 16 posters will be presented during a Moderated Poster Discussion session; and 102 posters will be on display throughout the conference in The Conference Connection.

1. A Global Electronic Research Ethics Review System?

P

Infonetica Manish K. Kainth, BScEng, MCIM

2. A Multipart Exercise on the IRB Mission and Procedures in the Undergraduate Classroom

P

Philadelphia University Richard Shain, PhD; Frank Wilkinson, PhD

3. A Performance Improvement Approach to Increasing IRB Member Regulatory Compliance

WellSpan Health Tara Moore; Melissa Schlenker, MS, CCRC, CIP

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P

P

4. A Process Improvement Study Evaluating Research Study Subjects’ Comprehension of the Informed Consent Document

S

5. Addressing the Educational Needs of the Research Community: IRBMED Development of a New Education & Training Program

P

6. Advancing Our Knowledge of Informed Consent: IRB Chair and Researcher Reflections on the Havasupai Lawsuit

S

7. Assessment of Self-Perceived Risk-Benefit Decision Patterns by Research Ethics Committee Members in Egypt

S

San Antonio Military Medical Center Lynda Jaskinia, MS, MT(ASCP)H; Ileana King-Letzkus, BS

posters

Many thanks are owed to the Poster Abstract SubCommittee, including chairs David Borasky and Susan Fish, and members Paula Bistak, Okyere “Boat” Boateng, Warren Capell, Cheryl Dubenezic, Samantha Ferrante, Lane Fischer, George Gasparis, Karen Hale, Michele Kennett, Patricia MacCubbin, Amal Matar, Nancy Olson, Nancy Ondrusek, Christine Philput, David Resnik,Tracy Rightmer, Carol Weil, and Sharon Zack for coordinating this conference event. Please note that the inclusion of posters featuring commercial products should not be considered an endorsement by PRIM&R.

University of Michigan S. Joseph Austin, JD, LLM; Judy Birk, JD

Stanford University Nanibaa’ Garrison, PhD

Cairo University Samia Rizk, MD, MPH; Michael Guirguis

programmatic submission

S

scientific submission

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a


Posters Selected for Presentation

8. Benefits of Conducting a Scientific Review Prior to Institutional Review Board

P

WellSpan Health Melissa Schlenker, MS, CCRC, CIP; Tara Moore

P

10. Building an Electronic Submission System from Scratch: A Recipe for Success

P

Indiana University John Baumann, PhD; Shawn Axe, CIP; Amy Waltz, JD, CIP; Sara Benken, CIP

University of Nebraska Medical Center Sue Logsdon, MS, CIP; Teresa Pisasale, BS

posters

P

12. Capacity Building for Non-Technical Members of Human Ethics Committees

P

13. Clinical Trials in Transition Societies: How to Avoid Ethical Failures?

P

Icon Key

P

P

16. Communication Breakdown

P

17. Compensation Impact on Healthy Volunteer Accrual

P

18. Comprehensive Model to Assess the Service Quality of the IRB Regulatory and Compliance Monitoring Activities

P

19. Debunking the Myth: The Institutional Review Board at Hackensack University Medical Center’s Only Agenda is to Delay Research

P

University of Pennsylvania Megan K. Singleton, JD, MBE, CIP; Tracy Ziolek, MS, CIP; Amy Schwarzhoff, BS, CIP; Heather Cathrall, CIP; Christine Davison; Jenna Dragani, MS, CIP

National Institute of Mental Health Barbara I. Karp, MD; Angela Williams

Vanderbilt University Angela Howard, PhD, CIP; Johny Tadros, BA; Dee Ann Scott, BS; Barbara Gibson, BS, BSN, RN, CCRC, CIP, CHRC

Tata Memorial Centre Tessie George; Meenakshi Thakur

15. Collaborative Approaches to Preparing IRB Staff for the CIP Exam

ProMedica Lynnea Lau, MPH; Lee A. Booze-Battle, CIP; Kelsey Reuther

University of California, San Diego Maria Adela Grando, PhD; Aziz Boxwala, MD, PhD; Richard Schwab, MD

Jagiellonian University Medical College Marcin Waligora, PhD; Jan Piasecki, PhD

P

Yale University Karen A. Hartman, RN, MSN; Stacey Scirocco

9. Beyond the Presentation Approach: New Outreach Practices at a Large Academic Medical Center

11. Can We Facilitate Research by Maximizing Data and Biosample Utility While Complying with Subject’s Consent?

14. Collaboration Efforts between Two Academic Health Centers to Share Knowledge and Strengthen Regulatory Support Services for Research

Hackensack University Medical Center Cheryl Dubenezic, RN, CIM, CIP; Phoebe Del Boccio; Dorothy Hilpmann; Rosemarie Sorce

programmatic submission

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

S

scientific submission


20. Did Reverse Engineering of the P IRB Process Work? The Analysis and Re-design of IRB Workflows and Processes for Efficiency—1 Year Analysis New York University School of Medicine Helen Panageas, CIP; Paul Thompson; Aileen Kunitz, CIM; Elan Czeisler, MA

21. Disclosure of Compensation in a Clinical Trial – An Ethical Review Dilemma

S

PS Medical College Barna Ganguly, MBBS, MD

22. Early Exposure to Ethical Conduct of Research amongst Medical Undergraduates: An Experience from an Indian Medical College

P

Kasturba Medical College Animesh Jain, MBBS, MD, DFH

P

Meharry Medical College Lauren B. Solberg

24. Establishing Mechanisms for Tracking and Evaluating Utilization of IRB Resources

P

University of Pennsylvania Tracy Ziolek, MS, CIP; Patrick Stanko, CIP; Dave Heagerty; Benjamin Hernberg; Ed Fong; Emma Meagher, MD

25. Ethical Challenges Confronting Most at Risk Populations (MARPS) in Liberia

S

27. Full Circle: IRB Member Evaluation

P

28. Global Clinical Trials: We’re Not In Kansas Anymore!

P

29. Global Pharma Studies in Developing Countries: Ethical Concerns

P

30. How to Effectively Conduct an IRB Committee Meeting in an Electronic Environment

P

31. HRPP in Peking University Health Science Center

P

Federal Teaching Hospital Abakaliki Uzoma M. Agwu, MBBS, FMCOG; Odidika Umeora; Chinedu Nwigwe

Durham VA Medical Center Virginia Rhodes, RN, MSN

Duke University Health System Charlotte H. Coley, MACT, CIP; Yvonne Higgins, BS, CIP; Barry Mangum, PharmD; Greg Koski, PhD, MD

International Centre for Diarrhoeal Disease Research, Bangladesh Wasif A. Khan, MBBS, MHS

School of Osteopathic Medicine at the University of Medicine and Dentistry of New Jersey Adarsh K. Gupta, DO, MS, FACOFP; Paula Bistak, DMH, RN, MS, CIP, CHRC; Donna Hoagland, LPN, BS, CIP, CCRC

Peking University Health Science Center Yali Cong, PhD

P

University of Liberia-Pacific Institute for Research and Evaluation Africa Center Jemee K. Tegli, BBA, MSc; Stephen B. Kennedy, MD, MPH; Ellen G. Williams, MSN; Cecelia Morris, MSN

selected for moderated discussion

selected for panel presentation

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

posters

23. Empowering Terminally Ill Populations through the Informed Consent Process: A Lesson for Researchers and Institutional Review Boards

26. Ethics Training for Medical Interns Using a Focus Group Discussion Model


Posters Selected for Presentation

32. Human Subjects Research P Concerns and Incidents of IRB Noncompliance Lead to National Science Foundation Grant Suspensions, Return of Grant Funds, and Modifications of Research Conducted by Investigators National Science Foundation Erik A. Runko, PhD; James T. Kroll, PhD

33. Implementation of an Electronic Document Management System: Ensuring Transparency and Institutional Memory for Efficient IRB Administration

P

BayCare Health System Yael Hoogland BSc, MHS

34. Implementation of a System-Wide IRB in Indiana

P

posters

Indiana University Sarah Crabtree, MS, CIP; Shelley Bizila, MS, CIP

35. Improving Efficiency, Review Quality, and IRB Member Satisfaction by Restructuring the Process

P

36. Improving Internal Communication Using an Intranet Web Portal

P

Wake Forest University School of Medicine and Baptist Health Joseph E. Andrews Jr., MA, CIP; J. Brian Moore, MS

Vanderbilt University Dena Johnson, CIP, CCRP; Jan Zolkower, CIP, CCRP; David Hiller, CIP; Rebecca Abel, MA, CIP

37. Improving IRB Submissions through Formal Researcher Consultation

P

Yale University Jean H. Larson, MBA; Cathleen Montano, JD, CIP; Jan Hewett, BSN, RN, JD

Icon Key

P

38. Improving the Protocol and Informed Consent Violation Submission and Review Process

P

Memorial Sloan-Kettering Cancer Center Roy Cambria; Collette Houston; Roger Wilson, MD

39. Incentivized Corrected S Feedback: A Combined Remedial and Motivational Approach for Improving Recall of Consent Information

Treatment Research Institute David S. Festinger, PhD; Karen L. Dugosh, PhD; Douglas B. Marlowe, JD, PhD

40. Incidental Pregnancy Follow-up and Data Collection: An Efficient Approach

P

41. Institutional Review Board and Information Technology Collaboration to Protect Patient Data

P

42. Institutional Review Boards Collaborating in Indian Country

P

43. In the Way of Approval: Required versus Recommended Revisions

P

University of Pennsylvania Tracy Ziolek, MS, CIP; Megan K. Singleton, JD, MBE, CIP; Melissa Eng, CIP; Meghan Blair, MS

School of Osteopathic Medicine at the University of Medicine and Dentistry of New Jersey Adarsh K. Gupta, DO, MS, FACOFP; Paula Bistak, DMH, RN, MS, CIP, CHRC; Cheryl A. Forst, RN, BSN CCRP

Choctaw Nation of Oklahoma Bobby Saunkeah, RN, CDE, CIP; Michael Peercy, MPH, MT(ASCP)H; Dannielle Branam; David Wharton, MPH, RN; Sohail Khan, MBBS, MPH, CIP; Julie Erb-Alvarez, MPH

ProMedica Lee A. Booze-Battle, CIP; Lynnea Lau, MPH; Kelsey Reuther

programmatic submission

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

S

scientific submission


44. IRB Forms and Process: Providing Fundamental Support to Our Research Community

P

45. IRB Member, Staff, and Investigator Assessments of IRB Competence to Review Adolescent Protocols

S

46. IRB Review and Vulnerable Populations: Investigator, IRB Member and Staff Capacity and Perceptions of Protocol Review for Cognitively Impaired Adults

S

New York University School of Medicine Royell Sullivan, BA; Joy Jurnack, RN; Helen Panageas, CIP

P

Centers for Disease Control and Prevention Edward Sinkule, MS; Cherie Estill, MS; Kathy Masterson; Gail McConnell, VMD, MPH; Paul Middendorf, PhD, MS; Sue Ross; Mark Toraason, PhD; Douglas Trout, MD, MHS; Ainsley Weston, PhD

P

P

The Ohio State University Ellen A. Patricia, MS, CIP; Sandra A. Meadows, MPH, CIP

53. Non-Technical Members of Human Ethics Committees (HEC): Their Special Contributions and the Challenges They Face

P

54. On the Job Student Training in Human Subjects Research

P

Tata Memorial Centre Tessie George; Meenakshi Thakur

University of California, Irvine Brandon Brown, MPH, PhD

P

Texas A&M University Catherine Higgins; Aline Lovings; Kathrine Mancuso; Kamau Richard; Robert Nobles

selected for moderated discussion

selected for panel presentation

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

posters

University of British Columbia Jennifer Bell, MA; Lynda G. Balneaves, RN, PhD; Anita Ho, BA, BComm, MA, MMus, PhD; Harriet Richardson; Kim Chi, MD; Karen Gelmon, MD

Summa Health System Jessica Conrad, MS, CIP; Christy Wise, BA

49. Maximizing HSPP Efficiencies in Preparation for AAHRPP Accreditation

51. NIOSH Institutional Review Board Guidance Resource for Preparing Protocols Containing Physical Activity or Exercise

52. “No Man is an Island”: Cancer S Patients’ Experience of Autonomy Related to Their Decision-Making Process about Clinical Trial Participation

Indiana University School of Medicine Amy Waltz, JD, CIP; Elizabeth E. Molnar, BA; Devon J. Hensel, PhD; Alexia M. Torke, MD, MS; Mary A. Ott, MD, MA

48. Life After Noncompliance: Making Lemonade Out of Lemons

P

SAIC-Frederick, Inc. Tracey Miller; Vali Sevastita; Sara Stallings; Kristin Young; Stacy Kopka; Doreen Chaitt; Jerome Pierson

Indiana University School of Medicine Mary A. Ott, MD, MA; Elizabeth E. Molnar, BA; Devon J. Hensel, PhD; Amy Waltz, JD, CIP

47. Lessons Learned: When Your Policy Does Not Say Enough— Investigator Responsibility Audit Results

50. New Program Shows Promise for Improving the Path to Clinical Research


Posters Selected for Presentation

55. Optimization of Incidental Findings Disclosure to Research Participants

S

Mind Research Network Jody M. Shoemaker, MS, CCRP, CIP; Deborah L. Helitzer, ScD; Mark T. Holdsworth, PharmD; Ronald Schrader, PhD; John P. Phillips, MD; Linda E. Petree, BA, CIP

56. Organizational Structure, Operations and Training Needs of Research Ethics Committees in Southeast Nigeria

S

Federal Teaching Hospital Abakaliki Odidika Umeora; Douglas Wassenaar, PhD

57. OUTREACH: Is It an Effective Tool for Reaching Out to the Research Community at New York University School of Medicine

P

posters

58. Pre-Review of Greater than Minimal Risk Studies: Good and Bad

P

59. Privacy Board Review: Decreasing Turnaround Times by Streamlining the Process

P

60. Protecting Confidentiality: Routine Monitoring of Minimal Risk Medical Record Review Studies

P

NYU Langone Medical Center Marina Godina; Helen Panageas, CIP

University of Michigan Judy Birk, JD; S. Joseph Austin, JD, LL.M

Icon Key

P

P

62. Real-Time IRB Assistance through ‘Live Chat’ Technology

P

63. Reinventing the University IRB: A Performance Management Perspective

P

64. Research and Intervention in Amazonian Indigenous Populations: Lessons from the Field

P

65. Research and Research Ethics in the Peruvian and Ecuadorian Navies

P

New York University Joy Jurnack, RN; Royell Sullivan, BA; Helen Panageas, CIP

Cedars-Sinai Medical Center Gordon Olacsi, CIP; Sarvenaz Aliabadi, CIP; Rebecca Flores Stella, CIP; Adam Pucci, CIP; Jonathan Copeland; Eifaang Li, DVM, MPH, CIP

University of La Verne Marcia L. Godwin, PhD

New York University Judy Kwak, MA; NehaKaul, BS, MS, MA; Helen Panageas, CIP; Godina Marina; Joy Jurnack, RN; Royell Sullivan, BA

Cedars-Sinai Medical Center Keren Dunn, CIP; Leah Silbert, MPH, CIP, CCRP; Eifaang Li, DVM, MPH, CIP

61. Reaching Investigators in a Grand Rounds Forum: A Challenge and an Opportunity

US Naval Medical Research Unit Six Luis Suarez-Ognio, MD; Hugo Rodriguez, MD; Alvaro Whitthembury, MD, MPH; Wilma Casanova, RN, PhD; Arbildo Viloche, MD; Silvia Montano, MD, MPH; A. Roxana Lescano, JD

US Naval Medical Research Unit Six Hugo Gallo, CAPT, MD; Giannella Sanchez, LT, MD; Dauma Gastiaburu, MD; Luis Loayza, LCDR, MSC; Hugo Romero, CAPT, MC; Claudio Rocha, MD, MPH; Hamilton Tilley, LCDR, MC; Andres G Lescano, MsC, MsC, PhD; Giselle Soto, MD, MPH; A. Roxana Lescano, JD

programmatic submission

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S

scientific submission


66. Responsible Conduct of Research Education: Considerations in Extending an Existing Educational Program for Basic Science Graduate Students Campus-Wide at a Medical University

P

S

Delta State University, Abraka Patrick Okonta, MD, FWACS, FMCOG, MPH; Theresa Rossouw, MBChB, MPH, DPhil

68. Stakeholder Perceptions of the Ethics of Qualitative Health Research in Ghana

S

University of Cape Coast Evelyn Anane-Sarpong, MPH, MSc, BA; Douglas Wassenaar, PhD

P

Yale University Sandra Alfano,PharmD, FASHP, CIP; Jennifer Marchitto, MS, CIP; Brandy Dionne, BS, CIP; Jean H. Larson, MBA

70. Stem Cells: Biology, Bioethics, and Applications - A Comprehensive Online Course

S

73. Striving For a Comprehensible Informed Consent: The Botswana Case

P

74. The Alaska Area Specimen Bank: A Tribal-Federal Partnership to Maintain and Manage a Resource for Health Research

P

75. The Ethics Application Repository

P

76. The Implementation of a Governance Framework for Research Ethics in Southern Taiwan

P

Academy of Sciences of Moldova Serghei Sprincean, PhD

Botswana-Harvard AIDS Institute Partnership Ernest M. Moseki, PGD

Centers for Disease Control and Prevention Arctic Investigations Program Alan Parkinson, PhD; H. Sally Smith

University of Otago Martin Tolich, PhD

P

Columbia University College of Physicians and Surgeons Ruth L. Fischbach, PhD, MPE; John Loike, PhD; Janet Mindes, PhD

selected for moderated discussion

72. Strengthening National Research Ethics Committees’ System of Republic of Moldova in East-European Social-Political Transitional Context

posters

69. Standardized Methodology for Defining Local Context for Central IRB Submissions

P

Abt Associates Inc. Teresa Doksum, PhD, MPH; Sean Owen, CISSP, CAP

The State University of New York Upstate Medical University Amy T. Campbell, JD, MBE; David C. Amberg, PhD

67. Scientific Misconduct: Attitudes, Perceptions, and Associated Factors in a Developing Country

71. Strategies for Helping Researchers Do the Unthinkable: Destroy Their Data

National Cheng Kung University Yu-Ping Cheng; Zhenrong Gan; Hua Tai

selected for panel presentation

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Posters Selected for Presentation

77. The ‘Myth’ of Participants’ Consent in a Vaccines Trial in a Peri-Urban Poor Township in Lusaka, Zambia

P

78. The Role of Reputation in Research Cancer Clinical Trial Participation

S

79. Timely and Efficient Communication between Researchers and IRBs Can Enhance Implementation of Research Studies

P

posters

S

84. Using Placemats to Improve IRB Conversations

P

85. Using the Institutional Review Board Researchers Assessment Tool to Assess Institutional Ethics Committees in Gujarat, India

S

86. Waiver of Documentation of Informed Consent in Minimal Risk Studies: An Effective Yet Sparsely Used Tool

P

Hospital Corporation of America David Vulcano, LCSW, MBA, CIP, RAC

Botswana-Harvard AIDS Institute Partnership Tuamalano Sekoto, BA; Ernest M. Moseki, PGD

80. US Department of Energy Responds to the Presidential Commission for the Study of Bioethical Issues

P

81. Understanding Why People Refuse to Participate in Research May Strengthen Research Ethics Standards: Experiences from Following Up Refusals in a Rural Coastal Community in Kenya

P

University of South Florida St. Petersburg Tiffany Chenneville, PhD; Lynette Menezes, PhD; Jayesh Kosambiya, MD; Rajendra Baxi, MD; Lauren Bylsma, MA; Angela Mann, MA

US Department of Energy Elizabeth White, MBA, MPH; John Ordaz, NNSA

KEMRI-WELLCOME Trust Research Programme Francis Kombe; Salim Mwalukore; Hassan Alphan; Evasius Bauni

P

83. Use of a Self-Assessment Tool in Assessing the Functioning of Research Ethics Committees in Developing Countries

Ain Wazein Hospital Rola Jafaar; H. Sleem; K. Moodley; N. Kumar; M. Malini; S. Naidoo; Henry Silverman

Fred Hutchinson Cancer Research Center and the Seattle Cancer Care Alliance Kathleen Shannon Dorcy, RN, MN, PhD

Icon Key

P

University of Michigan Brian Seabolt, BA; Judy Birk, JD; S. Joseph Austin, JD, LLM

Southern Africa Consortium for Research Excellence Bornwell Sikateyo, BSc, G Dip, MSc, FBioethics, MSocSc, Dip LSHTM, PhD

82. University of Michigan IRB Collaborative: Developing an Online Library of Audiovisual Materials for Education and Training

New York University School of Medicine Neha Kaul, BS, MS, MA; Helen Panageas, CIP; Judy Kwak, MA

programmatic submission

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S

scientific submission


87. Access to Human Biological Materials in Collaborative Research with Developed Countries Conducted in South Africa: A Case Study

S

Nelson R. Mandela School of Medicine, University of KwaZulu-Natal Mahomed Aslam Sathar, BSc, BA, MMedSci, MSc Med, PhD; Stephan Van der Linde, MSc; Ames Dhai, MB ChB, FCOG, LLM

88. Biorepository “Structural Engineering”—Development of the Office of Biorepository Regulatory Support at MD Anderson Cancer Center

P

89. Current Cognition about Biobanks in Japan

S

93. Use of Central Institutional Review Boards for Multicenter Clinical Trials

S

94. Use of a Central IRB—The Limitations of Managing Multiple Models

P

95. A Nationally Implementable, Locally Deliverable, Research Ethics Training Workshop for Community-Based Collaborators

P

96. Balancing Compliance with Community Engagement: A Model of Engaged Ethics to Protect Vulnerable Participants from Exploitation

P

Northwestern University Debra G. Tice, BS, CIP, CCRC; Paul Haschke, BS; Steven M. Belknap MD, FACP, FCP; Kelly Carroll, PhD; Heather J. Gipson, JD, MA, CIM; Dennis P. West, PhD, FCCP, CIP

P

Broad Institute Andrea Saltzman, RN, CIP; Stacey Donnelly, MPA; Sue Flynn, BSN; Emily Lipscomb, BA

S

Baptist Health Kathleen A. Seabolt, CIM

Yale University Jan Hewett, BSN, RN, JD; Jean H. Larson, MBA

Saint Louis University Stephanie R. Solomon, PhD; Patricia PiechowskiWhitney, MPH, MSW, MA; Brenda Eaken, MS; Rosalind Kirk, PhD; Ellen Champagne, BA; Kim Mayes; Nick Steneck, PhD

Kaiser Permanente Southern California Armida Ayala, PhD; Yvonne Hung, PhD; Francisco Morales

selected for moderated discussion

selected for panel presentation

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posters

Tokyo Medical and Dental University Yuka Ozasa RN, PhD; Miwa Suzuki; Naoko Nii, BN; Masumi Ai, MD; Eiichiro Kanda; Masayuki Yoshida, MD

91. Local IRB Chairmen’s Perceptions Regarding the Use of Central IRBs

S

Duke University Kathryn Flynn, PhD; Cynthia Hahn, CIP; Devon Check; Judith Kramer, MD, MS; Carrie Dombeck; Lawrence Muhlbaier, PhD; Jane Perlmutter; Kevin Weinfurt, PhD

MD Anderson Cancer Center Nicole Sieffert, CCRC; Ty Hoover, MD, JD

90. Enhancing Regulatory Compliance in a Large Scale Genomic Research Institute

92. Reduction in Risk of Harm by Local IRB Review of Centrally IRB-Approved Multicenter Clinical Trials


Posters Selected for Presentation

97. Concepts of Community Harms in Genomics Research in Developing Countries: A Pilot Study in Oyo State, Nigeria

S

West African Bioethics Training Program John-Moses Uwanduoma Maduabuchi, BMLS, MBBS, MSc; Clement Adebamowo, BM ChB Hons, FWACS, FACS, ScD

98. Public Awareness and Perceptions of Clinical Trials Questionnaire: A Pilot Study in Central-West India

S

Deenanath Mangeshkar Hospital and Research Centre Veena Joshi; Gauri Oak; Aditi Kulkarni; Varada Biwalkar

posters

99. Consenting Adults: An Innovative Informed Consent Workshop

P

Beth Israel Deaconess Medical Center Kaarkuzhali B. Krishnamurthy, MD; Margo Coletti, MLS; Stephen O’Neill, LICSW, BCD, JD; Daniel DeHainaut; Angela Lavoie, RN; Nancy J. Brown, RN; Michael D’Egidio; Ediss Gandelman; Shari Gold-Gomez

100. Framing Research Risk to Support the Decision to Participate

S

Public Health Ontario Nancy Ondrusek, PhD; Philip Hebert, MD, PhD, FCFPC; Ross Upshur, MA, MD, MSc; Ronald J. Heslegrave, PhD; James V. Lavery, PhD

101. Lessons Learned: When Your Policy Says Too Much: Informed Consent Audit Results

P

Summa Health System Christy Wise, BA; Jessica Conrad, MS, CIP

102. Measuring Autonomy in a Doubly Vulnerable Population: The Coercion Assessment Scale

S

Treatment Research Institute Karen L. Dugosh, PhD; David S. Festinger, PhD; Douglas B. Marlowe, JD, PhD

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posters

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Posters Selected for Panel Presentation

Four outstanding posters were selected for a special panel presentation during the conference. During this panel, poster authors will present innovative empirical research on research ethics and will provide audience members with concrete tools and strategies designed to improve the effectiveness of their human research protections program (HRPP) and institutional review board (IRB). The table below lists the posters that will be presented during the panel, while the following pages provide an opportunity to read the submitted abstracts.

posters

Panel III – Hot Off the Presses: Selected Posters on Innovative HRPP Programs and Research on Research Ethics Wednesday, December 5, from 9:30 to 10:45 AM, Ballroom 20AB Panel Moderators: David Borasky, MPH, CIP, and Susan S. Fish, PharmD, MPH POSTER NUMBER & TITLE

PANEL PRESENTER

11. Can We Facilitate Research

Maria Adela Grando, PhD

by Maximizing Data and Biosample Utility While Complying with Subject’s Consent? 39. Incentivized Corrected

David S. Festinger, PhD

Feedback: A Combined Remedial and Motivational Approach for Improving Recall of Consent Information

52. “No Man is an Island”:

of Autonomy Related to Their Decision-Making Process about Clinical Trial Participation

Researchers Do the Unthinkable: Destroy Their Data

University of California, San Diego Authors: Maria Adela Grando, PhD; Aziz Boxwala, MD, PhD; Richard Schwab, MD

Problem Statement: The developments in genomics have created a high demand for biological specimens (biospecimens) and associated medical data for research. This has boosted the creation of data warehouses and biobanks. The permissions and choices that research subjects have consented to for the use of their biospecimens could vary amongst these biobanks. This can create a challenge when aggregating specimens from different biobanks for studies. There is a need to provide uniform and institution-independent mechanisms to check for compliance with the subject’s consent when using a biospecimen.

Jennifer Bell, MA

Cancer Patients’ Experience

71. Strategies for Helping

Can We Facilitate Research by Maximizing Data and Biosample Utility While Complying with Subject’s Consent?

Teresa Doksum, PhD, MPH

Program Description: We have developed an ontology-based approach to capture the permissions and choices consented by subjects participating in a research study. An ontology is a formal language for defining the terms and their meanings within a specified domain, e.g. subject consent for research. For instance: “I consent to share with non-profit research organizations the following information obtained from my medical record when specimens are made available: age at time of blood collection,

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


diagnosis (tumor stage) and clinical outcome.” Furthermore, because the permission ontology supports powerful reasoning mechanisms, we have developed a resource mediator to facilitate researchers’ queries for accessing available data and biospecimens complying with subject’s permissions. For example: “I am leading a research study on ovary cancer research and I belong to a nonprofit US research organization. I want to request diagnosis and treatment information of patients for whom frozen ovary tumor and blood samples have been banked.” The mediator can reason about the investigator’s proposed use of the biospecimens and the subject’s permissions to identify the samples that could be used for this study and would be compliant with those permissions.

Suggestions for Future Use: We are planning to further evaluate the ontology incorporating subject’s permissions resulting from signing other informed consents used by the same biorepository. Furthermore, we aim to integrate the developed permission ontology into our existing informed consent management tool, to automatically extract the subject’s choices and permissions from signed consent forms. The choice of ontologies as a knowledge representation mechanism was based on our intention to provide a uniform, implementation independent, reusable and machine-understandable mechanism to interchange and share consent permissions between research institutions. The developed permission ontology could be easily integrated into existing consent management tools or databases encoding repositories of medical data and biospecimens.

Treatment Research Institute Authors: David S. Festinger, PhD; Karen L. Dugosh, PhD; Douglas B. Marlowe, JD, PhD Problem Statement: Our prior research demonstrated the efficacy of both a remedial consent procedure (corrected feedback; Festinger et al. 2010) and a motivational consent procedure (provision of incentives; Festinger et al. 2009). Although both strategies were found to be statistically superior to a standard consent procedure for improving consent recall, the effects were modest, with most participants still only able to recall about 50 percent of the consent information. The current two-year randomized control study extends our program of research by examining the effects of a combined incentivized consent and corrected feedback procedure on recall of consent information. We hypothesized that this combined consent procedure would result in greater consent recall because it both simplifies the cognitive task and increases participants’ motivation to learn the consent information. Research Description: The study included 104 misdemeanor drug court clients being consented to participate in an ongoing drug court study. Clients interested in participating in the host study were randomized in equal proportions to a consent as usual (CAU) condition (n = 52) or an incentivized corrected feedback (ICF) condition (n = 52). Participants in both conditions were informed that they would be quizzed on their recall of consent information following their 90-minute baseline assessment and again at their one, two, three, and four-month follow-ups. ICF participants were also informed that they would earn $5.00 for each item answered correctly on the 15-item post-intake consent quizzes (possible total of $75.00 at each assessment) and that they would receive corrected feedback on incorrectly answered items. Results of a mixed effects model revealed that total scale scores between conditions did not differ at baseline (p = 0.39, d = 0.2) but that scores in the ICF condition were significantly higher than those in the CAU condition at month one (p = 0.003, Cohen’s d = 0.6), d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

posters

Evaluation: We evaluated the applicability of the ontology using 700 de-identified patient cases (2635 clinical data record entries) from a biorepository. We evaluated the permission ontology by populating it with the permissions given by subjects who signed the informed consent form for this biorepository. Furthermore, we have tested the ontology reasoning mechanism by modeling 33 requests for biospecimens received by the same biorepository in a period of three years.

Incentivized Corrected Feedback: A Combined Remedial and Motivational Approach for Improving Recall of Consent Information


Posters Selected for Panel Presentation

month two (p < 0.0001, d = 1.4), month three (p < 0.0001, d = 1.6), and month four (p < 0.0001, d = 1.8). Overall, the ICF procedure increased recall of consent material from 72 to 83, compared to the CAU condition in which recall decreased from 69 to 59. Findings support the efficacy of a combined remedial and motivational consent procedure. As these findings are limited to a single population of drug court clients participating in a behavioral research trial, the ICF should be further examined with other populations involved in other types of research such as biomedical studies.

“No Man is an Island”: Cancer Patients’ Experience of Autonomy Related to Their Decision-Making Process about Clinical Trial Participation

posters

University of British Columbia Authors: Jennifer Bell, MA; Lynda G. Balneaves, RN, PhD; Anita Ho, BA, BComm, MA, MMus, PhD; Harriet Richardson; Kim Chi, MD; Karen Gelmon, MD

Problem Statement: Cancer clinical trials (CTs) are critical for validating novel therapeutics, informing practice, and improving outcomes. While an extensive body of research has described patient attitudes towards and barriers to participation in CTs, this literature has been primarily survey-based and driven by investigator-developed concepts informed by traditional notions of autonomy. This research has been limited in its understanding of patients’ perspectives of the CT decision-making process and the sociopolitical context in which these decisions are made. The purpose of this qualitative study was to explore cancer patients’ decision-making processes about CT participation through the lens of “relational autonomy.” Methods: Forty patients, including 20 breast and 20 prostate cancer patients, and 10 support persons were recruited. Semi-structured interviews were conducted to provide insight into the relational nature of the decision-making process and the best practices that support relational autonomy. Purposive sampling facilitated the selection of participants who accepted, declined, and withdrew from CTs. A grounded theory approach guided data collection and analysis. In addition, the theoretical lens of relational autonomy was applied to the analysis to explore the

ethical dimensions of CT decision making from the patients’ perspective. Results: The theory “no man is an island” captures the relational complexity of cancer patients’ CT decision-making process. While patients perceived their CT decisions to be independent and fully informed, subtle or overt sociopolitical influences and gaps in understanding related to the purpose of CTs were identified. Maintaining the physicianpatient relationship, managing social responsibilities, responding to disease stage, and grappling with doing what is right for oneself versus the moral obligation to further science all impacted patients’ decision making and experience of autonomy. Socioeconomic factors (i.e., literacy, income, availability of CTs, and access to health care) further enhanced or undermined patients’ autonomy in CT decisions. Conclusions: Multiple relational factors influence cancer patients’ decision-making experience about CT participation. These findings highlight the need for more targeted interventions as part of CT accrual procedures, such as decisional support for patients and families, and education for CT personnel in acknowledging the relational nature of CT decisions. Improvements to CT infrastructure are required to better support patients and their families in navigating CT decisions and ensuring CTs are accessible to all eligible patients, including those from marginalized populations. Limitations: As this study was confined to one urban cancer center and used purposive sampling the findings are not generalizable to the broader cancer population. Quantitative studies are required to determine whether these decision-making experiences are present in other populations.

Strategies for Helping Researchers Do the Unthinkable: Destroy Their Data

Abt Associates Inc. Authors: Teresa Doksum, PhD, MPH; Sean Owen, CISSP, CAP Problem Statement: Researchers are trained to collect, not destroy, data. Many have been coveting their data for decades, but during this time period, many state and federal laws have

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been passed that require destruction of personally identifiable information (PII) or protected health information (PHI). In addition, data providers began to increasingly require that researchers sign data use agreements with strict destruction requirements not understood by researchers. Institutional review boards (IRBs) focus more effort on reviewing the study protocol before implementation, and less effort helping researchers destroy data once the study is over and publications have been accepted years later. Electronic data is easily spread to multiple study partners and portable devices/servers and thus is more challenging to find and destroy. This poster focuses on “Project Cleanup,” a comprehensive, innovative yearlong initiative designed to improve compliance with destruction requirements for PII/PHI.

Suggestions for Future Use: Our institution is working to fully integrate this program into all department procedures and to train researchers to anticipate and prepare for data destruction when planning the initial stages of a study. We are also developing systems to identify all projects that do not require review by the IRB but might have PII/PHI to ensure compliance with destruction requirements. Other institutions can adapt our strategies to help improve researcher knowledge and acceptance of destruction requirements.

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posters

Program Description: Our IRB conducted an internal audit to identify the extent to which researchers were in compliance with data destruction requirements and then developed a comprehensive information risk management program to address the recommendations of the auditors. Project Cleanup required an interdisciplinary team including representatives from the IRB, information technology, information security, contract operations, compliance, and researchers. This team developed and implemented a program to 1) improve researcher

awareness and understanding of destruction requirements, and 2) find and destroy all forms of PII/PHI that required destruction (i.e. paper, media, electronic on server, in storage). Innovative methods used included 1) educating researchers, administrative staff, and company leadership via trainings, briefings, posters, emails, 2) developing a data use agreement tracking system, 3) one-onone study consults, 4) “room service” shredding pickups, and 5) door-to-door physical office, closet, and hall checks. Evaluation measures included staff awareness and attitudes, numbers of staff trained, data use agreements identified and closed out, project consults, paper/media shredded, and PII/PHI records destroyed.


Posters Selected for Moderated Discussion

posters

During the Moderated Poster Discussions, a select group of authors will briefly present their projects for discussion with attendees during the reception on December 5, from 3:45 to 5:00 PM. Sixteen posters organized into four topic areas will be presented; each discussion will be moderated by a member of the Poster Abstract Sub-Committee. BIOBANKING

CENTRAL IRB REVIEW

87. Access to Human Biological Materials in Collaborative Research with Developed Countries Conducted in South Africa: A Case Study

91. Local IRB Chairmen’s Perceptions Regarding the Use of Central IRBs

Nelson R. Mandela School of Medicine, University of KwaZulu-Natal Mahomed Aslam Sathar, BSc, BA, MMed Sci, MSc Med, PhD; Stephan Van der Linde, MSc; Ames Dhai, MB ChB, FCOG, LLM

88. Biorepository “Structural Engineering”—Development of the Office of Biorepository Regulatory Support at MD Anderson Cancer Center MD Anderson Cancer Center Nicole Sieffert, CCRC; Ty Hoover, MD, JD

89. Current Cognition about Biobanks in Japan

Tokyo Medical and Dental University Yuka Ozasa RN, PhD; Miwa Suzuki; Naoko Nii, BN; Masumi Ai, MD; Eiichiro Kanda; Masayuki Yoshida, MD

90. Enhancing Regulatory Compliance in a Large Scale Genomic Research Institute

Baptist Health Kathleen A. Seabolt, CIM

92. Reduction in Risk of Harm by Local IRB Review of Centrally IRB-Approved Multicenter Clinical Trials

Northwestern University Debra G. Tice, BS, CIP, CCRC; Paul Haschke, BS; Steven M. Belknap, MD, FACP, FCP; Kelly Carroll, PhD; Heather J. Gipson, JD, MA, CIM; Dennis P. West, PhD, FCCP, CIP

93. Use of Central Institutional Review Boards for Multicenter Clinical Trials

Duke University Kathryn Flynn, PhD; Cynthia Hahn, CIP; Devon Check; Judith Kramer, MD, MS; Carrie Dombeck; Lawrence Muhlbaier, PhD; Jane Perlmutter; Kevin Weinfurt, PhD

94. Use of a Central IRB—The Limitations of Managing Multiple Models Yale University Jan Hewett, BSN, RN, JD; Jean H. Larson, MBA

Broad Institute Andrea Saltzman, RN, CIP; Stacey Donnelly, MPA; Sue Flynn, BSN; Emily Lipscomb, BA

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COMMUNITY ENGAGEMENT

INFORMED CONSENT

95. A Nationally Implementable, Locally Deliverable Research Ethics Training Workshop for Community-Based Collaborators

99. Consenting Adults: An Innovative Informed Consent Workshop

Saint Louis University Stephanie R. Solomon, PhD; Patricia PiechowskiWhitney, MPH, MSW, MA; Brenda Eaken, MS; Rosalind Kirk, PhD; Ellen Champagne, BA; Kim Mayes; Nick Steneck, PhD

96. Balancing Compliance with Community Engagement: A Model of Engaged Ethics to Protect Vulnerable Participants from Exploitation

Kaiser Permenente Southern California Armida Ayala, PhD; Yvonne Hung, PhD; Isabel M. Sanchez

West African Bioethics Training Program John-Moses Uwanduoma Maduabuchi, BMLS, MBBS, MSc; Clement Adebamowo, BM ChB Hons, FWACS, FACS, ScD

98. Public Awareness and Perceptions of Clinical Trials Questionnaire: A Pilot Study in Central-West India

100. Framing Research Risk to Support the Decision to Participate Public Health Ontario Nancy Ondrusek, PhD; Philip Hebert, MD, PhD, FCFPC; Ross Upshur, MA, MD, MSc; Ronald J. Heslegrave, PhD; James V. Lavery, PhD

101. Lessons Learned: When Your Policy Says Too Much: Informed Consent Audit Results Summa Health System Christy Wise, BA; Jessica Conrad, MS, CIP

102. Measuring Autonomy in a Doubly Vulnerable Population: The Coercion Assessment Scale

Treatment Research Institute Karen L. Dugosh, PhD; David S. Festinger, PhD; Douglas B. Marlowe, JD, PhD

Deenanath Mangeshkar Hospital and Research Centre Veena Joshi; Gauri Oak; Aditi Kulkarni; Varada Biwalkar

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posters

97. Concepts of Community Harms in Genomics Research in Developing Countries: A Pilot Study in Oyo State, Nigeria

Beth Israel Deaconess Medical Center Kaarkuzhali B. Krishnamurthy, MD; Margo Coletti, MLS; Stephen O’Neill, LICSW, BCD, JD; Daniel DeHainaut; Angela Lavoie, RN; Nancy J. Brown, RN; Michael D’Egidio; Ediss Gandelman; Shari Gold-Gomez


Faculty List Emily Anderson, PhD, MPH

Donald Berry, PhD

Jeremy Block, MPP, PhD

Melissa Abraham, MS, PhD

Assistant Professor

Head, Division of

Postdoctoral Associate

Chairperson, Partners Human

of Bioethics

Quantitative Sciences

Center for Advanced

Research Committee;

Loyola University Chicago

M.D. Anderson Cancer Center

Biotechnology and Medicine

Assistant Clinical Professor

Session: C21

Session: Panel II

Rutgers University

Jaime Arango, EdD, CIP

Laura M. Beskow, PhD, MPH

A

Session: A17, D5

Harvard Medical School Session: C13

Assistant Director of Education,

Assistant Research Professor

Valerie Bonham, JD

Wilma Acosta, RN, BS, CHC

Human Subjects Protection

Duke Institute for Genome

Senior Attorney, Office of the

Manager, Health Sciences,

Program, CITI Program/

Sciences and Policy

General Counsel,

Governance and Regulatory Risk

University of Miami

Session: Panel IX

Public Health Division,

Deloitte & Touche

Sessions: D18

National Institutes of Health Anant Bhan, MBBS, MHSc

Session: C25

Bioethicist

Jeanne Adler, RN, MPH,

DVM, PhD

Sandra Rotman Centre

David Borasky, MPH, CIP

CCRP

Director, Office for Protection

Session: LRC

Deputy Director, Office of

Head, CIRB Strategy

of Research Subjects

and Operations;

University of California

Robert Bienkowski, PhD

University of North Carolina

Nurse Consultant, Division of

at Berkeley

Executive Director

at Chapel Hill

Cancer Treatment & Diagnosis

Session: D9

Baptist Clinical

Session: Panel III, LRC, E11

National Cancer Institute Session: A18

Human Research Ethics

Research Institute B

Session: D25, E25

Cornelius Baker

faculty

Session: E20

Rebecca Armstrong,

Kristina Borror, PhD Director, Division of

Philip Alberti, PhD

Senior Communications Advisor

Barbara Bierer, MD

Compliance Oversight

Senior Director, Health Equity

FHI 360 Center on AIDS and

Senior Vice President for

Office for Human

Research and Policy

Community Health

Research, Brigham and

Research Protections

Association of American

Senior Policy Advisor,

Women’s Hospital;

Session: A2, D22, E14

Medical Colleges

National Black Gay Men

Professor of Medicine,

Session: B7

Session: C27

Harvard Medical School

Jeffrey Botkin, MD, MPH

Session: Panel I, E1

Associate Vice President

Albert J. Allen, MD, PhD

Elizabeth Bankert, MA

Senior Medical Fellow,

Assistant Provost

Judith Birk, JD

University of Utah

Bioethics and Pediatric

Dartmouth College

Director, IRB-Health and

Session: Great Debate, E10

Capabilities

Session: B5

Behavioral Sciences

Eli Lilly and Company Session: LRC, Panel XI, D14

Jennifer Bell, MA

for Research Integrity

University of Michigan

Lois Brako, PhD

Session: D20

Assistant Vice President

PhD Candidate

for Research

Eric Allen, CIP, CPIA

University of British Columbia

Marianna J. Bledsoe, MA

University of Michigan

Associate Director of

Session: Panel III

Senior Program Manager,

Session: A20, B20

Consulting Services

Biorepository and Tissue

HRP Consulting Group, Inc.

Mark Barnes, JD, LLM

Banking, Biomedical

Adriana Brigatti, JD,

Session: A25, B25, E23

Partner

Laboratory R&D Service, Office

MPH, LLM, CIP

Ropes & Gray LLP

of Research & Development

Director, Research Regulatory

Session: B10, D10

Department of Veterans Affairs

Affairs, Children’s National

Session: A16, C16

Medical Center

Ofer Amit, MSEM, CHRC Research Compliance Administrator

Robert H. Bartlett, MD

Baptist Health South Florida

Professor of Surgery, Emeritus

Session: C25

University of Michigan Session: Plenary Address, Dec 4

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

Session: D6


Robert Brooks, MD,

Charlotte Coley, MACT, CIP

Susan Delano, CIP

Teresa Doksum, MPH, PhD

PhD, MBA

Director, IRB Educational

Deputy Managing Director

IRB Chair

Associate Director

Programs, Duke University

Research Foundation for

Abt Associates, Inc.

Office of Research Oversight

Medical Center

Mental Hygiene, Inc.

Session: E21, Panel III

Department of Veterans Affairs

Session: A6, D12, GF1

Session: D17

Yali Cong, PhD

Pierre Deschamps, BCL,

Member, Vermont House

Elizabeth Buchanan, PhD

Professor of Medical Ethics

LScR, Esq.

of Representatives;

Endowed Chair in Ethics;

Peking University Health

Lawyer

Editor, Counterpoint

Director, Center for

Science Center

McGill University

Session: Panel VII

Applied Ethics

People’s Republic of China

Session: A23

University of Wisconsin-Stout

Session: E11

Anne B. Donahue, JD

Session: C1

Janet Donnelly, RAC, CIP Fran DiMario, MD

Policy Analyst

Jeffrey Cooper, MD, MMM

Associate Chair, Dept. of

Food and Drug Administration

Vice President for

Pediatrics; IRB Chair; Medical

Session: C26

Alexander Capron, LLB

Global Consulting

Director HRPP

University Professor;

Copernicus Group IRB, Inc.

Connecticut Children’s

Kelly Dornin-Koss,

Vice Dean for Faculty and

Session: A9, B12

Medical Center

MPPM, RN, CIP

Session: D3

Director, Education and

Session: C21, E1 C

Academic Affairs; Scott H. Bice Chair in Healthcare Law,

Karena Cooper, JD, MSW

Policy, and Ethics; Co-Director,

Regulatory Counsel

David Dittrich

Subject Research

Pacific Center for Health

Food and Drug Administration

Security Engineer;

University of Pittsburgh

Policy and Ethics, University of

Session: A6, B1

Research Scientist;

Session: A19

Southern California Session: Panel I, Panel VI

Compliance Office for Human

IRB Committee Member Kellina Craig-Henderson,

University of Washington

Christine Drabick, MS

PhD

Session: B18

Consumer Safety Officer

Michael P. Caligiuri, PhD

Deputy Division Director;

Professor-in-Residence

Human Subjects

Lisa Dixon, MD, MPH

Department of Psychiatry

Protections Officer

Professor of Psychiatry,

University of California, San Diego

National Science Foundation

Columbia University;

James DuBois, PhD, DSc

Session: Panel VII

Session: D1

Director, Center for Practice

Director

Innovations, New York State

Center for Health Care Ethics

Food and Drug Administration Session: C8, E6

Gary Cseko, MSPH, MBA

Psychiatric Institute

Saint Louis University

Assistant Chief R&D Officer;

Administrator

Session: Panel VII

Session: C22

Director, PRIDE

Research Operations

Department of Veterans Affairs

Mayo Clinic

Sharron Docherty, PhD,

Claire Dunne, PhD, CIP

Session: C1

Session: B3, C5

CPNP (AC/PC)

IRB Coordinator

Associate Professor, School of

University of Colorado

Nursing; Associate Professor,

at Boulder Session: D23

Gary Chadwick, PharmD,

D

MPH, CIP

Liza Dawson, PhD

Department of Pediatrics, Duke

Associate Provost

Team Leader

University Medical School

University of Rochester

NIH/NIAID Division of AIDS

Session: E16

Session: E3

Session: A11 Anastasia Doherty, CIP

Executive Director

Jeffrey Cohen, PhD, CIP

Bertha deLanda, CIP

Senior IRB Manager

Johnson Center

Chief Executive Officer

IRB/SCRO Panel Manager

Stanford University

Grand Valley State University

HRP Consulting Group

Stanford University

Session: A3

Session: B4

Session: D17, E13

Session: B19

E

James Edwards, PhD

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

Lynn Cates, MD


Faculty List Susan Ellenberg, PhD

Michelle Feige, MSW,

Sharon Freitag

Bruce Gordon, MD

Professor of Biostatistics, and

LCSW-C

Director, Research Ethics Office

Executive Chairman, IRB;

Associate Dean for Clinical

Public Health Analyst

St. Michael’s Hospital

Professor of Pediatrics

Research, Perelman School

Office for Human Research

Session: B23

University of Nebraska Med

of Medicine, University of

Protections

Pennsylvania

Session: A23, B25, E26

Session: D6

Medical Center Melissa Frumin, MD, MS

James Feldman, MD, MPH

Partners HealthCare System

Valery Gordon, PhD, MPH

Terry Elliott, CIP

Research Director, Department

Session: E20

Acting Director,

IRB Co-Chair

of Emergency Medicine

Program for Appropriate

Boston University Medical Center

Technology in Health

Session: Panel VIII

Session: D11

Clinical Research Policy G

Dean Gallant

Office of Science Policy, NIH Session: A1

Assistant Dean for Research Robert Ferguson, Sr,

Policy and Administration

Julia Gayle Gorey, JD

Elizabeth Ellis, PhD

MA, CPM

Harvard University

Public Health Analyst

ORISE Associate Director

Unaffiliated/Non-Scientist

Session: Panel V, C23, E1

Office for Human Research

& IRB Chair

IRB Member

Department of Energy

Meridian Health System

George Gasparis, CIP

Session: D2

Session: C26

Executive Director, Human Subjects Protection Program

Maria Adela Grando, PhD

Carter Epstein, PhD

Dianne Ferris, MS, CIP

Columbia University

Postdoctoral Researcher

Scientist

Human Research Analyst

Medical Center

University of California San Diego

ABT Associates, Inc.

Dartmouth College

Session: A22, E4

Session: Panel III

Session: E21

Session: B5

Melissa Epstein, PhD, CIP

David Festinger, PhD

CEO, Healing Our Village, Inc;

Karen Hale, RPh, MPH, CIP

IRB Administrator

Director

Clinical Professor of Medicine

Director, Office of Responsible

Albert Einstein College of

Section on Law & Ethics

Emory University

Research Practices

Medicine, Yeshiva University

Treatment Research Institute

School of Medicine

Ohio State University

Session: E13, GF7

Session: Panel III

Session: Keynote, Dec 5

Session: D13, E12

Stanley Estime, MSCI, CIP

Susan Fish, PharmD, MPH

Richard Gilbert, PhD

Amanda Hammond, JD

QA/QI Specialist,

Director, MA in Clinical

Professor of Psychology

Deputy Director, Office for

Quality Improvement Program

Investigation; Professor

Loyola Marymount University

Human Research Studies

Office of Regulatory Affairs and

Boston University

Session: Panel V

Dana-Farber Cancer Institute

Research Compliance

School of Public Health

Harvard School of Public Health

Session: Panel III, A5, B26, D26

Protections

James Gavin, III, MD, PhD

faculty

Sessions: A6, D5

IRB Chair

Sessions: A12, C12, E12

H

Session: E6 Sara Goldkind, MD, MA Senior Bioethicist, Office of

Karen Hansen

David Forster, JD, MA, CIP

Good Clinical Practices

Director

Chief Compliance Officer

Food and Drug Administration

Institutional Review Office

Owen Faris, PhD

Western Institutional Review Board

Session: A7, C12, D4

Fred Hutchinson Cancer

Deputy Director

Session: B3

Session: C19 F

Research Center Jacquelyn Goldberg, JD

Division of Cardiovascular

Session: D12

Devices

Megan Frame

Head, Central IRB Initiative

Center for Devices and

Membership Coordinator

National Cancer Institute

Erica Heath, MBA, CIP

Radiological Health

PRIM&R

Session: A1

Director

Food and Drug Administration

Session: GF2

Session: C8

E&I Review Services Cynthia Gómez, PhD Director, Health Equity Institute San Francisco State University Session: B24, Panel X

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

Session: D8


Lynn Henley, MS, MBA

Ty Hoover, MD, JD

Public Health Analyst

Director, Biorepository

Michael Kalichman, PhD

Canada Research Chair in

Food and Drug Administration

Regulatory Support

Director, Research Ethics

Ethics, Law, and Technology

Session A8

M.D. Anderson Cancer Center

Program, University of California,

University of Ottawa

Session: A16

San Diego

Session: Panel V

Kimberly Hensle Lowrance,

Ian Kerr, LLB, PhD

K

Session: B22

EdM, PHR

Korin Hudson, MD

Managing Director

GERMS Director;

Julie Kaneshiro, MA

Chair, Department of

PRIM&R

EMS Rotation Coordinator

Policy Team Leader

Quantitative Health Sciences,

Session: GF2

Georgetown University

Office for Human Research

University of Massachusetts

Session: D4

Protections

Medical School

Session: A2, B12, C16, GF1

Session: Panel VIII

Jan L. Hewett, JD Director, Human Research

Catarina Kiefe, MD, PhD

I

Protection Program

John P.A. Ioannidis,

Nancy Kass, ScD

Paula Kim

Yale University

MD, PhD

Phoebe R. Berman Professor

President, CEO

Session: E5

Professor of Medicine;

of Bioethics and Public Health

Translating Research Across

C.F. Rehnborg Professor

Bloomberg School of Public

Communities

Lorna Hicks, MS, CIP

in Disease Prevention; and

Health, The Johns

Session: A16

Director, Program for the

Director, Stanford Prevention

Hopkins University

Protection of Human Subjects

Research Center, Stanford

Session: Panel X

in Non-Medical Research

University School of Medicine

Duke University

Session: Keynote, Dec 4

Jenny Kiratli, PhD Director, Clinical Research

Moira Keane, MA, CIP

Spinal Cord Injury Center

Retired: Executive Director

VA-Palo Alto Health

Andre Ivanoff, PhD

Human Research

Care System

Yvonne Higgins, CIP

Professor

Protection Program

Session: A17

Director, Quality Management

Columbia University

University of Minnesota

Copernicus Group IRB

Session: B17

Session: B20, D7, E3

Session: C23

Session: D12, GF1

Sarah Kiskaddon, JD, CIP Director of

J

Erin Kenneally, MFS, JD

Business Development,

J. Milburn Jessup, MD

Founder and CEO, Elchemy;

Communications, and Public

BSN, CIP

Chief

The Cooperative Association

Relations, AAHRPP

Director

Diagnostics Evaluation Branch

for Internet Data Analysis,

Session: C3

IRB for Health Sciences

National Cancer Institute

University of California,

Research, University of Virginia

Session: E8

San Diego

Richard Klein

Session: B18

HIV/AIDS Program Director

Session: E26 Steven Joffe, MD, MPH

Office of Special Health Issues

Elizabeth Hohmann, MD

Ethicist;

Cassandra Kennedy

Food and Drug Administration

Chair and Physician Director

Associate Professor of Pediatrics,

Senior Vice President,

Session: A8

Partners HealthCare

Harvard Medical School,

Global Quality Assurance

Massachusetts General

Dana-Farber Cancer Institute

Quintiles Transnational Corp.

Joseph Konstan, PhD

Hospital and Brigham and

and Boston Childrenâ&#x20AC;&#x2122;s Hospital

Session: LRC

Distinguished McKnight

Womenâ&#x20AC;&#x2122;s Hospital

Session: B9

University Professor of Cynthia Kern, RN,

Computer Science

Joy Jurnack, RN, CIP

CCRC, CIP

and Engineering

Diana Holt, MS, CIP

Education and Training

Assistant Director, Office for

University of Minnesota

Senior Administrative Analyst,

Manager, New York University

Investigator-Sponsored IND

Session: B23

Office for the Protection of

School of Medicine

and IDE Support, University

Human Subjects, University of

Session: E9

of Pittsburgh

Session: C13, D15

California Berkeley

Session: E19

Session: D21

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

Susie Hoffman, RN,


Faculty List Susan Kornetsky, MPH

Melody Lin, PhD

Director

Deputy Director

Clinical Research Compliance

Office for Human Research

Diane Maloney, JD

We Can Pediatric Brain

Boston Children’s Hospital

Protections

Associate Director for Policy

Tumor Network

Session: Great Debate, C7

Session: C4

Food and Drug Administration

Session: C26, GF6

Session: GF7

Gigi McMillan, BA Subject Advocate; Founder,

Session: B1 L

Lindsay McNair, MD, MPH

Scott Lipkin, DPM, CIP

Lester (Jao) Lacorte,

Chief, Network Office of

Barry Mangum, PharmD

Principal Consultant

MD, CCRP

Research and Innovation

Associate Professor of

Equipoise Consulting, LLC

Medical Officer

Lehigh Valley Health Network

Clinical Pharmacology;

Session: A5, B26

Food and Drug Administration

Session: A10, D3

Assistant Clinical Professor

Session: B8 Nicole Lockhart, PhD

Duke University Medical Center

William Meurer, MD, MS

Session: Panel XI

Assistant Professor

Lisa Leiden, PhD, CIP

Program Manager

Senior Director of

National Cancer Institute

Elizabeth Mansfield, PhD

Research Administration

Session: C18

Director Personalized Medicine Staff

Susan Miller, MD, MPH

Food and Drug Administration

Associate Professor

Senior Advisor

Session: E8

Weill Medical College

Elizabeth LeQuesne, MD

Presidential Commission for

Associate Director

the Study of Bioethical Issues

Greg E. Manship, MDiv,

The Methodist Hospital

General Clinical Research

Session: C2

MT(ASCP), CIP, CIM

Session: C24

Unit, New York State

Cornell University;

IRB Coordinator

Psychiatric Institute

Holly Fernandez Lynch,

University of Indianapolis

Meredith Minkler,

Session: C17

JD, MBioethics

Session: D24

DrPh, MPH Professor of Health and

Executive Director Joanne Less, PhD

Petrie-Flom Center for Health

Patricia Marshall, PhD

Social Behavior, University of

Director

Law Policy, Biotechnology and

Professor of Bioethics

California, Berkeley

Office of Good Clinical Practice

Bioethics, Harvard Law School

Case Western Reserve

Session: Panel V, B4

Food and Drug Administration

Session: Panel VI

University School of Medicine

Session: A8, B1

Session: Panel IV

Karen Moe, PhD Director

M

faculty

Session: Panel II

Paul Lombardo, JD, PhD

Seton Family of Hospitals Session: E15

University of Michigan

Robert Levine, MD

Patricia MacCubbin, MS

Susan McAndrew, JD

Human Subjects Division

Professor of Medicine;

President and CEO

Office for Civil Rights

University of Washington

Lecturer in Pharmacology

Research Ethics Group

United States Department of

Session: Panel XII, C15

Yale University

Session: C24

Health and Human Services

Session: A7, C12, Panel XI

Session: A15, D15 Kathleen MacQueen,

Lindsay Motz Manager, DOE Human

Roger Lewis, MD, PhD

PhD, MPH

Newell McElwee,

Subjects Research Database

Professor of Emergency

Senior Social Scientist

PharmD, MSPH

Department of Energy

Medicine; Vice Chair,

Behavioral and Social

Executive Director of U.S.

Session: D2

Academic Affairs, David Geffen

Sciences, Family

Outcomes Research

School of Medicine, UCLA

Health International

Merck Co., Inc.

Lisa Murtha, Esq., CHC

Session: Panel II

Session: C11, D11

Session: A4

Partner

Gregorio Lim, CIP

Eric Mah, MHS, CIP

Harry McGee, MPH

HSPP Administrator

Senior Director of

IRB Chair

The Boeing Company

Research Compliance

Michigan State University

Session: D18

University of California,

Session: B4

SNR Dentnon US LLP

San Francisco

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e

Session: C10, E10


N

P. Pearl O’Rourke, MD

Ivor Pritchard, PhD

P

Daniel Nelson, MSc, CIP

Director, Human Research Affairs

Dina Paltoo, PhD, MPH

Senior Advisor to the Director

Director, Office of Human

Partners Healthcare System, Inc.

Director, Genetics, Health, and

Office for Human Research

Research Ethics; Professor,

Session: B16, Panel IX,

Society Program

Protections

Social Medicine and Pediatrics

Panel XI

Office of Science Policy, NIH

Session: Panel I, A10, Panel

Session: A1

IV, C20, E4

University of North Carolina at Chapel Hill

Laura Odwazny, JD, MA

Session: C5, Panel XII

Senior Attorney

Helen Panageas, CIP

Kevin Prohaska, DO, MPH

Office of the General Consel, HHS

Associate Director, IRB

Division Director,

Session: A20, C21, D21

NYU Lagone Medical Center

Division of Safety Compliance

Session: A13

Food and Drug Administration

Robert “Skip” Nelson, MD, PhD Pediatric Ethicist

Nancy Olson, JD

Office of Pediatric Therapeutics

IRB Director

Efthimios Parasidis,

Food and Drug Administration

University of Mississippi

MBE, JD

Session: C7

Session: C20

Assistant Professor of Law

Edward Quigley, PhD,

Monica Neuman, JD

Session: B1, D14 Q

Saint Louis University

MBA

Associate

Nancy Ondrusek, MSc, PhD

School of Law

Research Administration

McDermott Will & Emery

Project Coordinator,

Session: Panel XII

Officer, Rady Children’s

Session: E15

Ethics Support Services

Eunice Yim Newbert, MPH

Hospital, University of

Public Health Ontario

Mitchell Parrish, JD

California, San Diego School

Session: C4

Regulatory Attorney

of Medicine

Quorum Review IRB

Session: Panel IX

Manager, Education and Quality Improvement Program

John Ordaz

Boston Children’s Hospital

National Nuclear Security

Session: E19

Administration Human Subjects

Heather Pierce, JD, MPH

Joan Rachlin, JD, MPH

Session: A7 R

Protection Program Manager,

Senior Director, Science Policy

Executive Director

Linda Nielsen, JD

Department of Energy

and Regulatory Counsel

PRIM&R

Vice President, European

Session: D2

Association of American

Session: GF6

Group on Ethics in Science

Medical Colleges

and New Technologies;

Argelis Ortiz, MSW, ACSW

Professor of Global Law and

IRB Member, University of

Governance, University

Southern California

Elizabeth Pike, JD, LLM

Professor of Philosophy

of Copenhagen

Session: A26

Former Post-Doctoral Fellow

Georgetown University

NIH Department of Bioethics

Session: Panel IV

Mary Ott, MD, MA

Henry S. Richardson, PhD, JD, MPP

Session: Panel XII

Rachel Nosowsky, JD

Associate Professor of

Acting Deputy General

Pediatrics, Indiana University

Jody Power, MS, MBA

PhD, Med

Counsel, University of

School of Medicine

Executive Director, DUHS IRB

Assistant Director, Community

California

Session: E17

Duke University Health System

Health Programs & Research

Session: E9

University of Virginia

Session: Panel X, B15

Jeanita Richardson,

Sean Owen, CISSP, CAP,

Session: A11, Panel IV

CRISC

Ernest Prentice, PhD

Kelley O’Donoghue,

Director

Associate Vice Chancellor

David Rickaby, PhD

MPH, CIP

Client Cybersecurity Center

University of Nebraska

Research Compliance Officer

Executive Director, IRB

Abt. Associates Inc.

Medical Center

Office of the Director

University of Rochester

Session: E21

Session: C10

Clement J. Zablocki VA

O

Session: B13, D18

Medical Center Session: D19

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

Session: LRC

Session: B7, D10


Faculty List James Riddle, MCSE,

Michele Russell-Einhorn, JD

Robyn Shapiro, JD

Ryan Spellecy, PhD

CNE, CIP

Senior Director, Office for

Partner, Health Law

Assistant Professor

Assistant Director

Human Research Studies

Drinker Biddle & Reath LLP

Medical College of Wisconsin

Institutional Review Office

Dana-Farber Cancer Institute

Session: B10

Session: D4

Fred Hutchinson Cancer

Session: Panel II, A16, E5 Cindy Shindledecker

Sujatha Sridhar, MBBS, CIP

Director

Director

Raphael Saginur, MD

Health Sciences and

Clinical Trials Resource Center

Suzanne Rivera, PhD, MSW

Chairman, Ottawa Hospital

Behavioral Sciences IRB

University of Texas Health

Associate Vice President

Research Ethics Board

University of Michigan

Science Center at Houston

for Research, Case Western

The Ottawa Hospital

Session: A20

Medical School

Reserve University

Session: C4

Research Center Session: B13

S

Shirley Roach, MSHS,

Elyn R. Saks, JD, PhD

Program Director, Biorepository

Maria Stagnitto, RN, MSN

RN, CCRP

Professor of Law, Psychiatry,

Regulatory Support

Extramural Human Research

Project Manager, Regulated

and Behavioral Sciences

M.D. Anderson Cancer Center

Protection Officer

Activities and Facilitated

University of Southern

Session: A16, C16

Office of Extramural

Training, Allied Technologies

California Law School

& Consulting

Session: Pillars of PRIM&R

Jerome Singh, LLB, LLM,

Session: C6

Lecture, Dec 6

PhD, MHSC Professor, University of

Barbara Stanley, PhD

Jeffery Rodamar

John Santelli, MD, MPH

KwaZulu-Natal South Africa

Director, Suicide Intervention

Protection of Human

Professor and Chair,

Session: A11

Center, New York State

Subjects Coordinator

Department of Population and

US Department of Education

Family Health

Nicholas Slack, MBE

Session: D23, E2

Mailman School of Public

Vice President of Consulting

Health, Columbia University

and Business Development

Laura Stark, PhD

Session: E17, A21

Western IRB

Assistant Professor

Session: B14

Vanderbilt University

Laura Lyman Rodriguez, PhD Director, Division of Policy,

faculty

Session: A3 Nicole Sieffert, BA, CCRC

Session: A13

Research, NIH Session: A1

Psychiatric Institute Session: E18

Communications, and

Cheryl Savini, CIP

Education, National Human

Principal, COO

Elizabeth Small, MPH, CIP

Genome Research Institute

HRP Consulting Group, Inc.

Administrative Director, IRB

Susan Stayn, JD

Session: B16, E16

Session: A12

New York State

Senior University Counsel

Psychiatric Institute

Stanford University

Session: E18

Session: A15

Session: B24

Susan L. Rose, PhD

James Saviola, OD,

Executive Director, Office

CAPT, USPHS

for Protection of Research

Director, Division of

Lynn Smith, JD, CIP

Michelle Stickler, DEd, CIP

Subjects, University of

Bioresearch Monitoring

Manager

Executive Director

Southern California

Food and Drug Administration

Huron Consulting Group

Office of Research Subjects

Session: A26, D20

Session: B1, D8

Session: D25

Protection, Virginia

Susan F. Rudy, MSN,

Ada Sue Selwitz, MA

Lauren Solberg, JD, MTS

CRNP, CORLN

Director

Assistant Vice President of

Health Scientist and Family

Office of Research Integrity;

Human Subjects Protection

Irene Stith-Coleman, PhD

Nurse Practitioner, Center

Adjunct Associate Professor,

and Research Integrity

Director

for Tobacco Products/Office

University of Kentucky

Meharry Medical College

Division of Policy and Assurances

of Science, Food and Drug

Session: A23, B12

Session: Panel X, B21

Office for Human Research

Commonwealth University Session: B6

Administration

Protections

Session: B8

Session: A2, B20, C23, D16, GF1

p ri m & râ&#x20AC;&#x2122; s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Walter Straus, MD, MPH

Erica Tauriello, CIP

Glenn Veit, JD, CIP

Carol Weil, JD

Global Director for Scientific

Manager

IRB Chair

Senior Advisor for

Affairs-Vaccines

Human Research Program

Copernicus Group IRB

Ethical and Regulatory Affairs,

Merck & Co., Inc.

Wentworth Douglas Hospital

Session: D14

Office of Biorepositories and

Session: A4, B14

Session: A25

Biopecimen Research Malia Villegas, EdD

National Cancer Institute Session: C18, D16

David Strauss, MD

Marc Teitelbaum, MD, MS

Director, National Congress of

Deputy Director for Research,

Medical Monitor

American Indians Policy

New York State Psychiatric

SAIC Frederick, Inc.

Research Center

Alan Wertheimer, PhD

Institute; Associate Clinical

Session: C9

Session: E24

Senior Research Scholar,

Columbia University

Steven Teutsch, MD, MPH

Wendy Visscher, PhD, CIP

National Institutes of Health

Session: Panel VII, C17

Chief Science Officer, Los

Senior Advisor and Privacy

Session: Panel VI, B17, E7

Angeles County Public Health

Officer, Office of Research

Session: A4

Protection, RTI International

Elizabeth White, MBA,

Session: B18

MPH, CIP

Professor of Psychiatry,

Jeremy Sugarman, MD,

Department of Bioethics

MPH, MA Harvey M. Meyerhoff Professor

Mya Thomae, RAC, CQA

of Bioethics and Medicine

CEO and Founder

Berman Institute of Bioethics

Myraqa, Inc.

Steven Wakefield

and Department of Medicine

Session: E8

Director of External Relations

The Johns Hopkins University Session: Panel I, D4

Hugh Tilson, MD, MPH, DrPH

Program Manager US Department of Energy

W

Session: A26, D2

HIV Vaccine Trials Network

Sarah White, MPH, CIP

Session: B11

Director, Human Research

Adjunct Professor and Senior

Quality Improvement Program

Elyse Summers, JD

Advisor, University of North

Jacqueline Wall, PhD,

Partners HealthCare

Director, Division of Education

Carolina at Chapel Hill

HSPP, CRC

Session: A19

and Development

School of Public Health

Associate Professor and

Office for Human Research

Session: A4

Director of Undergraduate

Donald Willison, ScD

Programs, University

Senior Scientist, Surveillance

Sandra Titus, PhD

of Indianapolis

and Epidemiology Division

Director, Intramural Research

Session: D24

Public Health Ontario

Protections Session: A2, D13, E22, GF5 Latanya Sweeney, PhD

Office of Research Integrity

Professor of Government &

Session: E22

Session: C4 Amelia Warner, Susan Wolf, JD

Jean Toth-Allen, PhD

Head, Clinical

McKnight Presidential Chair

Session: Great Debate, B21

Biophysicist

Pharmacogenomics

in Law, Medicine and Public

Food and Drug Administration

and Clinical Specimen

Policy, University of Minnesota

Session: A12, B12, GF1

Management, Merck Research

Session: Panel IX

T

Michael Cheng-tek Tai, PhD Head, Division of General

Laboratories, Merck & Co., Inc. V

Session: A14, C14

David Wright, PhD

Education; Professor

Terry VandenBosch, PhD,

of Bioethics & Medical

RN, CIP, CCRP

David A. Wallach, CIP

Office of Research Integrity

Humanities, Chungshan

Senior Research Compliance

Director, Einstein IRB

Session: D22

Medical University, Taiwan

Associate, University of

Albert Einstein

Session: D24

Michigan; Adjunct Associate

College of Medicine

David Wynes, PhD

Professor, School of Nursing,

Session: E6

Vice President for

Adrienne Tanner, CIP

University of Michigan

IRB Administrator, University of

Session: B19

Director

Research Administration Charles Weijer, MD, PhD

Emory University

California Berkeley

Professor, Canada Research

Session: A10

Session: D21

Chair in Bioethics, The University of Western Ontario Session: Panel VIII

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

PharmD, RPh

Harvard University

Technology in Residence


Plenary Biographies

Albert J. “AJ” Allen, MD, PhD, is

faculty

currently a senior medical fellow in the Development Center of Excellence at Eli Lilly and Company. Dr. Allen received an SB in chemistry and an MS in biochemistry from the University of Chicago, followed by an MD and PhD in pharmacology from the University of Iowa. He completed residencies in psychiatry and child psychiatry at Iowa, and a research fellowship in child psychiatry at NIMH before joining the faculty of the Institute for Juvenile Research, Division of Child Psychiatry at the University of Illinois at Chicago (UIC). Dr. Allen was introduced to research ethics through his research at NIMH and received a “crash course” as a member of one of UIC’s IRBs when OHRP suspended UIC’s federal-wide assurance in the late 1990s. In 2000 Dr. Allen joined the global development organization at Eli Lilly to work on Strattera (atomoxetine HCl, an ADHD medication). He was the global senior medical director for Strattera for seven years. Currently, he leads Eli Lilly’s pediatric capabilities effort and is chair of Eli Lilly’s Bioethics Advisory Committee, amongst other duties. Since 2011 he has been a member of SACHRP. For Dr. Allen, bioethics is critical in enabling research subjects to feel they are treated fairly and protected, and in instilling public trust in all research involving humans.

Robert H. Bartlett, MD, is professor

emeritus in the Section of General Surgery, Division of Acute Care Surgery at the University of Michigan, and continues to be active in the lab and clinical research. Prior to becoming professor emeritus in 2005, Dr. Bartlett was director of the Surgical Intensive Care Unit, program director of the Surgical Critical Care Fellowship, and director of the Extracorporeal Life Support Program at the University of Michigan Medical Center. He received his medical degree from the University of Michigan Medical School, cum laude, in 1963. In 2002, he was awarded the Medallion for Scientific Achievement from the American Surgical Association. In 2003, Dr. Bartlett received the Ladd Medal of the American Academy of Pediatrics and the American College of Surgeons Jacobson Award. In addition, he was honored with induction into the NIH Great Clinical Teachers Series and the Institute of Medicine of the National Academy of Sciences. Dr. Bartlett’s clinical interests include a full range of general and thoracic surgery with particular interest in acute physiology and critical care. Dr. Bartlett continues to maintain his active grant support and his cutting-edge research including the development of an artificial liver system for use in patients awaiting liver transplant. Along with his long-standing interest in medical history, Dr. Bartlett is a published fiction novelist.

COMMON ORGANIZATIONAL NAME ABBREVIATIONS AAHRPP Association for the Accreditation of Human

IRB

Institutional Review Board

Research Protection Programs

NCI

National Cancer Institute

ADA American Diabetes Association

NHLBI

AHRQ Agency for Healthcare Research and Quality ARENA Applied Research Ethics National Association,

NIH NIMH

PRIM&R’s former membership division

NSF

CCPC Core Conference Planning Committee

OHRP

CDC Centers for Disease Control and Prevention

SACHRP

DHHS Department of Health and Human Services FDA Food and Drug Administration HRPP Human Research Protection Program IOM Institute of Medicine

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National Heart, Lung, and Blood Institute National Institutes of Health National Institute of Mental Health National Science Foundation Office for Human Research Protections Secretary’s Advisory Committee on Human Research Protections

VA United States Department of Veterans Affairs WHO

World Health Organization


Donald Berry, PhD, is an international

expert in the field of biostatistics. He holds the Frank T. McGraw Memorial Chair for Cancer Research at The University of Texas M.D. Anderson Cancer Center, where he is chairman of the Department of Biostatistics and Applied Mathematics. He serves as the faculty statistician on the Breast Cancer Committee of the Cancer and Leukemia Group B, a national oncology group. In this role he designs and supervises the conduct and analysis of clinical trials in breast cancer. Dr. Berry received his PhD in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University, where he held the Edger Thompson Professorship in the College of Arts and Sciences. The author of more than 200 published articles as well as several books on biostatistics in medical research, Dr. Berry has been the principal investigator for numerous medical research projects funded by the NIH and the NSF. Another focus of Dr. Berry’s statistical research is designing clinical trials that utilize patients more efficiently and that treat patients in the trials more effectively. Dr. Berry is a statistics editor for the Journal of the National Cancer Institute and associate editor for Breast Cancer Research and Treatment and Clinical Cancer Research, and he is a Fellow of the American Statistical Association and of the Institute of Mathematical Statistics.

Laura Beskow, MPH, PhD, received

Anant Bhan, MBBS, MHSc, is trained

as a medical doctor with a masters’ degree in bioethics from the University of Toronto, and is based in Pune, India. He works as a researcher in the fields of bioethics and global health and as a senior research consultant with the Sandra Rotman Centre in Toronto, Canada. In the past, he has worked for non-governmental organizations and a government public health institution in India. Dr. Bhan has published in various national and international medical journals, and is an associate editor for Public Health Ethics, an Oxford University Press journal, and also serves on the International Advisory Board of the Asian Bioethics Review. He is also a member of the Ethics Working Group of the HIV Prevention Trials Network. Dr. Bhan has been a resource person for trainings in research ethics and public health ethics, and also serves as guest faculty in various educational institutions in India and abroad. He currently is a member of three ethics committees in India, including one for which he serves as chairperson, and has been a reviewer for multiple journals, conference scientific committees, and grant competitions. Dr. Bhan recently joined the working group set up to revise the 2002 Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Humans (CIOMS).

Barbara Bierer, MD, is senior vice

president for research at the Brigham and Women’s Hospital (BWH) and professor of medicine at Harvard Medical School. Dr. Bierer, a graduate of Harvard Medical School, is an internist and hematologist/oncologist with a research interest in immunology. She has been in her current position, as institutional official, since 2003. In 2006, Dr. Bierer established, and is director of, the Center for Faculty Development and Diversity at BWH. In addition, d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

her BS in nutrition from Iowa State University; her MPH with a concentration in health law from Boston University; and her PhD in health policy, with a minor in epidemiology, from the University of North Carolina at Chapel Hill. She is currently an assistant research professor at Duke University, where she focuses on ethics and policy issues in human subjects research. She was a member of SACHRP’s Subpart A Subcommittee, and is currently a member of the National Children’s Study Federal Advisory Committee. With regard to the return of individual genomic findings, Dr. Beskow was an invited speaker and participant in NCI and NHLBI workshops to develop recommendations concerning the disclosure of genomic research results to participants. She co-chaired a CDC workshop to develop disclosure criteria for return of results to National Health and Nutrition Examination Survey participants. Her own empirical research includes several projects

where issues surrounding return of results feature prominently, including a National Human Genome Research Institute-funded study on genotype-driven research recruitment and a Duke-funded study on the institutional issues in whole genome sequencing. She has first-authored several papers on disclosure of genomic results to research participants in publications such as The Journal of the American Medical Association and Science Translational Medicine.


Plenary Biographies

Dr. Bierer is the co-chair of the Partners HealthCare Committee on Conflict of Interest and the program director of the Regulatory Domain of the Harvard Catalyst, the Harvard Clinical and Translational Science Award. She has authored or co-authored over 150 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology. In addition to her academic responsibilities, Dr. Bierer was elected to, and was president of, the Board of Directors of AAHRPP, was on the Board of Directors of the Federation of American Societies for Experimental Biology, was on the Association of American Medical Colleges and the Association of American Universities Advisory Committee on Financial Conflicts of Interest in Clinical Research, and formerly served as chair of SACHRP. Currently, she serves on the National Academies of Science’s Committee on Science, Technology, and the Law.

faculty

David Borasky, MPH, CIP, works as

the deputy director in the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. He is a co-author of the award-winning Research Ethics Training Curriculum and the Research Ethics Training Curriculum for Community Representatives, which together have been used to train individuals in over 70 countries. He is a contributing author of Institutional Review Board: Management and Function (Amdur and Bankert, eds.). In addition, Mr. Borasky has provided hands-on assistance to IRBs throughout North America, Africa, and Asia, specializing in capacity building activities for IRBs in low-resource settings. He has served as a consultant for the WHO, the US Department of Energy, the Fogarty International Center, and numerous other institutions. Mr. Borasky frequently lectures on the challenges of the review of research in developing country settings, and has published articles on research ethics training and international perspectives on informed consent. He serves as treasurer of PRIM&R’s Board of Directors and chair of PRIM&R’s membership committee, and is a past president of ARENA, PRIM&R’s former membership division. In addition, he is a member of the 2012 AER Conference CCPC and co-chair of the PosterAbstract Sub-Committee.

Jeffrey Botkin, MD, MPH, is a professor of pediatrics at the University of Utah and an adjunct

professor of human genetics. 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 formerly was chair of the Committee on Bioethics for the American Academy of Pediatrics and is the current chair of SACHRP. Dr. Botkin is a member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns and Children. He chairs the NIH’s Embryonic Stem Cell Working Group and is an elected fellow of The Hastings Center.

Michael P. Caligiuri, PhD, is a professor in the Department of Psychiatry and director of the HRPP at the University of California, San Diego (UCSD). His research over the past two decades has focused on understanding the nature of brain mechanisms and treatment response in schizophrenia, depression, and bipolar disorder and more recently on the study of behavioral biomarkers for distinguishing Alzheimer’s disease from Lewy body dementia. Since 2006, Dr. Caligiuri has served as the director of the UCSD HRPP and oversees five IRBs. He is a voting member on three IRBs and provides expert review of psychiatric clinical trials. Dr. Caligiuri is directly involved in institutional policy development for research oversight and compliance with UCSD and its affiliate organizations.

Alexander Capron, LLB, holds the rank

of university professor at the University of Southern California (USC), where he occupies the Scott H. Bice Chair in Healthcare Law, Policy and Ethics; teaches public health law, health policy, torts, and bioethics in the Gould School of Law and the Keck School of Medicine; serves as co-director of USC’s Pacific Center for Health Policy and Ethics; and leads the Research Ethics Program of the Southern California Clinical and Translational Science Institute. Professor Capron previously taught at Georgetown University, the University of Pennsylvania, and Yale University. From 2002 to 2006, he served as the first director of Ethics, Trade, Human Rights, and Health Law at the WHO in Geneva, and from 1979 to 1983 he was the executive director of the President’s Commission for the Study of Ethical Problems in

p ri m & r’ s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Medicine and Biomedical and Behavioral Research. Professor Capron is a founding fellow of The Hastings Center, an elected member of the Institute of Medicine and of the American Law Institute, as well as a fellow of the American Association for the Advancement of Science. He has been president of the International Association of Bioethics and of the American Society of Law, Medicine and Ethics, and he currently serves as the secretary of PRIM&R’s Board of Directors. Professor Capron is a member of the 2012 AER Conference CCPC.

Lisa Dixon, MD, MPH, recently moved to

Anne B. Donahue, JD, has been a

member of the Vermont House of Representatives since 2003, serving on the Human Services Committee and as co-chair of the Joint Legislative Mental Health Oversight Committee. She is the

James Feldman, MD, MPH, is vice

chair for research in the Department of Emergency Medicine at Boston Medical Center, chair of the Boston University Medical Center IRB Panel Blue, and professor of emergency medicine at the Boston University School of Medicine. He graduated from Harvard University, the Albert Einstein College of Medicine, and Boston University School of Public Health. He completed his residency training in internal medicine at Boston City Hospital and has been a member of the faculty in the Department of Emergency Medicine since 1983. Dr. Feldman is board certified in internal medicine and emergency medicine. His research interests have included pre-hospital emergency medical care, acute cardiac ischemia, cocaine-induced cardiac ischemia, and public health. Dr. Feldman was president of the Massachusetts College of Emergency Physicians (MACEP). Among other professional activities, he has served on state and national organizations focused on quality measurement and quality measures development including the Massachusetts State Quality Advisory Committee. The recipient of several teaching and academic awards including being named senior reviewer for the Annals of Emergency Medicine, he recently received the Pinnacle Award from MACEP for his contributions to emergency medical care in Massachusetts.

Susan Fish, PharmD, MPH, is a

professor of biostatistics and epidemiology at the Boston University School of Public Health. Dr. Fish received her Doctor of Pharmacy degree from the University of Minnesota and her Masters of Public Health from Boston University. She received a bachelor’s degree in pharmacy from Massachusetts College of Pharmacy and Allied Health Sciences d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

the New York State Psychiatric Institute where she directs the Center for Practice Innovations (CPI). She is also an appointed professor of psychiatry at the Columbia College of Physicians and Surgeons, Columbia University. As CPI director, she oversees key activities for the Office of Mental Health in implementing evidenced-based practices for persons diagnosed with serious mental illness. She is currently the principal investigator of the NIMHfunded Recovery After Initial Schizophrenia Episode Implementation and Evaluation Study which has developed and fielded an innovative model designed to improve outcomes and reduce disability for the population of individuals experiencing their first episode of psychosis. Until April, 2012, Dr. Dixon was a professor of psychiatry and director of the Division of Services Research at the University of Maryland School of Medicine in the Department of Psychiatry, and acting director of the VA Capitol Health Care Network Mental Illness Research, Education, and Clinical Center. Dr. Dixon is an established health services researcher and has received continuous funding from NIMH, the VA, and various foundations since 1992. In addition, she has published more than 180 articles in peer-reviewed journals, edits a column in Psychiatric Services dedicated to public-academic partnerships, and received the 2009 American Psychiatric Association Health Services Senior Scholar Award as well as the Wayne Fenton Award for Exceptional Clinical Care. She was vice chair of the University of Maryland IRB for nine years.

editor of Counterpoint, the state’s tri-annual mental health consumer newspaper. Ms. Donahue was elected as a disclosed consumer with a history of multiple hospitalizations for treatment-resistant clinical depression, and was active in the efforts to establish the state’s 1997 parity law, which remains the most comprehensive in the nation. She is on the technical advisory group on mental health for the Green Mountain Care Board, which was established by statute to construct the state’s single payer health care system. She was recently re-elected to her sixth term in the Vermont House of Representatives.


Plenary Biographies

and a bachelor’s degree in chemistry and education from the University of Massachusetts. Dr. Fish is the co-director of the masters in clinical research program at Boston University School of Medicine (BUSM). She previously held positions as director of human subjects protection and associate director of the Office of Clinical Research at Boston University Medical Center (BUMC), director of the BUMC IRB, and director of research participant safety at the General Clinical Research Center at BUSM. She has also served as director of regulatory affairs at CareStat, Inc. (a contract research organization), vice chair for research in the Department of Emergency Medicine at Boston City Hospital/Boston Medical Center, and associate professor of emergency medicine at BUSM. Prior to that, she was associate director of the Massachusetts Poison Control System and an associate professor at Massachusetts College of Pharmacy and Allied Health Sciences. On the national level, Dr. Fish is an active member of many organizations, including the Society for Academic Emergency Medicine and PRIM&R, where she serves on the Board of Directors. Dr. Fish is a member of the 2012 AER Conference CCPC and is co-chair of the Poster-Abstract Sub-Committee.

Dean Gallant is the assistant dean for

faculty

research policy and administration in the Faculty

of Arts and Sciences at Harvard University. He is 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, where he long served as assistant director. He was director of Harvard’s undergraduate Science Center for 10 years. Since 1977, Mr. Gallant has been a member of Harvard’s Committee on the Use of Human Subjects in Research, where he is the 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 2012 AER Conference CCPC.

James R. Gavin, III, MD, MPH, is

clinical professor of medicine at Emory University School of Medicine and at the Indiana University School of Medicine. He currently serves as chief executive officer and chief medical officer of Healing Our Village, Inc. Dr. Gavin graduated from

COMMON ORGANIZATIONAL NAME ABBREVIATIONS AAHRPP Association for the Accreditation of Human

IOM

Institute of Medicine

Research Protection Programs

IRB

Institutional Review Board

ADA American Diabetes Association

NCI

National Cancer Institute

AHRQ Agency for Healthcare Research and Quality ARENA Applied Research Ethics National Association,

NHLBI NIH

PRIM&R’s former membership division

NIMH

CCPC Core Conference Planning Committee

NSF

CDC Centers for Disease Control and Prevention

OHRP

DHHS Department of Health and Human Services

SACHRP

FDA Food and Drug Administration HRPP Human Research Protection Program

National Institutes of Health National Institute of Mental Health National Science Foundation Office for Human Research Protections Secretary’s Advisory Committee on Human Research Protections

VA United States Department of Veterans Affairs WHO

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National Heart, Lung, and Blood Institute

World Health Organization


Livingstone College in Salisbury, NC, earned his PhD in biochemistry from Emory University and a medical degree from Duke University School of Medicine. He completed his internship, residency, and clinical fellowship training at Barnes-Jewish Hospital at Washington University Medical Center. Dr. Gavin served as a lieutenant commander in the US Public Health Service from 1971 to 1973 and continues to serve as a reserve officer. Dr Gavin is a past president of the ADA and was voted Clinician of the Year in Diabetes by the ADA in 1991. He is on the board of trustees for Emory University and Livingstone College, and is trustee emeritus for the Robert Wood Johnson Foundation. In addition, he is the national program director of the Harold Amos Faculty Development Program of the Robert Wood Johnson Foundation. Among many other awards, Dr. Gavin was a recipient of the 2009 Living Legend in Diabetes Award from the American Association of Diabetes Educators. He is also a 2010 recipient of the Public Policy Award from the ADA for contributions to advocacy on behalf of persons with diabetes.

Richard Gilbert, PhD, is professor

Cynthia A. Gómez, PhD, is the director

of the Health 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

John P.A. Ioannidis, MD, PhD,

graduated valedictorian of his class at Athens College and won a number of early awards, including the National Award of the Greek Mathematical Society in 1984. He earned his doctorate in biopathology from the School of Medicine, University of Athens, in 1990. He trained at Harvard and Tufts, specializing in internal medicine and infectious diseases. He has chaired the Department of Hygiene and Epidemiology at the School of Medicine, University of Ioannina, Greece since 1999, and he is currently the C.F. Rehnborg Professor in Disease Prevention, professor of medicine, and director of the Stanford Prevention Research Center at Stanford University School of Medicine. He has been adjunct faculty for the Tufts University School of Medicine since 1996, and is also an adjunct professor of epidemiology at the Harvard School of Public Health and visiting professor of epidemiology and biostatistics at Imperial College, London. Dr. Ioannidis has served as a member of the executive board of the Human Genome Epidemiology Network, president of the Society for Research Synthesis Methodology, and editor-in-chief of the European Journal of Clinical

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

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of psychology at Loyola Marymount University in Los Angeles, California where he directs the Psychological Research on Synthetic Environments Project (www.proseproject.info), a research lab conducting a systematic program of behavioral research on the psychology of 3D virtual worlds. In addition, he is the founder of Loyola Marymount Virtual University in Second Life; the co-chair of the Psychology of Immersive Environments working group of the Immersive Education Initiative; and a member of the editorial board of an upcoming series on virtual worlds by Springer Publishers. He received his BA in psychology from Princeton University and his PhD in clinical psychology at the University of California, Los Angeles.

science to community practice. Dr. Gómez earned a masters’ degree from Harvard and a PhD in clinical psychology from Boston University. Prior to her work in HIV, 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. Dr. Gómez has been a health policy advisor for nearly 20 years. 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. Over the years she 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 IOM’s Committee on Prisoners and Research. She is a member and past chair of the Board of Directors of the Guttmacher Institute and serves on several other boards including Planned Parenthood Shasta Pacific and the San Francisco Public Health Foundation. She currently serves as vice chair of PRIM&R’s Board of Directors.


Plenary Biographies

Investigation. He has received several awards, including the European Award for Excellence in Clinical Science for 2007. His 2005 paper in PLoS Medicine, “Why Most Published Research Findings are False,” has been the most-downloaded article in the history of Public Library of Science. His work combines skills in clinical research methodology and evidence-based medicine with the challenges of current molecular medicine and genomics.

faculty

Nancy 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 Bloomberg School of Public Health at The Johns Hopkins University. She is also a faculty associate of the Kennedy Institute of Ethics, Georgetown University and a fellow of the Hastings Center. She received her BA from Stanford University, completed her doctoral training in health policy from The Johns Hopkins School of Public Health, and was awarded a National Research Service Award to complete a postdoctoral fellowship in bioethics at the Kennedy Institute of Ethics, Georgetown University. Dr. Kass conducts empirical work in bioethics and health policy. Her publications are primarily in the fields of HIV/AIDS policy, genetics policy, public health ethics, and US and international research ethics. She served as a member of the IOM’s Committee on reducing the transmission of perinatal HIV and as a consultant to the National Bioethics Advisory Commission to examine American investigators’ experiences working in developing countries. Some of her current research projects examine genetics and privacy; informed consent in early phase cancer trials; justice and research with healthy volunteers; and ethics issues that arise 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 PhD program in bioethics and health policy and The Johns Hopkins-Fogarty African Bioethics Training Program.

Cassandra Kennedy serves as senior vice president for Global Quality Assurance at Quintiles, the world’s largest biopharmaceutical services company. In this position, she is a member of the Enterprise Compliance Office and the Compliance Management Committee of Quintiles. Ms. Kennedy

is responsible for leading Global Quality Assurance for Quintiles’ Clinical Research, Clinical Laboratories, Phase I Units, and Systems Compliance. Ms. Kennedy is regulatory affairs certified and is certified as a healthcare compliance professional with 25 years of clinical research experience. She has led quality assurance units in both the pharmaceutical and clinical research organization environments. Ms. Kennedy is a founding member of the Quintiles Data Privacy Board (Council on Data Protection), serves as vice chairman of the Ethics Board (Council on Research Ethics) at Quintiles, and represents Quintiles on the Association of Contract Research Organizations Ethics and Regulatory Compliance Committee. In 2010, Quintiles formed a women’s leadership program called the Women Inspired Network (WIN), with the vision of inspiring and developing strong women leaders in the biopharmaceutical industry. Ms. Kennedy was a founding member of the Advisory Board and currently serves as the WIN Board chair. Ms. Kennedy is on the Board of Directors for the nonprofit organization Dress for Success which serves to promote the economic independence of disadvantaged women by providing professional attire, a network of support, and the career development tools to help women thrive in work and in life.

Ian Kerr, LLB, PhD, holds the Canada

Research Chair in Ethics, Law, and Technology at the University of Ottawa, Faculty of Law, with cross appointments to the Faculty of Medicine, Department of Philosophy, and School of Information Studies. Dr. Kerr has published books and articles on topics at the intersection of ethics, law, and technology and is currently engaged in research on two broad themes: privacy and surveillance, and human-machine mergers. Building on his recent Oxford University Press book, Lessons from the Identity Trail, his ongoing privacy work focuses on the interplay between emerging public and private sector surveillance technologies, civil liberties, and human rights. His more recent focus on robotics and implantable devices examines legal and ethical implications of emerging technologies in the health sector. He is the co-director of the Canada Research Chair Laboratory in Law and Technology and has earned six awards and citations, including the Bank of Nova Scotia Award of Excellence in

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Undergraduate Teaching; The University of Western Ontario, Faculty of Graduate Studies, Award of Teaching Excellence; and the University of Ottawa Common Law Student Society, Teaching Excellence Award. Dr. Kerr sits on numerous editorial and advisory boards and is co-author of Managing the Law: The Legal Aspects of Doing Business, a business law text published by Prentice Hall and used by thousands of students each year at universities across Canada.

Catarina Kiefe, MD, PhD, is professor

Susan Z. Kornetsky, MPH, is the

director of clinical research compliance at Boston Children’s Hospital. For the past 27 years, her responsibilities have included: Directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures, and overseeing

Robert J. Levine, MD, is a professor

of medicine and lecturer in pharmacology, senior fellow in the Interdisciplinary Center for Bioethics (of which he was founding co-director), and director of the law, policy, and ethics core of the Center for Interdisciplinary Research on AIDS at Yale University. He is a fellow of The Hastings Center, pastpresident of the American Society of Law, Medicine, and Ethics (two terms), and past chairman of the Connecticut Humanities Council. Dr. Levine is the founding editor of IRB: A Review of Human Subjects Research and has served as consultant to several federal and international agencies involved in the development of policy for the protection of human subjects. Among many other honors, Dr. Levine was awarded the Outstanding Achievement Medal from OHRP in 2004 for his role in the development of the Belmont Report; he received the Lifetime Award for Excellence in Human Research Protection from the Health Improvement Institute in 2004; and he received PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in 2005. In the last 35 years, most of Dr. Levine’s research, teaching and publications have been in the field of medical ethics, with particular concentration on the ethics of research involving human subjects. Dr. Levine is a member of PRIM&R’s Board of Directors and a member of the 2012 AER Conference CCPC. d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

faculty

and inaugural chair of the Department of Quantitative Health Sciences at the University of Massachusetts Medical School, founded in June of 2009. Until this time, she was professor of medicine and biostatistics and director of the Division of Preventive Medicine at the University of Alabama at Birmingham (UAB), and the founding director of the UAB Center for Outcomes and Effectiveness Research and Education. She has served as either principal investigator (PI) or co-PI on multiple research grants funded by the NHLBI, NCI, AHRQ, VA, and the CDC. With federal funding, her group has conducted over a dozen cluster-randomized trials in the area of knowledge translation. With over 200 peer-reviewed publications, her work in the measurement of quality of health care and improvement of patient-associated outcomes is nationally and internationally recognized. Dr. Kiefe obtained a doctorate in mathematics at the State University of New York at Stony Brook, and her medical degree at the University of California, San Francisco. She completed residency training in internal medicine at the University of Minnesota. Dr. Kiefe has served on numerous AHRQ and NIH study sections, as well as VA Merit Review Boards. She is currently co-editor in chief of Medical Care, a leading scientific journal in health services research.

a quality improvement program for human research protections. 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 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. She has also served as a consultant for federal agencies. Ms. Kornetsky has been a member of PRIM&R’s Board of Directors since 2001, serving as vice chair from 2005 through 2007, and chair of the Education Committee from 2002 through 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 cochair of PRIM&R’s 2012 AER Conference.


Plenary Biographies

Roger Lewis, MD, PhD, received his

faculty

PhD in biophysics in 1986 and his MD in 1987 from Stanford University. He completed clinical training in emergency medicine in 1990 and is currently a professor at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and the vice chair for academic affairs in the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s areas of interest include adaptive and Bayesian clinical trials; translational, clinical, health services, and outcomes research; emergency department crowding and disaster preparedness; interim data analysis; the role and function of data monitoring committees; and difficulties surrounding informed consent in emergency research studies. Dr. Lewis has served as a research mentor for numerous fellows and junior faculty and frequently lectures on the topics of clinical research design and the statistical analysis of clinical trials. Dr. Lewis serves as the chair of data and safety monitoring boards for both federally-funded and industry-sponsored clinical trials. In 2009, Dr. Lewis was elected to membership in the IOM of the National Academies. He is a past president of the Society for Academic Emergency Medicine and a member of the Board of Directors for the Society for Clinical Trials. Dr. Lewis has authored or co-authored over 200 original research publications, reviews, editorials, and chapters.

Holly Fernandez Lynch, JD, MBioethics,

is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Her scholarly work focuses on the regulation of human subjects research domestically and internationally, pharmaceutical development and regulatory policy, conflicts of conscience in both the medical and legal professions, conflicts of interest in health care, and the legal issues surrounding pregnancy and childbirth. Ms. Lynch practiced law at Hogan & Hartson, LLP in Washington, DC (now Hogan Lovells), where she counseled pharmaceutical and biotechnology clients on complex regulatory matters involving the FDA. In addition, Ms. Lynch has government experience as a bioethicist working with the Human Subjects Protection Branch at NIH’s Division of AIDS, where she advised the Division, its clinical trial networks, and grant recipients on research ethics and human subjects regulatory issues arising in HIV/AIDS prevention, treatment, and co-infection studies. Ms. Lynch also served as senior policy and research analyst for President Obama’s Commission for the Study of Bioethical Issues, where she worked on the Commission’s investigation of the 1946-1948 Guatemala STD inoculation studies. She graduated from the University of Pennsylvania Law School, and

COMMON ORGANIZATIONAL NAME ABBREVIATIONS AAHRPP Association for the Accreditation of Human

IOM

Institute of Medicine

Research Protection Programs

IRB

Institutional Review Board

ADA American Diabetes Association

NCI

National Cancer Institute

AHRQ Agency for Healthcare Research and Quality ARENA Applied Research Ethics National Association,

NHLBI NIH

PRIM&R’s former membership division

NIMH

CCPC Core Conference Planning Committee

NSF

CDC Centers for Disease Control and Prevention

OHRP

DHHS Department of Health and Human Services

SACHRP

FDA Food and Drug Administration HRPP Human Research Protection Program

National Institutes of Health National Institute of Mental Health National Science Foundation Office for Human Research Protections Secretary’s Advisory Committee on Human Research Protections

VA United States Department of Veterans Affairs WHO

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National Heart, Lung, and Blood Institute

World Health Organization


earned her Master of Bioethics from the University of Pennsylvania School of Medicine.

Barry Mangum, PharmD, is an

Patricia Marshall, PhD, is an associate

professor of bioethics at Case Western Reserve University School of Medicine. She received her PhD in Anthropology from the University of Kentucky. Her research interests and publications have focused on multi-culturalism and the application of bioethics practices, international research ethics and informed consent, HIV prevention among injection drug users, procurement practices for organ transplantation in India, and clinical ethics consultations. In 1999 she co-edited Integrating Cultural, Observational, and Epidemiological Approaches in the Prevention of Drug Abuse and HIV/AIDS, and is now working a book that explores the relationship between anthropology and bioethics. She is also preparing a monograph for the WHO that addresses ethical

William Meurer, MD, MS, is an assistant

professor of emergency medicine and neurology at the University of Michigan in Ann Arbor. His major clinical and research focus is on the early care of patients with acute neurological illness and injury, with an emphasis on stroke treatment. He serves as a site principal investigator on the Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke - Enhanced Regimen acute stroke trial, and is a co-investigator on several acute stroke treatment trials. He works as a coinvestigator for the clinical coordinating center for the Neurological Emergencies Treatment Trials Network. In addition, he has an interest in the incorporation of flexible Bayesian adaptive clinical trial designs into confirmatory phase neurological emergency trial. Dr. Meurer received his MD from the University of Cincinnati in 2003 and completed clinical training in emergency medicine in 2006 at the MetroHealth/ Cleveland Clinic program in Cleveland, Ohio. He then completed a fellowship in stroke and cerebrovascular disease at the University of Michigan. While at the University of Michigan he obtained his MS in clinical research design and statistical analysis from the School of Public Health. Dr. Meurer has authored or co-authored over 50 original research publications, reviews, and book chapters in the fields of emergency medicine, neurology, and clinical trials.

Meredith Minkler, DrPh, MPH, is

professor and director of health and social behavior at the School of Public Health, University of California, Berkeley, where she also was founding director of the University’s Center on Aging. For over d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

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associate professor of clinical pharmacology and assistant professor of pediatrics at Duke University Medical Center. He is a graduate of The Medical University of South Carolina where he received his doctorate. Currently, Dr. Mangum is working at the Duke Clinical Research Institute as senior pediatrics faculty in pediatric clinical trials focusing on providing strategic planning and coordination of specialty pediatric population clinical research. Additionally, Dr. Mangum is the director of clinical pharmacology for the Duke Clinical Research Unit, an academic early phase clinical pharmacology unit designed to explore new therapies for diseases in children and adult patients. Dr. Mangum has an extensive background in neonatal and pediatric pharmacology and is the co-author and co-publisher of the leading drug dosing manual, NeoFax®: A Manual of Drugs Used in Neonatal Care. Dr. Mangum continues to be active in national and global leadership of pediatric clinical research as an educator and committee member of academic and pharmaceutical industry organizations. He has represented the interest of pediatric patients by chairing and speaking at meetings globally on the topic of neonatal pharmacology and legislative issues to support clinical research in children. Currently, Dr. Mangum is serving a four-year appointment to the WHO’s Expert Committee on the Selection and Use of Essential Medicines.

challenges related to biomedical and behavioral research in resource-scarce settings. Dr. Marshall is involved in many current research activities on a wide array of important topics. She is a past member of the executive boards of several ethical organizations, and also served on the advisory board for the Fogarty International Center at the NIH. She has served as a consultant to the President’s National Bioethics Advisory Commission and the WHO’s Council for International Organization of Medical Societies. Dr. Marshall was appointed to the National Academy of Science’s study panel on IRBs, Surveys, and Social Science Research in 2001 and, in 1991, was awarded a three-year Kellogg Foundation National Fellowship for creative leadership.


Plenary Biographies

35 years, she has undertaken health disparities and community-based participatory research (CBPR) with underserved communities including low income elders, people with disabilities, youth, and immigrant workers. Dr. Minkler’s current research includes a CBPR study of late stage HIV/AIDS diagnosis among African Americans and Latinos; photovoice with rural youth; and CBPR as a strategy for policy change. Her publications include over 130 peer-reviewed articles and eight books including Community-Based Participatory Research for Health: From Processes to Action (with Nina Wallerstein, 2nd edition 2008); Community Organizing and Community Building for Health (3rd edition, 2012); Critical Gerontology (with Carroll Estes); and Forgotten Caregivers: Grandmothers Raising the Children of the Crack Cocaine Epidemic (with Kathleen Roe).

Karen Moe, PhD, is the director of the

Human Subjects Division at the University of Washington (UW). She is also assistant vice provost for research, and a research associate professor in the Department of Psychiatry and Behavioral Sciences. She received her PhD in psychology/ behavioral neuroscience, and had an active federallyfunded research program on sleep in older humans for about 15 years prior to joining the UW Human Subjects Division in 2004. She became the director of the Human Subjects Division in 2007.

faculty

Daniel K. Nelson, MSc, CIP, is a

professor of social medicine, an adjunct professor of pediatrics, and is the director of the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. Trained in medical physiology, Mr. Nelson previously held faculty appointments at the Mayo Clinic—with a sabbatical fellowship conducting human studies in Europe—and at the University of Rochester, where he was director of research in a clinical gastroenterology unit and chair of a hospital IRB. A national leader in the field of human research protections, Mr. Nelson has served as pastpresident of ARENA, PRIM&R’s former membership division; charter member of the AAHRPP Council for Accreditation; a former member of Council for Certification of IRB Professionals; founding cochair of the IRB Sponsor Roundtable; consultant to OHRP; and liaison to the National Bioethics Advisory

Commission. Since 2005, he has co-chaired a SACHRP subcommittee that advises the DHHS on the regulations that govern human research protections (the “Common Rule”). Mr. Nelson is also a co-investigator on several grants from the NIH concerning issues surrounding research ethics, and has frequently lectures on related topics. He is also a member of the 2012 AER Conference CCPC.

Linda Nielsen, JD, is a member of

UNESCO’s International Governmental Bioethics Committee. She is also president of the Danish Cancer Society and is a member of the board of trustees of Queen Margrethe and Prince Henrik’s Foundation. Professor Nielsen is a former chairman of the Danish Council of Ethics, an expert group on Biotechnology and Ethics established by the Danish Government; the Nordic Committee on Bioethics; and is a former Member of the European Standing Bureau on Ethics committees, established by the Council of Europe. She has also functioned as an evaluator of the European Union Biotechnology Research projects with a focus on the ethical, legal, and social aspects, for the European Commission, and has been a member of a number of law reform commissions on such topics as genetic testing in the workplace, DNA-registers, biobanks, and informed consent questions. In addition, Professor Nielsen is the former president of the University of Copenhagen, Denmark. In this capacity, she oversaw over 33,000 students and 5,000 faculty and staff. Her research has focused on the interaction between bioethics and bio-law, and comparative analysis of the different legal systems within the European Union (EU) and between the EU and other parts of the world. She has been awarded the French Officier de l’Ordre National du Mérite and the Danish cross of an Order of Chivalry.

Rachel Nosowsky, JD, serves as acting deputy general counsel for health law and medical center services at the University of California (UC). She specializes in the area of research and clinical trials. Ms. Nosowsky provides UC medical centers and central campus units with regulatory analysis and advice on human research protections, FDA regulation, industry-academic relations, and related fraud and abuse and conflict of interest matters, reimbursement, health privacy, biobanking, data

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repositories, compliance, and misconduct. Ms. Nosowsky also supports the University’s responses to government inspections and oversight initiatives in these areas and reviews and assists in the negotiation of contracts and other legal documents. Before joining the University, Ms. Nosowsky worked in private practice and as assistant general counsel at the University of Michigan. She is a graduate of Carleton College and the University of California, Berkeley.

P. Pearl O’Rourke, MD, is the director

Efthimios Parasidis, JD, MBE, is

a member of the Center for Health Law Studies at Saint Louis University. His scholarship examines regulation of medical products and human subjects research, the interplay between health law and intellectual property, and how health information technology can inform public health policy. He is

Elizabeth Pike, JD, LLM, is a former

post-doctoral fellow with the Department of Bioethics at the NIH Clinical Center. Her research at NIH focused on compensation for research injuries and incidental findings in genetic research. Ms. Pike received her BA from Swarthmore College and her JD and LLM in global health law from Georgetown University Law Center. Ms. Pike spent three years in private practice at Shearman & Sterling, LLP, in Washington, DC, and worked in Tanzania and Rwanda as a legal researcher for the International Criminal Tribunal for Rwanda.

Ivor Pritchard, PhD, is the senior advisor

to the director of OHRP. He came to OHRP in 2004 from the Institute for 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’s authored or co-authored publications include “How Do IRB Members Make Decisions? A Review and Research Agenda” (JERHRE, 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

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

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of human research affairs at Partners HealthCare System in Boston 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 System Embryonic Stem Cell Research Oversight Committee. Dr. O’Rourke has worked as a pediatric critical care physician at the Children’s Hospital, Boston and at the Children’s Hospital, University of Washington, Seattle, 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. In Seattle, she served many years as a member of the IRB. Dr. O’Rourke has also been involved in international medical care, serving in China and Indonesia with Project HOPE. From 1995 to 1996, Dr. O’Rourke completed a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy. Following this fellowship, she 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 2012 AER Conference CCPC.

currently serving as a co-principal investigator with researchers at the NIH on a study that is analyzing compensation policies for research-related injuries. He is a member of the Law and Policy Workgroup of Missouri Health Connection, the entity responsible for creating Missouri’s health information exchange, and consults for the American College of Physicians on conflicts of interest in the medical and pharmaceutical industries. As a Fulbright Fellow, Professor Parasidis researched legal and ethical issues related to medical informed consent policies and practices in Greece. He is a recipient of the Thompson Coburn Faculty Scholarship Award and the 2012 Southeast Association of Law Schools Call for Papers Award, and was recently selected as a Health Law Scholar by the American Society of Law, Medicine, and Ethics.


Plenary Biographies

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. In 2011, Dr. Pritchard received PRIM&R’s Distinguished Service Award. He is a member of the 2012 AER Conference CCPC.

Edward Quigley, PhD, MBA, is the

faculty

research administration officer at Rady Children’s Hospital-San Diego/University of California, San Diego (UCSD) and is a member of the Executive Committee for the UCSD/Rady Children’s Hospital Pediatric Research Bio-Repository. He received a BChE degree in chemical engineering and MS and PhD degrees in biomechanics from the University of Delaware. He also received an MBA with a concentration in healthcare management from the University of South Florida. Dr. Quigley has held various positions in Children’s Hospitals over the past 18 years including director of orthopedic research at Rady Children’s Hospital, director of the motion analysis laboratory at Shriners Hospitals for

Children-Tampa, and assistant corporate director of research programs at Shriners Hospitals for Children International Headquarters. He has also served as adjunct faculty at San Diego State University and the University of South Florida, teaching undergraduate and graduate students, supervising graduate student thesis projects, and participating in curriculum development.

Henry S. Richardson, PhD, JD, MPP, is professor of philosophy and senior

research scholar at the Kennedy Institute of Ethics at Georgetown University. He is the author of Specifying Norms as a Way to Resolve Concrete Ethical Problems (Philosophy & Public Affairs, 1990) and three books, including Moral Entanglements: Medical Researchers’ Ancillary-Care Obligations (Oxford University Press, 2012). He is the editor-in-chief of Ethics. Dr. Richardson has twice been a visiting scholar at the Department of Bioethics at the NIH and has participated as a faculty member in researchethics courses organized by that department in Uganda and Tanzania.

Jeanita W. Richardson, PhD, MEd, is an associate professor in the University of Virginia School of Medicine, Department of Public Health

COMMON ORGANIZATIONAL NAME ABBREVIATIONS AAHRPP Association for the Accreditation of Human

IOM

Institute of Medicine

Research Protection Programs

IRB

Institutional Review Board

ADA American Diabetes Association

NCI

National Cancer Institute

AHRQ Agency for Healthcare Research and Quality ARENA Applied Research Ethics National Association,

NHLBI NIH

PRIM&R’s former membership division

NIMH

CCPC Core Conference Planning Committee

NSF

CDC Centers for Disease Control and Prevention

OHRP

DHHS Department of Health and Human Services

SACHRP

FDA Food and Drug Administration HRPP Human Research Protection Program

National Institutes of Health National Institute of Mental Health National Science Foundation Office for Human Research Protections Secretary’s Advisory Committee on Human Research Protections

VA United States Department of Veterans Affairs WHO

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National Heart, Lung, and Blood Institute

World Health Organization


Sciences and assistant director of community health programs and research. She earned her PhD in educational policy with a concentration in special interest group politics from the Woodrow Wilson School of Government and Foreign Affairs at the University of Virginia. Professionally she has worked as a corporate banker, public school educator, state-level policy analyst, university professor, and health and educational policy advocate. Current projects and research endeavors include the development and implementation of culturally respectful engagement practices in international and domestic contexts. Dr. Richardson’s scholarship highlights the needs of populations society devalues, particularly as it pertains to the nexus between the health and learning readiness of children and the role of culturally respectful approaches to research. Books to her credit include The Cost of Being Poor; Suffer the Little Children: National and International Dimensions of Child Poverty; The Full-Service Community School Movement: Lessons from the James Adams Community School; and the recently released School-Based Health Care: Advancing Both Educational Success and Public Health.

Michele Russell-Einhorn, JD, is the

Elyn Saks, JD, PhD, graduated summa

cum laude from Vanderbilt University before earning her master of letters from Oxford University and her JD from Yale Law School, where she also edited the Yale Law Journal. She holds a PhD in psychoanalytic science from the New Center for Psychoanalysis. Her recent research focuses on ethical dimensions of psychiatric research and forced treatment of the mentally ill. At the University of Southern California School of Law (USC Law), she teaches mental health law, mental health law and the criminal justice system, and Advanced Family Law: The Rights and Interests of Children. She also teaches at the Institute of Psychiatry and the Law at the Keck School of Medicine at USC, and is an adjunct professor of psychiatry at the University of California, San Diego. Professor Saks was a 2009 recipient of a MacArthur Foundation fellowship and, in the fall of 2010, announced she is using funds from the “genius grant” to create the Saks Institute for Mental Health Law, Policy, and Ethics. The Institute spotlights important mental health issues and is a collaborative effort that includes faculty from seven USC departments. In 2007, Professor Saks published The Center Cannot Hold: My Journey Through Madness (Hyperion), a memoir about her struggles and successes with schizophrenia and acute psychosis. Professor Saks won both the Associate’s Award for Creativity in Research and Scholarship and the Phi Kappa Phi Faculty Recognition Award in 2004.

Lauren Solberg, JD, MTS, is the

assistant vice president of human subjects protection and research integrity at Meharry Medical College, where she is responsible for overseeing activities related to the conduct of research with human subjects and animals; providing advice on ethics to researchers, IRB members, and institutional officials; and overseeing general and research-specific ethics education of researchers at the institution. She earned her JD from Vanderbilt University Law School, her MTS from Harvard Divinity School, and her BA from the University of Florida. Prior to

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a

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senior director of the Office for Human Research Studies at the Dana-Farber 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. Russell-Einhorn has over 30 years of professional expertise, including service as the conflicts of interest attorney for the NIH; director of regulatory affairs for the United States DHHS Office for the Protection from Research Risks and its successor OHRP; director in the global pharmaceuticals practice at Price Waterhouse Cooper; and associate general counsel for the J. Craig Venter Institute. She is a member of the SACHRP Subpart A Subcommittee, a member of PRIM&R’s 2012 AER Conference CCPC, and a member of the Vanderbilt University Steering Committee for an NIH grant on alternative IRB models. From 2009 to 2011, she was the co-chair of PRIM&R’s AER Conference. 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 in Regulatory Affairs Program.


Plenary Biographies

coming to Meharry, she held a number of positions in research compliance areas at Dana-Farber Cancer Institute and the University of Massachusetts, Boston. She has presented at national, regional, and local conferences on issues related to the protection of human subjects in research, and in particular on privacy issues related to uses of social media in research. She has also published articles on issues related to health law and policy, including one in the University of Illinois Journal of Law, Technology and Policy, titled “Data Mining on Facebook: A Free Space for Researchers or an IRB Nightmare?,” and one in the Northern Kentucky Law Review titled “Regulating Human Subjects Research in the Information Age: Data Mining on Social Networking Sites.” Recently, she has been the program leader on an NIH-funded grant related to bioethics education.

faculty

David Strauss, MD, is deputy director for

research 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 Humans Subjects Research. He co-chairs Columbia University’s Standing Committee on the Conduct of Research, and serves 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 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 and psychopharmacology, and teaches, lectures, and consults widely on matters of human subjects protections and applied research ethics. Dr. Strauss is a co-chair for the 2012 AER Conference.

Jeremy Sugarman, MD, MPH, MA, is the Harvey M. Meyerhoff Professor of Bioethics

and Medicine, professor of medicine, professor of Health Policy and Management, 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 over 200 articles, reviews, and book chapters. He has also edited or co-edited four books. He is a senior adviser to the Presidential Commission for the Study of Bioethical Issues. He previously served as a senior policy and research analyst for the White House Advisory Committee on Human Radiation Experiments and as a consultant to the National Bioethics Advisory Commission. Dr. Sugarman currently serves on the Board of Directors of PRIM&R. In addition, he is chair of 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 of Clinical Investigation and the IOM. He is a fellow of the American Association for the Advancement of Science, the American College of Physicians, and The Hastings Center.

Latanya Sweeney, PhD, has made a

career of weaving together technology and policy. Dr. Sweeney develops algorithms and constructs real-world systems that allow information to be shared with provable guarantees of privacy (legally and scientifically) while remaining practically useful. Dr. Sweeney has made numerous discoveries related to identifiability and privacy technologies, and she has had significant impact on American privacy policy. Her work has received awards from numerous organizations, including the American Psychiatric Association, the American Medical Informatics Association, and the Blue Cross Blue Shield Association. Dr. Sweeney’s work has appeared in hundreds of news articles, numerous academic papers, was cited in the original publication of the HIPAA Privacy Rule, and was praised in the Technology and Privacy Advisory Committee Report that reviewed the Total Information Awareness Project of the Defense Advanced Research Projects Agency. She has also testified before the Privacy

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and Integrity Advisory Committee of the Department of Homeland Security and the European Union Commission. Companies have licensed and continue to use her privacy technologies. Dr. Sweeney is a distinguished career professor of computer science, technology, and policy in the School of Computer Science at Carnegie Mellon University, where she also founded and serves as the director of the Data Privacy Lab. She received her PhD in computer science from Massachusetts Institute of Technology. Her undergraduate degree in computer science was completed at Harvard University.

Charles Weijer, MD, PhD, is professor

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 University of San Diego, and professor of political science at University of Vermont. He has held fellowships at the Institute

Susan Wolf, JD, is McKnight Presidential

Professor of Law, Medicine, and Public Policy; Faegre Benson Daniels Professor of Law; and professor of medicine at the University of Minnesota, and is also a faculty member in the University’s Center for Bioethics. Professor Wolf is founding chair of the University’s Consortium on Law and Values in Health, Environment, and the Life Sciences and Founding Director of the University’s Joint Degree Program in Law, Health, and the Life Sciences. She received her AB from Princeton University and her JD from Yale Law School, with graduate work at Harvard University. In 1984, she became a National Endowment for the Humanities Fellow and then associate for law at The Hastings Center. She also taught law and medicine at New York University Law School for six years as an adjunct associate professor. She was a fellow in the Program in Ethics and the Professions at Harvard University before joining the Minnesota faculty in 1993. She is executive editor of the Minnesota Journal of Law, Science & Technology and a member of the editorial boards for the Journal of Law, Medicine & Ethics; Journal of Urban Health; and Neuroethics. She is author or co-author of over 100 articles and chapters, law reviews, and other publications. She writes on a wide range of issues in health care, biomedical research, and oversight of emerging technologies. Her work addresses genetics and genomics, neuroscience, nanotechnology, reproductive technologies, death and dying, women’s health, and other topics in health law, law and science, and bioethics.

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in the departments of philosophy and medicine, Canada Research Chair in Bioethics, and former director of the Rotman Institute of Philosophy at Western University in London, Canada. He received his MD from the University of Alberta in 1988 and PhD from McGill University in 1997, supervised by the late Benjamin Freedman. His research interests include the ethical analysis of benefits and harms in research, research in developing countries, and cluster randomized trials. He served as a consultant to the Joint United Nations Programme on HIV/AIDS, the US National Academies IOM, President Clinton’s National Bioethics Advisory Commission, the WHO, and the World Medical Association. Dr. Weijer was elected a Fellow of The Hastings Center (2002), Fellow of the Royal College of Physicians and Surgeons of Canada (2003), Fellow of the American College of Physicians (2007), and Fellow of the Canadian Academy of Health Sciences (2007).

for Advanced Study at Princeton University, and the Program in Ethics and the Professions at Harvard University. Prior to joining the 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 2012 AER Conference CCPC.


Maps

Breakout Sessions

Upper Level

Ballrooms: Plenaries

Hilton

Omni, Residence Inn, Hotel Solamar, Horton Grand Hotel Breakout Sessions

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Escalators: To General Session and exit/entrance

Boo


The Conference Connection: Meals, Supporters and Exhibitors, the PRIM&R Booth, Poster Presentations, Affinity Group meeting spots, The Greater Good exhibit, Internet Cafe, and more

Hyatt

Bookstore

Conference Registration Area and Help Desk

maps

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Maps

Exhibit Hall D: General Session, Plenaries

Ground Level

Hilton

maps

Omni, Residence Inn, Hotel Solamar, Horton Grand Hotel

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Escalator: To Conference Registration area, Breakout Sessions, Plenaries, The Conference Connection, and more


ries

Hyatt

area, ies, on,

maps

d e c e m b e r 4 - 6, s a n d i e g o, c a l i f or n i a


maps

Maps

p ri m & râ&#x20AC;&#x2122; s 20 1 2 adv anci ng e th i ca l r e s e a rc h c on f e r e n c e


Pleas

Instructions

the sessions and workshops that you attended. The number of hours for each activity is indicated to the right of its title/number.

Keynote Addresses

Workshop and Didactic Sessions

__ D1 (1.25) __ D2 (1.25) __ D3 (1.25) __ D4 (1.25) __ D5 (1.25) __ D6 (1.25) __ D7 (1.25) __ D8 (1.25) __ D9 (1.25) __ D10 (1.25) __ D11 (1.25) __ D12 (1.25) __ D13 (1.25) __ D14 (1.25) __ D15 (1.25) __ D16 (1.25) __ D17 (1.25) __ D18 (1.25) __ D19 (1.25) __ D20 (1.25) __ D21 (1.25) __ D22 (1.25) __ D23 (1.25) __ D24 (1.25) __ D25 (1.25) __ D26 (1.25) __ Keynote: John P.A. Ioannidis, MD, PhD (0.75) __ Plenary: Robert H. Bartlett, MD (0.75) __ Keynote: James R. Gavin III, MD, PhD (0.75) __ Lecture: Elyn R. Saks, JD, PhD (0.75)

__ Panel VII (1.25) __ Panel VIII (1.25) __ Panel IX (1.25) __ Panel X (1.25) __ Panel XI (1.25) __ Panel XII (1.25)

Plenary Sessions __ Panel I (1.25) __ Panel II (1.25) __ Panel III (1.25) __ Panel IV (1.25) __ Panel V (1.25) __ Panel VI (1.25)

Debates & More __ GD: Genomic Research (1.25) __ LRC: Whose Ethics Matter? (1.25)

Grand Finale

__ C1 (2.5) __ C2 (1.25) __ C3 (1.25) __ C4 (2.5) __ C5 (2.5) __ C6 (1.25) __ C7 (2.5) __ C8 (2.5) __ C9 (1.25) __ C10 (1.25) __ C11 (1.25) __ C12 (1.25) __ C13 (1.25) __ C14 (1.25) __ C15 (1.25) __ C16 (2.5) __ C17 (1.25) __ C18 (1.25) __ C19 (1.25) __ C20 (1.25) __ C21 (2.5) __ C22 (2.5) __ C23 (2.5) __ C24 (1.25) __ C25 (1.25) __ C26 (2.5) __ C27 (2.5)

Total number of hours: _______ (Note: Maximum number of hours is 18) Please write the total number of

__ B1 (1.25) __ B2 (1.25) __ B3 (1.25) __ B4 (1.25) __ B5 (1.25) __ B6 (1.25) __ B7 (1.25) __ B8 (1.25) __ B9 (1.25) __ B10 (1.25) __ B11 (1.25) __ B12 (1.25) __ B13 (1.25) __ B14 (1.25) __ B15 (1.25) __ B16 (1.25) __ B17 (1.25) __ B18 (1.25) __ B19 (1.25) __ B20 (1.25) __ B21 (1.25) __ B22 (1.25) __ B23 (1.25) __ B24 (1.25) __ B25 (1.25) __ B26 (1.25)

__ A1 (1.25) __ A2 (1.25) __ A3 (1.25) __ A4 (1.25) __ A5 (1.25) __ A6 (1.25) __ A7 (1.25) __ A8 (1.25) __ A9 (1.25) __ A10 (1.25) __ A11 (1.25) __ A12 (1.25) __ A13 (1.25) __ A14 (1.25) __ A15 (1.25) __ A16 (1.25) __ A17 (1.25) __ A18 (1.25) __ A19 (1.25) __ A20 (1.25) __ A21 (1.25) __ A22 (1.25) __ A23 (1.25) __ A24 (1.25) __ A25 (1.25) __ A26 (1.25) __ GF: Ask the Experts (1.25) __ GF: Connecting through PRIM&R (1.25) __ GF: Affinity Groups (1.25) __ GF: How to Survive a Plague (1.25) __ GF: Jeopardy (1.25) __ GF: The Evolution of Research Ethics (1.25) __ GF: The Uncomfortable Conversation (1.25)

__ E1 (1.25) __ E2 (1.25) __ E3 (1.25) __ E4 (1.25) __ E5 (1.25) __ E6 (1.25) __ E7 (1.25) __ E8 (1.25) __ E9 (1.25) __ E10 (1.25) __ E11 (1.25) __ E12 (1.25) __ E13 (1.25) __ E14 (1.25) __ E15 (1.25) __ E16 (1.25) __ E17 (1.25) __ E18 (1.25) __ E19 (1.25) __ E20 (1.25) __ E21 (1.25) __ E22 (1.25) __ E23 (1.25) __ E24 (1.25) __ E25 (1.25) __ E26 (1.25)


Have a question about human subjects research or IRB operations? Looking to share your expertise? Join the IRB Forum! The IRB Forum, an online discussion and news forum for past and current members of Institutional Review Boards (IRB) or Research Ethics Committees (REC), IRB/REC administrators, individuals involved in IRB/REC oversight, and others with professional involvement in IRB/REC and/or research activities, promotes the discussion of ethical, regulatory and policy concerns with human subjects research. The IRB Forum strives to create an atmosphere for open and respectful conversation about issues of mutual interest to the members. TO LEARN MORE, PLEASE VISIT THE IRB FORUM AT www.irbforum.org


PLATINUM SUPPORTER

SILVER SUPPORTERS

BRONZE SUPPORTERS

EXHIBITORS

Committed to the Protection of Research Subjects

National Cancer Institute Central IRB Initiative


Conference Schedule-at-a-Glance Monday, December 3 7:00 AM 8:30 AM 4:00 PM 4:00 PM

-

8:30 AM 5:00 PM 6:00 PM 6:00 PM

Continental breakfast Pre-Conference Programs Pre-Conference Networking Reception Affinity Group Pre-Conference Networking Reception

Ballroom 20AB See program for room locations. 28ABCD 28ABCD

Tuesday, December 4 7:00 AM 7:00 AM 7:00 AM 8:00 AM 8:30 AM 9:15 AM 10:00 AM 10:30 AM 12:00 PM 12:00 PM 12:00 PM 12:00 PM 1:00 PM 1:15 PM 2:00 PM 3:15 PM 3:45 PM 5:00 PM

- 8:00 AM - 8:00 AM - 8:00 AM - 8:30 AM - 9:15 AM - 10:00 AM - 10:30 AM - 11:45 AM - 1:00 PM - 1:00 PM - 1:00 PM - 1:00 PM - 1:45 PM - 1:45 PM - 3:15 PM - 3:45 PM - 5:00 PM - 6:30 PM

Continental breakfast First-Time Attendee Continental Breakfast Affinity Group Networking Breakfast Welcome and Conference Overview Keynote Address: John P. A. Ioannidis, MD, PhD Plenary Address: Robert H. Bartlett, MD Break Didactic Sessions and Workshops Series A Lunch with Plenary Speaker Robert H. Bartlett, MD Lunch with Keynote Speaker John P. A. Ioannidis, MD, PhD Research Ethics Book Group with Jonathan Haidt, PhD Common Ground Networking Lunch Meet and Greet with Supporters, Exhibitors, and Poster Presenters PRIM&R’s Online Course and Knowledge Center Demonstration Plenary Sessions Break Didactic Sessions and Workshops Series B 2012 AER Conference Welcome Reception

Sails Pavilion 28ABCD 25B Exhibit Hall D Exhibit Hall D Exhibit Hall D Sails Pavilion See program for room locations. 25B 26AB 28ABCD Sails Pavilion Sails Pavilion Sails Pavilion See program for room locations. Sails Pavilion See program for room locations. Sails Pavilion

Wednesday, December 5 7:00 AM 7:00 AM 8:00 AM 8:30 AM 9:15 AM 9:30 AM 10:45 AM 11:15 AM 12:45 PM 12:45 PM 12:45 PM 12:45 PM 12:45 PM 2:15 PM 3:30 PM 3:45 PM 3:45 PM

- 8:00 AM - 8:00 AM - 8:30 AM - 9:15 AM - 9:30 AM - 10:45 AM - 11:15 AM - 12:30 PM - 2:00 PM - 2:00 PM - 2:00 PM - 2:00 PM - 1:15 PM - 3:30 PM - 5:30 PM - 5:00 PM - 5:00 PM

Continental breakfast CIP® Breakfast Welcome and ARENA Legacy Award Presentation: Susan Delano Keynote Address: James R. Gavin III, MD, PhD Break Plenary Sessions Break Didactic Sessions and Workshops Series C Lunch Lunch with Keynote Speaker James R. Gavin III, MD, PhD Lunch and Book Signing with Panelist Henry S. Richardson, JD, PhD Research Ethics Book Group Lunch and Book Signing with Laura Stark, PhD PRIM&R’s Online Course and Knowledge Center Demonstration Plenary Sessions; Didactic Sessions and Workshops Series D Meet and Greet the Supporters, Exhibitors, and Poster Presenters Moderated Poster Discussions Speed Mentoring

Sails Pavilion 28ABCD Exhibit Hall D Exhibit Hall D See program for room locations. Sails Pavilion See program for room locations. Sails Pavilion 26A 26B 28ABCD Sails Pavilion See program for room locations. Sails Pavilion Sails Pavilion Sails Pavilion

Thursday, December 6 7:00 AM 7:00 AM 8:00 AM 8:30 AM 9:15 AM 9:30 AM 10:45 AM 10:45 AM 11:15 AM 12:45 PM 12:45 PM 12:45 PM 12:45 PM 1:15 PM 2:00 PM 3:15 PM 3:30 PM 4:45 PM

- 8:00 AM - 8:00 AM - 8:30 AM - 9:15 AM - 9:30 AM - 10:45 AM - 11:15 AM - 11:15 AM - 12:30 PM - 1:45 PM - 1:45 PM - 1:45 PM - 1:45 PM - 1:45 PM - 3:15 PM - 3:30 PM - 4:45 PM - 5:45 PM

Continental breakfast PRIM&R Online Connections & Resources Continental Breakfast Welcome and Recognition of Melinda Hurst Pillars of PRIM&R Lecture: Elyn R. Saks, JD, PhD Break Plenary Sessions Break Book Signing with Pillars of PRIM&R Lecturer Elyn R. Saks, JD, PhD Didactic Sessions and Workshop Series E Lunch Lunch with Melinda Hurst, Pioneering “Community Member” Lunch and Book Signing with Pillars of PRIM&R Lecturer Elyn R. Saks, JD, PhD What’s New at the CITI Program? Lunch PRIM&R’s Online Course and Knowledge Center Demonstration Plenary Sessions Break Grand Finale Sessions Closing Reception

Sails Pavilion 28ABCD Exhibit Hall D Exhibit Hall D See program for room locations. Sails Pavilion Lobby 20 See program for room locations. Sails Pavilion 25B 26AB 28ABCD Sails Pavilion See program for room locations. See program for room locations. 28ABCD


2012 Advancing Ethical Research Conference Guide