2014 AER Conference Guide

Schedule at a Glance

7:00-8:30 AM 8:30 AM 4:30-6:00 PM

Continental Breakfast Pre-Conference Programs Pre-Conference Programs Networking Reception

Ballroom III See schedule for room locations Camden Lobby

Friday, December 5 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 7:00-8:00 AM 7:00-8:00 AM 7:00-8:00 AM 8:00-8:15 AM 8:15-8:30 AM 8:30-9:15 AM 9:15-9:30 AM 9:30-10:45 AM 10:45-11:15 AM 11:15 AM-12:30 PM 12:45-1:45 PM 12:45-2:00 PM 1:45-2:05 PM 1:45-2:30 PM 1:45-2:30 PM 2:10-2:30 PM 2:45-4:00 PM 4:00-4:15 PM 4:15-5:30 PM 5:30-6:45 PM

Continental Breakfast Continental Breakfast to Welcome First-Time Attendees Affinity Group Peer-to-Peer Networking Continental Breakfast Welcome from the Conference Co-Chairs Welcome from PRIM&R’s Executive Director Keynote Address: John T. Wilbanks Break Panels I, II, III Coffee break Innovations in… Series Common Ground Networking Lunch with the Supporters and Exhibitors Research Ethics Book Group Lunch Demonstration of PRIM&R’s Ethical Research Oversight Course Meet and Greet the 2014 AER Conference Poster Authors Meet and Greet the Conference Supporters and Exhibitors Demonstration of PRIM&R’s Knowledge Center Didactic Sessions and Workshops Series A Coffee break Panels IV, V, VI 2014 AER Conference Welcome Reception

Exhibit Hall FG Room 314-317 Room 309-310 Exhibit Hall E Exhibit Hall E Exhibit Hall E

See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG Room 314-317 Exhibit Hall FG Exhibit Hall FG Exhibit Hall FG Exhibit Hall FG See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG

Sunday, December 7 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Continental Breakfast Welcome from the Conference Co-Chairs Membership Update Keynote Address: Susan E. Lederer, PhD Break Didactic Sessions and Workshop Series D Coffee Break Didactic Sessions and Workshops Series E Lunch The Uncomfortable Conversation: Talking about Diversity Lunch Living Room Conversation: An Update on the Henrietta Lacks Case

Exhibit Hall FG Exhibit Hall E Exhibit Hall E Exhibit Hall E

See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG Room 328 Exhibit Hall E

Baltimore, MD

7:00-8:00 AM 8:00-8:15 AM 8:15-8:30 AM 8:30-9:15 AM 9:15-9:30 AM 9:30-10:45 AM 10:45-11:15 AM 11:15 AM-12:30 PM 12:45-1:45 PM 12:45-1:45 PM 2:00-3:15 PM

n

Continental Breakfast Exhibit Hall FG CIP® Continental Breakfast Room 314-317 Welcome from the Conference Co-Chairs Exhibit Hall E Presentation of the ARENA Legacy and Distinguished Service Awards and Exhibit Hall E Announcement of the Felix Gyi Memorial CIP® Scholarship Keynote Address: Anthony S. Fauci, MD Exhibit Hall E Break

Panels VII, VIII, IX See schedule for room locations Coffee break Exhibit Hall FG Didactic Sessions and Workshops Series B See schedule for room locations Lunch Exhibit Hall FG Affinity Group Peer-to-Peer Networking Lunch Room 314-317 Policy and Practice Recommendations for Ethical Sharing and Room 336 Use of Biospecimens/Data Speed Mentoring Exhibit Hall FG Meet and Greet the Conference Supporters and Exhibitors, and View the Exhibit Hall FG 2014 AER Conference Poster Presentations Didactic Sessions and Workshops Series C See schedule for room locations The Drama of DNA: An Interactive Play (Light refreshments will be served.

Ballroom I & II Show starts at approximately 4:45 PM.) Young Professionals Networking Reception Pratt Street Ale House

December 5-7

7:00-8:00 AM

7:00-8:00 AM

8:00-8:10 AM

8:10-8:30 AM

8:30-9:15 AM

9:15-9:30 AM

9:30-10:45 AM

10:45-11:15 AM

11:15 AM-12:30 PM

12:45-1:45 PM

12:45-1:45 PM

1:30-2:45 PM

1:45-2:45 PM

1:45-2:45 PM

3:00-4:15 PM

4:30-6:00 PM

6:30-8:30 PM

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Saturday, December 6 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

PRIM&R’s 2014 Advancing Ethical Research Conference

Thursday, December 4 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

FACULTY Faculty List Plenary and Keynote Biographies

74 81

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

86

SUPPORTERS & EXHIBITORS

94 95 96 97

ABOUT PRIM&R Board of Directors Staff CIP® In Memoriam

98

MAPS

112

posters

SCHEDULES Schedule: December 4 Your Guide to the Conference Schedule Your Guide to the Tracks Schedule: December 5-7 CME Accreditation Statement

56 64

NOTES

supporters & exhibitors

Common Abbreviations and Acronyms

maps

HRPP Human Research Protections Program IOM Institute of Medicine IRB Institutional Review Board IDE Investigational Device Exemption IND Investigational New Drug NCI National Cancer Institute NIH National Institutes of Health NSF National Science Foundation OHRP Office for Human Research Protections OIG Office of Inspector General ORI Office of Research Integrity PHS US Public Health Service PRIM&R Public Responsibility in Medicine and Research QA Quality Assurance QI Quality Improvement SACHRP Secretary’s Advisory Committee on Human Research Protections SBER Social, Behavioral, and Educational Research VA US Department of Veterans Affairs WHO World Health Organization

about PRIM&R

AAAS American Association for the Advancement of Science AAHRPP Association for the Accreditation of Human Research Protection Programs, Inc. ARENA Applied Research Ethics National Association, PRIM&R’s former membership division CCPC Core Conference Planning Committee CBER Center for Biologics Evaluation and Research (FDA) CDRH Center for Devices and Radiological Health (FDA) CDC Centers for Disease Control and Prevention CIP® Certified IRB Professional CME Continuing Medical Education CIOMS Council for International Organizations of Medical Sciences DOD US Department of Defense DOE US Department of Energy DHHS US Department of Health and Human Services EPA US Environmental Protection Agency FDA US Food and Drug Administration GCP Good Clinical Practice HIPAA Health Insurance Portability and Accountability Act

faculty

14 15 16 18 55

CONFERENCE INFORMATION Welcome from PRIM&R’s Executive Director Welcome from the Conference Co-Chairs Announcements & Reminders Affinity Groups Continuing Education Credits Scholarships ARENA Legacy Award Distinguished Service Award

schedules

2 3 4 8 10 11 12 13

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Contents

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Welcome from PRIM&R’s Executive Director Dear Friends, Thank you for joining us at PRIM&R’s 2014 Advancing Ethical Research (AER) Conference: 40 Years of Human Research Protections: Reflecting on the Past, Shaping the Future. My colleagues and I are so pleased to welcome you to Baltimore for this opportunity to learn, share, and connect around our common goal of advancing the highest ethical standards in human subjects research.

This is a special meeting for us. PRIM&R celebrated its 40th anniversary this year, and as with all such milestones, this one presented an occasion to reflect on our four decades of promoting humane and ethically responsible research programs with human subjects and animals, and to look forward to the challenges and opportunities ahead.

As you can see in the pages that follow, this year’s conference does just that. Using our shared history and experiences—around the HIV/AIDS epidemic, the use of Henrietta Lacks’ tissue, and the conduct of research across national borders, among other things—as jumping off points, we will examine topics as wide-ranging as privacy and confidentiality, race, the relationship between clinical care and research, and the role of subjects and communities in research, and how our thinking on each has evolved. We will also explore emerging topics such as the Facebook emotional contagion study, patient-centered outcomes research, genomic data sharing, mobile health technologies, and e-consent, as well as perennial issues around determining risk and benefit, IRB administration and education, protocol review, vulnerable populations, conflict of interest, and ethical study design.

Such content diversity wouldn’t be possible without the many volunteers and professionals who contributed to this endeavor. First, I’d like to thank Boston University School of Medicine and the Association of American Medical Colleges for their ongoing support of this meeting. We appreciate their assistance in making this learning experience possible for our community.

I also want to thank our three planning committees who worked tirelessly over many months to craft this exceptional program. They did so under the wise and capable leadership of our six co-chairs: Susan Z. Kornetsky and David H. Strauss (CCPC), Susie R. Hoffman and Elyse I. Summers (Workshop/Didactic Sub-committee), and Susan S. Fish and Nancy A. Olson (Poster Abstract Subcommittee). We couldn’t have asked for more dedicated stewards of the planning process.

Thanks, too, to more than 300 conference faculty members, more than 100 poster presenters, and 13 Affinity Group facilitators who will spend our time together providing you

with the most current information, the newest and best practices, and their professional expertise and wisdom, so that you might return to your institutions ready and able to strengthen your research programs. We’re grateful for their leadership and many hours of careful preparation.

Finally, thank you for being here and demonstrating your commitment to advancing ethical research. It’s an exciting, but challenging time to be involved in the research enterprise: regulatory change is in the air, budgets are tight, and research technologies and methodologies are evolving—and you’re expected to keep up with it all!

Fortunately, you have come to the right place. At the 2014 AER Conference, you’ll have many opportunities to attend thought-provoking and hands-on sessions, browse posters, visit with exhibitors, network with colleagues, and seek expert advice. I encourage you to find the combination of activities that best addresses the challenges you face. And, if you have an idea for something you’d like to see at a future conference, please let us know by filling out the evaluation.

Before I close, I wanted to mention a second reason this year’s meeting is special, one that’s much more personal.

This is my first AER Conference as PRIM&R’s executive director. I was honored to take the helm back in April and I have embraced this opportunity to serve PRIM&R’s extraordinary and diverse community. I’ve spent much of the past eight months listening to members of our community as they share with me their challenges and priorities, and their hopes for PRIM&R’s future. I look forward to meeting many more of you over the next few days, and hearing about how PRIM&R can continue to support you. Please introduce yourself when you see me out and about!

Again, thank you for being here. I hope you leave Baltimore armed with new colleagues and friends, fresh ideas, and a renewed sense of purpose.

Kind regards,

Elisa A. Hurley, PhD Executive Director

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Welcome to the 2014 AER Conference and to Baltimore. As your conference co-chairs, we are pleased to share with you the conference schedule developed by this year’s planning committees and by you.

For 40 years, PRIM&R has hosted educational events where professionals gather to consider and learn about ideas related to research ethics and human subjects protections. This year, we’ll examine how our field has evolved over the past four decades, reflect on our progress, and consider current challenges that will shape our future. While the conference will explore the larger ethical, social, and scientific context in which our work occurs, it will also offer essential tools to deepen your knowledge and enhance your skills. And, of course, there will be ample opportunity for networking.

The planning process for this year’s event started nearly a year ago, and involved more than 50 dedicated volunteers.

These individuals selected three keynote speakers, designed 13 plenary sessions, planned 134 breakout sessions, identified more than 300 faculty members, and reviewed 130 poster submissions.

The 2014 AER Conference will feature three keynote speakers. John T. Wilbanks, chief commons officer at Sage Bionetworks and an advocate for the use of technology to pool medical data, will speak about informed consent in the mobile era. Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, will join us to discuss the impact of the HIV/AIDS pandemic on research ethics. And, Susan E. Lederer, PhD, Robert Turell Professor of the History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health, will discuss the enduring legacy of Henry K. Beecher and his call for reform in clinical research ethics.

You can read more about these outstanding professionals on pages 64-73.

Our 13 plenary sessions were designed to speak to the diversity of interests and institutions our conference attendees represent, and will address issues related to privacy and confidentiality, the concept of race in research, the “Common Rule,” global health research, mobile health applications, and much more. In addition, we are honored that members of the family of Henrietta Lacks, along with Ruth Faden, PhD, MPH, director, Berman Institute of Bioethics, Daniel E. Ford, MD, MPH, vice dean for clinical investigation, Johns Hopkins School

of Medicine, and Kathy Hudson, PhD, deputy director for science, outreach, and policy, NIH, will join us on December 7 from 2:00 to 3:15 PM for a special closing session to discuss the controversies surrounding the HeLa cell line and the implications of a newly drafted agreement between the NIH and the Lacks family.

Finally, this year’s Annual Poster Presentation will include 104 posters displayed in The Conference Connection, nine of which will be highlighted during our Innovations in… panel series on December 5 from 11:15 AM to 12:30 PM. Please also join us on December 5 from 1:45 to 2:30 PM in The Conference Connection to talk with all the poster authors about their important work.

Thank you for contributing your ideas, feedback, and perspective; it makes this conference stronger. More than any prior AER Conference, this year’s meeting was shaped by your suggestions and proposals. We received 104 submissions through our Call for Session Proposals and Speaker Suggestions, 32 of which were accepted as sessions (these are represented by a “star” icon on the program). Don’t forget to submit a session proposal or poster abstract for the 2015 AER Conference. Visit www.primr.org/aer15 for more details.

Welcome, again, to the 2014 AER Conference. We are confident you will enjoy the meeting and a conference schedule that is content-rich, current, and exciting. We expect you will return to your institutions inspired by novel ideas and innovative strategies, as well as better connected with others in the field who share your passion for human subjects protections.

Warmly, Susan Z. Kornetsky, MPH Director, Clinical Research Compliance Boston Children’s Hospital David H. Strauss, MD Director of Psychiatric Research, New York State Psychiatric Institute; Vice Chair for Research Administration, Ethics, and Policy, Columbia University Department of Psychiatry d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

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Welcome from the Co-Chairs

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Announcements & Reminders Baltimore’s Show Your Badge Program

You are eligible for exclusive discounts at Baltimore’s many restaurants and attractions! Show your conference badge at participating establishments to receive a special promotion or discount. For a complete list of participants, to make reservations, or to plan your itinerary, stop by the Convention Concierge Desk located in the Pratt Street Lobby on Level 300.

Bookstore

Spotlighting books and other reference materials on human subjects protections, research ethics, and IRB management, the onsite Bookstore will offer the latest resources to those working in research oversight. The Bookstore is located in the Pratt Street Lobby on Level 300 and will be open during the following hours: • December 5: 7:00 AM-5:30 PM • December 6: 7:00 AM-3:00 PM • December 7: 7:00 AM-3:00 PM

Certificate of Attendance

• Use the My Planner function to select the sessions you don’t want to miss.

• Take notes directly on slides while you are watching presentations live.

• Connect with other attendees who are using the app.

• Get conference updates and announcements.

Download the free app in the Apple app store or Google Play store—just search for PRIM&R 2014 AER Conference app. Visit www.primr.org/aer14/app to learn more. PRIM&R would like to thank Evisions for sponsoring the conference mobile app.

Conference Dialogue and Discourse

The objective of PRIM&R’s educational programs and conferences is to provide a safe and respectful environment for attendees to increase their knowledge and understanding of ethical and regulatory requirements, learn best practices, grapple with both late-breaking and longstanding challenges, and confer with peers and experts in the research ethics field in a constructive way.

A certificate of attendance for the 2014 AER Conference will be provided to attendees upon completion of the online conference evaluation. Please note that this year attendees will be emailed an evaluation at the conclusion of each conference day on December 5, 6, and 7. The certificate of attendance will be included at the end of the evaluation that will be sent on December 7.

PRIM&R is committed to being an impartial convener within the research ethics field, which encompasses people with a range of differing opinions. PRIM&R values freedom of expression, constructive and respectful dialogue, and spirited discussion, as they are essential to finding common ground and advancing the goal of responsible, ethical conduct of research with human subjects and animals.

Certificates of attendance for the pre-conference programs will also be available upon completion of the course evaluation, which will be emailed to attendees on December 4.

To preserve the objectives and integrity of its educational programming and conferences, PRIM&R will not tolerate the disruption of conference sessions that results in:

Such certificates are useful for obtaining continuing education credits from various professional associations.

Please note that each association’s guidelines for acceptance of conference credit hours may differ, and you should consult the appropriate association representative for information as to whether, and how many, credits from PRIM&R conferences may be used.

Charging Station

Forgot your charger? Don’t worry! Visit the charging station located in the Pratt Street Lobby to charge your phone, laptop, iPad, or other electronic devices.

PRIM&R would like to thank Schulman Associates IRB for supporting the charging station.

Conference Mobile App—New in 2014!

Enhance your conference experience with the 2014 AER Conference app: • Access the conference schedule, session materials, speaker profiles, and exhibitor information.

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• The inability for the learning objectives of sessions to be met • The inability for dialogue, discussion, debate, learning, and/or networking to take place • Harassment, badgering, or verbal threats • The use or threat of physical force by any individual or group of individuals against another • Destruction of property Aisle microphones will be set up in the keynote and plenary sessions, so please come forward with questions and/ or comments. In the interest of promoting learning for all participants, please keep questions and comments as brief and on-point to the session topic as possible, identify yourself when you ask your question, and be mindful of others who wish to participate in the discussion.

Courtesy Reminder

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

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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 Exhibit Hall FG on Level 100. An emergency medical technician will be available during the following hours: • December 4: 7:00 AM-6:00 PM • December 5: 7:00 AM-6:30 PM • December 6: 7:00 AM-6:00 PM • December 7: 7:00 AM-3:30 PM

Help Us Improve

Our goal is to make each AER Conference a positive experience for all who attend, but we can’t do it without you. We want to hear your thoughts on what we did well and what we could do better. Please use the notepaper in the back of this guide to capture your thoughts, and then take a few minutes to complete the daily evaluations, which will be emailed to you at the conclusion of each conference day on December 5, 6, and 7. Thank you in advance for your feedback.

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

In Case of Emergency

First-Time Attendees

In case of an emergency onsite, please do not dial 911 from your cell phone. Rather, please dial 7055 from any house phone to be connected to the Public Safety Office, or you may also see a PRIM&R staffer at the Help Desk for assistance.

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

Handouts To access session materials using the interactive schedule: 1. Visit bit.ly/aer14schedule.

2. Locate the specific session on the full schedule by scrolling or using the search field. You can also search by clicking on the Conference Schedule, which allows you to browse by date, title, target audience, track, Affinity Group, or keyword.

3. If materials are available for a session, a document icon will appear next to or below the session title.

4. Click on the session title to access the materials.

5. Enter the handout code found on the back of your name badge (this was also emailed to you before the conference).

Alternatively, you can access conference handouts using the conference app: 1. Search for PRIM&R 2014 AER Conference in the Apple app store or Google Play store.

2. Download the app.

3. Once you have set up your app account, click on the Presentations icon.

4. B rowse by day, session title, speaker, or track to find the session you are looking for. Click on the session.

5. Sessions with materials available have either a Handout button or a View Slides button available.

Please check the interactive schedule and conference app periodically, as additional materials are posted as they are received. Please note that not all sessions have handouts.

You may print materials for any and all of the sessions that interest you. After the conference, audio and video recordings for designated presentations will be accessible through the interactive schedule.

If friends or family need to contact you and cannot reach you directly, they should call the Baltimore Convention Center’s Public Safety Office, which is staffed 24 hours a day, seven days a week at 410.649.7055.

Internet Café and Wireless Internet

Want to check email, access the conference app from your mobile device, or review the conference handouts electronically? You’re welcome to use one of the computers in the Internet Café located in the Pratt Street Lobby on Level 300, or you may connect wirelessly using your own device. To access the wireless internet, select PRIMR2014 from your list of wireless networks and enter baltimore as the password.

If you are using a smartphone or tablet, please connect to the wireless network using the instructions above. Please note that you will have to open your web browser and enter the user name and password before you can use any application requiring the internet.

Please log off the wireless internet when you are not using it, and please refrain from downloading large files.

PRIM&R would like to thank Schulman Associates IRB for supporting the wireless internet.

Job Board

Stop by the job board in the Registration area to browse job descriptions from employers across the country.

Lead Retrieval at the 2014 AER Conference

In an effort to help facilitate connections between our attendees and supporters and exhibitors, a lead retrieval system will be used by supporters and exhibitors. A quick response (QR) code that stores your contact information (name, title, institution, and email address) as it appears in our database is printed on your name badge. While you’re in The Conference Connection, supporters and exhibitors participating in the lead retrieval program may ask to scan your badge in order to collect your contact d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

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Announcements & Reminders information. Please note this service is optional and meant to be helpful to those looking for information and those wanting to provide it. You may decline to have your badge scanned. Please visit the Help Desk if you have questions.

Lost and Found

Please dial 7055 from any house phone to be connected to the Public Safety Office for assistance with lost and found items.

Luggage Storage

On the morning of your departure, we recommend that you check your luggage at the bell stand of your hotel and plan to return there prior to your departure. If you need to bring your luggage to the Baltimore Convention Center, there will be an unmanned luggage storage area available in the Pratt Street Lobby on Level 300 from 7:00 AM to 4:00 PM on December 7. Please note, PRIM&R is not liable for the items stored in this space.

“M” on Badges

The letter “M” on your badge designates your status as a member of PRIM&R. If there is no “M” on your badge and you would like to become a member, please visit the Help Desk.

Messages

Looking for a colleague? Please post messages to the bulletin board located in the Pratt Street Lobby.

Name Badges and Agendas

Please wear your name badge at all times. Please note the personalized agenda included with your name badge may not reflect the most recent schedule changes or cancellations, so please double check your schedule against the daily schedules emailed to you each day and available at Registration.

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 at Registration. Networking ribbons are designed to enhance community building and to help you connect with colleagues who share similar professional experiences.

Nursing Mothers

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

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Onsite Photography

A professional photographer will be onsite to capture images from this event, as part of PRIM&R’s efforts to create an enduring photo archive. We hope you are willing to be a part of it. Photos taken at this year’s conference may be used on our website and/or for other promotional purposes.

If you do not wish to have your photograph taken and used

by PRIM&R, please alert the photographer. We are using passive consent for this project, but the photographer has been instructed to honor the request of anyone not wishing to be photographed.

PRIM&R’s Green Initiatives

We’re doing our best to make the 2014 AER Conference another “green” PRIM&R meeting, and hope you’ll join us in our efforts! PRIM&R’s environmentally conscious initiatives include: using an electronic evaluation; providing a reusable tote bag; printing this guide using soy-based ink; and using a printer for this guide that runs entirely on wind energy.

The Baltimore Convention Center is also devoted to maintaining and cultivating green meeting practices. The Center’s policies and practices include, but are not limited to: reduced waste through use of china dinnerware and recycling paper, plastic, bottles, and cans; decreased electricity consumption due to lighting and motion sensors in meeting rooms; and conserved energy through a sustainable local purchasing system.

Registration and the Help Desk Registration and the Help Desk are located in the Pratt Street Lobby on Level 300, and will be open during the following hours: • Wednesday, December 3: 4:00-7:00 PM • Thursday, December 4: 7:00 AM-6:00 PM • Friday, December 5: 7:00 AM-5:30 PM • Saturday, December 6: 7:00 AM-4:30 PM • Sunday, December 7: 7:00 AM-12:00 PM (except the Help Desk, which closes at 3:00 PM) Please stop by the Help Desk with questions, and a PRIM&R staff member will be happy to assist you.

Religious Observance and Prayer

For those requiring a quiet space to pray and/or observe other religious practices during our conference, PRIM&R has set aside Room 350 on Level 300 for your use. This room will remain open to all throughout the conference.

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Sessions

To keep the conference running on time, please familiarize yourself with the location of the sessions you plan to attend, so you can arrive promptly at the session’s start time. 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. Also, it’s important that you attend the sessions for which you pre-registered, as space is limited. Please refer to the schedule in this guide for more information.

Shipping, Fax, and Photocopy Services ABC Imaging Business Center, located in the Pratt Street Lobby on Level 300, offers shipping, mailing, faxing, and photocopying services. The business center is open as follows: • December 4: 8:00 AM-6:00 PM • December 5: 8:00 AM-6:00 PM • December 6: 8:00 AM-6:00 PM • December 7: 8:00 AM-4:00 PM

Special Meals

If you indicated a specific dietary request as part of your registration, please alert a server to your needs before you are seated. Please see a PRIM&R staff member (wearing a staff badge) in the meals rooms or at the Help Desk with questions or concerns.

The Conference Connection Join us in The Conference Connection—home to the supporters and exhibitors, poster presentations, the PRIM&R Pavilion, breakfast, lunch, morning and afternoon breaks, and the welcome reception.

The Conference Connection is located in Exhibit Hall FG on Level 100 and will be open during the following hours:

December 5: 7:00-8:00 AM

10:45-11:15 AM 12:45-2:30 PM 4:00-4:15 PM 5:30-6:45 PM

December 6: 7:00-8:00 AM

10:45-11:15 AM 12:45-2:45 PM

December 7: 7:00-8:00 AM

10:45-11:15 AM 12:45-1:45 PM Map of The Conference Connection can be found on page 98 of this guide. d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

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Affinity Groups To help those attending the 2014 AER Conference connect with colleagues with similar responsibilities and interests, PRIM&R hosts Affinity Groups (AGs). These small groups share areas of specialized professional interest, and are designed to foster networking and community building before, during, and after the conference.

Color-coded networking ribbons are available to help members identify one another, based on the color of the AG titles below. Also, the conference sessions that would be of interest to members of each AG are listed below.

2014 AER Conference AGs Global Research: This AG is for non-US-based research professionals and US-based professionals working outside North America who are interested in the conduct of ethical research across geographic and cultural borders.

Facilitators: Karen Hansen, Paul Ndebele, PhD, and Paulina O.Tindana, DPhil Sessions/Tracks: Innovations A, Panel II, Panel VIII, Global Research Track, A25, D18, E10 IRB Administrators/Coordinators: This AG is for IRB administrators and coordinators interested in networking with one another to discuss best practices, challenges and solutions, share resources and strategies, and learn more about career development.

Facilitators: Donna Hogan, LPN, CIP, CCRC, CHRC, and Melissa Schlenker, MS, CCRC, CIP Sessions/Tracks: Innovations A, Innovations B, Innovations C, Panel I, Panel II, Panel III, Panel IV, Panel V, Panel VI, Panel VII, Panel VIII, Panel IX, Living Room Conversation, A Dialogue with the Feds I and II Tracks, Advanced Forum for IRB Professionals Track, Educating and Training Track, IRB Boot Camp Track, IRB Operations and Toolkit Track, QA/QI and Post-Approval Monitoring Track, Regulatory Balance Track, Research Involving the Internet & Social Networking Track, Self-Assessment and Accreditation Track, Small Research Programs Track, SBER I – Basic Track, SBER II – Advanced Track, A6, A8, A9, A12, A16, B5, B7, C5, C7, C13, C16, C18, D9, D16, D18, E6, E18, E27 IRB Chairs: This AG is for IRB chairs interested in engaging with each other about “hot button” issues and everyday aspects of their positions.

Facilitators: J. Andrew Bertolatus, MD, and Patience Stevens, MD, MPH Sessions: Innovations A, Innovations B, Innovations C, Panel I, Panel II, Panel III, Panel IV, Panel V, Panel VI, Panel VII, Panel VIII, Panel IX, A Dialogue with the Feds I and II Tracks, Advanced Forum for IRB Professionals Track, Empirical Research Ethics Track, Ethical Issues Track, FDA Regulations Track, Global Research Track, HRPP Leadership and Institutional Officials, Issues for Pharma/Biotech Track, Legal Track, Out of Body Experiences: Research Involving Tissue and Data Track, Platinum Supporter Track, Populations Requiring Additional Protections Track, Potpourri Track, Regulatory Balance Track, Research Involving the Internet & Social Networking Track, SelfAssessment and Accreditation Track, Small Research Programs Track, SBER I – Basic Track, SBER II – Advanced Track, A19, B19, C10, E10 Non-Scientist IRB Members: This AG is for non-scientist IRB members interested in discussing essential, basic scientific topics and strategies for IRB review, as well as connecting with others in this role.

Facilitators: Troy Brinkman, JD, MA, CIP, and Dahron Johnson, BA Sessions: Innovations A, Innovations B, Innovations C, Panel I, Panel II, Panel III, Panel IV, Panel V, Panel VI, Panel VII, Panel VIII, Panel IX, A Dialogue with the Feds I and II Tracks, Empirical Research Ethics Track Issues for Pharma/Biotech Track, Global Research Track, Non-Scientist IRB Members, Populations Requiring Additional Protections Track, Research Involving the Internet & Social Networking Track, SBER I – Basic Track, SBER II – Advanced Track, A18, A20, B6, B11, B12, B15, B16, B19, B20, C6, C11, C15, C20, D6, D12, D15, D18, E22, E26, E27

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Small Research Programs: This AG is geared toward those working in small research programs, recognizing that “small” is typically a self-imposed designation, and may be given on one or more of the following bases: protocol workload, number of full-time equivalent (FTE) IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a “small” research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.

Facilitators: Neha Kaul, MS, MA, and Greg Manship, D.Bioethics MDiv, CIP, CIM Sessions: Small Research Programs Track, IRB Boot Camp Track, IRB Operations and Toolkit Track, A9, A19, B22, C13, C22, D9, D13, D18, D19, D22, E19, E20 SBER: This AG is for those involved and/or interested in the conduct and review of SBER. Facilitators: Katherine Lerner, JD, CIP, and Laura Moll, CIP, MA Sessions: Panel II, Panel V, Panel VII, Panel VIII, SBER I – Basic Track, A20, A21, A25, C23, C25, D25, E24

2014 AER Conference AG Onsite Activities

Members of the AGs have access to the following onsite activities: •O ne-on-one meetings with AG facilitators (times set by facilitators; please see your AG facilitator welcome letter) • AG Peer-to-Peer Networking Continental Breakfast on December 5, 7:00-8:00 AM in Room 319-320 • AG Peer-to-Peer Networking Lunch on December 6, 12:45-1:45 PM in Room 314-317

Interested in participating in an AG at the 2014 AER Conference?

Visit the Help Desk in the Pratt Street Lobby located on Level 300 and a PRIM&R staff member will happily assist you.

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conference information

Continuing Education A certificate of attendance for the 2014 AER Conference will be included at the end of the evaluation that will be sent on December 7. Certificates of attendance for the pre-conference programs will also be available upon completion of the course evaluation, which will be emailed to attendees on December 4.

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

A maximum of 18.75 CE credit hours are available for the 2014 AER Conference. Credit hours for the preconference programs vary depending upon the duration of the course.

CME Credits

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 providership of Boston University School of Medicine and PRIM&R. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Boston University School of Medicine designates this live activity for 18.75 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 18.75 hours of risk management study.

CME eligible sessions are noted with a conference schedule.

icon on the

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CME applications will be available online at https://www.surveymonkey.com/s/PRIMR2014.

Attendees must complete the online claim for credit and evaluation form within four weeks of the conference to receive a CME certificate. Once the forms are completed, a certificate will be issued by Boston University School of Medicine. For more information about CME credits, please visit the Help Desk in the Pratt Street Lobby located on Level 300.

Please note we do not offer specific credit for nurses, pharmacists, and members of other professions not already listed here. You are welcome to apply for such credits on your own using the certificate of attendance included at the end of the evaluation that will be sent on December 7.

CIP® Recertification

CIPs who are eligible to recertify by CE may earn a maximum of 18.75 CE credit hours issued by a recognized accrediting body at the 2014 AER Conference. Sessions that meet CIP® recertification requirements are designated with a blue icon on the conference schedule. Please note that only those sessions that are marked with both the blue icon and the green icon count towards accredited hours.

Additional information on qualifying CE activities for CIP® recertification purposes can be found at www.primr.org/certification.

Global Research Scholarship Program

PRIM&R is dedicated to improving communication among research ethics committees (RECs), researchers, and other professionals involved in international research. This is especially important today as more and more research is being conducted outside of the United States. Many RECs in low- to middleincome countries lack adequate funding to develop their research programs, and thus may not be able to build strong research ethics oversight into these programs.

Therefore, there is an urgent need to increase awareness and facilitate networking and collaboration among those involved in research globally.

Many thanks to CITI for helping to support this year’s Global Research Scholarship Program!

Institutional Capacity Building Scholarship Program

Many small, underfunded institutions of higher education in the United States need—and lack—fully

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

Community (Unaffiliated/Non-Scientific) IRB Member Scholarship Program

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

Pillars of PRIM&R Award Jeanelle Graham, BS, MPH, is the recipient of the 2013-2014 Pillars of PRIM&R Award. Ms. Graham is a research compliance specialist at the University of Alabama at Tuscaloosa. Her poster abstract, titled Pillars of PRIM&R Project: Effects of an In-Meeting Intervention on Meeting Length, Approval Time, and Member Satisfaction, will be on display in The Conference Connection at the 2014 AER Conference.

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Scholarships

conference information

2014 ARENA Legacy Award The ARENA Legacy Award recognizes PRIM&R members who have made an exemplary contribution to the mission and goals of PRIM&R by actively promoting the ethical conduct of research through mentoring, teaching, and leadership. This award was developed not only to recognize the chosen individual(s), but also to honor the living legacy created by ARENA, which was the membership division of PRIM&R from 1986 to 2006.

PRIM&R is proud to announce that Susie R. Hoffman, RN, BSN, CIP, has been selected as the 2014 recipient of PRIM&R’s ARENA Legacy Award.

Ms. Hoffman is a longtime PRIM&R leader and teacher, having been a member of the organization since 1999 and a faculty member for 12 consecutive conferences. During that time, Ms. Hoffman served as a member of the former ARENA Council (2004 and 2005), president-elect of the ARENA Steering Committee (2005), president of ARENA (2006), a member and chair of the Membership Committee (2006-2011 and 2006-2007, respectively), a member of the Poster Abstract Sub-committee (2010), and a co-chair of the Workshop/Didactic Sub-committee (WDSC) for PRIM&R’s AER Conference (2005, 2006, and 2012-2014).

Given this long list, it is clear that Ms. Hoffman unfailingly devotes incredible amounts of time, energy, thought, and passion to PRIM&R, and for that, we thank her.

As Ms. Hoffman’s nominator put it: “ Having worked closely with Susie during her last four years of service on the AER Conference WDSC (the last three of those years as its co-chair), I have seen Susie’s awe-inspiring dedication to serving as a leader in the field. She leads the WDSC with a firm, but gentle hand, inspiring great confidence and discipline in all of the committee members. Under her co-leadership, the committee’s work has become more efficient and streamlined, and the conference programs that resulted have been some of PRIM&R’s most exciting, diverse, and thoughtfully put together. Susie is always willing to spend extra hours making sure that conference sessions are in the best shape they can be, and that we are choosing faculty speakers as wisely as we can be.

Susie’s breadth and depth of knowledge as she leads the WDSC is remarkable. It is evident in absolutely everything Susie does that she cares deeply about providing the PRIM&R community with the highestquality educational programming possible. In all of these ways, she is an inspiring leader and remarkable asset not just to PRIM&R and its community, but to the human subjects protections field.” p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

This commendation is just one testament to Ms. Hoffman’s dedicated volunteer work that has so greatly benefited the PRIM&R community, including the attendees who have joined us here in Baltimore for the 2014 AER Conference.

Ms. Hoffman’s commitment to advancing ethical research is longstanding. She has served as the director of the IRB for Health Sciences Research at the University of Virginia (UVA) since 1999. In this role, Ms. Hoffman manages UVA’s educational program for IRB members, research investigators, and study coordinators. A nurse by education, she has worked in the research field since 1987—as both a research coordinator and as the director of clinical trials for a radiopharmaceutical company.

PRIM&R is especially grateful to Ms. Hoffman for her leadership in membership growth. The year she was president of ARENA, PRIM&R experienced a 27% increase in its membership community. While serving on PRIM&R’s Membership Committee, Ms. Hoffman championed the PRIM&R Regional Connections program, a benefit designed to help members connect locally by providing small grants to support networking and continuing education events.

She has supported the regional model in her home state of Virginia, as well. The Virginia IRB Consortium Conference, an annual educational event that has received PRIM&R Regional Connections funding, has thrived and grown under Ms. Hoffman’s guidance and leadership, educating hundreds of individuals working in the field of human subjects protections in Virginia and other nearby states.

Ms. Hoffman continues to influence and shape the landscape of the PRIM&R community, and thus with tremendous gratitude for her valuable contributions we present her with the ARENA Legacy Award.

PRIM&R’s 2014 ARENA Legacy Award will be presented to Ms. Hoffman on December 6 at 8:10 AM in Exhibit Hall E.

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

PRIM&R is pleased to announce that Paula L. Knudson has been selected as the 2014 recipient of PRIM&R’s Distinguished Service Award.

A longtime mentor of IRB members and administrators, Ms. Knudson has actively supported the education of anyone who expresses an interest in learning about ethical research. As noted by Ms. Knudson’s nominator: “ Ms. Knudson has educated the clinical research community in the Texas Medical Center, the largest medical center in the world, on a variety of topics related to human subjects protections, ethics, and IRB history. As I have said before, if clinical research had a coin, she would be on one side of it for her dedication to ethical conduct and promoting GCP. She has worked with everyone in and out of academic medical institutions, [the] Society of Clinical Research Associates, [the] Associat[ion] of Clinical Research Professionals, and helped found the Association of Clinical Research Nurses, on which the International Association of Clinical Research Nurses is based.

She also participates in research to ‘walk the walk’ and routinely provides stories and examples of how to conduct research keeping in mind the regulations and spirit of ethics in all we do.”

This is but one of many testimonials to Ms. Knudson’s dedication to educating those in our field. She has inspired generations of medical students and researchers, imparting the importance of ethical conduct in research, while teaching ways to operationalize the Belmont principles in everyday practice. Although she has held many positions, Ms. Knudson has always taken it upon herself to teach those around her.

For the last 10 years, Ms. Knudson has served as the special advisor for human subject research and faculty in the Center for Clinical Research and Evidence Based Medicine at The University of Texas Health Science Center Houston (UTHSCH). Previously she was the executive coordinator for the Committee for the Protection of Human Subjects for 27 years.

In addition to the many contributions she has made at UTHSCH, Ms. Knudson has also been a leader in the field of human subjects protections. She was instrumental in providing commentary on the emergency waiver provision of 45 CFR 46, and has similarly worked with Office for the Protection from Research Risks, OHRP, and FDA when new regulations and guidance were being considered. As noted by one of the two individuals who nominated her, Ms. Knudson “has been a voice for the protection of research participants since the beginning.” She has many interests within the human subjects protections field, including community consultation, HIV/AIDS, international research, conflicts of interest, and the inclusion of women and minority populations in research, to name a few.

Ms. Knudson has been a driving force within the PRIM&R community as well. She has served on the planning committees and as faculty at nearly every PRIM&R human subjects protections conference since the 1980s, and hosted four successful conferences in Houston.

Ms. Knudson has served as a member of the IRB 101sm faculty, and has taught nationally and internationally. She served on PRIM&R’s Board of Directors from 1984 to 2010, helping guide the organization from its early years to the thriving entity that we know today. She served on the Board’s Nominations and Elections Sub-committee for six years and on the Governance Committee for four years.

Ms. Knudson also served as creator and editor of PRIM&R Through the Years, a compilation of presentations from more than 50 PRIM&R conferences held between 1974 and 2005.

Ms. Knudson is passionate about her work and dedicated to the advancement of ethical research as evidenced by her continuing commitment to both PRIM&R and those working in the field. It is truly a pleasure and an honor to bestow this award upon her.

PRIM&R’s 2014 Distinguished Service Award will be presented to Ms. Knudson on December 6 at 8:10 AM in Exhibit Hall E.

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2014 Distinguished Service Award

schedules

Schedule Schedule: Thursday, December 4 Recognition Conference Information PRIM&R’s 2014 AER Pre-Conference programs will be held on Thursday, December 4. Only those attendees who pre-registered are able to participate in these courses.

A continental breakfast will be served from 7:00 to 8:30 AM in Ballroom III. Boxed lunches will be provided for all sessions, also in Ballroom III. Please review your program’s agenda, as lunch times differ for each course. All those registered for pre-conference programs are welcome to attend the Pre-Conference Programs Networking Reception, from 4:30 to 6:00 PM in the Camden Lobby. Light refreshments will be served.

Certificates of attendance for pre-conference programs will be provided to attendees upon completion of the online evaluation. A link to the evaluation will be sent to attendees via email on December 4. The number of continuing education credits will differ for each course, and will be listed on the certificate of attendance.

Thursday, December 4 8:30 AM-5:00 PM Room 336

AHRPP Accreditation: Everything You A

8:30 AM-4:30 PM Room 339-340

Faculty: John R. Baumann, PhD; Wesley G. Byerly, PharmD; Sarah Giannakopoulos, MA; Sarah H. Kiskaddon, JD, MA; Kathleen Lawry, CIP, MSSA, LISW; Scott J. Lipkin, DPM, CIP; Judy Matuk, MS; Wayne Patterson, PhD; Sujatha Sridhar, MBBS, MCE; Elyse I. Summers, JD; Candice A. Yekel, MS

8:30 AM-4:30 PM Room 331-332

Need to Know About Becoming an Accredited Organization

8:30 AM-4:30 PM Room 326

Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent Faculty: Moira A. Keane, MA, CIP; Daniel K. Nelson, MSc, CIP

8:30 AM-5:00 PM Room 324-325

Contemporary Issues in Biobanking: Engagement, Governance, and Trust

Faculty: Mark Barnes, JD, LLM; Marianna J. Bledsoe, MA; Lynn Dressler, DrPH; William (Bill) Grizzle, MD, PhD; Michele Russell-Einhorn, JD

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Critical Topics in SBER

Faculty: Dean R. Gallant; Lorna Hicks, MS, CIP

Fundamentals of Clinical Research and Study Design Faculty: Susan S. Fish, PharmD, MPH; Celia B. Fisher, PhD; Lindsay McNair, MD, MPH, MSBioethics

8:30 AM-4:30 PM Room 328

IRB 101sm

Faculty: Elizabeth Bankert, MA; Ada Sue Selwitz, MA 8:30 AM-4:30 PM Room 321-323

IRB 201: An In-Depth Analysis of the Criteria for Review Faculty: Karen N. Hale, RPh, MPH, CIP; Susan Z. Kornetsky, MPH

8:30 AM-4:30 PM Room 337-338

IRB Chairs Boot Camp: Tools for Successful IRB Leadership Faculty: Bruce G. Gordon, MD; James Feldman, MD, MPH, FACEP; Paul J. Reitemeier, PhD

Your Guide to the Conference Schedule

We advise you to use the session descriptors in the conference schedule to identify the sessions that are most relevant to you. As you consult these descriptions, please also note the following: 1. Double sessions are held over lunch and include a boxed meal. Attendees should pick this up at The Conference Connection located in Exhibit Hall FG before arriving at the session. Please note that preregistration was required for these sessions to help ensure adequate seating. If you did not pre-register, but would like to attend, please go to the session room and wait until the session starts to see if seats are available.

2. The tracks are not meant to be exclusionary; everyone is welcome to attend any session. For example, feel free to attend a session in the Legal Track even if you’re not an attorney, or a session in the Small Research Programs Track even if you’re not affiliated with a small research program.

3. Sessions marked basic provide an introduction to the given topic for individuals with little or no prior knowledge. These sessions can also be helpful to those in need of a refresher on the fundamentals.

Teaching mode will be mainly lecture and the focus will be on introducing, explaining, and illustrating basic concepts, principles, regulations, policies, and best practices.

4. S essions marked advanced assume mastery of central ethical concepts and principles, of the regulations, and of the processes of applying them to the day-to-day work of protocol review or other research oversight activities. These sessions aim to provide attendees with in-depth knowledge of an area and a robust set of skills required for addressing difficult problems and navigating “grey areas,”

improving their HRPPs, shaping their institutional cultures, or advancing their careers. Sessions will often make heavy use of active learning techniques, such as case studies and question-based lectures.

Attendees are expected to have sufficient experience and understanding in order to actively contribute to the discussion and the solution of difficult problems discussed. These sessions will not review basic concepts.

5. S essions that do not have a learning level are intended for all audiences.

Icon Key Indicates a didactic session (lecture-based) Indicates a workshop (interactive) Indicates a double session (hybrid workshop/ didactic sessions; see note above about double sessions) Indicates session will be recorded for Conference Proceedings Qualifies for CME credit Qualifies for CIP® recertification credit Pre-registration required. Please visit the Help Desk to inquire about availability.

Indicates a session chosen from our Call for Session Proposals

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schedules

The 2014 AER Conference features a wide variety of breakout sessions.

To help you gain the most from your conference experience, and to make the breakout sessions easier to navigate, they are organized into 26 thematic “tracks.” Within the tracks, we offer three types of breakout sessions: workshops (interactive), didactic sessions (lecture-based), and double sessions (hybrid workshops/didactic sessions that are twice as long as the regular breakout sessions).

Your Guide to the Tracks Recognition Conference Information schedules

TRACKS

DESCRIPTORS

1&2

A Dialogue with the Feds I and II

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

3

Advanced Forum for IRB Professionals

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

4

Educating and Training

This track will help attendees develop effective educational programs for the assorted stakeholders involved in human subjects protections. Faculty members in these sessions will also describe and discuss the various resources available for education and training.

5

Empirical Research Ethics

Through a series of presentations by institutions currently conducting research on IRBs, vulnerable populations, empirical ethics literature, and research in usual settings, this track will help attendees learn how to read and interpret empirical research ethics literature and make assessments on what counts as valid research.

6

Ethical Issues

This track will explore the underlying ethical principles of human subjects research and issues that may arise for HRPPs/IRBs when those principles are translated from the theoretical to the research setting.

7

FDA Regulations

This track will provide attendees with an opportunity to connect with representatives from the FDA about regulations and guidance that pertain to FDA-regulated clinical investigations.

8

Global Research

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

9

Hot Topics

This track consists of sessions addressing issues related to human subjects research that may be novel and/or particularly complex.

10

HRPP Leadership and Institutional Officials

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

11

IRB Boot Camp

This track is designed for those new to the field of human subjects protections and IRB review and administration, or those in need of a refresher. It will provide a rigorous training in the elements of IRB operations that are key to a successful HRPP.

12

IRB Operations and Toolkit

This track is designed to provide IRB administrators, coordinators, and other professionals with practical tools and strategies to achieve administrative efficiency and effectiveness.

13

Issues for Pharma/ Biotech

This track will provide representatives from HRPPs and drug, device, and biotechnology industries with an opportunity to discuss topics of mutual interest, including adaptive clinical trial design; clinical trial websites and social media; investigator-initiated studies; informed consent; and genome sequencing.

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TRACKS

DESCRIPTORS

Legal

This track will cover legal, legislative, and compliance issues. Participants will gain greater understanding of the role legal counsel can play within an HRPP and how understanding and managing legal risks contributes to human subjects protections.

15

Non-Scientist IRB Members

This track will introduce non-scientist IRB members to basic scientific topics and foundational strategies for IRB review. Following the conference, a Certificate of Core Competency will be awarded to those who attend at least four of the five sessions in this track.

16

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

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

17

Platinum Supporters

This track will feature sessions presented by the Platinum Supporters of this year’s conference. Please note the sessions included in this track and the content presented therein are not endorsed by PRIM&R.

18

Populations Requiring Additional Protections

This track will explore issues related to vulnerable populations, including regulations, guidance, best practices, ethical principles, and community engagement. In addition, this track will redefine vulnerability by looking beyond populations recognized in the federal regulations.

19

Potpourri

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

20

QA/QI and PostApproval Monitoring

This track will address current topics and issues faced by QA/QI programs, postIRB approval monitoring programs, and other institutional entities, including how to establish a QA/QI program, risk-based assessment in clinical research, accountability and integrity, and lean thinking.

21

Regulatory Balance

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

22

Research Involving the Internet and Social Networking

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

23

Self-Assessment and Accreditation

This track will focus on strategies for assessing the HRPP/IRB through accreditation, as well as the promotion of career development for IRB staff via the CIP® credential.

Small Research Programs

This track will address the special challenges faced by small research programs at entities such as community hospitals, colleges, and research institutions. The sessions in this track recognize that the designation “small” is typically self-imposed and variable. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three full-time IRB staff members.

SBER I and II

These tracks will cover basic issues related to the conduct and review of SBER, including deception, exempt and expedited research, school research, student-led research, and advanced issues related to the conduct and review of SBER, including cultural ethics and standards, scientific merit in qualitative research, psychology subject pools, the “Common Rule,” and more.

24

25 & 26

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14

Schedule Recognition Conference Information Friday, December 5 7:00 AM-5:30 PM Pratt Street Lobby

privacy are both deeper and broader than what is discussed by federal law. In the internet age, what was formerly considered “private” information is now widely displayed and available. On the other hand, the broad public and political concern about National Security Agency data collection, demonstrates that the current power and scope of surveillance, including non-voluntary collection, storage, and the use of personal data, raises serious concerns. Much current research, especially on the population level, involves creating, collecting, analyzing, storing, and disseminating information in more comprehensive and sophisticated ways than in the past. While research ethics often starts with individual consent, requiring individual consent may not be possible or realistic when dealing with patient records, tissue samples, and the possible re-identification of previously anonymous information or samples. This panel will discuss the evolving nature of privacy, what privacy means in today’s environment, how ethics and law have evolved in this area, and approaches to resolving privacy dilemmas.

schedules

Registration Open

7:00-8:00 AM

Exhibit Hall FG

Continental Breakfast

PRIM&R would like to thank Huron Consulting Group for supporting breakfast on December 5.

7:00-8:00 AM

Room 314-317

Continental Breakfast to Welcome First Time Attendees Looking to connect and network with other first-time attendees before the conference starts? If so, please join us at this breakfast where you’ll have an opportunity to meet with colleagues, as well as hear answers to the top 10 most frequently asked questions about the conference from the PRIM&R staff.

7:00-8:00 AM

Room 309-310

Affinity Group (AG) Peer-to-Peer

Networking Continental Breakfast

Join your AG facilitators and fellow members before the conference starts to connect and network! All attendees registered for an AG are welcome, and discussion questions for each group will be available to kick-start conversation.

8:00-8:15 AM

Exhibit Hall E

Welcome from the Conference Co-Chairs

Susan Z. Kornetsky David H. Strauss

8:15-8:30 AM

Exhibit Hall E

Welcome from PRIM&R’s

Executive Director Elisa A. Hurley

8:30-9:15 AM

Exhibit Hall E

Keynote Address: Informed Consent in

the Mobile Era John T. Wilbanks, Chief Commons Officer, Sage Bionetworks

9:15-9:30 AM

Break

9:30–10:45 AM

Concurrent Plenary Sessions

Exhibit Hall E

Panel I: The Evolving Nature of Privacy

and Confidentiality

Moderator: Laura Odwazny Panelists: Mark A. Rothstein, John T. Wilbanks Privacy is an evolving concept that has responded to social and cultural expectations over time. While many people think of medical privacy in terms of HIPAA requirements, the legal and ethical issues with regard to

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Ballroom I & II

Panel II: Global Research Ethics:

Challenges and Strategies – Past, Present, and Future

Moderator: Adnan Ali Hyder Panelists: Anant Bhan, Nancy E. Kass, Robert J. Levine, Nelson Sewankambo This panel will explore key challenges and foci in global research ethics over the last several decades, and why the field should consider these critical issues moving forward. More specifically, panelists will review the issues animating discussions of global research in recent decades as well as today, and how these issues have changed over time. For example, the central conceptual framework animating discussions about global research ethics has shifted from cross-cultural consent to standard of care to justice, including who controls research design and research products. Panelists will link the issues that emerged with a review of key events in global research ethics history that prompted the drafting or modification of key international research ethics guidelines. Inconsistences across those international guidance documents will be presented and assessed.

Friday, December 5

Panel III: When All Else Fails: The

Promise and Peril of Expanded Access to Investigational Treatment

Moderator: Walter L. Straus Panelists: Richard Klein, Michael Rosenblatt, Nilofer S. Azad, Gianna McMillan Expanded access programs (formerly known as compassionate use programs) were conceived to provide investigational therapies to desperately ill patients who have exhausted all reasonable alternate treatments.

Such programs involve tragically ill patients, unlicensed products, and treatment outside of the highly regulated clinical trials process and, therefore, give rise to complex ethical challenges in both policy and practice. Recent revisions to the FDA regulations for expanded access programs and several high profile cases make this issue timely and relevant for the AER Conference audience, and panelists will describe ethical tensions raised by expanded access from the perspectives of a policymaker, an industry leader, and a clinician.

10:45-11:15 AM

Paul Ndebele, Medical Research Council of Zimbabwe

•P OSTER 37: Pre-Procedure Consent Process vs. Post-Procedure Consent Process for Biorepository Sample Acquisition: A Prospective Survey at the Time of Pre-Admission Yasmin Isler, ProMedica Toledo Hospital

Exhibit Hall FG

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Innovations in...Series

•P OSTER 22: IRB Collaborative: Continuing to Build and Refine an Online Library of Audiovisual Educational Materials

Drawn from a rich pool of poster abstract

submissions, the Innovations in… panels will feature poster authors whose cuttingedge research and practices are advancing the field of human subjects protections.

Judith Birk, University of Michigan

•P OSTER 28: The Ordinary Life Experiences Rating Scale: Development of a New Instrument to Measure Minimal Risk in the Context of OHRP Terminology

Ballroom III

Innovations A: Innovations in

Communication with Research Subjects

Moderator: Susan S. Fish Clear communication with subjects regarding all aspects of their participation in research is a necessary condition for performing ethical research. Considerable efforts are undertaken by research teams and IRBs to ensure subjects are fully informed of the relevant details of their participation, including risks, benefits, privacy, confidentiality, and more. Yet many questions remain about how best to communicate with research subjects. This panel will highlight the ethical and practical challenges of obtaining consent/assent through three presentations:

•P OSTER 4: No Laughing Matter: Comic Assent for Biobanking Leah R. Eisenberg, University of Arkansas for Medical Sciences

Respecting and Protecting Research Subjects

Moderator: Alan Wertheimer The Belmont Report outlines three basic ethical principles that are essential in the conduct of human subjects research: respect for persons, beneficence, and justice. However, even in the most straightforward setting, putting these principles into practice requires careful consideration and the development of practical tools and educational resources. This panel will demonstrate some of the ways in which the Belmont principles are operationalized in the field of human subjects protections using examples from three different institutions:

Join us in The Conference Connection for coffee.

PRIM&R would like to thank iMedRIS Data Corporation for supporting this break.

11:15 AM–12:30 PM

Exhibit Hall E Innovations B: Innovations in

Evan Harrington,The Chicago School of Professional Psychology

•P OSTER 75: Righting Research Wrongs: How US IRBs Respond to Participant Complaints, Concerns, and Injuries Celia B. Fisher, Fordham University (first author: Kristen Underhill, Yale University)

Ballroom I & II

Innovations C: Innovations in

Institutional Collaborations

Moderator: Moira A. Keane When conducting multi-site studies, and/ or when there is a multi-institutional review of research, there can be challenges with

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• POSTER

34: An Intervention for Improving Understanding of Clinical Trial Procedures Among Low Literacy Populations: An Intervention Within a Microbicide Trial in Malawi

Ballroom III

Schedule Recognition Conference Information schedules

with effective research review, including differences in institutional policies and procedures, sharing of information and resources, return of results, internal and external communication, and research integrity.

However, multi-institutional collaborations can be beneficial to the research, research teams, institutions, and subjects if practices and systems are implemented that foster communication, thoughtful planning, sharing of resources, and assessment of policies and procedures. Through a series of three presentations, this panel will address effective models of collaboration:

•P OSTER 5: Translational Health Research Initiative: An InterOrganizational Partnership Model for Fostering Research Integrity Paula Garcia McAllister, Northern Arizona Healthcare

Meyer, Suzanne M. Rivera, Carol J. Weil, Leslie E. Wolf Participate in a vibrant discussion of Human Subjects Research Regulation: Perspectives on the Future with the authors and your peers. During this lunch, the authors will discuss the major book themes including: the regulation of risk; protecting vulnerable populations; researcher, subject, and IRB roles; specimens, data, and privacy; and paradigm shifts, and they will take questions and answers from the audience. Copies of the book will be available for purchase at the onsite Bookstore. The authors will be available for book signings and to talk more in-depth about the book during this lunch.

1:45-2:05 PM

• POSTER 24: Sharing SI IND/IDE Resources: A Contributory Network Model of Scalable Adoptable IND/ IDE Support Services across Massachusetts Academic Institutions?

Colleen Kohashi, University of California, Berkeley

12:45-1:45 PM

12:45-2:00 PM

1:45-2:30 PM

Common Ground Networking Lunch with the Supporters and Exhibitors

1:45-2:30 PM

Barbara E. Bierer, Adam L. Braddock, Alexander M. Capron, I. Glenn Cohen, Barbara Evans, Heidi Li Feldman, Gail H. Javitt, Greg Koski, Holly Fernandez Lynch, Michelle N.

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Meet and Greet the 2014 AER Conference Poster Authors

Exhibit Hall FG

Meet and Greet the Conference Supporters and Exhibitors

Network with this year’s conference Supporters and Exhibitors, and learn about their important services.

Room 314-317

Research Ethics Book Group Lunch

and Meet the Authors: Human Subjects Research Regulation: Perspectives on the Future

Exhibit Hall FG

Visit with the authors of the posters featured in the 2014 AER Conference Poster Presentation Program and learn about their innovative and important work on new program initiatives, empirical research, and conceptual analysis. The development and presentation of scientific and programmatic posters promotes interdisciplinary sharing and collaboration, and facilitates the exchange of ideas, information, and practical strategies for managing the many challenges faced by research professionals.

Exhibit Hall FG

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

All are welcome! PRIM&R would like to thank Quorum Review IRB for supporting this lunch.

Demonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC)

Join us in the PRIM&R Pavilion for a demonstration of our interactive online course, E-ROC. During this 20-minute presentation, you will be provided with an introduction on how to use this tool to strengthen your understanding of the core regulations and underlying ethical principles of human subjects protections. If you are unable to join us for this presentation, but would like to learn more about E-ROC while onsite at the conference, please stop by the PRIM&R Pavilion for a one-on-one demonstration.

Sabune Joane Winkler, Harvard Catalyst, The Harvard Clinical and Translational Science Center

•P OSTER 52: University of California (UC) IRB Reliance Registry: Facilitating Human Subject Review for MultiCampus Studies in the UC System

Exhibit Hall FG

2:10-2:30 PM

Exhibit Hall FG

Demonstration of PRIM&R’s Knowledge Center

Join us in the PRIM&R Pavilion for a demonstration of our online resource for members, the Knowledge Center. During this

Friday, December 5

2:45-4:00 PM A1

Didactic Sessions and Workshops Series A

A4

Room 326

A Dialogue with OHRP

(A Dialogue with the Feds I Track)

A5

Room 312

Advanced

Ballroom IV

Reconciling Regulatory Frameworks:

Dealing with Research Misconduct Involving Noncompliance in Human Subjects Protections (Advanced Forum for IRB Professionals Track)

Mark Barnes, Barbara E. Bierer, Kristen Grace, Yvonne Lau During this session, faculty will: • Address the complex intersection of research protections, research misconduct, and clinical research • Describe the distinct regulatory frameworks that govern research subjects protections and research misconduct, and the differences between the respective OHRP

Room 345

Empirical Ethics Research on Research

in Usual Settings (Empirical Research Ethics Track)

Sheila Fireman, Steven Joffe, Sandra Soo–Jin Lee, Jeremy Sugarman, Kevin P. Weinfurt Four NIH-funded projects are examining the ethical issues related to research in usual care settings, such as comparative effectiveness research and pragmatic clinical trials. During this session, faculty will: • Describe these projects examining the ethical issues related to research in usual care settings • Review what has been learned to date in conducting these projects • Illustrate how data from these projects will have direct application to informing not only the deliberations of IRBs, but also ongoing policy debates about this issue

A Dialogue with the DOE

(A Dialogue with the Feds II Track)

Christine Byrne, Heidi A. Hahn, John Ordaz, Elizabeth P. White This session will be led by representatives from the DOE. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Learn about the DOE’s Human Subjects Research Database • Participate in an open discussion of issues relevant to DOE stakeholders • Ask questions about new and ongoing initiatives at the DOE

A3

Principles of Adult Learning: Teaching

Adults the Way they Want to Learn

(Educating and Training Track) Rebecca D. Armstrong, Carrie A. McKeague During this session, faculty will: • Review how adults learners process and retain information • Outline the methods to use with adult learners that enable retention of sometimes difficult or dry material • Provide information about new and effective techniques and tools to use when teaching to adult learners

Room 337-338

Kristina C. Borror, Jerry Menikoff, Ivor A. Pritchard, Irene E. Stith-Coleman, Andrew Zacher This session will be led by representatives from OHRP. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from OHRP representatives about evolving initiatives, issues, and guidance • Participate in an open discussion about topics relevant to OHRP stakeholders • Ask questions of OHRP representatives

A2

and ORI oversight jurisdictions • Discuss recent SACHRP and IRB/Research Integrity Officer/Institutional Official Working Group activities in this area, as well as the Hastings Center Report Special Report, The Intersection of Research Fraud and Human Subjects Research: A Regulatory Review (July/August 2014)

A6

Room 347

The Ethics of Paying Research

Participants (Ethical Issues Track)

Alan Wertheimer Ethical and practical justifications exist for providing money or other payment to study participants, but concerns about undue influence and fairness in participant selection exist as well. This session will explore the territory of participant payment and discuss the IRB’s role in assessing compensation/ remuneration practices. During this session, faculty will: • Review applicable regulations • Analyze and evaluate ethical concerns

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20-minute presentation, you will gain insight into how you can use the resources found in the Knowledge Center as tools for continuing education at your institution. If you are unable to join us for this presentation, but would like to learn more the Knowledge Center while onsite at the conference, please stop by the PRIM&R Pavilion for a one-on-one demonstration.

schedules

Schedule Recognition Conference Information surrounding the topic of payment to research participants • Discuss ethical issues specific to the payment of participants/parents in pediatric studies •O ffer concrete guidance as to which concerns merit the IRB’s attention A7

A9

Room 324-325

Room 331-332

Basic

The Impact of IRB Significant and

Non-Significant Risk Determinations on Medical Device Investigations (FDA Regulations Track)

Fabienne Santel, Carmella (Carol) Simmons When reviewing medical device investigations, IRBs are responsible for determining whether a study is significant risk or non-significant risk. An incorrect determination can have farreaching effects on the study sponsor, clinical investigators, and the FDA’s ability to review a marketing application, as well as place human subjects at risk. During this session, faculty will: •P rovide a general overview of the regulatory requirements for risk determination for medical device studies •E xplore points to consider when evaluating significant risk and non-significant risk medical device studies •D iscuss examples of medical device cases to illustrate main points

A8

Room 348

A10

Basic

A11

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(HRPP Leadership and Institutional Officials Track) Eric Mah, F. Lisa Murtha, Delia Y. Wolf During this session, faculty will: • Identify the key components and characteristics of a strong compliance program • Discuss the challenges of day-to-day operations of such a program •O utline compliance program performance metrics Room 343

The Ins and Outs of IRB Offices

(IRB Boot Camp Track)

Hallie Kassan, Brenda L. Ruotolo During this session, faculty will: • Explore different ways of processing IRB submissions through an IRB office • Identify responsibilities of the different staff in an IRB office • Review processes that work well for IRB offices in facilitating the approval process

Room 320

Managing Subject Complaints

(IRB Operations and Toolkit Track)

Stephanie Collins Reed, Ilene F. Wilets During this session, faculty and attendees will: • Review a step-by-step process for addressing subject complaints, allegations, or questions • Explore how to apply and adapt a standard operating procedure for managing subject complaints using case studies from biomedical and behavioral research • Share guidance for determining the legitimacy of a complaint or allegation • Discuss the special considerations for complaints from at-risk and marginalized study subjects

The Use of International Multi-IRBs in Addressing Challenges of Multiple Ethical Reviews (Global Research Track)

Karen M. Hansen, Lama Jamhawi, Nandini K. Kumar, Paul Ndebele International research is expanding, and this creates challenges when multiple ethical reviews are required for the same protocol conducted at each of the performance sites. Challenges can also arise when there are multiple regulatory authorities and governmental policies informing the ethical review processes for the IRBs and research ethics committees responsible for the review. During this session, faculty will: • Discuss the challenges of conducting multiple ethical reviews in an international setting •S hare case studies highlighting the complexity of international regulations and policies that impact the ethical review processes (e.g., compensation for research subjects, regulatory oversight, researcher training requirements) •S hare experiences in using various models of joint review committees involved with international research, including their successes and advantages to the researchers and administrators

Understanding the Elements of a Strong

Compliance Program

A12

Room 349

The Clinical Trials Transformation Initiative (CTTI) Informed Consent Project: Findings and Next Steps (Issues for Pharma/Biotech Track)

Annemarie Forrest, Michele Kennett, Jennifer Lentz, Jane Perlmutter CTTI’s mission is to identify and promote practices that will increase the quality and efficiency of clinical trials. The objectives of CTTI’s Informed Consent Project are to understand previous and current efforts to improve informed consent documents and the informed consent process; understand barriers and identify potential remedies

Friday, December 5

A13

Room 321

Advanced

Basic

A15

The “State” of Affairs: The Impact of

State Laws on Multi-State Research (Legal Track)

Robyn S. Shapiro State laws can complicate the requirements for researchers and institutions in many ways.

With increased use of social media and internet research, the jurisdictional reach of studies is expanding. This session will address the challenges of conducting multi-jurisdictional research across varying state requirements, as well as state law issues that should be analyzed in connection with any federal Common Rule and FDA requirements. During this session, faculty will: • Define who a “child” is under applicable state law for purposes of consent/assent • Identify who can serve as a surrogate decision maker to enroll participants • Discuss when electronic signatures may be used in the consent process given applicable state e-signature laws • Determine what constitutes the “practice of medicine” in clinical research carried out at sites in different states • Explore how to balance obligations under state mandatory reporting requirements (e.g., public health and infectious disease reporting, child and elder abuse reporting, etc.) with competing obligations under federal privacy and confidentiality laws

A14

As key members of the IRB, non-scientist members join with other IRB members to shape the culture and conduct of research within their institutions. During this session, faculty will: • Examine the ethical and regulatory responsibilities of the non-scientist IRB member • Discuss recent academic articles about the perceptions of the role of the non-scientist IRB member • Review research on and guidance for the non-scientist IRB member • Provide an overview of the responsibilities and challenges of lay review in a variety of IRB scenarios • Solicit information from attendees about experiences and discuss real issues attendees face

Room 322

The Roles and Responsibilities of the

Non-Scientist Member of the IRB (Non-Scientist IRB Members Track)

Hal Blatt (OHRP resource person for session), Dahron A. Johnson, Susan L. Rose

Room 307

Have We Decided that All Tissue Is

Identifiable? Is the Default Now Consent for All? (Out of Body Experiences: Research Involving Tissue and Data Track)

Stacey A. Donnelly, Julie Kaneshiro, P. Pearl O’Rourke The ability to de-identify tissue (and to some degree data) is being challenged; contributors include the explosion of genetic data, as well as the increased use of big data and the power of data aggregation. Given the fact that identifiability determines the reach of the Common Rule, what happens if all tissue is considered identifiable? Does all use of tissue in research now require consent? If so, must that consent include all elements proscribed by the Common Rule? If consent can be waived, what conditions should apply? During this session, faculty will: • Address the difficulty of defining identifiability • Review the implications of considering all tissue identifiable •O utline the various options for consent/permission • Explore possible conditions for waiving consent

A16

Room 311

Platinum Supporter: Provision Research Compliance Services (partner, Schulman Associates IRB): Improving Clinical Quality and Human Subjects Protections (Platinum Supporter Track) Michael J. Woods GCP and Human Research Protections (HRP) requirements share the fundamental objective to conduct safe research, which leads to more compliant submissions and more rapid approvals for patient therapies.

Examining and improving your organization’s

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to concisely communicating the required elements of informed consent; create a more effective process for ensuring research participants’ understanding of critical informed consent elements; and identify potential strategies and opportunities for pilot testing the informed consent process improvement recommendations. This session will describe the ongoing Informed Consent Project, offer the first public opportunity to share late-breaking findings, and provide an early look at project next steps. During this session, faculty will: • Describe key themes that emerged from the project’s literature review and expert interview activities • Share how findings from these activities were analyzed and applied to project next steps • Discuss opportunities for the dissemination of findings and future recommendations to a broad array of stakeholders

Schedule Recognition Conference Information schedules

GCP quality assurance and HRP programs is crucial to ensure organizational compliance with regulatory and ethical obligations, but conducting this kind of assessment can be challenging, especially when institutional resources are limited. Provision Research Compliance can help. In collaboration with your organization’s Clinical Quality Assurance (CQA) program and HRPP, Provision’s demonstrated expertise and customized services will help you maintain compliance, minimize regulatory risk, and protect the safety and welfare of clinical trial subjects. During this session, faculty will: •D escribe the relationship between CQA and HRPPs and the importance of evaluating and refining these processes •O utline Provision’s CQA and HRP consulting services for institutions •D efine Provision’s customized approach to helping organizations improve overall GCP and HRP compliance Please note that PRIM&R does not endorse the content presented in this session.

A17

A19

Defining Vulnerability: Regulations

and Beyond (Populations Requiring Additional Protections Track)

Room 341

The ABCs of Genetics, DNA, and

Related Research Issues (Potpourri Track)

Bertha de Landa, Susan Brown Trinidad, Melissa P. Wasserstein During this session, faculty will: •D iscuss what can be learned from specimens and their DNA, and how this may lead to new treatments

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Room 344

The Nuts and Bolts of Setting Up a QA/

QI Program (QA/QI and Post-Approval Monitoring Track) Kelly Dornin-Koss, Jessica A. Randall, Sarah A. White This session will introduce participants to the key concepts and practical strategies to consider when developing an auditing component of a QA/ QI program. During this session, faculty will: • Address the points to consider when developing a QA/QI program • Review basic investigator site auditing concepts • Discuss the details involved in investigator site audits/onsite reviews including: determining a sample size, advantages of standard observations, and follow up after the audit/onsite review • Compare and contrast how two established QA/QI programs work

Room 346

Jeremy N. Block, Michelle Feige, Bruce G. Gordon This session will provide an explanation of what the regulations require for conducting research with vulnerable populations. During this session, faculty will: •D iscuss an expanded view of vulnerability beyond that outlined in the human subjects protections regulations •S hare examples of different types of vulnerabilities and explore how to think about these examples in the context of clinical research •R eview the threshold questions an IRB should address before permitting research with these subjects • I dentify examples of risks to subjects that may be different in nature or frequency •E xplore examples of incorporating additional protections into informed consent

A18

• Identify the risks associated with genetic information and ways to protect subjects who participate in genetic research • Review confidentiality issues related to specimen banking, including how to determine whether a specimen is anonymous, de-identified, or identifiable

A20

Room 308

You’ll Know it When You See it: Defining

“Human Subjects Research” Under the DHHS Regulations (Regulatory Balance Track)

David G. Forster, Julia G. Gorey, Ada Sue Selwitz Evaluating whether an investigator is engaging in research involving human subjects has many important ramifications for both the institution and the investigator in terms of cost, time, and requirements for the activity.

Since interpretation of key definitions in the regulations, including “systematic,” “generalizable,” “engaged,” and “human subject” can be tricky, thorough consideration is needed to ensure the appropriate application of the regulations. During this session, faculty and attendees will use case examples to: • Outline a process and set of criteria for determining whether an activity is research involving human subjects according to the federal regulations • Explore key decision points for determining that one is “engaged” in a research activity, and the impact of institutional determinations on other institutions/investigators involved in the project • Discuss when the evaluation of data or specimens involves human subjects, with attention to what constitutes “identifiable” data without the use of a non-disclosure agreement

Friday, December 5 A21

The Internet and the IRB: A Review of

Human Subjects Issues in Facebook, Twitter, mTurk, and Survey Tools (Research Involving the Internet & Social Networking Track)

A24

Basic

Brenda Curtis, Sharon Freitag, Laura Odwazny This session will address issues to consider when reviewing research involving social media. An overview of the types of internet venues will be provided, along with examples of ongoing internet research. Participants are encouraged to bring questions/case scenarios for discussion. During this session, faculty and attendees will: • Review a brief description of how research is conducted using various types of social media • Gain an understanding of privacy and consent issues in social media research • Discuss, through illustration, how social media websites are currently used for recruitment for research, and the specific challenges this presents for privacy and confidentiality and informed consent

A22

Room 319

The CIP® Credential: What’s it About?

(Self-Assessment and Accreditation Track)

Gregorio Lim, Kelley O’Donoghue, Lori Roesch This session is geared toward those who are interested in sitting for the CIP exam. During this session, faculty and attendees will: • Discuss the CIP credential and the steps involved in pursuing it • Review eligibility and recertification requirements • Outline the types of questions on the CIP exam

A23

Room 318

Outsourcing IRB Review While

Maintaining a Robust HRPP at Basic an Institution with a Small Research Program (Small Research Programs Track)

Shannon L. Harr, Scott J. Lipkin This session will describe how an institution with a self-described small research program maintains an effective HRPP while outsourcing some or all of its IRB review. During the session, faculty will: • Explore the ethical tensions involved in outsourcing IRB review • Identify shared and single-sourced responsibilities, accountabilities, and liabilities between the home institution and the outsourced IRB • Discuss how to measure and maintain an effective HRPP when some or all protocol review is outsourced

A25

Room 323

Basics of Using Deception in SBER

(SBER I – Basic Track)

Dean R. Gerstein, Katherine Lerner, Matthew D. Stafford Many psychology lab experiments and some marketing research projects use mild subject deception to avoid respondent bias. Yet, voluntary informed consent is the touchstone of the ethical conduct of human subjects research. This session will explore the ethics of different types and degrees of deception and the variable need for post-facto disclosure of deception. During this session, faculty and attendees will: • Discuss the limited regulatory foundation and federal guidance with regard to deception in research • Identify the IRB’s role in determining postfacto disclosure requirements • Outline the importance of Certificates of Confidentiality concerning the type, scope, and limitations of protections available, which agencies issue them, and when to consider applying for one Room 342

Aligning IRB Review with Community

Cultural Ethics and Standards Advanced (SBER II – Advanced Track)

Edward E. Bartlett, David A. Borasky, Jr., Kathleen M. MacQueen In some cultural contexts, informed consent of study subjects is necessary, but insufficient for ensuring that appropriate permissions are in place for human subjects research. This session will present points IRBs should consider with respect to differing cultural norms, community authorizations to conduct research, community consultation, and context-specific risk assessment. During this session, faculty will: • Compare regulations and cultural norms in different countries • Address the cultural need for non-participant authorization to conduct research • Review culturally sensitive/specific risk assessments • Identify general and local resources on regulations and cultural considerations in research •O utline US regulations for waivers of consent and assent and documentation thereof

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Basic

Room 339-340

Schedule Recognition Conference Information A26

schedules

Room 329

Central IRBs for the Clinical and

Translational Science Awards (CTSA) Program (Hot Topics Track)

George Gasparis, Alan I. Green, Petra Kaufmann The CTSA program is a unique national resource to help turn discoveries into better health. To accelerate that process, the CTSA program is promoting the use of central IRBs for the review of multi-site research in its programs. During this session, faculty will: •O utline the goals for utilizing central IRBs for review of multi-site research conducted within the CTSA program •D iscuss the challenges and opportunities for relying on, or serving as, a central IRB •P rovide insights on IRB vs. institutional responsibilities in the oversight of human subjects research

4:00-4:15 PM

Exhibit Hall FG

Break

Join us in The Conference Connection for coffee.

PRIM&R would like to thank EnterpriseWeb LLC and the Ideate Research Management Suite for supporting this break.

4:15-5:30 PM

Concurrent Plenary Sessions

Ballroom III

Panel IV: Considerations of Race

and Ethnicity in Research and Research Protections

Moderator: David H. Strauss Panelists: Charmaine D. M. Royal, Anne L. Taylor Consideration of racial and ethnic equality in research has played a central role in the public and academic discourse on the ethics of research. Research on racial differences itself has sparked much controversy related to group stigma and burden. Ongoing efforts to address healthcare disparities require the identification of population differences attributable to race and ethnicity, yet the notion of race- or ethnicityspecific restrictions on subject inclusion raises new scientific and ethical concerns.

Furthermore, the “prior history of the use of race in biomedicine in America suggests that we [are] deeply confused about how to define it and how to interpret its significance.” (Taylor, A. Circulation. 2005; 112: 3654-3666.) This panel will address these issues related to race and ethnicity in research in greater depth.

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Ballroom I & II

Panel V: Changes to the Common Rule:

Challenges and Opportunities for IRBs

Moderator: Robert J. Levine Panelists: Melissa E. Abraham, Constance F. Citro, Celia B. Fisher The Advance Notice of Proposed Rulemaking for Revisions to the Common Rule included, among its several objectives, simplification and clarification of the Common Rule to remove unnecessary burdens on investigators and IRBs. This panel will address these proposed changes, how IRBs might optimize these changes for improved functioning, and the challenges IRBs might face as a result. The moderator will introduce the session by describing how the regulatory definition of human subjects research may impact interpretations of the revised regulations. This will be followed by a presentation on the continually evolving tension between data sharing and confidentiality in the Common Rule, and the future role of IRBs in evaluating informational risk in light of developments such as the collection of biospecimens in population surveys and the advent of “big data.” The next presentation will focus on the challenges that may arise if the excused category of human subjects research is adopted, with shifting roles of investigators and IRBs, and how IRBs might approach oversight and review of research involving both biomedical and social and behavioral methods. In addition, the speaker will address how some institutions/HIPAAcovered entities may face special challenges in this area. The panel will conclude with a discussion of how changes to the Common Rule may impact interpretations of minimal risk and informed consent for research involving vulnerable populations and socially sensitive research, as well as assignment of protocols to expedited and full board review.

The perspectives of each of the panelists are influenced by their membership on or consultancy to the National Research Council’s Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Please note the speakers on this panel are not speaking on behalf of the National Research Council Committee, nor do they intend to present a complete account of its Report.

Friday, December 5 Exhibit Hall E

Moderator: Jeremy Sugarman Panelists: Clifton O. Bingham III, P. Pearl O’Rourke, Holly L. Peay, Joe V. Selby PCOR is challenging many long-accepted norms in research and clinical care. A fundamental assumption of PCOR is that patients are active collaborators at every stage of research including research development, conduct, and oversight. This panel will describe the role of patients in the PCOR process; review how PCOR differs from traditional research; and outline what challenges are associated with it.

Leadership from the Patient Centered Outcomes Research Institute and a patient advocate will describe the opportunities associated with PCOR, while a researcher and institutional official will reflect on the challenges associated with conducting and overseeing this research in practice.

5:30-6:45 PM

Exhibit Hall FG

2014 AER Conference Welcome Reception Join us in The Conference Connection to celebrate the opening of the 2014 AER Conference and PRIM&R’s 40th year.

During this time, you’ll be able to meet our conference Supporters and Exhibitors, view the Poster Presentations, and receive a complimentary mini-massage. Light refreshments will be served.

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Panel VI: Patient-Centered Outcomes

Research (PCOR): Opportunities and Challenges Related to Having Patients as Collaborators

Schedule Recognition Conference Information Saturday, December 6 7:00 AM-4:30 PM Pratt Street Lobby

groups, and other constituents can assert their needs and priorities from within the research enterprise. Most major research funders in the US, including the Agency for Healthcare Research and Quality, the NIH, and the Patient Centered Outcome Research Institute, have adopted a stance in favor of community engagement in at least some phases of research design and conduct.

These new models of stakeholder-engaged research rely on close collaboration between researchers and community partners and appear to involve novel ethical approaches.

The panel will address how members of the community evaluate the ethics of research projects, highlighting recent instances of research misconduct in under-resourced communities and related mistrust in research and researchers; how the shift in focus from “subject” to “participant” poses new ethical dilemmas for stakeholder-engaged researchers; and how the development of trust in community-engaged research projects can both ensure ethical practices and facilitate the conduct of research activities.

schedules

Registration Open

7:00-8:00 AM

Exhibit Hall FG

7:00-8:00 AM

Room 314-317

Continental Breakfast CIP® Continental Breakfast

Interested in earning your CIP credential?

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

8:00-8:10 AM

Exhibit Hall E

Welcome from the Conference Co-Chairs

Susan Z. Kornetsky David H. Strauss

8:10-8:30 AM

Exhibit Hall E

Presentation of PRIM&R’s ARENA

Legacy Award to Susie R. Hoffman, RN, BSN, CIP, Director, IRB for Health Sciences Research, University of Virginia Presented by Elisa A. Hurley

Presentation of PRIM&R’s Distinguished

Service Award to Paula L. Knudson, Special Adviser for Human Subject Research and faculty in the Center for Clinical Research and Evidence Based Medicine at The University of Texas Health Science Center Houston Presented by Alex M. Capron

Announcement of the Felix Gyi Memorial

CIP® Scholarship Presented by Susan Z. Kornetsky

8:30-9:15 AM

Exhibit Hall E

Keynote Address: Addressing the HIV/

AIDS Pandemic: Ethical Challenges Anthony S. Fauci, MD, Director, National Institute of Allergy and Infectious Diseases

9:15-9:30 AM

Break

9:30-10:45 AM

Concurrent Plenary Sessions

Ballroom I & II

Panel VII: The Ethics of Community Engaged Research

Moderator: Bowen Chung Panelists: Elizabeth Bromley, Loretta Jones, Dmitry Khodyakov Community members play substantively different roles in health research than they did just a few decades ago. Today, patients, family members, agency leaders, advocacy

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Ballroom III

Panel VIII: Issues Related to the

HIV/AIDS Epidemic and the Populations Affected

Moderator: A. Cornelius Baker Panelists: Anthony S. Fauci, Gregg Gonsalves, Nancy E. Kass, Veronica Miller, Darrell P. Wheeler HIV/AIDS has changed the research field’s attitudes and conceptions around the way subject communities engage with research as partners and participants. HIV/AIDS is one of the first areas of research to require that review committees include a patient advocate to assist with the prioritization of research efforts and provide input on engaging the relevant community in decision making. The epidemic has also resulted in many changes within the regulatory environment for human subjects research. For example, the FDA developed a new regulatory approval process that resulted in patients getting access to investigational drugs faster. Some suggest that the works of HIV/AIDS activists in the 1980s and 1990s is responsible for a dramatic shift in our collective thinking about research subjects and their relationships to the benefits and burdens of research–from research as a burden from which subjects need protection, to research participation as a means to gain beneficial access to new and promising therapies.

During this session, panelists will reflect on the complex issues raised over the 30-plus years

Saturday, December 6

provide attendees with an opportunity to: • Hear from and ask questions of ORD 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 B2

Room 311

Exhibit Hall E

Jeffery Rodamar This session will be led by a representative from the Department of Education. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from Department of Education representative 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

Panel IX: Science on the Move: The Use of Mobile Technologies in Human Subjects Research

Moderator: Dean R. Gallant Panelists: Scott Bradner, Camille Nebeker, Saul M. Shiffman Dramatic developments in mobile technology have led to powerful and affordable new tools, both for “passive” data collection (e.g., smartphones, cameras, activity monitors, physiological sensors, geo-location devices), and for “active” interaction with subjects (e.g., tablets, smartphones, and devices still being invented). Research protocols that take advantage of these tools often present technical and ethical challenges for IRBs. For example, how do these applications work?

How does, and how should, IRBs understand the risks associated with these tools? What risks are reasonable in relation to the potential benefits? What standards for identifiability of data should apply? How should, or how can, subjects’ privacy be protected? This panel will share real-world experience via case studies, and review ongoing research on the IRB’s experience reviewing mHealth protocols.

10:45-11:15 AM Exhibit Hall FG

Break

Join us in The Conference Connection for coffee.

PRIM&R would like to thank HRP Consulting Group, Inc. for supporting this break.

11:15 AM-12:30 PM Didactic

Sessions and Workshops Series B

B1

A Dialogue with the Department

of Education (A Dialogue with the Feds II Track)

Room 345

A Dialogue with the VA Office of Research and Development (ORD) and Office for Research Oversight (ORO) (A Dialogue with the Feds I Track)

Robert L. Brooks, Theresa Gleason, C. Karen Jeans, Peter N. Poon, J. Thomas Puglisi Attendees are encouraged to come with questions of interest to all. This session will

B3

Ballroom IV SOLD OUT! IRB Chairs Forum: A

Structured Discussion for Experienced IRB Chairs (Advanced Forum for IRB Professionals Track)

Advanced

Melissa E. Abraham, James A. Feldman, R. Peter Iafrate, J. Walton Senterfitt, Ryan Spellecy, Richard D. Stevenson, Glenn Veit Given that it can be difficult to find venues where experienced IRB chairs can convene to discuss and wrestle with tough questions, this session will provide IRB chairs a forum to share ideas and best practices. In advance of the conference, attendees were surveyed on topics of interest to them. The final list of topics will be sent to attendees before the meeting, and faculty members will provide a summary of each issue during the session. The discussions on each topic will be facilitated by the faculty ensuring no one dominates the conversation.

Any off-topic issues that arise during discussion will be placed in a “parking lot” for later discussion if time permits. Participants are encouraged to bring relevant policies, forms, etc., with them to share with the group. During this session, faculty and attendees will: • Review and discuss contemporary issues related to human subjects protections that are commonly faced by IRB chairs, and that may not have clear guidance in the federal regulations • Share best practices, policies and

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of the epidemic, and explore what these issues and, in some cases, their resolution, mean for the future of research and subjects protections, including whether HIV/AIDS is prototypical or an aberration; what HIV/AIDS has taught the field about the interface between clinical intervention, surveillance data, and research; what we can learn from HIV/AIDS moving from a disease that can now be treated to one that requires prevention; and what the emerging challenges are for HIV/AIDS research and research more generally.

Schedule Recognition Conference Information schedules

procedures, forms, and methods that aid in resolving difficult issues presented by investigators and research study staff •D evelop a list of contacts so attendees can share ideas or benchmark issues that arise once they return to their institutions •P articipate in topic development for future IRB chairs offerings Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

B4

B5

Room 348

Inside the Black Box: Empirical Research on IRBs (Empirical Research Ethics Track)

Philip J. Candilis, Steven Joffe, Laura Stark Few studies have used direct observation to examine the processes by which IRBs arrive at and justify their decisions. In this session, social scientists who have conducted groundbreaking qualitative and ethnographic research among IRBs will share their findings and insights.

During this session, faculty will: • Describe the nature of IRB deliberations and the phenomenon of the “Silent Majority” • Discuss the roles that unaffiliated members play in IRB decision-making • Address the importance of local precedents in arriving at decisions • Share the challenges of studying IRBs

Room 324-325

When Noncompliance Processes Collide:

How to Manage Multiple Different Internal Advanced Investigations of an Event (Educating and Training Track)

Lisa R. Buchanan (OHRP resource person for session), Bruce G. Gordon, Megan Kasimatis Singleton, Andrew Rusczek, Andrew Zacher One allegation or problem in a clinical study, such as a concern that a researcher has falsified research data, can spiral or uncover additional noncompliance and thereby trigger multiple requirements and policies for investigation and resolution. This session will present a root cause analysis of noncompliance issues, and offer strategies and training models for dealing with these events.

During this session, faculty and attendees will: •B riefly review (using a case example) the various legal issues and institutional policies and processes that may be triggered by a noncompliance event, including IRB serious/ continuing noncompliance investigations, research misconduct proceedings, and medical staff/peer review processes •L earn how to identify regulatory disconnects and knowledge gaps that lead to noncompliance issues in research, and recognize the ways in which the substantive and procedural requirements and standards applicable to different processes may overlap or be in tension •S hare practical strategies for coordinating and conducting multiple investigations and stakeholders in a way that maximizes efficiency, but also maintains the integrity of the various processes • Explore the use of a training model for investigators and staff that addresses the knowledge gaps that lead to noncompliance issues Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

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B6

Room 341

Advanced

Assessing the Prospect of Direct Benefit

in Pediatric Studies (Ethical Issues Track) Susan Z. Kornetsky, Robert “Skip” Nelson Under Section 405, Subpart D of the DHHS regulations, pediatric research that presents more than minimal risk, but holds the prospect of direct benefit for the individual participant, may be approvable. This session will discuss approaches to IRB review of such studies.

During 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 the use of component analysis during the review of pediatric studies Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

B7

Room 342

FDA’s Bioresearch Monitoring (BIMO)

IRB Inspection Program: Are You Ready for an Inspection?

(FDA Regulations Track)

Christine Drabick, Catherine Parker The FDA’s BIMO program is a comprehensive program of onsite inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The overarching goals of the agency’s BIMO program are to protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; to determine the accuracy and reliability of clinical

Saturday, December 6

B8

Room 321

Room 343

B10

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

Barbara E. Bierer, Katherine Gallin Heffernan During this session, faculty will: • Review the areas where the research interests and missions of academia and industry

Room 347

Essential Documentation: IRB Membership, Recordkeeping, Meeting Basic Minutes, and More (IRB Boot Camp Track)

Janet C. Donnelly, Michelle Feige, Ada Sue Selwitz Federal regulations define the requirements for IRB membership, and for documenting IRB discussions, decisions, findings, and communication of IRB decisions. This session will focus on the basic regulatory requirements for documenting IRB activities. During this session, faculty will: • Outline the basic federal requirements for IRB documentation • Discuss the 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

Determining the Effectiveness of

Community Engagement in Global Health Research (Global Research Track)

James V. Lavery, Kathleen M. MacQueen, Paulina O. Tindana Community engagement has been recognized as an important ethical requirement for global health research. Various models have been used by researchers to engage with communities. However, challenges remain with determining the effectiveness of various models/strategies for engaging communities.

During this session, faculty and attendees will: • Examine the value and science of community engagement in global health research • Share practical examples of community engagement models based on experience, including what works, best practices, and challenges • Elicit information about models and best practices in community engagement in research sites from session participants • Review the various ways of evaluating the effectiveness of community engagement, including what works and the way forward Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

B9

intersect and complement one another, and how these synergies can be maximized • Explore the ways in which principled partnership between industry and academia can be undermined through frictions, miscommunications, and inefficiencies • Outline common ground and solutions to the identified challenges in order to maximize the benefits of these principle partnerships without sacrificing the quality or ethics of the research under collaboration

B11

Room 339-340

Under Pressure: Maintaining Ethical

Review in the Electronic Age (IRB Operations and Toolkit Track)

Patricia M. Alt, Mary Louise Healy, Patricia A. MacCubbin This session will explore advantages and disadvantages of electronic submission and review systems, ways to deal with pressures to act on applications ever more quickly (and therefore pressure for IRBs to meet less often), and potential efficiencies (and difficulties) that can be realized through collaboration with other IRBs. During this session, faculty and attendees will: • Discuss strategies for streamlining IRB review, including the advantages and disadvantages • Outline efficiencies (and potential problems) that can be realized by cooperating/ collaborating with other IRBs • Review the importance of managing applicants’ expectations as an overall educational strategy, and discuss three ways in which these expectations can be managed

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trial data submitted to the FDA in support of research or marketing applications; and to assess compliance with the FDA’s regulations governing the conduct of clinical trials, including those for informed consent and ethical review. During this session, faculty will: • Provide a general overview of the FDA BIMO IRB inspection program, including information on what to expect during an inspection • Present the FDA’s annual BIMO inspection metrics and discuss the most common IRB deficiencies found during inspections • Summarize the administrative actions available to the FDA for noncompliance, and answer your IRB inspection questions

Schedule Recognition Conference Information B12

schedules

Room 337-338

Investigator-Initiated Studies: Investigator Responsibilities and IRB Considerations (Issues for Pharma/Biotech Track)

B14

Statistics Without Tears (Non-Scientist IRB Members Track)

Susan S. Ellenberg, Susan S. Fish This session will explain the intimidating statistical terms that make your eyes glaze over! To begin, attendees will review the statistical basics and then, half-way through, the group will split so those who need more study of the basics can obtain that information, while others ready for the next level can move on to more advanced topics. During this session, faculty and attendees will: • Outline the basic concepts of testing • Discuss different ways to be right and wrong, e.g., type 1 and type 2 errors • Review the concept of “power,” the types of statistical tests, and when to bring in a statistician • Explore the relationship between statistics and ethics • Apply statistical vocabulary Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

George Gasparis, Soma Kalb A sponsor-investigator is an individual who initiates and actually conducts, alone or with others, an investigation, and under whose immediate direction the test article is administered, dispensed, or used.

Investigators who conduct such studies and IRBs that review them must understand that the obligations of a sponsor-investigator include the regulatory responsibilities of both an investigator and a sponsor. During this session, faculty will: •O utline the challenges of conducting an investigator-initiated study and the responsibilities a sponsor-investigator takes on when conducting such a study •D iscuss IRB considerations when reviewing investigator-initiated studies •E xplore investigator-initiated device studies and strategies for how IRBs can help researchers work with the FDA

B13

Basic

Room 318

Certificate of Confidentiality (CoC):

When, Why, and So What?

(Legal Track)

Julia Hesse, Kate Tapley, Leslie E. Wolf A CoC is often an area of confusion and consternation for investigators and IRBs. Determining when a study warrants one and what the process is for obtaining one are only the first steps. Confusion and misinformation also exist as to the scope of protection this document offers. During this session, faculty and attendees will: •D efine the scope of legal protection and privilege afforded to researchers under a CoC, including a review of the applicable regulations and federal guidance • Review considerations around when it would be prudent to obtain a CoC and how to avoid potential pitfalls when implementing one • Outline how a CoC interfaces with state requirements •S hare strategies for defending a CoC if challenged •D iscuss the implications for informed consent and how a CoC interfaces with other protective laws and possible disclosures Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

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Room 328

B15

Room 336

NIH Genomic Data-Sharing: Tips from the Trenches (Out of Body Experiences: Research Involving Tissue and Data Track)

E. Charlisse F. Caga-anan, Tiffany Green, Laura Lyman Rodriguez, Dina N. Paltoo The NIH data-sharing policy encourages investigators to make de-identified data available to qualified researchers. This session will review the applicable regulatory requirements and the issues that can arise, and present tested approaches to data submission.

During this session, faculty and attendees will: • Review the applicable NIH policies around genomic data-sharing • Discuss the practical implications of the data submission process, including timing, required materials, study registration, and data release • Describe the roles and responsibilities of the IRB, the investigators, and the institutional official with respect to certification and submission • Outline ethical and pragmatic issues that may arise in complying with NIH datasharing policies Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Saturday, December 6 B16

Room 308

Hot Topics in Vulnerable Populations (Populations Requiring Additional Protections Track)

Jessica D. Bardill, Jeremy N. Block, Susie A. Han, Ernest D. Prentice, Amy Terpstra Vulnerable populations receive their own section under the Common Rule, and debate over protections for these subjects is ongoing.

This session will review a series of recent cases related to vulnerable populations and the associated ethical and regulatory issues.

Topics to be discussed include: individuals with diminished capacity; the Markingson Case; immigrant populations and undocumented individuals; and the sharing of genomic and other data within indigenous communities.

During this session, faculty and attendees will: • Discuss the ethical and regulatory implications and challenges of each case • Explore where the field could reasonably be going with respect to clarifying and revising regulations for protection of these subjects • Share best practices and methods related to the issues that arise within these cases

B18

Room 323

It Is Not Always About Money: Non Financial Conflicts of Interest (NFCOI) and the IRB (Potpourri Track)

Alberto Ortiz-Osorno, Tanisha Savage Regulations 45 CFR 46.107(e) and 21 CFR 56.107(e) say, “…No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.” The implementation of these regulations poses a real challenge when establishing what degree of financial conflict of interest a member may or may not have and, even more challenging, when recognizing and addressing NFCOIs. A NFCOI can be the result of personal beliefs (e.g., based on religion, moral convictions, socially accepted norms, family or cultural environment, etc.), or personal circumstances (e.g., due to immediate and extended family, close professional relationships, household responsibilities to others, as well as friends and acquaintances who have an indirect impact in one’s daily life). Regulation 45 CFR 46.107(a) requires that “…The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects...” Although the intention of the law is clearly to promote the development of appropriately balanced committees from the viewpoints of expertise and experience, the capacity of these diverse members to review all research objectively and follow rational thinking cannot be guaranteed by the mere nature of this arrangement. Also, objectivity and rational thinking are, at best, qualities exhibited by few and, in most cases, a true goal or a learned behavior to be developed. During this session, faculty and attendees will: • Discuss how to categorize potential NFCOI, and share practical examples of NFCOI • Review the potential impact of NFCOI on an IRB/research ethics committee • Outline possible operational approaches to dealing with perceived and real NFCOI when an IRB/research ethics committee is reviewing a specific research study

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IRB Primer: Incidental and Secondary Findings (Hot Topics Track)

Misti Ault Anderson, Karen M. Meagher, Elizabeth R. Pike The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recommends that researchers have a plan for the ethical management of incidental and secondary findings that arise in research, and that the plan is put in place ahead of time, is clearly communicated to potential participants, and is vetted and supported by an IRB or expert review structure. The Bioethics Commission’s IRB Primer will aid with the issues around recognizing and analyzing incidental and secondary findings; implementing an informed consent process that accounts for incidental and secondary findings; and returning incidental and secondary findings. During this session, faculty and attendees will: • Review and analyze incidental and secondary findings • I dentify an informed consent process that accounts for incidental and secondary findings • Discuss the importance of an ethically appropriate plan for the management of incidental and secondary findings Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

B17

Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Room 331-332

Schedule Recognition Conference Information B19

Making Your QA/QI Program Work for You

(QA/QI and Post-Approval Monitoring Track)

schedules

Leslie M. Howes, Eunice Yim Newbert This session will provide strategies and tools for developing an effective QA/QI program within an organization, regardless of whether it conducts social and behavioral research or biomedical/clinical research. Considerations for QA/QI efforts in international research will also be discussed. This session will provide an opportunity for faculty and attendees to share techniques and ideas that can help improve QA/QI programs. During this session, faculty and attendees will: • I dentify the elements needed to develop and customize a QA/QI program that fits the institution’s needs and available resources •D iscuss a wide range of QA/QI activities and services specific to different types of research, from social and behavioral to biomedical/clinical, and from domestic to international • Address how to identify, establish, and evaluate benchmarks to assess the quality of a HRPP •R eview strategies for developing effective education and training opportunities for investigators •S hare and discuss QA/QI sample documents, including onsite review/audit checklists, QA/QI report templates, and various study management tools Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

B20

the regulatory definition of a ”child,” and issues around assent, parental permission, and documentation of assent/permission Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Room 344

B21

Basic

Finding and Applying Flexibility in the

Federal Regulations (Regulatory Balance Track)

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Security, Privacy, and Confidentiality Issues in Dispersed Environments (Cloud and Mobile) (Research Involving the Internet & Social Networking Track)

Adarsh K. Gupta, Laura Odwazny, James Riddle This session will introduce participants to the basics of Cloud-based computing and mobile technologies, and how IRBs can assess the risks and benefits of research involving dispersed technologies. It will also explain Cloud-based computing concepts and mobile applications for your IRB and research participants. During this session, faculty and attendees will: • Review Cloud-based computing and why researchers are increasingly using Cloudbased technologies • Discuss how IRBs can evaluate the risks and benefits associated with Cloud-based computing technologies in research • Explore practical suggestions for educating IRBs about Cloud-based computing technologies, detecting Cloud-based computing in research proposals, and disclosing Cloud-based computing risks to participants during the consent process • Examine the regulations that pertain to securing research data • Address the steps needed to secure mobile devices • Share strategies for securing data storage that can be used to protect institutions from a data breach Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Room 319

Martha F. Jones, Sujatha Sridhar, Irene E. Stith-Coleman This session will explore various procedures that incorporate flexibilities within the regulations while providing equivalent protections to research subjects. During this session, faculty and attendees will: •R eview the flexibilities in Subpart B, including the definition of “pregnancy” as an important decision point in assessing Subpart applicability •C onsider the flexibilities in Subpart C, including the circumstances under which a subject is a “prisoner,” and a prisoner is a “subject” (the use of a DHHS Secretarial Waiver for inclusion of prisoners in epidemiology will also be discussed) •E xamine the flexibilities in Subpart D, including

Room 309-310

B22

Room 346

Study Review Using Central Mechanisms: An In-Depth Look at Advanced Central IRBs (Hot Topics Track)

Daniel K. Nelson, P. Pearl O’Rourke The use of central IRBs is on the rise, and there is increasing pressure to conduct study review using centralized mechanisms (for example, the NIH is now offering funding priority for the use of centralized IRB review for some grants).

Research protections professionals being asked to respond to the growing mandate

Saturday, December 6

B23

B26

Room 320

Ethics in the Time of Ebola

(Hot Topics Track)

Brandon J. Brown, Nancy E. Kass, Bavon Mupenda, Aminu A.Yakubu In this session, speakers will explore ethical issues faced in complex emergencies, with a focus on the current Ebola epidemic in Western Africa. During this session, faculty will: • Describe ethical issues faced by healthcare workers in the Ebola epidemic • Assess ethical issues related to the use of experimental drugs during the Ebola outbreak • Evaluate the impact of Ebola misunderstanding on black market treatment and stigma

Room 312

Flying Solo: A Moderated Discussion on

Challenges Encountered by Single Staff IRB Offices (Small Research Programs Track)

Scott J. Lipkin, Ann Morrison During this session, faculty and attendees will: • Review job duties and workload expectations for individuals working in single staff IRB offices • Identify priorities for securing administrative support • Discuss daily, weekly, and annual operational tasks •S hare solutions to the recognized challenges

B24

Room 326

Speed it Up: Exempt, Expedite, Relax!

(SBER I – Basic Track)

Basic

B25

• Discuss strategies for assessing scientific merit and generalizability in qualitative research • Identify risks to subjects and affected populations in qualitative research • Share IRB training resources Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Advanced

Jeffrey M. Cohen, Dean R. Gallant, Julia G. Gorey During this session, faculty and attendees will: • Discuss the procedural sequence process for review of SBER • Use case vignettes to test the review process and classification system • Identify flexibility in the regulations consistent with ethical research Please note this is a double session and will end at 1:45 PM. Please use the ticket included on your name badge to get your boxed lunch in Exhibit Hall FG before the session.

Room 307

Scientific Merit, Generalizability, and

Risks in Qualitative Research: A Case Study Approach (SBER II – Advanced Track)

Ellen Marakowitz, Matthew D. Stafford This session will provide an introduction to issues and strategies IRBs can use in assessing scientific merit, generalizability, and risk in SBER, followed by interactive discussion of selected case studies. During this session, faculty and attendees will: • Review a quick study guide with regard to the types of qualitative research methods

B27

Ballroom III

Disclosing Risks Appropriately in Research About Standards of Care

(Hot Topics Track)

Julie Kaneshiro, Jerry Menikoff, Ivor Pritchard In this session, faculty will explore the issue of appropriately disclosing reasonably foreseeable risks to prospective subjects in studies about standard of care treatments.

During this session, faculty will: • Explain the ethical concepts embodied in the Common Rule that relate to determining what risks should be disclosed to subjects • Apply those concepts to studies about standard of care treatments • Review the draft guidance on this issue that was recently released for public comment

12:45-1:45 PM

Exhibit Hall FG

Lunch

PRIM&R would like to thank the PEER Consulting Group for supporting the boxed lunches on December 6.

12:45-1:45 PM

Room 314-317

Affinity Group (AG) Peer-to-Peer

Networking Lunch

Join your AG facilitators and fellow members during lunch to connect, network, and discuss what you’ve learned at the conference thus far!

All attendees registered for an AG are welcome, and discussion questions for each group will be available to kick-start conversation.

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to use central IRBs must be educated about the different models of centralized review, the technicalities of working with a central IRB, and the implications of centralizing review. During this session, faculty will: • Review different central IRB models (e.g., share and non-share models, etc.), and the distinct characteristics and the respective institutional and IRB responsibilities for each model • Outline the logistics of using a central IRB and potential implications for an institution • Discuss the benefits and costs of central IRBs, and solutions for potential challenges

Schedule Recognition Conference Information schedules

1:30-2:45 PM

encouraged to come with questions of interest to all. In this session, attendees will: • Hear about the Bioethics Commission’s latest work • Review topics relevant to Bioethics Commission stakeholders, including the Bioethics Commission’s recent recommendations concerning ethics integration in neuroscience research; the Bioethics Commission’s current projects; and new Bioethics Commission educational materials, including materials developed especially for IRB members • Participate in a question and answer session with Bioethics Commission staff

Room 339-340

Policy and Practice Recommendations

for Ethical Sharing and Use of Biospecimens/Data

Jeffrey R. Botkin, Aaron S. Goldenberg, Steven Joffe, Karen Maschke, Suzanne M. Rivera, Erin Rothwell IRBs currently operate without a clear regulatory framework for how to provide oversight of collaborative research involving biospecimens and associated data. The project team for a National Human Genome Research Institute-funded grant invites participants to a highly interactive session designed to give feedback on its draft recommendations. Attendees will be provided links to articles and other materials prior to the meeting so they can prepare for the discussion. During this session, faculty and attendees will: •R eview findings from empirical studies performed under a National Human Genome Research Institute-funded grant focused on collection, sharing, and use of specimens and data •D iscuss draft recommended guidelines for facilitation of ethical data/specimen sharing and use •P rovide the project team feedback and suggestions for refining the recommended guidelines in preparation for proposal to regulatory agencies and professional societies

1:45-2:45 PM

Exhibit Hall FG SOLD OUT! Speed Mentoring

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

1:45-2:45 PM

Exhibit Hall FG

Meet and Greet the Conference Supporters and Exhibitors, and View the 2014 AER Conference Poster Presentations Network with this year’s conference Supporters and Exhibitors, and learn about their important services. The posters accepted for the 2014 AER Conference Poster Presentation Program will also be on display during this time.

3:00-4:15 PM

D idactic Sessions and Workshops Series C

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Room 339-340

A Dialogue with the Presidential

Commission for the Study of Bioethical Issues (Bioethics Commission) (A Dialogue with the Feds I Track)

Michelle Groman, Lisa M. Lee This session will be led by representatives from the Bioethics Commission. Attendees are

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Room 312

A Dialogue with DHHS OIG

(A Dialogue with the Feds II Track)

Jessica Fargnoli, Chris Galvin, Talisha M. Searcy This session will be led by representatives from OIG. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Receive an overview of OIG’s structure and initiatives • Learn about OIG’s evaluation work related to oversight of human subjects protections • Ask questions of OIG representatives Please note this session will last only 60 minutes.

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Room 308

Advanced

Conflicts of Interest (COI) in Human

Research: An Update from the Trenches (Advanced Forum for IRB Professionals Track) Katherine Gallin Heffernan, Heather H. Pierce, Delia Y. Wolf In the wake of the revised PHS regulations imposing more stringent requirements around investigator COI, institutions may wonder what, if any, changes should be made to other areas where conflicts may impact the conduct or oversight of research. This session will look specifically at the Common Rule’s existing prohibition on any IRB member participating “in the IRB’s initial or continuing review of any project in which the member has a conflicting interest” (45 CFR 46.107(e) and 21 CFR 56.107(e)). While financial conflicts are a component of this, arguably the more challenging task facing institutions and IRBs is defining the intangible relational conflicts IRB members sometimes face in evaluating their friends’ and colleagues’ work. Furthermore, IRB member conflicts have historically been managed through self-identification and recusal, arguably the opposite end of the spectrum from where investigator conflicts reside. During this session, faculty will: • Explore whether and, if so, how the PHS

Saturday, December 6

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forms in HIV-related research is limited and there may be unknown barriers preventing the implementation of shorter consent forms.

Further, limited data exist on the costs and burdens that long consent forms place on staff, participants, and the efficiency of study implementation. Effective Delivery of Informed Consent is partnering with the HIV Prevention Trials Network, to collect such data to inform longstanding debates regarding the length of consent documents. During this session, faculty will: •D escribe preliminary data from interviews with key stakeholders regarding what types of information each stakeholder group believes is critical to communicate to potential research subjects about research participation • Review what types of information can be reduced or excluded from the consent form • Examine the barriers to using shortened consent forms

Room 342

The Role of Study Partners in Dementia Research and its Implications for IRBs (Hot Topics Track)

Betty Black, Yvonne K. Higgins, Holly A. Taylor In this session, findings from a qualitative study on the role of study partners for participants in a range of dementia research studies will be presented. The discussion will highlight issues of relevance to IRBs including the characteristics of study partners, their role responsibilities, the challenges and burdens they face in this role, and the potential benefits that study partners may derive from their involvement in research. During this session, faculty will: • Review the critical role of study partners in the conduct of dementia research •D efine the factors (e.g., study and participant characteristics) that influence study partners’ roles • Discuss the interests of study partners as caregivers to persons with dementia

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Room 346

William L. Freeman, Carol R. Horowitz, Mei-Ling Isaacs, Susan Brown Trinidad CBPR theory posits that capacity building and “giving back” are an ethical requirement of research with communities. While communities may see job training, capital goods, or employment as benefits of research, many IRBs prohibit researchers from presenting them as such. During this session, faculty will: •R eview the ethical arguments in support of capacity-building within the CBPR framework • Outline the regulatory requirements regarding the definition of benefit • Discuss case examples of conflict around defining benefit • Explore model approaches for balancing communities’ expressed interests with regulatory requirements surrounding benefit

Room 324-325

Using Empirical Evidence to Reduce

Consent Form Length (Empirical Research Ethics Track)

Amy Corneli, Jeremy Sugarman Sufficient understanding of research is necessary for potential participants to make an informed decision about participation in research; yet, subjects often do not fully understand the research in which they are enrolled. A contributing factor to limited understanding is the length of consent forms.

Long consent forms can negatively affect subjects’ understanding of research, as well as contribute to a time-consuming enrollment process. Despite such data, long forms remain commonplace. More recently, short consent forms have been shown to be as effective or better at providing relevant information and enhancing subjects’ understanding compared to long forms; however, evidence on the noninferiority of short consent forms has not led to widespread changes in the length of consent forms. Empirical evidence identifying superfluous information to remove from standard consent

Defining Benefit in Community-Based

Participatory Research (CBPR) (Ethical Issues Track)

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Ballroom IV

FDA Expectations of IRBs When Using

Electronic Recordkeeping Systems (FDA Regulations Track)

Jonathan S. Helfgott IRBs are responsible for complying with all elements of 21 CFR Part 56. There is a growing trend for IRBs to implement electronic recordkeeping systems, which must simultaneously comply with both 21 CFR Parts 11 and 56. This session will provide an overview of the FDA’s expectations of IRBs when electronic recordkeeping systems are used, the applicable regulatory requirements, and recommendations from FDA guidance.

During this session, faculty will:

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framework for investigator conflicts should inform institutional policies around IRB member conflicts • Provide suggestions for the ways in which IRBs and institutions can craft policies or processes to target relational and other nonfinancial COI • Review the ways in which managing IRB member conflicts intersects with the broader issue of institutional conflicts

Schedule Recognition Conference Information schedules

•P rovide a general overview of the FDA’s regulatory requirements for IRBs when utilizing electronic recordkeeping systems •O utline the unique regulatory considerations for IRBs implementing electronic recordkeeping systems •D iscuss how to prepare for an FDA onsite inspection of IRBs when electronic recordkeeping systems are used •H ighlight real-life case studies of electronic IRB recordkeeping systems C8

considered unanticipated problems • Review the practical mechanisms for IRB receipt and review of reports of unanticipated problems C11

European Union (EU) Clinical Trial and Data Sharing Regulations (Global Research Track)

Room 319

Mergers, Acquisitions, and

Consolidations: Implications for HRPPs Advanced (HRPP Leadership and Institutional Officials Track)

Wesley G. Byerly, Wayne R. Patterson During this session, faculty will: •P rovide examples of the types of mergers, acquisitions, and consolidations in higher education and academic medical centers •D escribe the impact mergers, acquisitions, and consolidations may have on the HRPP •R eview the role of the institutional official and HRPP leadership in navigating organizational change

C10

Basic

Room 309-310

Unanticipated Problems and Adverse

Events: A Practical Approach for IRBs (IRB Boot Camp Track) Albert J. Allen, Jeffrey A. Cooper During this session, faculty will: •D iscuss what is considered an unanticipated problem involving risk to subjects or others, and the overlap with adverse events •P resent case examples to determine whether certain events should be

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Total IRB Transformation: Aligning

IRB Members, Staff, Procedures, and Systems to Meet the Needs of a Growing Research Enterprise (IRB Operations and Toolkit Track)

Heather J. Gipson, Karen N. Hale, Jonathan M. Hunter IRBs are always looking for ways to improve efficiency and compliance and, oftentimes, major changes in practice need to be adopted in order for this to occur. Faculty in this session will discuss the IRB transformation initiatives underway at Northwestern University, which include (a) adopting the flexible model for IRB review; (b) training and designating IRB staff to conduct non-committee reviews; (c) streamlining standard operating procedures to improve efficiency and consistency; and (d) upgrading IRB software to support review activities and to meet institutional reporting needs. During this session, faculty will: • Provide an overview of the IRB transformation process and the practical considerations for implementation at attendees’ own institutions • Review the mechanics of a flexible IRB model and the resources necessary for adoption • Outline best practices for ensuring consistency and transparency for the entire review process

Room 326

Mark Barnes, Edward E. Bartlett, Robert Jim Terwiel US researchers are increasingly affected by changes in other countries, especially Europe.

In April 2014, the EU approved sweeping changes to its Clinical Trials Regulation. In addition, the European Medicines Agency is currently debating a new Data Sharing Policy.

During this session, faculty will: • Explain the global impact and evolution of human subjects protections standards in the EU •O utline the key requirements of the recently approved EU Clinical Trials Regulation •D escribe the controversies surrounding the proposed Data Sharing Policy

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Room 337-338

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Advanced

Room 345

Flexible Adaptive Clinical Trial Designs

and Implications for Informed Consent and IRB Review (Issues for Pharma/Biotech Track) William J. Meurer, Michele Russell-Einhorn There is great interest in the possibility that clinical trials can be designed with adaptive features (i.e., changes in design or analyses guided by examination of the accumulated data at an interim point in the trial) that may make the studies more efficient, more likely to demonstrate an effect of the drug if one exists, and/or more informative. During this session, faculty will: • Provide a general overview of the why, when, and how of adaptive clinical trial designs • Present a case study of an actual trial for discussion on the clinical, logistical, and ethical issues • Discuss some of the challenges of

Saturday, December 6 preparing an informed consent form for, and conducting IRB review of, an adaptive clinical trial protocol

Basic

Room 343

The Nuts and Bolts of IRB Reliance

Agreements: What Institutions and IRBs Need to Address for a Successful Relationship (Legal Track)

Emily Chi Fogler, Susan Z. Kornetsky, Sabune Joane Winkler The Advance Notice of Proposed Rule Making for Revision to the Common Rule’s proposal for mandatory single-IRB review of certain research has renewed interest in the establishment of cooperative IRB review arrangements on both large and small scales. In addition, the NIH has increasingly incorporated single-IRB review as a condition of or preferential factor in awarding grant funding. Models for documenting cooperative IRB review arrangements range from onepage reliance agreements to multi-document agreements and standard operating procedures. Although such agreements need not be overly complicated, establishing an agreement that is effective both legally and in real-world practice is not as simple as the regulations and existing federal materials might suggest. During this session, faculty will: • Describe the regulatory authority of and requirements for documentation of cooperative IRB review of human research studies (“reliance” agreements) • Briefly review various types of/options for reliance arrangements (e.g., “share” vs. “non-share” models, single vs. multiple protocols, institutional and independent IRBs, one-way vs. reciprocal arrangements) • Provide an overview of key issues to address in a robust reliance agreement from the perspectives of both the relying institution and the reviewing IRB • Discuss operational and other requirements necessary for successful implementation after the agreement is signed

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Basic

Room 349

Let’s Review a Protocol! Regulatory

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

Kristina C. Borror, Kaarkuzhali B. Krishnamurthy, Matthew D. Stafford During this session, faculty and attendees will: • Review the regulatory criteria for approval • Discuss fundamental strategies and tools used to facilitate protocol review • Systematically review sample protocols and participate in the decision-making process

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Room 307

Emerging Issues in Research Banks

(Out of Body Experiences: Research Involving Tissue and Data Track)

Jeffrey R. Botkin, Barbara Evans, Mark A. Rothstein Ethical and regulatory requirements relevant to the return of research results have generated active debates in the last several years and, increasingly, investigators and IRBs must address the appropriate return of research results. During this session, faculty will: • Provide an overview of the return of results debate, including general study results, individual results, and incidental findings • Describe the legal and ethical considerations that require, permit, or prohibit the return of research results • Review the current controversies on whether compliance with the Clinical Laboratory Improvement Amendments and with FDA’s device regulations is required in order to return genetic research results to study participants who want them

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Room 321

Platinum Supporter: Aligning Institutions and Research Sponsors for the Efficient Conduct of Clinical Trials (Platinum Supporter Track)

Stuart Horowitz, Nicholas Slack During this session, faculty will: • Discuss the growing trend of institutional reliance on independent IRBs for the review of industry-sponsored trials • Review how WIRB-Copernicus Group, as the leader in providing regulatory review support for institutions, can participate in increasing the efficiency of clinical trial startup and drive more research to institutions • Explain the best practices in institutional reliance on an independent IRB, including review of the recent FDA final guidance on transfer of local IRB oversight Please note that PRIM&R does not endorse the content presented in this session.

C17

Advanced

Room 331-332

Populations on the Edge: The Homeless,

Substance Abusers, and More (Populations Requiring Additional Protections Track) Jeffrey M. Cohen, Amy Terpstra There are many populations that have vulnerabilities related to their marginalized status. Thus, it is important for IRBs to understand the expertise needed to review studies with these populations and some of

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that leads to approval or request for revisions

Schedule Recognition Conference Information schedules

the special or heightened concerns related to these groups. During this session, faculty and attendees will: • I dentify vulnerable populations beyond those addressed by the federal regulations who are, nonetheless, vulnerable because of homelessness, substance abuse, undocumented residency, or other issues • Examine the special considerations that study teams should consider when designing a study involving these populations, and that IRBs should be aware of when reviewing these studies, such as payment and undue influence •R eview the threshold questions an IRB should address before permitting research with these subjects •D iscuss complex issues such as how to assure confidentiality; how to balance concerns about criminal liability with the need to protect subjects and conduct valuable research; the need for assistance to avoid individual harm; and whether Certificates of Confidentiality should be a prerequisite for these studies •E xplore how to recruit and maintain contact with subjects from these populations C18

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Overview of FDA and NIH Collaborations

in ClinicalTrials.gov Compliance (Potpourri Track)

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QA and Clinical Studies: A Risk-Based

Assessment Advanced (QA/QI and Post-Approval Monitoring Track)

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Beyond the Regulations: Strategies

for Obtaining Informed Consent (Regulatory Balance Track)

Room 341

Recruitment and Consent Challenges and Opportunities in Internet Research (Research Involving the Internet & Social Networking Track) Brenda Curtis, Laura Odwazny This session will address ethical, regulatory, and methodological issues associated with recruitment and consent in internet research. A basic understanding of internet venues and tools is assumed. During this session, faculty will: • Outline current guidelines and strategies for protecting privacy and confidentiality • Discuss what constitutes adequate consent with regard to the type of data collected • Provide IRB decisional strategies for reviewing legally and socially sensitive research that utilizes social media for recruitment using case studies

Room 348

Karen M. Hansen, Jan L. Hewett This session will provide insights on how QA processes can be applied, even with limited resources, to evaluate a department’s or institution’s research portfolio using a risk-based stratification assessment tool.

Operational tools and strategies to conduct assessments of clinical research will be

Room 323

Elizabeth Bankert, Susie R. Hoffman Researchers continue to struggle with the consent form and process, and they are looking for practical methods to improve the form and process in order to obtain truly informed consent. During this session, faculty will: • Review methods and concepts to improve the consent form and process • Discuss the components of the Valid Informed Consent Education

Room 318

Patrick J. McNeilly, Rebecca J. Williams ClinicalTrials.gov is a registry and results databank of publicly and privately supported clinical studies of human participants conducted around the world. This workshop will discuss the statutory requirements related to clinical trial registration and results reporting, as well as the roles of the FDA and the NIH for compliance with the requirements. During this session, faculty and attendees will: •R eview ClinicalTrials.gov and the unique responsibilities of the NIH and the FDA • Discuss the requirements and definitions for clinical trial registration and results submission •E xamine the FDA’s compliance and enforcement use of ClinicalTrials.gov

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discussed. The session will then briefly discuss corrective action plans and suggestions for education, training, and follow-up. During this session, faculty and attendees will: • Review how to design and develop a mechanism to assess the portfolio of research conducted by a department, unit, or institution in order to begin a comprehensive QA review program • Discuss how to design, develop, and implement a risk-based stratification assessment tool for current and future clinical research • Share strategies for identifying and implementing a system to follow the clinical research conducted across a department, unit, or institution in order to create and maintain a compliant HRPP

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Room 322

Building a Comprehensive HRPP: What

to Expect When We’re Accrediting (Self-Assessment and Accreditation Track) Sarah H. Kiskaddon, Kathleen Lawry, Elyse I. Summers, Candice A. Yekel

Saturday, December 6

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Ethical Issues with Introductory

Psychology Subject Pools Advanced (SBER II – Advanced Track)

Joseph S. Brown, Toby L. Schonfeld Many colleges and universities have established research pools of introductory-level psychology students to participate in research studies and other projects. This session will review applicable regulatory and ethical standards, as well as considerations in reviewing research in which students serve as investigators or study staff.

During this session, faculty and attendees will: • Distinguish research from common nonresearch projects • Review and discuss subject pools, especially data security and selection bias • Outline the roles and accountability of students as research administrators/principal investigators (especially undergraduates) • Discuss ethical and regulatory justifications for waiver of parental permission for minoraged college students, including jurisdictions where majority age is not 18 (Nebraska is 19; Mississippi and Puerto Rico is 21)

Building and Maintaining an HRPP at a

Primarily SBER Institution with a Small Research Portfolio (Small Research Programs Track)

Room 347

Ethical and Regulatory Issues in Social and Behavioral Research Basic (SBER I – Basic Track)

Julie Kaneshiro, Ivor A. Pritchard This session will use dramatic presentations of case studies of social and behavioral research studies to raise questions about IRB review and approval. The ethical principles of the Belmont Report, (respect for persons, beneficence, and justice), as well as the regulatory provisions which apply those principles, will be called into play. A discussion on the application of the principles of the Belmont Report, and tensions between those principles, will be included. During this session, faculty and attendees will: • Discuss at least two ethical challenges in social and behavioral research • Discuss at least two issues involving the

Room 336

Room 311

Eric Allen, Shannon L. Harr This session will focus on the challenges of developing and maintaining an effective HRPP at an institution doing limited and primarily SBER. Topics will include managing individualized and web-based training for IRB members and investigators; student led research; consent waivers and alterations; research involving minor-aged college students; data security without encryption; and more. Attendees will interactively explore challenging structural and operational aspects common in small HRPPs, and identify ideas for effective solutions. During this session, faculty and attendees will: • Explore and outline how to establish and maintain an effective HRPP in an institution with a small SBER program • Identify proven strategies for engaging senior leadership, investigators, IRB members, and HRPP staff

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application of the regulations in social and behavioral research

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Room 344

Manipulating Emotions on the Internet: The Cases of Facebook and OkCupid Advanced (Hot Topics Track)

Rebecca D. Armstrong, Jerry Menikoff, Michelle N. Meyer Much has been written about a week in 2012 when Facebook manipulated its newsfeed algorithms for close to 700,000 users. And, recently, OkCupid admitted to manipulating customer data to see how users of its dating service would react to one another.

Outcry surrounded issues related to privacy and consent, but what responsibilities do commercial sites like Facebook and OkCupid have to notify its users of such experiments?

This session will present various perspectives on this controversial issue in the face of social media, big data, and research. During this session, faculty will: • Describe the Facebook experiment from the perspective of human subjects research considerations • Review issues of engagement, minimal risk, and consent in social media experiments • Debate IRB approaches to and considerations around social media research • Discuss ethics and regulation as they apply to non-regulated research

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This session will focus on building the infrastructure of a comprehensive HRPP, with an eye toward accomplishing (or maintaining) accreditation. During this session, faculty will: • Discuss the components of a comprehensive HRPP and why they’re important to accomplishing and maintaining accreditation • Provide an overview of accreditation standards as they relate to human subjects protections programs • Share strategies on how to prepare for a site visit

Schedule Recognition Conference Information C27

Open

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Room 320

schedules

Non-Scientific IRB Member Affinity Group (AG) Session

Connect with your fellow Non-Scientific IRB Member AG members during this education and networking session. Discuss what you’ve learned thus far; ask questions of the AG facilitators and members about issues challenging you; share strategies and insight on the topics discussed; and discuss ways to stay connected after the meeting. All registered for the Non-Scientific IRB Member AG are welcome to attend!

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Room 328

SBER Affinity Group (AG) Session

Connect with your fellow SBER AG members during this education and networking session.

Discuss what you’ve learned thus far; ask questions of the AG facilitators and members about issues challenging you; share strategies and insight on the topics discussed; and discuss ways to stay connected after the meeting. All registered for the SBER AG are welcome to attend!

4:30-6:00 PM

societal implications that may ensue when reconceptualizing boundaries of “normalcy” as discoveries are made with whole genome sequencing on vulnerable populations.

Lynn Wein Bush and Karen H. Rothenberg will be available after the session to sign copies of their book, The Drama of DNA: Narrative Genomics. Copies of the book will be available for purchase at the onsite Bookstore. Light refreshments will be served.

Show starts at approximately 4:45 PM.

Ballroom I & II

The Drama of DNA: Implications of

Genomic Protocols that Reconceptualize the Boundaries of “Normalcy”

Faculty: Lynn Wein Bush, Karen H. Rothenberg Actors: Mark Barnes, Barbara E. Bierer, Jeffrey R. Botkin, Alexander M. Capron, Ruth L. Fischbach, Christine Grady, Sara C. Hull, Elisa A. Hurley, Susan Z. Kornetsky, Greg Koski, Robert “Skip” Nelson, P. Pearl O’Rourke, Laura Lyman Rodriguez This dramatic narrative provides the opportunity to imagine, contemplate, and debate complex ethical and psychosocial dilemmas posed by research protocols that increasingly propose the application of cutting-edge genomic technologies in ways that challenge the boundaries of current ethical norms – especially when whole genome sequencing involves pregnant women and their fetuses, newborns, and unaffected children. Autism spectrum disorder will be the condition used in this hypothetical vignette to explore shifting perspectives of “normal” in the context of genomic findings, as well as phenotypic expression, and to illuminate how genetic variations, behavioral manifestations, and their categorizations are subject to modification over time. The provocative research protocol is intended to help us grapple with personal, professional, and

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6:30-8:30 PM

Pratt Street Ale House

Young Professionals Networking Reception Connect with other young professionals interested in research ethics and relax after a busy day in Baltimore at the Pratt Street Ale House, located just a four-minute walk from the Baltimore Convention Center. Don’t forget to bring the drink ticket you received with your registration materials! While all attendees are welcome, complimentary drink tickets are reserved for young professional registrants.

Sunday, December 7 Sunday, December 7 7:00 AM-12:00 PM Pratt Street Lobby 7:00-8:00 AM

Exhibit Hall FG

Continental Breakfast

7:00 to 8:00 AM Ballroom I & II

Plenary Breakfast Session: Tough

Questions about Ebola: Scientific, Regulatory, and Ethical Issues with Experimental Treatments and Vaccines

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Moderator: Alexander M. Capron Panelists: Walter L. Straus, Holly A. Taylor The current outbreak of Ebola Virus Disease in West Africa has led to urgent calls for the rapid development and distribution of treatments and vaccines to care for patients and to control the spread of the virus. In this session, experts will discuss the scientific, medical, industrial, regulatory, social, and ethical considerations related to using experimental interventions and adopting various trial designs to test them in the midst of this devastating epidemic. Please note a continental breakfast will be served during this session starting at 6:30 AM.

8:10-8:15 AM

Welcome from the Conference Co-Chairs

Exhibit Hall E

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Room 324-325

Advanced

PRIM&R Membership Update

Keynote Address: Beyond the

Bombshell: The Legacy of Henry K. Beecher’s Call for Reform in Clinical Research Ethics

Susan E. Lederer, PhD, Robert Turell Professor of the History of Medicine and Bioethics, University of Wisconsin School of Medicine and Public Health Break

9:30-10:45 AM

Didactic

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Sessions and Workshops Series D Room 331-332

A Dialogue with SACHRP

(A Dialogue with the Feds I Track)

David A. Borasky, Jr., Jeffrey R. Botkin, David G. Forster, Michele Russell-Einhorn This session will be led by representatives from SACHRP. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from SACHRP representatives about evolving initiatives, issues, and guidance,

Patient-Centered Outcomes

Research (PCOR) (Advanced Forum for IRB Professionals Track)

Katherine Bevans, P. Pearl O’Rourke, Alexander Ommaya, Holly L. Peay During this session, faculty will: • Describe the fundamental principles of the PCOR “movement” • Identify opportunities and challenges in pursuing PCOR • Distinguish PCOR as a concept from the Patient-Centered Outcomes Research Institute as an organization • Illuminate the human subjects’ protections issues raised by the pursuit of PCOR

Exhibit Hall E

9:15-9:30 AM

A Dialogue with the FDA

(A Dialogue with the Feds II Track)

Owen Faris, Richard Klein, Joanne R. Less Diane M. Maloney, Catherine Parker, Kevin A. Prohaska, James F. Saviola This session will be led by representatives from the FDA. Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from representatives of the FDA about new and evolving issues, initiatives, regulations, and guidance • Participate in an open discussion about topics relevant to FDA stakeholders • Ask questions about evolving issues at the FDA, including warning letters

Susan S. Fish

8:30-9:15 AM

Exhibit Hall E

Susan Z. Kornetsky David H. Strauss 8:15-8:30 AM

Room 337-338

D4

Room 322

Clinical Research Education Program:

Building a Business Case (Educating and Training Track)

Donna D. Buckley, Mina P. Busch This session will provide an opportunity for attendees to learn how to build a business case to justify a clinical research education program.

During this session, faculty will: • Address the elements inherent in conducting a needs assessment, including survey administration • Identify metrics to use for the business justification and to monitor progress/success

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including forthcoming recommendations on Certificates of Confidentiality, engagement, and cluster randomized trials • Participate in an open discussion about topics relevant to SACHRP stakeholders • Discuss best practices currently under consideration by SACHRP • Ask questions of SACHRP representatives

Registration Open

schedules

Schedule Recognition Conference Information •D escribe tools/techniques that could be incorporated at attendees’ own sites to launch or refine their clinical research education program •D iscuss the benefits of organizing a professional group to advocate for clinical research needs D5

Marianna J. Bledsoe, Laura Lyman Rodriguez, Aminu A. Yakubu Genomic research presents a range of ethical issues related to the collection, export, storage, and reuse of human biological samples; the establishment of biorepositories; and the consent requirements for each of these. This session will focus on the ethical issues arising in the conduct of genomic research in an international research setting, using the Human Heredity and Health in Africa initiative (H3Africa) as a case study. During this session, faculty will: • Discuss key ethical issues arising in the conduct of international genomic research, sharing experiences from the H3Africa project, including broad consent and reconsent for future uses of samples and feedback of findings (including what to do with incidental findings) • Examine the rationale and guidelines for storage of biospecimens and data gathering/ sharing practices; how access is controlled among multiple sites spread internationally; policies for the sharing of specimens across institutions and countries; and guidelines for biobanks in different countries • Outline examples/models of data and sample access committees, including the committee’s roles and responsibilities and who is able to analyze the data • Review the role of IRBs and research ethics committees in international collaborative genomic research

Room 319

How to Read the Empirical Ethics Literature

(Empirical Research Ethics Track) James M. DuBois, Christine Grady During this session, faculty and attendees will: •D iscuss key aspects of research methods relevant to assessing empirical studies of ethical issues •C onsider common logical fallacies in drawing conclusions from empirical data •R eview and discuss an empirical study with a critical eye

D6

Advanced

Room 341

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

Moira A. Keane Institutions and HRPPs have discretion in interpreting the regulations, and risk tolerance varies among institutions and over time.

This session will focus on identifying when adjustments in risk tolerance may be appropriate and how to manage this change within the IRB and the institution. During this session, faculty will: •O utline approaches to assessing risk tolerance in IRB administration and review •D iscuss options for recalibrating risk and evaluating how to make changes in practice •E xplore ways to introduce flexibility into practice while maintaining regulatory compliance

D7

Room 309-310

Advanced

D8

Advanced

Biological Products: Is an IND Required?

(FDA Regulations Track)

Rachael F. Anatol, Wellington Sun Representatives from the FDA’s CBER will present current topics of interest with a focus on the requirement for an IND. Topics of discussion will include cell therapies, probiotics, and fecal microbial transplant. During this session, faculty will: •D escribe CBER products and requirements for an IND •R eview the applicable regulatory requirements and guidance documents Room 349

The Ethics of Genomic Research in

International Settings (Global Research Track)

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Room 343

Institutional Considerations When

Accepting IRB Review from an Advanced Independent IRB or Academic Partner: The Clinical Trials Transformation Initiative (CTTI) Central IRB Advancement Project (HRPP Leadership and Institutional Officials Track)

Sara Calvert, Cynthia Hahn Is the use of a central IRB right for your organization and, if so, what must be considered as part of the implementation process? The CTTI Central IRB Advancement project has worked to assess and propose solutions for areas of concern about using central IRBs for multi-center clinical trials.

During this session, faculty will: • Describe steps for assessing institutional culture and opportunities for using a single IRB of record for multi-center clinical trials • Discuss implementation including business and operational strategies • Provide a toolkit to assist with adoption that covers separation of responsibilities, policy identification, and template agreements

Sunday, December 7 D10

D13

When it Happens to You: Identifying and

Managing Privacy Breaches in Research Advanced (Legal Track)

Kristina C. Borror, Lisa A. Griffin, Christina Heide, Carlotta Rodriguez, Susan Stayn When a privacy or data security incident occurs in research, it may trigger reporting obligations under HIPAA regulations, as well as under federal human subjects regulations and specific state laws. Each of these laws/ regulations has a different definition of a reportable incident and different requirements for who must receive notification. In addition, within an institution, different offices or groups, including the Privacy Office and the IRB, are responsible for analyzing and reporting incidents and determining appropriate corrective actions in response. The existence of different reporting standards and requirements, and of multiple institutional “owners,” can cause confusion and create risks and challenges for institutions and investigators in identifying, reporting, and managing these incidents. During this session, faculty and attendees will: • Review an overview of the various legal and regulatory requirements applicable to privacy/security incidents • Work through case examples of breach analyses and possible resolutions • Share practical strategies for improved coordination of multiple processes, communication among institutional stakeholders, and investigator compliance with reporting requirements

Room 339-340

Institutional IRB Performance:

Benchmarking and Optimization (IRB Operations and Toolkit Track)

Jeffrey A. Cooper, Stuart Horowitz, Daniel K. Nelson This session will present data from 105 institutions defining the current state of IRB performance. Data are derived from the electronic IRB platform used by the participating IRBs, and have been analyzed and compared to performance benchmarks.

During this session, faculty and attendees will: • Assess the current state of IRB performance, in terms of administrative, review, and investigator functions in hospitals and academic institutions • Recognize and identify both essential and avoidable practices that affect key performance indicators • Formulate a plan to address process constraints and weaknesses in IRB operations

D12

Room 344

Consent for Whole Genome Sequencing

(Issues for Pharma/Biotech Track) Peter Shaw, Kathleen M. Smith, Amelia Wall Warner IRBs often change the language of “optional” consent for collection of samples for future genomic research. This practice results in a large burden for the pharmaceutical industry.

This session will explore alternatives to modifying informed consent language to allow the pharmaceutical and diagnostics industries to facilitate more streamlined processes to

Room 348

D14

Room 318

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

Susan S. Fish, Lindsay McNair This session will serve as a primer on the scientific process, clinical study designs, and the structure of research programs for the non-scientist IRB member. During this session, faculty and attendees will: • Begin with a review of the scientific process, from observation to hypothesis generation and testing, to peer review/

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Empowering Staff, Sharing Workload:

Integral Staff Involvement in the Review Process (IRB Boot Camp Track)

Rebecca D. Armstrong, Martha F. Jones, Tani L. Prestage, Jeanne Velders Increasingly, IRBs are asked to do more with less. In this session, faculty will explore different review models that may improve the quality and consistency of reviews, as well as lessen turnaround times and staff turnover.

The session will also briefly describe flexible policies and procedures that institutions have implemented to alleviate investigator and IRB member burden. In this session, faculty will: • Identify the ways IRB professional staff can reduce IRB member workload and increase efficiency of review • Formulate hiring and training procedures for implementing in-depth staff management • Develop flexible policies and procedures while maintaining regulatory compliance

D11

protect subjects’ personal information. During this session, faculty will: • Provide an understanding of the relevance of genomic research in support of personalized medicine • Discuss the impact to industry partners of changing the wording of informed consent forms • Explore how to protect research subjects’ privacy while allowing for genomic and future research

Room 326

Schedule Recognition Conference Information schedules

critique of conclusions •R eview the basics of clinical study design •D iscuss the clinical research process D15

Basic

Room 347

Unique Challenges in Pediatric Biobanking

(Out of Body Experiences: Research Involving Tissue and Data Track)

Julie Kaneshiro, Robert “Skip” Nelson, Carol J. Weil This session will explore ethical and regulatory considerations that arise in the procurement and storage of biospecimens from infants and children. During this session, faculty will: •D escribe the unique issues that arise in biobanking in pediatric settings •O utline approaches to managing data/ consent when pediatric participants reach the age of majority • Discuss the return of incidental findings in biobanking research with pediatric participants

D16

• Review complex issues such as assuring confidentiality and balancing concerns about stigma • Discuss additional risks, such as violence, discrimination, depression, and suicide • Explore how to recruit and maintain contact with subjects from these populations D18

Connect with PRIM&R: Membership Resources for Networking, Volunteering, and Advancing Your Career (Potpourri Track)

Avery Avrakotos, Megan Frame, Anne Meade, Alysa Perry, Marley Thrasher Join the PRIM&R staff for a session that will help you learn more about PRIM&R’s membership benefits, including educational programs and professional development initiatives, and how these resources can benefit you after the conference. During this session, faculty will: • Outline PRIM&R’s membership benefits • Discuss PRIM&R’s Ethical Research Oversight Course, and explain its benefits as they relate to continuing education (members receive a discounted subscription) • Describe PRIM&R’s At Your Doorstep program, an effort through which PRIM&R courses can be brought to your institution • Explore the Knowledge Center, an online educational resource for members that features PRIM&R program archives; workplace tools, templates and standard operating procedures; Workload Salary Survey Reports; and more.

• Highlight ways to connect with other members and the community at large through our Mentoring Program, volunteer opportunities, and the Regional Connections program, as well as through PRIM&R’s website, social media channels, and the IRB Forum

Room 321

Platinum Supporter: Maximizing the Collaborative Institutional Training Initiative (CITI) Program Educational Experience at Your Organization (Platinum Supporter Track)

Jaime A. Arango, David Burnham This presentation will cover how institutions, administrators, and learners can utilize, adapt, and customize the CITI educational experience at their organizations. New content offerings will be introduced, as well as tools that are available to connect with CITI. New users and current subscribers will be able to learn what is new at CITI and how best to use the CITI Program. During this session, faculty will: •S how attendees how to utilize the CITI Program tools to best meet institutional training needs •D escribe new modules and courses at the CITI Program • Discuss ways to improve learners’ educational experience with the CITI Program Please note that PRIM&R does not endorse the content presented in this session.

D17

Advanced

Room 336

Research With and About the Lesbian,

Gay, Bisexual, Transgender, and Questioning (LGBTQ) Community (Populations Requiring Additional Protections Track)

John A. Guidry During this session, faculty and attendees will: • Examine the special considerations study teams should address when designing a study involving members of the LGBTQ community

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Room 323

D19

Room 307

“Lean” Thinking for IRB

Process Improvement (QA/QI and Post-Approval Monitoring Track) Ross A. Hickey, Yvonne K. Higgins, Tara L. Moore This session will emphasize hands-on application of commonly used Lean tools and techniques, and attendees will learn how Lean concepts can enhance their continuous improvement efforts.

During this session, faculty will: • Outline the key concepts behind a Lean thinking system that enables continuous improvement within any organization • Review how Lean thinking can help attendees improve their IRB review process • Discuss how to manage for continuous performance improvement

Sunday, December 7 D20

Respecting Persons in an Age of Big Data (Research Involving the Internet & Social Networking Track)

D24

Basic

Institutional Memory: How Did We

Handle this the Last Time? Consistency in Protocol Review Procedures and Approval Standards When Reviewing Low Volume Protocol Submissions Involving Greater than Minimal Risk (Small Research Programs Track)

Room 342

School Rules! Conducting Research

in Elementary and Secondary Public Schools (SBER I – Basic Track)

Eric Allen, Michael B. Hawes, Ivor A. Pritchard (OHRP resource person for session), Jeffrey Rodamar, Julie Slayton This session will cover the regulatory requirements for protecting confidentiality of students’ academic records and identify areas of flexibility to enable research on students and records, especially in challenging populations, venues, and districts with historically low parental involvement. During this session, faculty and attendees will: • Review the Family Educational Rights and Privacy Act and the Protection of Pupil Rights Amendment, including what is required, permitted, prohibited, and waivable • Identify who has “school authority” to release information • Share strategies for developing relationships with local school districts for ongoing research activity presence • Discuss waivers and alterations of assent/ consent/permission standards as they apply in schools with low parent involvement • Outline considerations for regulatory oversight of distance learning beyond exemption category 1

Room 311

The Value Added from HRPP Accreditation

(Self-Assessment and Accreditation Track) Jennifer I. Kucera, Martin Letendre, Michael Pagliaro, Peter Vasilenko This session will highlight the value added to organizations by the HRPP accreditation process, that is, how the accreditation process and standards can add improvements to HRPP and IRB function to make them more compliant, more efficient, and more knowledgeable and effective. During this session, faculty will: • Discuss how the accreditation standards and process help HRPPs and IRBs • Provide examples of value added to organizations by HRPP accreditation • Outline both the resource and financial

Room 345

Maria J. Arnold, Paul J. Reitemeier During this session, faculty and attendees will: • Identify study-related features that affect IRB protocol approval decisions including external authorizations and oversight, investigator qualifications, study site adequacy, and risk to subjects • Explore ways to identify, record, track, and retrieve key information from prior IRB approval decisions using both paper-based and electronic record systems • Discuss when IRB approval practices and standards should become formal policies

Room 308

Emily E. Anderson, Ryan Spellecy Many institutions have large data banks to facilitate research and, recently, regional networks pooling institutional data banks have been funded and will soon be operational. Though consent is often waived, those in the field still have a responsibility to uphold the principle of respect for persons.

This session will discuss two models of community engagement as a means of respecting persons: emergency research with an Exception From Informed Consent (EFIC) and Community Engaged Research (CEnR). During this session, faculty will: • Describe the unique challenges to respect for persons that research with large data sets presents • Discuss how EFIC and CEnR fulfill respect for persons in methods other than traditional informed consent • Outline methods for conducting research with large data sets

D22

D23

D25

Ballroom IV

Poorly Prepared SBER Protocols that

Are Otherwise Exempt Advanced (SBER II – Advanced Track)

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The Flexible IRB: Benefits, Challenges,

and Implementation (Regulatory Balance Track) Rebecca Dahl, Madeleine Williams During this session, faculty will: • Describe what a flexible IRB model is using the Children’s Hospital of Los Angeles as an example • List the benefits and challenges of the flexible IRB model compared to more traditional IRB models • Provide implementation considerations for the flexible IRB model

D21

cost of accreditation, as well as the benefits of accreditation

Room 346

Schedule Recognition Conference Information schedules

Judith Birk, Roberto L. Veloso When a study that ”should“ qualify for exempt status under the regulations is poorly designed—thus threatening to waste subjects’ time—what are the IRB’s responsibilities and options? This session will offer practical advice on how IRBs can proceed in such cases.

During this session, faculty and attendees will: •R eview six exempt categories and their relationship to the regulations • Discuss potential for harm to subjects or others from poorly prepared exempt protocols •E xplore the justification of IRB non-approval based on risk to institutional reputation • Address the role of the IRB in counseling student principal investigators and/or faculty advisors D26

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 E2

Room 346

Laura R. Brosch, Joseph V. Cohn This session will be led by representatives from the DOD, and is for researchers who have or are seeking extramural DOD funding.

Attendees are encouraged to come with questions of interest to all. During this session, attendees will: • Hear from DOD staff about policies affecting the conduct of DOD-funded research • Ask questions about current issues and initiatives • Participate in an open discussion about DOD-related topics relevant to the research community

Room 312

Ethical and Regulatory Challenges in the

Ebola Virus Epidemic (Hot Topics Track) Clement Adebamowo, Edward E. Bartlett, Bruce G. Gordon, Michelle Roth-Cline Ebola Virus Disease (EVD) poses a number of vexing ethical and regulatory challenges for the conduct of clinical trials involving vaccines, postexposure prophylaxis, and medical treatments of symptomatic patients. This session will feature presentations from key individuals involved in EVD research. During this session, faculty will: •D escribe the scientific, regulatory, and logistical challenges involved in the control of the EVD epidemic •O utline the ethical tensions involved in current efforts to prevent and treat EVD •E xplain the use of novel research designs in facilitating the rapid implementation of EVD clinical trials

E3

Room 343

Break

11:15 AM-12:30 PM Didactic

Sessions and Workshops Series E

E1

Room 342

A Dialogue with the NIH

(A Dialogue with the Feds I Track)

Sarah Carr, Kathy L. Hudson This session will be led by representatives from the NIH. Attendees are encouraged to come with questions of interest to all. During this workshop, attendees will: •H ear from representatives of the NIH Office of Science Policy, the NIH Office of Extramural Research, and NCI about

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Making Subpart Determinations

When Reviewing Research Involving Vulnerable Populations: Case Studies (Advanced Forum for IRB Professionals Track)

Jeremy N. Block, Bruce G. Gordon, Irene E. Stith-Coleman During this session, faculty and attendees will: • Use case studies to examine research protections for vulnerable populations in biomedical and behavioral studies • Examine the protections that must be in place in order to include vulnerable populations in research • Review the ethical and regulatory guidelines for including these groups in research

10:45-11:15 AM Exhibit Hall FG Join us in The Conference Connection for coffee.

PRIM&R would like to thank IRBNet for supporting this break.

A Dialogue with the DOD: Updates for

DOD-Funded Researchers (A Dialogue with the Feds II Track)

E4

Room 308

Creating a Social Media Presence for

Your HRPP Advanced (Educating and Training Track)

Lois Brako, Charlotte H. Coley, Martha F. Jones, Yvonne Lau, Anne Meade, Jamie Roberts This session will provide attendees with innovative ideas about how to create and maintain a social media presence for their institutions and HRPPs that which helps with education, training, recruitment, and transparency. Faculty will provide simple, concrete, and effective techniques for communicating both within and outside attendees’ institutions. During this session,

Sunday, December 7

E5

Room 326

Enhancing Protections for Vulnerable Populations Through Research on Research Ethics (Empirical Research Ethics Track)

Michelle Broaddus, Celia B. Fisher, Adam L. Fried, Shira M. Goldenberg This session will feature presentations on empirical research on research ethics, which can help evaluate human subjects protections for research involving vulnerable populations.

This research is sponsored by the Fordham University Center for Ethics Education and will draw on the perspectives of research stakeholders to illuminate opportunities and barriers to the responsible conduct of HIV, drug use, and mental health research. During this session, faculty will: • Present on focus groups and interviews that illuminate the perceived health and community benefits and social and economic risks of participation in HIV prevention research among female sex workers in Guatemala • Describe the results of a national survey exploring the organization ethics climate, ethical challenges, and related moral stress encountered by research staff who conduct face-to-face interviews for studies involving participants with affective disorders, including post-traumatic stress disorder and depression • Review a mixed-methods approach used to explore the ethical intricacies of using new forms of mobile phone text-messaging versus traditional small group interventions to enhance sexual negotiation skills among uninsured and underinsured African American women living in the US Midwest

E6

Room 324-325

The Hidden Lives of Subjects: Rule Breaking and Ethics (Ethical Issues Track)

Rebecca S. Dresser, Alan Wertheimer When their personal interests conflict with study requirements, subjects may surreptitiously break the rules. Rule-breaking reduces the value of

research and can create risks for subjects and others, but some strategies for reducing rulebreaking carry ethical risks of their own. During this session, faculty will: • Describe evidence of research subjects’ concealed rule-breaking • Identify ethical problems with subject rulebreaking and factors that contribute to this behavior • Examine the ethics of different strategies to reduce subject rule-breaking and the ethical considerations relevant to these strategies E7

Room 339-340

FDA’s IDE Decisions and Communications:

What You Need to Know (FDA Regulations Track) Owen Faris An IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification 510(k) submission to the FDA. Significant risk clinical studies with devices must be approved by the FDA and by an IRB before the study can begin. During this session, faculty will: • Provide a general overview of the FDA’s device classification, explain what an IDE is, and generally discuss the different types of IDE studies • Share the FDA’s decision-making process for IDEs • Review FDA’s IDE decision letters and discuss some of the IRB challenges in understanding the FDA’s decision letters (e.g., conditions of approval deficiencies, study design considerations, future considerations)

E8

Basic

Room 344

Global Health Systems Research Ethics

(Global Research Track)

Anant Bhan, Adnan Ali Hyder, Walter L. Straus Health systems research is a growing area in global health, and increasingly required by sponsors. Health systems research involves activities that have a public health focus, and are intended to assess the ability of a health system to support novel efficacious interventions, e.g., a new diagnostic or a new vaccine. These initiatives are often conflated with conventional biomedical research such as clinical trials. However, given the distinct aims, approaches, and methodologies involved in health systems research, it may raise novel ethical issues. During this session, faculty will: • Review the ethics of global health systems research and highlight unique aspects • Outline the ethical issues arising in the

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faculty will: • Review how to use Twitter, Facebook, LinkedIn, blogging, webinars, etc., to educate and communicate effectively • Demonstrate how to set up streams and feeds from the top five listservs for the research community • Outline how to target particular populations via social media • Discuss how to improve outreach to subjects • Provide reference documents of educational resources from ORI, OHRP, and PRIM&R

schedules

Schedule Recognition Conference Information conduct of health systems research in lowand middle-income countries •D iscuss examples/case studies of global health systems research that raise ethical issues, including demonstration projects and research with vulnerable populations E9

center campus. During this session, faculty and attendees will: • Share funny, anonymous, and true stories about the jaw-dropping and head-scratching questions, comments, and requests heard in the IRB office, and how attendees handled those situations • Provide feedback on how they would have handled the situations described by other attendees • Discuss general strategies for dealing with situations where IRB staff may not speak up to their colleagues or higher-ups about situations that have occurred for fear of retribution

Room 331-332

Litigation and Enforcement Actions

in Clinical Research: Recent Developments, Trends, and Tips to Minimize Risk (HRPP Leadership and Institutional Officials Track)

Jennifer S. Geetter, Robyn S. Shapiro During this session, faculty will: •R eview and analyze recent claims and enforcement actions brought against researchers, research institutions, and IRBs related to human subjects protections, research misconduct, fraud, and abuse • Address approaches for minimizing risk of litigation •U tilize hypothetical cases to illustrate institutional risk minimization

E10

E12

Ask the Experts! Everything You Wanted to Know, but Were Afraid to Ask (IRB Boot Camp Track)

E11

Ballroom IV

You Want to Do What?! True Stories

from the IRB (IRB Operations and Toolkit Track)

Kristin J. Craun, Susan L. Rose, Lauren B. Solberg The goal for this session is to have a fun and honest conversation with attendees about the wild and crazy side (yes, there is one!) of running an IRB office on a university/medical

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Is Facebook Hurting Your Study? Ethical

and Study Integrity Concerns When Participants Use Social Media (Issues for Pharma/Biotech Track)

Elizabeth A. Buchanan, Lindsay McNair With the ever-increasing use of social media, study participants are just one of many groups becoming increasingly connected online. The proliferation of interactions and opportunities for inter-subject discussions have raised concerns with researchers and research sponsors that discussion about adverse events and the perceived efficacy of investigational drugs could introduce bias in the conduct of clinical studies. Comparison of trial experiences and personal information (for example, the taste of study drug) can even lead to inadvertent or intentional unblinding during studies. During this session, faculty will: • Discuss the benefits and challenges of study participant communication through social media platforms • Explore implications to the study conduct and data validity when participants share study experiences • Review specific tools and techniques for participant education, including the Center For Information and Study on Clinical Research Participation’s “Speak Out, but Speak Smart” website and videos

Room 322

Kristina C. Borror, Jeffrey M. Cohen, George Gasparis, Patricia Holobaugh, Patrick J. McNeilly, James F. Saviola, Elyse I. Summers Are you new to the field of research ethics?

Do you still have a nagging question regarding HRPPs and IRBs? Join us for this session where experienced veterans in the field 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 peers.

During this session, faculty and attendees will: •P articipate in an open and interactive discussion about a broad range of issues in human research protections •S hare ideas and strategies for addressing myriad issues about protocol review, HRPP/ IRB operations, and the regulations

Room 319

E13

Room 312

Human Subjects Research at the US EPA: What’s New, What’s Different, What’s Unique?

(A Dialogue with the Feds II Track)

Daniel K. Nelson, Toby L. Schonfeld While the US EPA has adopted the Common Rule, EPA-supported research presents special challenges, and there are some unique regulatory restrictions and requirements.

This session will feature two representatives

Sunday, December 7

E14

Room 336

Identifying Red Flags: Protocol Review for the Non-Scientist IRB Member Basic (Non-Scientist IRB Members Track)

• Discuss how to determine when a genomic test is investigational • Outline how to apply the IDE regulation to uses of genomic analyses within clinical studies, including how to analyze relevant risk E16

Platinum Supporter: Introducing Cayuse IRB (from Evisions): A Collaboration with Representatives from the Research Community (Platinum Supporters Track) Joe Chin, Joshua Fedewa, Anita Mills, Charlotte L. Shupert How do you deliver a modern, cloud-based solution including features and functionality unavailable in existing systems? Collaboration!

The Cayuse IRB solution was recently launched on a brand new architecture, and it is easy to use and feature-rich. Developing the solution involved many people with a diverse base of experience, but perhaps the most critical input was gathered through collaboration with development partners directly from the research community. Evisions worked with several existing clients who were looking for an IRB solution with functionality that was unavailable in existing systems.

During this session, faculty will: • Review the collaborative effort that went into design and delivery of Cayuse IRB • Discuss the key features of the Cayuse IRB modern solution • Outline the impact the Cayuse IRB solution has had with early adopters Please note that PRIM&R does not endorse the content presented in this session.

Michelle Feige, Nancy A. Olson, Cheryl A. Savini When it all sounds like Greek, how does the non-scientist IRB member know when to be concerned? This session will address the potential red flags that non-scientist IRB reviewers should be aware of when reviewing a study protocol. During this session, faculty will: • Identify problematic areas of protocols • Define specific issues for consideration in IRB review • Provide suggestions for the non-scientist IRB member in reviewing protocols

E15

Advanced

Room 349

Applying FDA Regulations to the Use of

Genomics in Research (Out of Body Experiences: Research Involving Tissue and Data Track)

Jonathan M. Gitlin, Kellie B. Kelm, Ernest D. Litwack, Laura Lyman Rodriguez The inclusion of genomics in human subjects research, including delivering research results to healthcare professionals and patients, is becoming more commonplace. It is incumbent upon scientists conducting this research, and the IRBs providing oversight, to be aware of the FDA regulations that may apply to such research. Using short presentations and case studies, the faculty will address the current and future uses of genomics in research studies, and the challenges this can present to IRBs when data will be generated in and for clinical contexts. In particular, discussion will focus on questions to consider when assessing if diagnostic tests that are part of the research protocol are “investigational” and, if so, when and how FDA medical device regulations apply. During this session, faculty will: • Review future directions for genomic research within clinical studies

Room 311

E17

Room 345

Community-Based Participatory

Research (CBPR) as a Corrective Lens for Research: Case Studies (Populations Requiring Additional Protections Track)

Kathleen O’Hara, Patrick Stanko Despite regulatory safeguards, traditional research approaches often stigmatize marginalized and vulnerable communities.

CBPR emerges as an effective paradigm that aims to make research more inclusive and democratic by fostering partnerships between communities and scientists to address disparities and community-relevant priorities.

This session will foster capacity building in the practice and ethics of CBPR through case studies. During this session, faculty and attendees will: • Consider, identify, and problem solve

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who will give an update on EPA structure and initiatives. During this session, faculty and attendees will: • Review the regulatory restrictions and requirements that are unique to EPAsponsored research • Address some of the special challenges with the types of research conducted or supported by EPA • Discuss initiatives and organizational developments within the EPA

Schedule Recognition Conference Information schedules

ethical conflicts in CBPR that might affect community subjects, researchers, institutions, and research outcomes •E xamine best practices for weighing risks to individuals and the community •D iscuss how to anticipate ethical concerns and recognize boundary issues within the practice and situated ethics of a CBPR collective, including the practice of “process consent,” transparency for an authentic CBPR research agenda, inside-outside tensions, and more •E xplore social validity and the value of hybrid knowledge as benefits of research •S hare tools for ethics in practice through two lenses: community of interest and the research enterprise •R eview IRB strategies for working with community members E18

protections practices E19

Aligning GCP and Human Research Protections (Potpourri Track)

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IRB Management: Innovative Ways to

Foster Accountability and Integrity (QA/QI and Post-Approval Monitoring Track)

Yvonne K. Higgins, Courtney A. Jarboe, Kirsten Walters How do you reasonably monitor the quality of the IRB? How do you engage IRB members and staff around training and performance? This session will explore innovative ways to foster accountability and integrity among IRB members and staff. During this session, faculty will: • Identify effective practices for monitoring and managing the quality of the IRB review process • Discuss alternative training models for IRB members and staff using technology such as Sophia and SharePoint • Explore ways to manage the performance of IRB members and staff utilizing the model called “Content, Pattern, Relationship” in coaching conversations

Room 347

Julie Blasingim, Cheryl J. Priest The current environment for the conduct of clinical trials requires robust procedures to ensure study integrity and quality, as well as to verify ethical study conduct and the safety of study subjects. GCP and human research protections are fundamental requirements mandated for studies involving human subjects; yet, they are implemented under distinct regulatory bodies and directives. Despite the differences, these requirements share the same objective: to conduct safe research that provides quality outputs for the advancement of treatment. Therefore, there is a clear opportunity for a closer alignment of GCP and human research protections to meet objectives for the successful performance of clinical studies, while more effectively protecting the health and welfare of study subjects. During this session, faculty and attendees will: •C onsider the key elements of GCP and human research protections, including the differences and common objectives in providing standards and practices for the ethical and safe conduct of clinical research studies •D iscuss the GCP concepts integrated with human research protections principles and the criteria used for approvals •R eview recommendations for implementing a program with a stronger synergy of GCP and human research protections •W ork through case examples that demonstrate the successful application and alignment of GCP and human research

Room 337-338

E20

Room 309-310

Electronic Consent: A Discussion of

the eConsent Experience, Ethical and Regulatory Considerations, and the IRB Review Process (Regulatory Balance Track)

J. Andrew Bertolatus, Donna A. Messner During this session, faculty will: • Review the use of electronic consent using iPad and computer-based interactive approaches • Discuss the work that has been done to develop the consent form and the preliminary data from comparing iPad consent with traditional paper consent using a case study on “remote consent” (a pilot study of iPad-based consent) • Outline the regulatory requirements of IRB review and consent documentation in the context of an electronic informed consent process • Explore the potential ethical challenges of using electronic technology in streamlining the informed consent process

E21

Room 323

Use of Multimedia Tools for Consent/ Assent in Pediatric Biomedical Research (Research Involving the Internet & Social Networking Track) Holly Antal, Kathryn Blake, Tim Wysocki During this session, faculty will: • Provide information about the use of multimedia tools in the consent/assent process

Sunday, December 7

E22

Room 341

Research-Related Information and the Electronic Medical Record (EMR): Challenges, Lessons Learned, and Suggestions for Best Practices (Hot Topics Track)

Megan Kasimatis Singleton, Megan Morash, Julie Ozier Increasingly, many research studies utilize clinical systems to support study conduct, track study participation, and maintain study-related data.

The introduction of research-based information to the clinical information environment (e.g., the EMR) may impact clinical care, research subject privacy, confidentiality, and research conduct.

This session aims to provide practical solutions for IRBs, investigators, and information privacy and security experts based on the experiences of three major academic medical centers addressing the challenges in this new domain.

During this session, faculty will: • Share best practices related to researchrelated information and the EMR • Review approaches to protecting subject privacy and confidentiality in settings where research interacts with existing clinical EMR systems • Outline strategies for developing language to be used as part of the consent form and process; IT solutions for managing researchrelated information within the EMR; and solutions for protecting sensitive research information that should not be included in the clinical record

E23

• Outline how to establish and maintain an effective HRPP in a large health system with a small research program • Explore challenging structural and operational aspects common in small HRPPs and identify ideas for effective solutions • Share strategies for engaging senior leadership, investigators, IRB members, and those who work in other components of the HRPP • Review how to create action priority lists and timelines • Identify effective institutional change agents, offices, mechanisms, etc.

Room 321

Building and Maintaining a HRPP in

a Large Health System With a Small Research Portfolio (Small Research Programs Track)

Francis DiMario, Lori Roesch This session will focus on the challenges of developing and maintaining an effective HRPP in a large health system with a small biomedical research program. Topics will include credential review of investigators; study site adequacy; interactions with grants offices and chief medical officers; biosafety and radiation safety requirements; compliance with FDA regulated drug and device research; emergency test article research; and more.

During this session, faculty and attendees will:

E24

Basic

Room 307

Special Problems in Reviewing Student Led Research (SBER I – Basic Track)

Eric Allen, Donna H. Eaton This session will focus on assessing and minimizing institutional reputational risk, research subject risk, and maximizing scientific merit in student-conducted research. During this session, faculty and attendees will: • Distinguish human subjects research requiring IRB review from an academic project, class assignment, or independent study (i.e., did the institution check the box for federal funding? If not, do the regulations apply?)

• Discuss the IRB’s role in assessing principal investigator qualifications, assuring ethical access to study data/records, assuring data management, security, and retention, and oversight of intellectual property • Explore how to assess risk to participants and the principal investigator’s institutional reputation • Outline the role and responsibility of the faculty advisor/co-investigator

E25

Advanced

Room 348

Ethically Valid Consent and Assent

in Persons with Diminished Cognitive Capacity (SBER II – Advanced Track)

Theresa Bacon-Baguley, Paul J. Reitemeier Ethical and regulatory standards for approving research involving participants with diminished cognitive capacity provide limited guidance to IRBs. This session will describe the issues involved in reviewing such studies and will present one approach to balancing risks and benefits in research involving persons with diminished cognitive capacity. During this session, faculty and attendees will: • Distinguish cognitive capacity from consent capacity • Identify IRB roles and responsibilities in light of many states having no explicit

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schedules

• Demonstrate how to apply learning theory principles to the development and evaluation of multimedia consent/assent processes • Review guidance for working with the IRB to facilitate development of successful and ethically sound multimedia consent/assent tools

schedules

Schedule Recognition Conference Information laws or regulations on legally authorized representatives •D iscuss a proposed framework for classifying approvable research with subjects with diminished cognitive capacity E26

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. During this interactive lunchtime session, participants will 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?

Room 312

Organ Donor Management Research:

Building Consensus in the Donation and Transplantation Community (Hot Topics Track) Teresa M. Beigay, James M. DuBois, Katherine Gallin Heffernan This session will focus on the challenging issues raised by research on deceased organ donors (i.e., interventions on donors who have been declared brain dead and who are on artificial ventilation prior to the recovery of organs for transplantation), and research on organs ex vivo (i.e., interventions on organs after they have been recovered from the donor, such as putting an organ on an oxygen perfusion device prior to transplantation).

During this session, faculty and attendees will: •D iscuss why this research is critical to improving recipient’s outcomes and to advancing the field of transplantation •R eview the complex legal, ethical, and logistical challenges for this research, including: (i) Who is a human subject in these projects? (ii) When is IRB oversight warranted? (iii) Which IRB should review the project (the donor hospital and/or the recipient hospital)? (iv) What type of consent is appropriate and from whom? (v) How the existing organ allocation process may interfere with identifying the recipient/human subject (and even the recipient site) in advance •E xamine the movement toward consensus around these issues at a conference sponsored jointly by the Health Resources and Services Administration and the Organ Donation and Transplantation Alliance

12:45-1:45 PM

Exhibit Hall FG

Lunch

PRIM&R would like to thank InfoEd Global for supporting the boxed lunches on December 7.

12:45-1:45 PM

Room 314-317

The Uncomfortable Conversation: Talking About Diversity Lunch

Melissa Epstein, Dorotha Love Hall, Roberto L. Veloso The issue of diversity is not directly addressed in the federal regulations governing human subjects research, although it is referenced

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2:00-3:15 PM

Closing General Session Exhibit Hall E

Living Room Conversation: An Update

on the Henrietta Lacks Case

Moderator: Alexander M. Capron Panelists: Ruth R. Faden, Daniel E. Ford, Kathy L. Hudson, David J. Lacks, Jr., Veronica Spencer, Jeri Lacks Whye During this informal living room conversation, members of the Lacks family, a representative from The John Hopkins University (where Henrietta Lacks was a patient), a representative of the NIH, and an ethicist will reflect on the Henrietta Lacks case and its legacy for the research community.

Participants will discuss what has happened since the publication of Rebecca Skloot’s book, The Immortal Life of Henrietta Lacks, including the creation of an unprecedented agreement between the Lacks family and the NIH that allows researchers controlled access to the whole genome data from the HeLa cell line. Participants will also share the decisionmaking and negotiation processes that led to the drafting and finalization of the agreement, and reflect on the agreement’s implications for future uses of the HeLa cell line and other cell lines in research.

CME Accreditation Statement

Boston University School of Medicine designates this live activity for 18.75 AMA PRA Category 1 Credits .

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

TM

This program meets the criteria of the Massachusetts Board of Registration in Medicine for 18.75 hours of risk management study.

Course director: Leonard Glantz, JD, Professor, Health Law, Bioethics, and Human Rights, Boston University School of Public Health Target audience: The target audience of this activity includes 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 Registration Area at the Baltimore 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. Americans with Disabilities Act (ADA) statement: The Baltimore Convention Center is a handicap accessible facility. To request reasonable accommodations for a disability, please visit the Help Desk located in the Pratt Street Lobby on Level 300. d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

schedules

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 providership of Boston University School of Medicine and PRIM&R. Boston University School of Medicine is accredited by the ACCME to provide CME for physicians.

Faculty List Recognition Conference Information

faculty

A

Melissa E. Abraham, PhD, MSc Chair, Human Research Committee, Partners HealthCare; Assistant Professor, Harvard Medical School; Assistant Psychologist, Massachusetts General Hospital. Panel V, B3.

Clement A. Adebamowo, MD, ScD Professor of Public Health and Epidemiology, Institute of Human Virology, University of Maryland; Chairman, National Health Research Ethics Committee of Nigeria. D26.

Albert J. Allen, MD, PhD Senior Medical Fellow, Bioethics and Pediatric Capabilities, Eli Lilly and Company. C10.

Eric Allen, CIP, CPIA Associate Director of Consulting Services, HRP Consulting Group, Inc. C23, D24, E24.

Patricia M. Alt, PhD Professor, Towson University; IRB Chair, Maryland Department of Health and Mental Hygiene. B11.

Rachael F. Anatol, PhD Associate Director, Policy-New Legislation, Office of Cellular, Tissue, and Gene Therapies, CBER, FDA. D7.

Emily E. Anderson, PhD, MPH Assistant Professor of Bioethics, Loyola University Chicago. D21.

Misti Ault Anderson, MS, MA Research Analyst, Presidential Commission for the Study of Bioethical Issues. B16.

Holly Antal, PhD, ABPP Licensed Psychologist, Nemours Children’s Clinic. E21.

Jaime A. Arango, EdD, CIP Director, Collaborative IRB Training Initiative (CITI) Educational Initiatives, University of Miami/CITI Program. D16.

Rebecca D. Armstrong, DVM, PhD Director, Research Subject Protection, University of California, Berkeley. A4, C26, D10.

Maria J. Arnold, CIP IRB Clinical Research Manager, Baptist Health System-South Florida Baptist Hospital. D23.

Nilofer S. Azad, MD Assistant Professor of Oncology, Johns Hopkins Hospital. Panel III.

B

Theresa Bacon-Baguley, PhD Professor; Associate Dean for Research, College of Health Professions, Grand Valley State University. E25.

A. Cornelius Baker Deputy Coordinator for Affected Populations and Civil Society Leadership, US Department of State’s Office of the US Global AIDS Coordinator. Panel VIII. Elizabeth Bankert, MA Assistant Provost and Interim IRB Director, Dartmouth College. IRB 101 Pre-Con, C20.

Jessica D. Bardill, PhD Assistant Professor of Native American Literatures, East Carolina University. B17.

Mark Barnes, JD, LLM Partner, Ropes & Gray Law Firm. Biobanking Pre-Con, A3, C8, The Drama of DNA. Edward E. Bartlett, PhD International Human Research Liaison, DHHS, OHRP. A25, C8.

Teresa M. Beigay, DrPH Director of Special Donation Initiatives, Health Resources and Services Administration. E26.

J. Andrew Bertolatus, MD IRB Co-Chair, Research Services Administration, University of Iowa. E20.

John R. Baumann, PhD Executive Director, Human Research Protection Program, Indiana University. AAHRPP Accreditation Pre-Con. Katherine Bevans, PhD Assistant Professor of Pediatrics, Children’s Hospital of Philadelphia/University of Pennsylvania School of Medicine. D3.

Anant Bhan, MBBS, MHSc Bioethics and Global Health Researcher, Yenepoya University; Senior Research Consultant, Sandra Rotman Centre. Panel II, E8.

Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School, Brigham and Women’s Hospital. Research Ethics Book Group Lunch and Meet the Authors: Human Subjects Research Regulation: Perspectives on the Future, A3, B9, The Drama of DNA. Clifton O. Bingham, III, MD Associate Professor, Divisions of Rheumatology and Allergy and Clinical Immunology, The Johns Hopkins University; Director, Johns Hopkins Arthritis Center. Panel VI. Judith Birk, JD Director, Medical School IRBs, University of Michigan. Innovations B, D25.

Betty Black, PhD Associate Professor, Gerontology, Johns Hopkins School of Medicine. C4.

Kathryn Blake, PharmD, BCPS, FCCP Principal Research Scientist, Nemours Children’s Clinic. E21.

Julie Blasingim, MBA, CIP Board Chair, Schulman Associates IRB, Inc. E18.

Hal Blatt, DDS Health Policy Analyst, OHRP. A14.

Marianna J. Bledsoe, MA Independent Research Professional/Consultant; Adjunct Assistant Professor, Departments of Clinical Research and Leadership and Pathology, George Washington University School of Medicine and Health Sciences. Biobanking Pre-Con, D8.

Jeremy N. Block, PhD, MPP Vice-Chair, IRB, New York Eye & Ear Infirmary of Mount Sinai; Assistant Professor, Department of Population Health Science and Policy; Sr. IRB Manager, Program for the Protection of Human Subjects, Icahn School of Medicine at Mount Sinai. A17, B17, E3.

David A. Borasky, Jr., MPH, CIP Vice President, Quality Management, Copernicus Group IRB. A25, D1.

Kristina C. Borror, PhD Director, Division of Compliance Oversight, OHRP. A1, C14, D13, E10.

Jeffrey R. Botkin, MD, MPH Associate Vice President for Research Integrity, University of Utah. Policy and Practice Session, C15, The Drama of DNA, D1.

Adam L. Braddock, MD Associate Physician, University of California, San Diego. Research Ethics Book Group Lunch.

Scott Bradner Senior Technical Consultant, Office of the Chief Technology Officer, Harvard University. Panel IX. Lois Brako, PhD Assistant Vice President for Research, University of Michigan. E4.

Michelle Broaddus, PhD Assistant Professor, Psychiatry and Behavioral Medicine, Medical College of Wisconsin. E5.

Elizabeth Bromley, MD, PhD Assistant Professor, Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles; Research Psychiatrist, Desert Pacific Mental Illness Research, Education, and Clinical Centers, West Los Angeles VA. Panel VII. Robert L. Brooks, MD, PhD Associate Director, Research Compliance Education and Policy, Department of Veterans Affairs Office of Research Oversight. B1.

Laura R. Brosch, RN, PhD Director, Office of Research Protections, Human Research Protections Office Headquarters, US Army Medical Research and Materiel Command. E2. p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

Brandon J. Brown, MPH, PhD Assistant Professor, Department of Population Health and Disease Prevention; Director, Global Health Research Education and Translation, University of California, Irvine. B26.

Joseph S. Brown, PhD Professor of Psychology, University of Nebraska-Omaha. C25.

Elizabeth A. Buchanan, PhD Endowed Chair in Ethics; Director, Center for Applied Ethics, University of Wisconsin Stout. E12.

Lisa R. Buchanan, MAOM, CIP Public Health Analyst, Compliance Oversight, OHRP. B4.

Donna D. Buckley, MEd, CCRP Senior Clinical Research Coordinator, Cincinnati Children’s Hospital Medical Center. D4.

David Burnham, BBA Manager, Corporate Sales, University of Miami/Collaborative IRB Training Initiative Program. D16.

Mina P. Busch, MS, CCRP, CIP Office of Research Compliance and Regulatory Affairs Education Consultant, Cincinnati Children’s Hospital Medical Center. D4.

Lynn Wein Bush, PhD, MS, MA Faculty, Pediatric Clinical Genetics, Columbia University Medical Center; Faculty Associate, Center for Bioethics, Columbia University. The Drama of DNA. Wesley G. Byerly, PharmD Research Compliance Officer, University of Texas System. AAHRPP Accreditation Pre-Con, C9.

Christine Byrne IRB-IACUC Compliance Specialist, Lawrence Berkeley National Laboratory. A2.

Sarah Carr Associate Director for Policy, Office of Biotechnology Activities, NIH. E1.

E. Charlisse F. Caga-anan, JD, MA Program Director, NCI. B15.

Sara Calvert, PharmD Senior Clinical Project Manager, Clinical Trials Transformation Initiative, Duke Translational Medicine Institute. D9.

Philip J. Candilis, MD, DFAPA Director, Forensic Psychiatry Fellowship, St. Elizabeth’s Hospital. B5.

Alexander M. Capron, LLB University Professor; Scott H. Bice Chair in Healthcare Law, Policy, and Ethics; Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California. Research Ethics Book Group Lunch, The Drama of DNA, Plenary Breakfast, Henrietta Lacks Closing Session.

Joe Chin Director of Product Management, Evisions. E16.

Bowen Chung, MD, MSHS Assistant Professor-in-Residence, Department of Psychiatry and Biobehavorial Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA); Adjunct Scientist, RAND Corporation; Attending Psychiatrist, HarborUCLA Medical Center. Panel VII. Constance F. Citro, PhD Director, Committee on National Statistics, National Academy of Sciences/National Research Council. Panel V. I. Glenn Cohen, JD Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. Research Ethics Book Group Lunch.

Jeffrey M. Cohen, PhD, CIP Chief Executive Officer, HRP Consulting Group, Inc. B24, C17, E10.

Joseph V. Cohn Deputy Director, Human Performance, Training, and BioSystems Directorate; Associate Director, Human Research Protections, Office of the Assistant Secretary of Defense for Research and Engineering. E2.

Charlotte H. Coley, MACT, CIP Training Coordinator, University of North Carolina at Chapel Hill. E4.

Stephanie Collins Reed, PhD IRB Administrator, New York State Psychiatric Institute; Assistant Professor of Clinical Neurobiology, Columbia University Medical Center. A11.

Jeffrey A. Cooper, MD, MMM Vice President Global Consulting, WIRB-Copernicus Group. C10, D11.

Amy Corneli, PhD, MPH Scientist II, FHI 360. C5.

Kristin J. Craun, MPH, CIP IRB Director, University of Southern California. E11.

Brenda Curtis, PhD, MSPH Health Communication Research Scientist, Treatment Research Institute. A21, C21.

D

Rebecca Dahl, PhD, CIP Director, Human Subjects Protection Program, Children’s Hospital Los Angeles. D20.

Bertha de Landa, CIP, BA IRB/Stem Cell Research Oversight Panel Manager, Stanford University. A18.

Francis DiMario, MD, MA, CIP HRPP Medical Director; IRB Chair, Connecticut Children’s Medical Center. E23.

Janet C. Donnelly, RAC, CIP Policy Analyst, Office of Good Clinical Practice, FDA. B10.

Stacey A. Donnelly, MPA Director, Sponsored Research, Broad Institute. A15.

Kelly Dornin-Koss, MPPM, RN, CIP Director, Education and Compliance, Office for Human Subject Research, University of Pittsburgh. A19.

Christine Drabick, MS Consumer Safety Officer, FDA. B7.

Rebecca S. Dresser, JD Daniel Noyes Kirby Professor of Law; Professor of Ethics in Medicine, Washington University in St. Louis School of Law. E6.

James M. DuBois, PhD, DSc Professor of Medicine, Division of General Medical Sciences; Director of the Center for Clinical Research Ethics, Washington University in St. Louis. D5, E26.

E

Donna H. Eaton, RN, MSN, MHA Director, Research Compliance and Ethics; Research Integrity Officer, North Carolina A&T State University. E24.

Leah R. Eisenberg, JD, MA Assistant Professor, Medical Humanities, University of Arkansas for Medical Sciences. Innovations A. Susan S. Ellenberg, PhD Professor of Biostatistics, Perelman School of Medicine, University of Pennsylvania. B14.

Melissa Epstein, PhD, CIP IRB Administrator, Albert Einstein College of Medicine of Yeshiva University. Diversity Lunch.

Barbara Evans, JD, PhD, LLM Director, Center on Biotechnology and Law, University of Houston. Research Ethics Book Group Lunch, C15. d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

faculty

C

Faculty List Recognition Conference Information

faculty

F

Ruth R. Faden, PhD, MPH Andreas C. Dracopoulos Director, Berman Institute of Bioethics; Philip Franklin Wagley Professor of Biomedical Ethics; The Johns Hopkins University. Henrietta Lacks Closing Session.

Jessica Fargnoli, MPH Program Analyst, DHHS. C2.

Owen Faris, PhD Acting Director, Clinical Trials, Office of Device Evaluation, CDRH, FDA. D2, E7.

Anthony S. Fauci, MD Director, National Institute of Allergy and Infectious Diseases, NIH. Keynote Address (December 6), Panel VIII. Joshua Fedewa, CIP Senior Research Compliance Coordinator, Children’s Hospital of Chicago Research Center. E16.

Michelle Feige, MSW, LCSW-C Chief Education Specialist, Public Health Analyst, OHRP. A17, B10, E14.

Heidi Li Feldman, JD, PhD Professor of Law, Georgetown University. Research Ethics Book Group Lunch.

James A. Feldman, MD, MPH, FACEP Professor of Emergency Medicine; Research Director, Department of Emergency Medicine; Chair, IRB Panel Blue, Boston University Medical Center. Chairs Boot Camp Pre-Con, B3.

Sheila Fireman, JD, CIP Director, Research Integrity and Compliance, Harvard Pilgrim Health Care Institute. A5.

Ruth L. Fischbach, PhD, MPE Director, Center for Bioethics, Columbia University. The Drama of DNA. Susan S. Fish, PharmD, MPH Professor, Biostatistics and Epidemiology, Boston University School of Public Health. Clinical Research Pre-Con, Innovations A, B14, D14.

Celia B. Fisher, PhD Marie Ward Doty Endowed University Chair and Professor of Psychology; Founding Director, Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute, Fordham University. Pre-Con Fundamentals of Clinical Research and Study Design, Innovations B, Panel V, E5.

Emily Chi Fogler, JD Senior Legal Counsel, Office of the General Counsel, Partners HealthCare. C13.

Daniel E. Ford, MD, MPH David M. Levine Professor of Medicine in the Welch Center for Prevention, Epidemiology, and Clinical Research; Professor of Psychiatry, Epidemiology, and Health Policy and Management, Johns Hopkins Bloomberg School of Public Health; Vice Dean for Clinical Investigation; Director, Office of Human Subjects Protection, Johns Hopkins School of Medicine. Henrietta Lacks Closing Session.

Annemarie Forrest, RN, MS, MPH Clinical Project Manager, Clinical Trials Transformation Initiative. A12.

David G. Forster, JD, MA, CIP, Chief Compliance Officer, WIRB-Copernicus Group. A20, D1.

William L. Freeman, MD, MPH, CIP Human Protections Administrator; Program Director, Center for Health, Northwest Indian College. C6.

Sharon Freitag Director, Research Ethics Office, St. Michael’s Hospital. A21.

Adam L. Fried, PhD Assistant Director, Center for Ethics Education; Director, Master of Arts in Ethics and Society Program, Fordham University. E5.

G

Dean R. Gallant Retired-Assistant Dean for Research Policy and Administration, Harvard University. SBER Pre-Con, Panel IX, B24.

Chris Galvin, MBA Analyst, Office of Inspector General, US DHHS. C2.

George Gasparis, CIP President, The PEER Consulting Group. A26, B12, E10.

Jennifer S. Geetter, JD Partner, McDermott, Will & Emery. E9.

Dean R. Gerstein Vice Provost, Director of Research, and Research Professor, Division of Behavioral and Organizational Sciences, Claremont Graduate University. A24 Sarah Giannakopoulos, MA Director of Operations, AAHRPP. AAHRPP Accreditation Pre-Con. Heather J. Gipson, JD, MA Director of IRBs, Northwestern University. C11.

Jonathan M. Gitlin, BSc, PhD Science Policy Analyst, National Human Genome Research Institute. E15.

Theresa Gleason, PhD Acting Director, Clinical Science Research and Development Service, Office of Research and Development, Department of Veteran Affairs. B1.

Aaron J. Goldenberg, PhD, MPH Assistant Professor of Bioethics, Case Western Reserve University. Policy and Practice Session.

Shira M. Goldenberg, PhD Postdoctoral Fellow, Gender and Sexual Health Initiative, British Columbia Centre for Excellence in HIV/ AIDS, Department of Medicine, University of British Columbia. E5.

Gregg Gonsalves, BS Co-Director, Yale Global Health Justice Partnership; Lecturer in Law, Yale University. Panel VIII. Bruce G. Gordon, MD Executive Chairman, IRB; Professor, Pediatrics, University of Nebraska Medical Center. Chairs Boot Camp PreCon, A17, B4, D26, E3.

Julia G. Gorey, JD Public Health Analyst, OHRP. A20, B24.

Kristen Grace, MD, PhD Senior Scientist-Investigator, ORI. A3.

Christine Grady, RN, PhD Chief, Department of Bioethics, NIH Clinical Center. The Drama of DNA, D5.

Alan I. Green, MD Chair and Professor of Psychiatry; Professor of Pharmacology and Toxicology, Geisel School of Medicine, Dartmouth College Tiffany Green, MHS, MPH Program Analyst, NCI. B15.

Lisa A. Griffin, JD, MPH Research Compliance Associate, Brigham and Women’s Healthcare. D13.

William (Bill) Grizzle, MD, PhD Professor of Pathology, University of Alabama, Birmingham. Biobanking Pre-Con. Michelle Groman, JD Associate Director, Presidential Commission for the Study of Bioethical Issues. C1.

John A. Guidry, PhD Consultant, Icahn School of Medicine at Mount Sinai; IRB Chair, Gay Men’s Health Crisis. D17.

Adarsh K. Gupta, DO, MS, FACOFP Director, Center for Medical Weight Loss and Control; Director, Center for Information Mastery; Chair, School of Osteopathic Medicine IRB, Rowan University. B21.

p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

H

I

R. Peter Iafrate, PharmD Chairman, Health Center IRB, University of Florida. B3.

Mei-Ling Isaacs, MPH IRB Director, Papa Ola Lokahi. C6.

Yasmin Isler, PhD Biorepository Research Specialist, ProMedica Toledo Hospital. Innovations A.

J

Lama Jamhawi, MSc, CIP IRB Member, Weill Cornell Medical College–Qatar, Hamad Medical Corporation. A8.

Courtney A. Jarboe, MA, CIP IRB Administrator; Supervisor, Dissertation Support Center, Capella University. E19.

Gail H. Javitt, JD, MPH Counsel, Sidley Austin LLP; Research Scholar, Berman Institute of Bioethics, The Johns Hopkins University.

Research Ethics Book Group Lunch.

C. Karen Jeans, PhD, CCRN, CIP Associate Director of Regulatory Affairs, Clinical Science Research and Development, Department of Veteran Affairs. B1.

Steven Joffe, MD, MPH Emanuel and Robert Hart Associate Professor; Director, Penn Fellowship in Advanced Biomedical Ethics; ViceChair, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania. A5, B5, Policy and Practice Session.

Dahron A. Johnson, BA Chaplain; Community Member Non-Scientist, Tennessee Valley Healthcare System. A14.

Loretta Jones, MA Founder and CEO, Healthy African American Families, Phase II. Panel VII. Martha F. Jones, MA, CIP Executive Director of the Human Research Protection Office, Washington University in St. Louis. B20, D10, E4.

K

Soma Kalb, PhD Acting Investigational Device Exemption Director, CDRH, FDA. B12.

Julie Kaneshiro, MA Deputy Director, OHRP. A15, B27, C24, D15.

Nancy E. Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health, Berman Institute of Bioethics; Professor, Department of Health Policy and Management, Bloomberg School of Public Health, The Johns Hopkins University. Panel II, Panel VIII, B26. d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

faculty

Cynthia Hahn Vice President, Clinical Research and Regulatory Affairs, North Shore-Long Island Jewish Health System. D9.

Heidi A. Hahn, PhD Executive Advisor, Los Alamos National Laboratory; Visiting Research Professor, Department of Systems Engineering, Naval Postgraduate School. A2.

Karen N. Hale, RPh, MPH, CIP Director, Office of Responsible Research Practices, The Ohio State University. IRB 201 Pre-Con, C11.

Dorotha Love Hall, PhD, MPA, CIP Senior Public Health Advisor, CDC. Diversity Lunch.

Susie A. Han, MA, MA Deputy Director and Principal Policy Analyst, New York State Task Force on Life and the Law, New York State Department of Health. B17.

Karen M. Hansen Director, Institutional Review Office, Fred Hutchinson Cancer Research Center. A8, C19.

Shannon L. Harr, CIM, EdD Director, Research Integrity and Compliance, Morehead State University. A23, C23.

Evan Harrington, PhD Associate Professor, The Chicago School of Professional Psychology. Innovations B. Michael B. Hawes Statistical Privacy Advisor, US Department of Education. D24.

Mary Louise Healy, MS Director, University Research Services, Towson University. B11.

Katherine Gallin Heffernan, JD Counsel, Verrill Dana LLP. B9, C3, E26.

Christina Heide, JD Acting Deputy Director for Health Information Privacy, Office for Civil Rights, DHHS. D13.

Jonathan S. Helfgott Associate Director for Risk Science (Acting), FDA. C7 Julia Hesse, JD, MBioethics Partner, Choate, Hall & Stewart LLP. B13.

Jan L. Hewett, BSN, JD Director, HRPP, Yale University. C19.

Ross A. Hickey, JD, CIP, CPIA Assistant Provost for Research Integrity, University of Southern Maine. D19.

Lorna Hicks, MS, CIP Director, Program for the Protection of Human Subjects in Non-Medical Research, Duke University. SBER Pre-Con. Yvonne K. Higgins, MS, CIP Senior Consultant, WIRB-Copernicus Group. C4, D19, E19.

Susie R. Hoffman, RN, BSN, CIP Director, IRB for Health Sciences Research, University of Virginia. C20.

Patricia Holobaugh, MS Chief, Bioresearch Monitoring, CBER, FDA. E10.

Carol R. Horowitz, MD, MPH Co-Director, Center for Health Equity and Community Engaged Research, Mount Sinai School of Medicine. C6.

Stuart Horowitz, PhD, MBA President, Institutions and Institutional Services, WIRB-Copernicus Group. C16, D11.

Leslie M. Howes, MPH, CIP Director, Office of Human Research Administration, Harvard School of Public Health/Harvard Faculty of Medicine. B19.

Kathy L. Hudson, PhD Deputy Director for Science, Outreach, and Policy, NIH. E1, Henrietta Lacks Closing Session.

Sara C. Hull, PhD Director, National Human Genome Research Institute Bioethics Core; Faculty, Clinical Center, Department of Bioethics, NIH. The Drama of DNA. Jonathan M. Hunter, MA, CIP Associate, Research Services, Huron Consulting Group. C11.

Adnan Ali Hyder, MD, MPH, PhD Professor and Director, Health Systems Program; Associate Chair, Department of International Health, Bloomberg School of Public Health, The Johns Hopkins University. Panel II, E8.

faculty

Faculty List Recognition Conference Information Hallie Kassan, MS, CIP Director, Human Research Protection Program, North Shore-Long Island Jewish Health System. A10.

Petra Kaufmann, MD, MSc Director, Division of Clinical Innovation, National Center for Advancing Translational Sciences. A26.

Moira A. Keane, MA, CIP Human Research Protections Professional; Retired-Executive Director, HRPP, University of Minnesota.

Consent Pre-Con, Innovations C, D6.

Kellie B. Kelm, PhD Scientific Reviewer/Biologist, Division of Chemistry and Toxicology Devices, FDA. E15.

Michele Kennett, JD, RN, CIP Assistant Vice Chancellor for Research, University of Missouri Columbia. A12.

Dmitry Khodyakov, PhD Sociologist, RAND Corporation; Faculty, Pardee RAND Graduate School. Panel VII. Sarah H. Kiskaddon, JD, MA Director of Global Development and Public Affairs, AAHRPP. AAHRPP Accreditation Pre-Con, C22.

Richard Klein Director, Patient Liaison Program, Office of Health and Constituent Affairs, FDA. Panel III, D2.

Colleen Kohashi, MA, CIP IRB Coordinator, Office for Protection of Human Subjects, University of California, Berkeley. Innovations C. Susan Z. Kornetsky, MPH Director, Clinical Research Compliance, Boston Children’s Hospital. IRB 201 Pre-Con, B6, C13, The Drama of DNA. Greg Koski, PhD, MD President and Co-Founder, Alliance for Clinical Research Excellence and Safety. Research Ethics Book Group Lunch, The Drama of DNA. Kaarkuzhali B. Krishnamurthy, MD Director, Women’s Health in Epilepsy, Beth Israel Deaconess Medical Center. C14.

Jennifer I. Kucera, MS, CIP IRB Administrator/Education Coordinator, University of Nebraska Medical Center. D22.

Nandini K. Kumar Dr. TMA Pai Endowment Chair; Adjunct Professor, Kasturba Medical College, Manipal University. A8.

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David J. Lacks, Jr. Grandson of Henrietta Lacks. Henrietta Lacks Closing Session.

Yvonne Lau, MBBS, MBHL, PhD Director, Division of Education and Development, OHRP. A3, E4.

James V. Lavery, MSc, PhD Research Scientist and Assistant Professor, McLaughlin-Rotman Center for Global Health, University of Toronto. B8.

Kathleen Lawry, CIP, MSSA, LISW Director, Reliant Review Cleveland Clinical and Translational Science Award, The MetroHealth System. AAHRPP Accreditation Pre-Con, C22.

Susan E. Lederer, PhD Robert Turell Professor of the History of Medicine and Bioethics, University of Wisconsin School of Medicine and Public Health. Keynote Address (December 7).

Lisa M. Lee, PhD, MS Executive Director, Presidential Commission for the Study of Bioethical Issues. C1.

Sandra Soo-Jin Lee, PhD Senior Research Scholar, Stanford Center for Biomedical Ethics, Stanford University School of Medicine. A5.

Jennifer Lentz, CCRP Global Informed Consent Form Process Owner, Eli Lilly and Company. A12.

Katherine Lerner, JD, CIP Associate Director, Social and Behavioral Sciences IRB, University of Chicago. A24.

Joanne R. Less, PhD Director, Office of Good Clinical Practice, FDA. D2.

Martin Letendre, LLB, LLM Managing Director, Veritas IRB, Inc. D22.

Robert J. Levine, MD Professor of Medicine; Chair, Executive Committee of the Center for Bioethics, Yale University. Panel II, Panel V. Gregorio Lim, CIP HSPP Administrator, The Boeing Company; Chair, Council for Certified IRB Professionals. A22.

Scott J. Lipkin, DPM, CIP Managing Director, Health Solutions, FTI Consulting, Inc. AAHRPP Accreditation Pre-Con, A23, B23.

Ernest D. Litwack, PhD Staff Fellow, FDA. E15.

Holly Fernandez Lynch, JD, MBioethics Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. Research Ethics Book Group.

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Patricia A. MacCubbin, MS President and CEO, Research Ethics Group. B11.

Kathleen M. MacQueen, PhD, MPH Senior Social Scientist, Behavioral and Social Sciences, Family Health International 360. A25, B8.

Eric Mah, MHS, CIP Interim Chief Ethics and Compliance Officer; Senior Director, Research Compliance, University of California, San Francisco. A9.

Diane M. Maloney, JD Associate Director for Policy, FDA. D2.

Ellen Marakowitz, PhD, CIP Lecturer in Anthropology; Advisor, Master’s Program in Anthropology, Columbia University. B25.

Karen Maschke, PhD Research Scholar, The Hastings Center; Editor, IRB: Ethics & Human Research. Policy and Practice Session.

Paula Garcia McAllister, PhD, CIP IRB Research Specialist, Northern Arizona Healthcare. Innovations C. Carrie A. McKeague, PhD Chief Learning Officer, UL EduNeering, Inc. A4.

Gianna McMillan, BA Content Manager, People & Perspectives, PRIM&R; Community Engagement Director, Editorial Advisory Board, Narrative Inquiry in Bioethics. Panel III. Lindsay McNair, MD, MPH, MSB Chief Medical Officer, WIRB-Copernicus Group. Clinical Research Pre-Con, D14, E12.

Patrick J. McNeilly, PhD, CIP Senior Health Policy Analyst, FDA. C18, E10.

Karen M. Meagher, PhD Senior Policy and Research Analyst, Presidential Commission for the Study of Bioethical Issues. B16.

Jerry Menikoff, MD, JD Director, OHRP. A1, B27, C26.

Donna A. Messner, PhD Research Director, Center for Medical Technology Policy. E20.

William J. Meurer, MD, MS Assistant Professor, University of Michigan. C12.

Michelle N. Meyer, PhD, JD Assistant Professor and Director of Bioethics Policy, Union Graduate College, Icahn School of Medicine at Mount Sinai. Research Ethics Book Group Lunch, C26. p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

Veronica Miller, PhD Executive Director, Forum for Collaborative HIV Research. Panel VIII. Anita Mills, CRA Solutions Consultant, Evisions. E16.

Tara L. Moore Quality Assurance Specialist for Research, Wellspan Health - York Hospital. D19.

Megan Morash, BSN, MEd IRB Chair, Partners HealthCare. E22.

Ann Morrison, PhD Assistant Professor, Metropolitan State University of Denver. B23.

Bavon Mupenda, MA, MPH, PhD Deputy Director, Kinshasa School of Public Health, Center for Bioethics. B26.

F. Lisa Murtha, JD, CHC, CHRC Senior Managing Director and Practice Leader, Clinical Research and Compliance Practice, FTI Consulting, Inc. A9.

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Kelley O’Donoghue, MPH, CIP Director, Office for Human Subject Protection, University of Rochester. A22.

Laura Odwazny, JD, MA Senior Attorney, Office of the General Counsel, US DHHS. A21, B21, C21.

Kathleen O’Hara, MSW PhD Candidate, Columbia University School of Social Work. E17.

Nancy A. Olson, JD Director, Human Research Office, University of Mississippi Medical Center. E14.

Alexander Ommaya, DSc Senior Director, Clinical Effectiveness and Implementation Research, Association of American Medical Colleges. D3.

John Ordaz Manager, Human Subjects Protection Program; Senior Technical Safety Manager, Office of the Associate Administrator for Safety and Health, National Nuclear Security Administration, DOE. A2.

P. Pearl O’Rourke, MD Director, Human Research Affairs, Partners HealthCare. A15, Panel VI, B22, The Drama of DNA, D3.

Alberto Ortiz-Osorno, MS, PMP, CIPM Clinical Research Implementation Subject Matter Expert, Division of AIDS, National Institute of Allergy and Infectious Diseases. B18.

Julie Ozier, MHL, CHRC, CIP Director, HRPP, Vanderbilt University. E22.

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Michael Pagliaro, RN Director, Alion HRPP Accreditation Program, Alion Science and Technology. D22.

Dina N. Paltoo, PhD, MPH Director, Genetics, Health, and Society Program, Office of Science Policy, NIH. B15.

Catherine Parker, RN, BSN Team Lead, Human Subject Protection Branch, Division of Safety Compliance, Office of Scientific Investigation/Office of Compliance, FDA. B7, D2.

Wayne R. Patterson, PhD Associate Vice President for Research, University of Texas at Austin. AAHRPP Accreditation Pre-Con, C9.

Holly L. Peay, MS, CGC Director, DuchenneConnect Registry; Senior Vice President, Community Engagement, Parent Project Muscular Dystrophy. Panel VI, D3.

Jane Perlmutter, PhD, MBA Founder and President, Gemini Group. A12.

Heather H. Pierce, JD, MPH Senior Director, Science Policy and Regulatory Counsel, Association of American Medical Colleges. C3.

Elizabeth R. Pike, JD, LLM Senior Policy and Research Analyst, Presidential Commission for the Study of Bioethical Issues. B16.

Peter N. Poon, JD Deputy Executive Director, Office of Research Oversight, Department of Veteran Affairs. B1.

Ernest D. Prentice, PhD Associate Vice Chancellor for Academic Affairs; Professor of Genetics, Cell Biology, and Anatomy, University of Nebraska Medical Center. B17.

Tani L. Prestage, MPA, MA, CIP Assistant Director, University of California, Berkeley. D10.

Cheryl J. Priest, RN Managing Partner and Executive Director, Good Clinical Practice Services, Falcon Consulting Group, LLC. E18.

Ivor A. Pritchard, PhD Senior Advisor to the Director, OHRP. A1, B27, C24, D24.

Kevin A. Prohaska, DO, MPH Senior Medical Policy Analyst, FDA; Captain, US Public Health Corps. D2.

J. Thomas Puglisi, PhD Chief Officer, Office of Research Oversight, VA. B1.

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Jessica A. Randall, MA, CIP Manager, Research Quality Assurance and Compliance, Human Research Protections Program, Yale University. A19.

Paul J. Reitemeier, PhD Chair, Human Research Review Committee (IRB), Grand Valley State University (GVSU); Associate Professor of Philosophy, GVSU and Michigan State University School of Human Medicine. IRB Chairs Boot Camp Pre-Con, D23, E25.

James Riddle, MCSE, CNE, CIP, CPIA Assistant Director, Institutional Review Office, Fred Hutchinson Cancer Research Center. B21.

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Paul Ndebele, PhD Director, Medical Research Council of Zimbabwe. Innovations A, A8.

Camille Nebeker, EdD, MS Assistant Professor, Department of Family and Preventive Medicine; Director, Collaborative to Advance Professional and Research Integrity, University of California, San Diego. Panel IX. Daniel K. Nelson, MSc, CIP Director, Human Research Protection Office, EPA; Adjunct Professor of Social Medicine and Pediatrics, University of North Carolina at Chapel Hill. Consent Pre-Con, B22, D11, E13.

Robert “Skip” Nelson, MD, PhD Senior Pediatric Ethicist, Office of Pediatric Therapeutics, FDA. B6, The Drama of DNA, D15.

Eunice Yim Newbert, MPH Manager, Education and Quality Improvement Program, Boston Children’s Hospital. B19.

faculty

Faculty List Recognition Conference Information Suzanne M. Rivera, PhD, MSW Vice President, Research and Technology Management, Case Western Reserve University. Research Book Group Lunch, Policy and Practice Session.

Jamie Roberts, MA, CCRP, MPH Clinical Trial Specialist, National Institute of Neurological Disorders and Stroke. E4.

Jeffery Rodamar Protection of Human Subjects Coordinator, US Department of Education. B2, D24.

Carlotta Rodriguez, MS, CIP, CHRC Director of the IRB, Rutgers Health Sciences Campus at Newark. D13.

Laura Lyman Rodriguez, PhD Director, Division of Policy, Communications, and Education, National Human Genome Research Institute. B15, The Drama of DNA, D8, E15.

Lori Roesch, CIM, CIP Senior IRB Administrator, Milwaukee VA Medical Center. A22, E23.

Susan L. Rose, PhD Executive Director, Office for Protection of Research Subjects, University of Southern California. A14, E11.

Michael Rosenblatt, MD Executive Vice President and Chief Medical Officer, Merck & Co., Inc. Panel III. Michelle Roth-Cline, MD, PhD Pediatric Ethicist, Office of Pediatric Therapeutics, FDA. D26.

Karen H. Rothenberg, JD, MPA Senior Advisor to the Director on Genomics and Society, National Human Genome Research Institute.

The Drama of DNA. Mark A. Rothstein, JD Herbert F. Boehl Chair of Law and Medicine, Director, Institute for Bioethics, Health Policy, and Law, University of Louisville School of Medicine. Panel I, C15.

Erin Rothwell, PhD, CTRS Adjunct Associate Professor, College of Nursing and Division of Medical Ethics, University of Utah. Policy and Practice Session.

Charmaine D. M. Royal, PhD, MS Associate Professor, Department of African and African American Studies; Director, Center on Genomics, Race, Identity, Difference, Duke University. Panel IV. Brenda L. Ruotolo, CIP Executive Director, Human Research Protection Program, Columbia University. A10.

Andrew Rusczek, JD, MBioethics Counsel, Verrill Dana LLP. B4.

Michele Russell-Einhorn, JD Senior Director, Office for Human Research Studies, Dana-Farber Cancer Institute. Biobanking Pre-Con, C12, D1.

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Fabienne Santel, MD Medical Officer, Office of Compliance, Division of Bioresearch Monitoring, CDRH, FDA. A7.

Tanisha Savage Health Specialist, Protection of Participants, Evaluation, and Policy Branch, Division of AIDS, The Henry Jackson Foundation, National Institute of Allergy and Infectious Diseases. B18.

Cheryl A. Savini, CIP Principal, Chief Operating Officer, HRP Consulting Group, Inc. E14.

James F. Saviola, OD, CAPT, USPHS Director, Division of Bioresearch Monitoring, FDA. D2, E10.

Toby L. Schonfeld, PhD Human Subjects Research Review Official; Director, Program in Human Research Ethics and Oversight, EPA. C25, E13.

Talisha M. Searcy, MPA, MA Deputy Director, Evaluation, Planning, and Support Division, Office of Inspector General, US DHHS. C2.

Joe V. Selby, MD, MPH Executive Director, Patient-Centered Outcomes Research Institute. Panel VI. Ada Sue Selwitz, MA Director, Office of Research Integrity; Adjunct Associate Professor, Department of Behavioral Science, University of Kentucky College of Medicine. IRB 101 Pre-Con, A20, B10.

J. Walton Senterfitt, PhD, MPH IRB Chair and Administrator, Los Angeles County Department of Public Health. B3.

Nelson Sewankambo, MBChB, MSc, MMED, FRCP, Doctor of Laws, Honoris Causa Professor of Medicine; Head Principal, Makerere University College of Health Sciences. Panel II. Robyn S. Shapiro, JD Partner, Health Law, Drinker Biddle & Reath LLP. A13, E9.

Peter Shaw, MD Senior Director, Molecular Profiling and Pharmacogenetics, Merck Research Laboratories. D12.

Saul M. Shiffman, PhD Research Professor of Clinical and Health Psychology, Psychiatry, and Pharmaceutical Sciences, University of Pittsburgh. Panel IX. Charlotte L. Shupert, PhD, CIP Product Manager, Compliance Solutions, Evisions. E16.

Carmella (Carol) Simmons, MS, RN, FNP Lead Consumer Safety Officer, Division of Bioresearch Monitoring, FDA. A7.

Megan Kasimatis Singleton, JD, MBE, CIP Associate Director, Human Research Protections, University of Pennsylvania. B4, E22.

Nicholas Slack, MBE Vice President, Consulting and Business Development, Western Institutional Review Board. C16.

Julie Slayton, JD, PhD IRB Chair, University of Southern California. D24.

Kathleen M. Smith, PhD Immunology Biobank Lead, AbbVie Bioresearch Center. D12.

Lauren B. Solberg, JD, MTS Assistant Professor, Program in Bioethics, Law, and Medical Professionalism, University of Florida College of Medicine. E11.

Ryan Spellecy, PhD Associate Professor of Bioethics, Medical College of Wisconsin. B3, D21.

Sujatha Sridhar, MBBS, MCE Executive Director, Research Compliance, Education, and Support Services, University of Texas Health Science Center at Houston Medical School. AAHRPP Accreditation Pre-Con, B20.

Veronica Spencer Great-Granddaughter of Henrietta Lacks. Henrietta Lacks Closing Session.

Matthew D. Stafford, BA IRB Manager, Office of Clinical Investigation, Boston Children’s Hospital; Co-Chair, Harvard Catalyst Regulatory Working Group SBER Sub-Committee. A24, B25, C14.

Patrick Stanko, BA, CIP IRB Assistant Director, University of Pennsylvania. E17.

Laura Stark, PhD Assistant Professor; Medicine, Health, and Society, Vanderbilt University. B5.

Susan Stayn, JD Senior University Counsel, Stanford University. D13.

Richard D. Stevenson, MD Professor of Pediatrics, Department of Pediatrics, University of Virginia. B3.

Irene E. Stith-Coleman, PhD Director, Division of Policy and Assurances, OHRP. A1, B20, E3. p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

Walter L. Straus, MD, MPH Global Director for Scientific Affairs-Vaccines, Merck & Co., Inc. Panel III, Plenary Breakfast, E8.

David H. Strauss, MD Director of Research, New York State Psychiatric Institute; Vice Chair for Research Administration, Ethics, and Policy, Columbia University Department of Psychiatry. Panel IV. Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine, Deputy Director for Medicine, The Johns Hopkins University. A5, Panel VI, C5.

Elyse I. Summers, JD President and CEO, AARHPP. AAHRPP Accreditation Pre-Con, C22, E10.

Wellington Sun, MD Director, Division of Vaccine Review and Product Applications, FDA. D7.

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Peter Vasilenko, PhD Program Director, Alion HRPP Accreditation Program, Alion Science and Technology. D22.

Glenn Veit, JD, CIP IRB Chair, Copernicus Group IRB. B3.

Jeanne Velders, JD, RN, CIP Associate Director, Human Research Protection Office, Washington University in St. Louis. D10.

Roberto L. Veloso, JD Associate Professor and IRB Chair, Rocky Mountain University of Health Professions. D25, Diversity Lunch.

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Kirsten Walters, PhD, CIP Dissertation Support Center Manager, Capella University. E19.

Amelia Wall Warner, PharmD, RPh Founder and CEO, Global Specimen Solutions, Inc. D12.

Melissa P. Wasserstein, MD Director, Program for Inherited Metabolic Diseases, Mount Sinai School of Medicine. A18.

Carol J. Weil, JD Program Director, Ethical and Regulatory Affairs, NCI. Research Ethics Book Group Lunch, D15.

Kevin P. Weinfurt, PhD Associate Professor, Department of Psychiatry, Duke University Medical Center. A5.

Alan Wertheimer, PhD Senior Research Scholar, Department of Bioethics, NIH. Innovations B, A6, E6.

Darrell P. Wheeler, PhD, MPH, ACSW Professor and Dean, School of Social Work, Loyola University Chicago. Panel VIII. Elizabeth P. White, MBA, MPH, CIP Program Manager, DOE. A2.

Sarah A. White, MPH, CIP Director, Human Research Quality Improvement Program, Partners HealthCare. A19.

Jeri Lacks Whye Granddaughter, Henrietta Lacks; Domestic Violence Unit, Judiciary System of Baltimore. Henrietta Lacks Closing Session.

John T. Wilbanks Chief Commons Officer, Sage Bionetworks. Keynote address (December 5), Panel I. Ilene F. Wilets, PhD, CIP Executive Director, IRB, New York State Psychiatric Institute. A11.

Madeleine Williams, MA, CIP Senior Director, Huron Consulting Group. D20.

Rebecca J. Williams, PharmD Assistant Director, ClinicalTrials.gov, National Library of Medicine. C18.

Sabune Joane Winkler, JD Director, Regulatory Affairs Operations, Harvard Clinical and Translational Science Center, Harvard Medical School. Innovations C, C13.

Delia Y. Wolf, MD, JD, MSCI, CIP Associate Dean, Regulatory Affairs and Research Compliance, Harvard School of Public Health; Assistant Professor of Radiology, Harvard Medical School. A9, C3.

Leslie E. Wolf JD, MPH Professor, Georgia State University College of Law. Research Ethics Book Group Lunch, B13.

Michael J. Woods President and CEO, Schulman Associates IRB, Inc. A16.

Tim Wysocki, PhD, CIP IRB Chair, Nemours Children’s Clinic. E21.

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Aminu A. Yakubu Principal Research Officer; Desk Officer, National Health Research Ethics Committee, Federal Ministry of Health, Nigeria. B26, D8.

Candice A. Yekel, MS Assistant Vice President for Research, Pennsylvania State University. AAHRPP Accreditation Pre-Con, C22.

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Andrew Zacher, JD General Attorney, US DHHS. A1, B4.

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Kate Tapley, JD Senior Attorney, NIH. B13.

Anne L. Taylor, MD Senior Vice President for Faculty Affairs and Career Development for Columbia University Medical Center, Columbia University. Panel IV. Holly A. Taylor, PhD, MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health; Core Faculty, Berman Institute of Bioethics, The Johns Hopkins University. C4, Plenary Breakfast.

Amy Terpstra, MSW Director of Research, Heartland Alliance. B17, C17.

Robert Jim Terwiel, LLM Senior Legal Policy Advisor, Dutch Ministry of Health. C8.

Paulina O. Tindana Bioethicist/Senior Researcher, Navrongo Health Research Centre. B8.

Susan Brown Trinidad, MA Research Scientist, University of Washington. A18, C6.

Plenary and Keynote Biographies Recognition Conference Information

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Melissa E. Abraham, PhD, MSc, is chair of the Partners Human Research Committee (PHRC), an assistant professor at Harvard Medical School, and an assistant psychologist at Massachusetts General Hospital. She obtained her doctorate in clinical psychology from Northwestern University Medical School in Chicago, Illinois, and a master’s degree in epidemiology from the Harvard School of Public Health. Dr. Abraham completed the Fellowship in Medical Ethics at Harvard Medical School and went on to become a chair at the PHRC in 2004 where she also reviews minimal risk and SBER conducted in a biomedical setting. She is interested in issues related to SBER review in the biomedical setting, and has developed guidance on topics related to the use of the internet in research for the IRB and investigator community at Partners HealthCare.

Nilofer S. Azad, MD, is assistant professor of oncology and a member of the Gastrointestinal Oncology Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Dr. Azad received her undergraduate degree from the University of Texas in Austin before completing her medical degree and residency at Baylor College of Medicine in Houston. She completed her fellowship in Medical Oncology at NCI before becoming a member of The Johns Hopkins University faculty in July 2008. Dr. Azad serves as co-director of the phase I clinical research program at the Kimmel Cancer Center. She is the principal investigator of multiple early phase clinical trials that are supported through competitive peer-reviewed grant mechanisms.

She is a member of the Stand Up 2 Cancer Epigenetics Dream Team and focuses on clinical drug development of novel agents for advanced cancer patients.

A. Cornelius Baker is the Deputy Coordinator for Affected Populations and Civil Society Leadership at the US Department of State’s Office of the US Global AIDS Coordinator. Mr. Baker serves on the boards of PRIM&R, the Black AIDS Institute, Broadway Cares/Equity Fights AIDS, and Us Helping Us, and serves on the executive committee of the Forum for Collaborative Research on AIDS. In 2009, he was appointed to the President’s Advisory Council on HIV/AIDS. Previously, he served as the senior policy advisor for the National Black Gay Men’s Advocacy Coalition, a technical advisor at the Center on AIDS and Community Health at FHI 360, the executive director of Whitman-Walker Clinic, and executive director of the National Association of People with AIDS. Mr. Baker also worked as a confidential assistant to the assistant secretary for health at the US DHHS in the National AIDS Program Office. He has received the Courage Award at the Washington AIDS Walk for his outstanding leadership in living with the HIV disease, the National Lesbian and Gay Health Association’s Diego Lopez Award for leadership in HIV advocacy, the American Foundation for AIDS Research Award of Courage for Community Building, and the National Association of People with AIDS’ Braveheart Award. He was honored by Planned Parenthood of Metropolitan Washington in 2004 for his support of women’s health and community leadership. He received his undergraduate degree at Eisenhower College/Rochester Institute of Technology.

Anant Bhan, MBBS, MHSc, is trained as a medical doctor with a master’s degree in bioethics from the University of Toronto. Based in Pune, India, Dr. Bhan works as a bioethics and global health researcher at Yenepoya University, 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 p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

published in various medical journals, is an associate editor for Public Health Ethics, 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 for trainings in research and public health ethics, and also serves as guest faculty in various educational institutions in India and abroad. He is a member of three ethics committees in India, and serves as chair for one, and has been as a reviewer for multiple journals, conference scientific committees, and grant competitions. Dr. Bhan recently joined the working group created to revise the 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Humans.

Clifton O. Bingham, III, MD, is an associate professor in the divisions of rheumatology and allergy and clinical immunology at The Johns Hopkins University (JHU), and the director of the Johns Hopkins Arthritis Center. Prior to joining JHU in 2005, Dr. Bingham directed the Bellevue Arthritis Clinic and the Seligman Center for Clinical Research in New York. Dr. Bingham serves as codirector and deputy director for clinical research of the Rheumatic Diseases Research Core Center P30. He has led a number of pivotal studies of biologic disease-modifying drugs in rheumatoid arthritis, structure-modifying drugs for osteoarthritis, and in evaluating the effect of biological therapies on immune responses to vaccines. He has served as a member of international groups to develop new classification criteria for rheumatoid arthritis, define radiographic erosions, and update guidelines on biologic drug use. Dr. Bingham is on the executive leadership committee for the Outcome Measures in Rheumatology Clinical Trials. Important to this work is the inclusion of patients through all stages of research in identifying relevant aspects of health affected by disease, analyzing, commenting, and presenting research findings, and developing research agendas and specific projects. This work served as the nidus for a project funded as one of the first 50 pilot projects from the Patient Centered Outcome Research Institute to evaluate the NIH Patient Reported Outcomes Measurement Information System. Dr. Bingham is author of more than 95 peerreviewed manuscripts, case reports, and 12 book chapters, and is currently the co-editor of Arthritis and Rheumatism.

Judith Birk, JD, is the director of the IRBs of the University of Michigan Medical School (IRBMED), an AAHRPP-accredited institution. She is responsible for daily operational oversight and regulatory compliance of the five IRBs that comprise IRBMED. Ms. Birk serves on numerous committees and working groups in support of the University of Michigan’s HRPP. She is also responsible for developing innovations and demonstration projects to reduce regulatory burdens and increase IRB efficiencies. From 2003 to 2012, she was the director of the health sciences and behavioral sciences IRBs at the University of Michigan where she has also held positions in other research and clinical support capacities, and served on numerous policy, compliance, ethics, and regulatory committees.

Scott Bradner is a senior technical consultant in the office of the Harvard University Chief Technology Officer, where he does work in the areas of identity management; exploring, developing, and upgrading technology; and monitoring changing technology trends and exploring their potential for use. Mr. Bradner has been involved in the design, operation, and use of data networks at Harvard University since the days of the Advanced Research Projects Agency Network. He was involved in the design of

the original Harvard University data networks, the Longwood Medical Area network (LMAnet), and New England Academic and Research Network (NEARnet), and was founding chair of the technical committees of LMAnet, NEARnet, and the Corporation for Research and Enterprise Network. Mr. Bradner has served in a number of roles in the Internet Engineering Task Force (IETF), is a member of the IETF Administrative Support Activity, and is a trustee of the IETF Trust. He was a member of the Internet Engineering Steering Group, and was an elected trustee of the Internet Society, where he currently serves as the secretary to the Board of Trustees.

Mr. Bradner founded the Harvard Network Device Test Lab, is a speaker at technical conferences, is a weekly columnist for Network World, and does independent consulting.

Lynn Wein Bush, PhD, MS, MA, is on the faculty of pediatric clinical genetics at Columbia University Medical Center, a faculty associate at their Center for Bioethics, and serves as an ethicist and liaison on pediatric and genomic advisory committees for numerous academic medical centers and professional organizations. Dr. Bush has an interdisciplinary background in clinical and developmental psychology, bioethics, genomics, public health, and neuroscience, all of which inform her research, writing, and teaching on the ethical, psychological, and policy challenges of genomic diagnosis, screening, clinical care, and research involving fetuses, newborns, infants, and children. Dr. Bush’s focus is on ethical dilemmas posed during the prenatalneonatal period and with pediatric chronic and acute conditions, including unknown or rare diseases and neurodevelopmental disorders. She developed narrative genomics with Karen Rothenberg as a creative pedagogical approach to bring to life these complex issues, enhance ethical reflection, and foster interdisciplinary discourse. Dr. Bush received a PhD in clinical psychology with child subspecialty from Columbia University, completed her internship in child clinical psychology at EinsteinMontefiore Medical Center, and served multi-year fellowships in infant psychiatry and pediatric liaison at Mt Sinai Medical Center.

She also earned her MS in bioethics and her MA in developmental psychology at Columbia.

Alexander M. Capron, LLB, is a university professor, occupant of the Scott H. Bice Chair in Healthcare Law, Policy, and Ethics, and co-director, of the Pacific Center for Health Policy and Ethics at the University of Southern California. An honors graduate of Swarthmore College and Yale Law School, he previously

Bowen Chung, MD, MSHS, is an assistant professor-in-residence in the department of psychiatry and biobehavioral sciences at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), and an adjunct scientist at the RAND Corporation.

Dr. Chung is currently an attending child and adolescent psychiatrist at Harbor-UCLA Medical Center in Torrance, California, where he sees patients and teaches medical students, general psychiatry residents, and child and adolescent psychiatry fellows. He received his undergraduate education at Williams College with a BA in English literature, his MD at the Mount Sinai School of Medicine, and his MSHS at the UCLA School of Public Health. Dr. Chung’s career interests are in community partnered participatory research, community based participatory research, depression quality improvement, and health disparities.

Constance F. Citro, PhD, is director of the Committee on National Statistics (CNSTAT), a standing unit at the National Academy of Sciences/National Research Council. She was the senior study director with CNSTAT from 1984 to 2004 and, prior to that, held senior positions with Mathematica Policy Research, Inc., and Data Use and Access Laboratories, Inc. Dr. Citro is a fellow of the American Statistical Association, an elected member of the International Statistical Institute, and recipient of the Roger Herriot Award for Innovation in Federal Statistics and the Joseph Waksberg Award in Survey Methodology. She received her BA in political science from the University of Rochester, and her MA and PhD in political science from Yale University. For CNSTAT, Dr. Citro directed evaluations of the 2000 census, the Survey of Income and Program Participation, microsimulation models for social welfare programs, and the NSF science and engineering personnel data system, in addition to studies on IRBs and social science research, estimates of poverty for small geographic areas, data and methods for retirement income modeling, and a new approach for measuring poverty. She co-edited the 2nd–5th editions of Principles and Practices for a Federal Statistical Agency.

Leah R. Eisenberg, JD, MA, is currently an assistant professor in medical humanities at the University of Arkansas for Medical Sciences. Previously she completed a fellowship in bioethics research at Mayo Clinic after earning a master’s degree in bioethics from Case Western Reserve University and a JD from the University of Wisconsin. Ms. Eisenberg’s education and experience give her unique insight into problems that arise at the intersection of law, medicine, and ethics. One of her particular d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

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Elizabeth Bromley, MD, PhD, has been a faculty member since 2008 in the department of psychiatry and biobehavioral sciences at the David Geffen School of Medicine, University of California, Los Angeles (UCLA). She is also a research psychiatrist at the Desert Pacific Mental Illness Research, Education, and Clinical Centers, West Los Angeles VA, and an anthropologist. Dr. Bromley earned her BA in history from Rice University, and her MD and MA in the history of health sciences from the University of California, San Francisco. She completed residency and a chief residency in psychiatry at Columbia University and the New York State Psychiatric Institute. Dr. Bromley was a UCLA/VA Robert Wood Johnson Clinical Scholar from 2004 to 2006, and completed her PhD in anthropology in 2008. Dr. Bromley’s research focuses on the therapeutic beliefs and institutional contexts that shape clinical practices and psychiatric research. Her studies address functional recovery in schizophrenia, research ethics, mental health stigma, and physician culture.

taught at Georgetown University, the University of Pennsylvania, and Yale University. Professor Capron was the executive director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a congressionally chartered body that prepared 14 reports on subjects ranging from equitable health care access to human genetic engineering, and whose recommendations led to the creation of the Common Rule. From 2002 to 2006, he served as the first director of ethics, trade, human rights, and health law at the World Health Organization in Geneva. Professor Capron is an elected member of the IOM and of the American Law Institute, as well as a fellow of the AAAS. He is also a founding fellow of The Hastings Center. He has served as president of the International Association of Bioethics, president of the American Society of Law, Medicine, and Ethics, and vice president of CIOMS. He is currently chair of PRIM&R’s Board of Directors and is a member of the 2014 AER Conference CCPC.

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interests is developing forms and processes that help individuals understand medical and legal documents. As someone trained in bioethics, she is concerned about the fact that many people sign consent forms without understanding them and, as a lawyer, she is dismayed that legal regulations are often cited as the reason such forms are incomprehensible. Ms. Eisenberg knows that complex jargon is not necessary to meet the requirements for legal documents. Utilizing plain language, she drafted a significant portion of the patient materials used for biobanking at Mayo Clinic.

To further increase participant engagement and understanding, she has collaborated with the Mayo Clinic Center for Innovation and Center for Individualized Medicine to produce and evaluate graphic versions of these documents.

Ruth R. Faden, PhD, MPH, is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics and the Philip Franklin Wagley Professor of Biomedical Ethics. Dr. Faden is a member of the IOM, and a fellow of The Hastings Center and the American Psychological Association. She has served on numerous national advisory committees and commissions, including President Clinton’s Advisory Committee on Human Radiation Experiments, which she chaired. Dr. Faden is a co-founder of the Hinxton Group, a global community committed to advancing ethical and policy challenges in stem cell science, and the Second Wave project, an effort to ensure the health interests of pregnant women are fairly represented in biomedical research and drug and device policies. Dr. Faden is the author and editor of many books and articles on biomedical ethics and health policy including Social Justice: The Moral Foundations of Public Health and Health Policy (with Madison Powers) and A History and Theory of Informed Consent (with Tom L. Beauchamp). Dr. Faden’s current research focuses on justice theory and on national and global challenges in learning healthcare systems, health systems design and priority setting, and access to the benefits of global investments in biomedical research. In 2011, Dr. Faden received the PRIM&R Lifetime Achievement Award for Excellence in Research Ethics, and the Lifetime Achievement Award from the American Society for Bioethics and Humanities and PRIM&R. Anthony S. Fauci, MD, is director of the National Institute of Allergy and Infectious Diseases (NIAID) at NIH. Since his appointment as NIAID director in 1984, Dr. Fauci has overseen an extensive research portfolio devoted to preventing, diagnosing, and treating infectious and immune-mediated diseases. Dr. Fauci is also chief of the NIAID Laboratory of Immunoregulation, where he has made important discoveries related to HIV/AIDS, and he is one of the most-cited scientists in the field. Dr. Fauci serves as one of the key advisors to the White House and DHHS on global AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza. He was one of the principal architects of the President’s Emergency Plan for AIDS Relief, which has already been responsible for saving millions of lives throughout the developing world. Dr. Fauci is a member of the US National Academy of Sciences and is the recipient of numerous prestigious awards for his accomplishments, including the National Medal of Science, the Mary Woodard Lasker Award for Public Service, and the Presidential Medal of Freedom. He has been awarded 38 honorary doctoral degrees and is the author, coauthor, or editor of more than 1,200 scientific publications, including several major textbooks.

Susan S. Fish, PharmD, MPH, is a professor of biostatistics p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

and epidemiology at the Boston University School of Public Health. Dr. Fish received the Doctor of Pharmacy degree from the University of Minnesota, a Masters of Public Health degree from Boston University, a bachelor’s degree in pharmacy from Massachusetts College of Pharmacy and Allied Health Sciences, and a bachelor’s degree in chemistry and education from the University of Massachusetts. Dr. Fish is the former director of the masters in clinical research program at Boston University School of Medicine (BUSM), and was previously the director of human subjects protections 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 also served as director of regulatory affairs at CareStat, Inc., vice chair for research in the department of emergency medicine at Boston City Hospital/BUMC, and associate professor of emergency medicine at BUSM. Dr. Fish was also the associate director of the Massachusetts Poison Control System and an associate professor at Massachusetts College of Pharmacy and Allied Health Sciences. Dr. Fish is an active member of many organizations, including PRIM&R, where she serves on the Board of Directors, is a member of the 2014 AER Conference CCPC, and is co-chair of the 2014 AER Conference Poster Abstract Sub-committee.

Celia B. Fisher, PhD, is the Marie Ward Doty Endowed University Chair and Professor of Psychology and the founding director of the Fordham University Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training Institute, which is funded by the National Institute on Drug Abuse. She chaired the EPA’s Human Studies Review Board and the American Psychological Association’s Ethics Code Task Force, and was a member of SACHRP, the National Academies’ Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, the National Institute of Mental Health Data Safety and Monitoring Board, and the IOM’s Committee on Clinical Research Involving Children. Dr. Fisher was awarded the Lifetime Achievement Award for Excellence in Human Research Protection in 2010, and was named a 2012 Fellow of the AAAS. She is the author of Decoding the Ethics Code: A Practical Guide for Psychologists (3rd edition, 2013); co-editor of eight books, including The Handbook of Ethical Research with Ethnocultural Populations and Communities (2006, Sage Publications) and Research with High-Risk Populations: Balancing Science, Ethics, and Law (2009, APA Publications); and over 150 theoretical and empirical publications.

Daniel E. Ford, MD, MPH, is the David M. Levine Professor of Medicine in the Welch Center for Prevention, Epidemiology, and Clinical Research at The Johns Hopkins University (JHU) School of Medicine, and holds joint appointments in the departments of psychiatry, epidemiology, and health policy and management in the Johns Hopkins Bloomberg School of Public Health. He was appointed the vice dean for clinical investigation and institutional official for the JHU School of Medicine in 2005, and is the director for the Office of Human Subjects Protection. Dr. Ford is the principal investigator for the JHU Clinical and Translational Science Award, and was appointed the director of the Institute for Clinical and Translational Research in 2007. Dr. Ford’s research interests include the biological pathways accounting for the relationship between depression and cardiovascular disease, and how to improve treatment of chronic diseases in medical settings through information technology. Dr. Ford did his undergraduate work at

Cornell University, received his MD from the State University of New York at Buffalo, and completed the Osler medicine residency at JHU. Dr. Ford received additional training as a clinical epidemiology fellow at the National Institute of Mental Health, and received a MPH from the Johns Hopkins Bloomberg School of Public Health.

Gregg Gonsalves, BS, is co-director of the Yale Global Health Justice Partnership, a lecturer at Yale Law School, and a PhD candidate at Yale School of Public Health. Mr. Gonsalves has been an AIDS activist for more than 20 years and his work was profiled in the 2012 documentary “How to Survive a Plague,” and in Steven Epstein’s book, Impure Science: AIDS, Activism, and the Politics of Knowledge. He has worked on AIDS drug development, and clinical and basic research policy, focusing on the efforts of the NIH, FDA, and the pharmaceutical industry, and has worked internationally, with the WHO and the Joint United Nations Programme on HIV/AIDS, on access to medicines and diagnostics in resource-poor settings. Mr. Gonsalves was a member of the AIDS Coalition to Unleash Power, co-founded the Treatment Action Group, and later worked with Gay Men’s Health Crisis and the AIDS and Rights Alliance for Southern Africa. Mr. Gonsalves is a former fellow of the Open Society Foundations and the department of global health and social medicine at Harvard Medical School, and was the inaugural recipient of the John M. Lloyd AIDS Leadership award in 2008. In 2011, Mr. Gonsalves received his BS in biology as an Eli Whitney student in Yale College.

Evan Harrington, PhD, is an associate professor at The Chicago School of Professional Psychology. Dr. Harrington joined The Chicago School in 2005 and teaches statistics, research methods, and mental health law. His community involvement includes serving on the board of advisors for the National Center for Reason and Justice, and serving on the IRB Committee for the Illinois Criminal Justice Information Authority. His research interests include the ideology and decisions of members of the US Supreme Court, the provocation defense to murder, the nocebo (negative placebo) effect, and mental health law. Dr. Harrington completed his doctoral work in social psychology at Temple University where he studied with research methodologist Ralph Rosnow, and earned BA degrees in psychology and criminal justice from the State University of New York-Albany.

Adnan Ali Hyder, MD, MPH, PhD, serves as professor and the director of the Health Systems Program and as associate chair in the department of international health at the Bloomberg School of Public Health, The Johns Hopkins University (JHU).

He also serves as director of the International Injury Research Unit, which is a leading center on injury research and training for the developing world, and a WHO Collaborating Center for Injuries, Violence, and Accident Prevention. Dr. Hyder is associate director for Global Bioethics of the Johns Hopkins Berman Institute of Bioethics. He serves as co-director of the NIH-Fogarty International Research Ethics Training Program at the Bloomberg School of Public Health. He has published and worked for 20 years on issues related to health systems development, equity, and ethics in low- and middle-income countries of Africa and Asia, and has co-authored over 200 papers in international literature.

Fundamental to his efforts is a desire to build research capacity around ethics in developing countries. Dr. Hyder obtained his MPH and PhD degrees from JHU, and his MD from the Aga Khan University in Pakistan.

Yasmin Isler, PhD, is a biorepository research specialist at ProMedica Toledo Hospital. She received her doctorate degree in chemistry from Kent State University in 2011. Dr. Isler relocated to Toledo, Ohio, with her family when she accepted the job of starting a biorepository from the ground up. The biorepository first opened in 2012, and Dr. Isler has been working on improving both its operation and functionality to best accommodate the patients and to help advance research in the medicinal and scientific fields.

Loretta Jones, MA, is founder and CEO of Healthy African American Families, Phase II. She is also an associate professor at Charles R. Drew University of Medicine and Science in the Community Faculty Prefix Series. A “community gatekeeper,” Ms. Jones has dedicated her life to pushing toward the hope and healing of community and society at large. Her career as a civil rights activist, health policy advocate, and social architect has spanned more than 40 years. She has published in the Journal of the American Medical Association and Ethnicity & Disease, and is a co-author on more than 40 peer-reviewed articles. She is a current and past co-investigator of numerous NIH and CDC d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

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Dean R. Gallant retired in 2013 as assistant dean for research policy and administration in the Faculty of Arts and Sciences at Harvard University. In that capacity, he was responsible for the oversight of human subjects and animal research, professional conduct, and general issues of research policy. Mr. Gallant has a background in social psychology and worked at the Alcohol and Drug Abuse Research Center at McLean Hospital, where he studied the behavioral effects of marijuana use, before moving to the Center for Behavioral Sciences at Harvard University, where he long served as assistant director. He was director of the Harvard University Science Center for 10 years and, for 35 years, Mr. Gallant was a member of Harvard University’s Committee on the Use of Human Subjects in Research, where he served as executive officer. He is an active member of PRIM&R, where he frequently serves on 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 2014 AER Conference CCPC.

Kathy L. Hudson, PhD, is the deputy director for science, outreach, and policy at the NIH. Dr. Hudson leads the science policy, legislation, and communications efforts of the NIH and serves as a senior advisor to the NIH director. She is responsible for creating new strategic and scientific initiatives for NIH, and was a key architect of the National Center for Advancing Translational Sciences and the NIH Brain Research through Advancing Innovative Neurotechnologies Initiative. She directs the agency’s efforts to advance biomedical science through policy development and innovative projects and partnerships. Dr. Hudson’s professional experience includes serving as the acting deputy director of the National Center for Advancing Translational Sciences, NIH; the NIH chief of staff; the assistant director of the National Human Genome Research Institute, NIH; and the founder and director of the Genetics and Public Policy Center at The John Hopkins University (JHU). While also at JHU, Dr. Hudson was an associate professor in the Berman Institute of Bioethics, Institute of Genetic Medicine, and department of pediatrics. Dr. Hudson holds a PhD in molecular biology from the University of California, Berkeley, an MS in microbiology from the University of Chicago, and a BA in biology from Carleton College.

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research projects, and serves on the University of California, Los Angeles (UCLA) IRB. Ms. Jones was awarded the inaugural Ruth Roemer Social Justice Leader Award by the UCLA Fielding School of Public Health and the 2014 Team Science Award from the Association for Clinical and Translational Science and the American Federation for Medical Research. She is also the recipient of the Charles R. Drew University of Medicine and Science President’s Award, the Black Caucus of Health Workers of the American Public Health Association Community Service Award, and the National Community-Based Organization Network Lucille Webb Award.

Nancy E. Kass, ScD, is the Phoebe R. Berman Professor of Bioethics and Public Health in the Berman Institute of Bioethics at The Johns Hopkins University, and professor in the department of health policy and management at the Johns Hopkins Bloomberg School of Public Health. She is also a fellow of The Hastings Center. She received her bachelor’s degree from Stanford University, doctoral training from the Bloomberg School of Public Health, and was awarded a National Research Service Award to complete a postdoctoral fellowship at the Kennedy Institute of Ethics at Georgetown University. Dr. Kass conducts empirical work in bioethics and health policy. She served as a member of the IOM’s Committee on Perinatal Transmission of HIV and as a consultant to the National Bioethics Advisory Commission to examine American investigators’ experiences working in developing countries. Her current research projects examine ethics and learning healthcare systems, informed consent, obesity and public health ethics, and ethics issues in international health research. Dr. Kass has taught courses on HIV/AIDS policy, research ethics, and international research ethics. She also directs the Johns Hopkins PhD program in Bioethics and Health Policy and the Johns Hopkins-Fogarty African Bioethics Training Program.

Moira A. Keane, MA, CIP, retired in June 2012 as the executive director of the HRPP at the University of Minnesota. The HRPP, which includes IRBs and the IBC, oversees the research of all University of Minnesota campuses and encompasses review of basic science, clinical research, and social and behavioral science projects conducted by faculty, staff, and students. She continues to be actively involved in subjects protections through service on the Board of Directors of PRIM&R and as member and chair of the PRIM&R Certification Committee. Ms. Keane served as chair of the AAHRPP Council on Accreditation, as member and former vice chair of the Council on Certified IRB Professionals, and as a member of the SACHRP Subpart A Subcommittee. She is a frequent speaker on research issues, including during the IRB 101sm, IRB 201, and IRB 250 courses, and on PRIM&R webinars.

Ms. Keane holds a MA in communication from the University of Minnesota, and has more than 25 years of experience in research administration, including oversight of human subjects protections programs, animal care and use programs, accreditation, education, conflict of interest management, and compliance oversight.

Dmitry Khodyakov, PhD, is a sociologist at the RAND Corporation and a faculty member at the Pardee RAND Graduate School. Dr. Khodyakov is an expert on communityacademic partnered research, approaches to expert elicitation and stakeholder engagement, quality improvement intervention evaluation, and qualitative and mixed-methods research. He is p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

currently co-leading, with Dr. Elizabeth Bromley, an ORI/National Institute of Environmental Health Sciences-funded R21, which evaluates the impact of partnerships with community on research integrity. This project is based on Dr. Khodyakov’s analysis of the impact of community-academic partnered approaches on quality improvement intervention implementation and outcomes in underserved communities, which received the 2011 National Institute of Mental Health New Investigator Award and the 2014 Lawrence W. Green Paper of the Year Award from Health Education & Behavior. Dr. Khodyakov is a co-developer of ExpertLens, an innovative online system for expert elicitation and stakeholder engagement that has been used in numerous studies in the United States and Europe funded by NIH, Patient-Centered Outcomes Research Institute, VA, DoD, and European Commission, among others. The ExpertLens system was recently used to engage more than 500 stakeholders in the development of A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save Lives that informed the National Strategy for Suicide Prevention.

Richard Klein is the director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, the primary interface between the FDA and patient and patient advocate communities.

The program interacts extensively with outside communities and within the agency’s scientific offices to facilitate patient engagement and to address issues and concerns of patients in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. The program ensures that patient communities are represented in approval and policy decisions, and at FDA advisory committee meetings. Mr. Klein has been with the FDA for more than 30 years, and has worked in various capacities giving him a well-rounded understanding of the regulatory issues that affect patients. He helped develop revised expanded access regulations and guidelines. He also developed the agency’s patient web pages, and disease-specific electronic listservs. Prior to his current role, he managed the agency’s HIV/AIDS Program and, earlier, was involved in human subject protection policy development for the agency, working closely with other federal agencies and DHHS to ensure consistent and meaningful policy for the protection of human subjects in biomedical research.

Colleen Kohashi, MA, CIP, is an IRB coordinator at University of California (UC), Berkeley’s Office for Protection of Human Subjects (OPHS). Upon joining OPHS in 2009, she became the lead IRB coordinator tasked with supporting multi-campus applications for the UC system. She worked closely with other UC IRB administrators and the UC Office of the President (UCOP) staff to contribute to the UC Online Reliance Registry, which was built in-house by UCOP and deployed in 2012 (scheduled to be updated again in late 2014). Ms. Kohashi is a former Fulbright Fellow and her review expertise includes international-based development research and computer-based experimental research. Prior to joining OPHS, Ms. Kohashi worked at Teachers College Columbia University. She is a graduate of American University and Columbia University.

David J. Lacks, Jr., is the grandson of Henrietta Lacks and son of David “Sonny” Lacks. Mr. Lacks has a degree in computer information systems and has traveled around the United States and Canada setting up computer systems and labs for various companies and educational institutions. He lends his talent

and expertise to helping create and maintain the Lacks Family website. Mr. Lacks represents the Lacks family on the National Institute of the Science’s panel that reviews applications to conduct research using the HeLa genome.

Robert J. Levine, MD, is professor of medicine and chair of the executive committee of the Center for Bioethics at Yale University. He is a fellow of The Hastings Center and the American College of Physicians, past president of the American Society of Law, Medicine, and Ethics, and a member of PRIM&R’s Board of Directors. Dr. Levine was chair of the IRB at Yale-New Haven Medical Center (1969-2000) and founding editor of IRB: A Review of Human Subjects Research (now IRB: Ethics and Human Research). He has served several agencies involved in policy development for human subjects protections, including the CIOMS Steering Committee for the 1993 and 2002 revisions of International Ethical Guidelines for Biomedical Research Involving Human Subjects (chairperson); the World Medical Association Working Group to Propose a Revision to the Declaration of Helsinki (chairperson); and, currently, the National Research Council Committee on Proposed Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. He was co-author of The Belmont Report. Dr. Levine received PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics in 2005. Dr. Levine serves on PRIM&R’s Board of Directors and is a member of the 2014 AER Conference CCPC. Paula Garcia McAllister, PhD, CIP, is an IRB research specialist at Northern Arizona Healthcare, where she facilitates the review of research that is primarily biomedical. She has coordinated IRB activities at two different institutions over the past seven years.

At Northern Arizona University, she ran a one-woman IRB office where she coordinated board activities, developed educational materials, and facilitated the review of over 300 research protocols per year that were primarily social, behavioral, and educational in

Gianna McMillan, BA, is currently the content manager for People & Perspectives, PRIM&R’s online archive of stories from the research ethics community. She is a member of the Editorial Advisory Board for Narrative Inquiry in Bioethics (Johns Hopkins University Press) and serves as their director of community engagement. In 1996, she co-founded We Can, Pediatric Brain Tumor Network and was We Can’s executive director for 10 years. She has extensive experience as a non-scientific/ unaffiliated member on local and national IRBs and spent six years on SACHRP’s Subpart A Sub-Committee evaluating federal regulations that govern human subjects protections. Ms. McMillan is a patient representative for the FDA’s Pediatric Oncology Drugs Advisory Committee, has been a PRIM&R faculty member for 10 years, and received the 2011 ARENA Legacy Award for mentoring, teaching, and leadership.

Veronica Miller, PhD, is the executive director of the Forum for Collaborative HIV Research, a public/private partnership addressing cutting edge science and policy issues. Dr. Miller is an expert in the process of engaging stakeholders to resolve significant health policy and public health issues. Under her leadership, the Forum’s deliberative process to advance regulatory science was extended to Hepatitis C (HCV), the treatment of liver diseases, and human cytomegalovirus disease in solid organ and stem cell transplant patients. Efforts led by Dr. Miller to advance public health policy include the National Summit program, which focuses on the implementation of the National HIV/AIDS Strategy and the Viral Hepatitis Action Plan. Dr. Miller developed and teaches a course on FDA and drug development based on case studies from the Forum’s experience facilitating drug development to Berkeley and Bay Area graduate students and postdoctoral researchers. Dr. Miller has served on industry and government advisory boards and has published more than 90 peer-reviewed publications on HIV treatment strategies and regulatory strategies for HIV and HCV. She joined the Forum in 2001 after directing the HIV research group at the JW Goethe University in Frankfurt, Germany. She co-founded and chaired the Euro-Guidelines Group on HIV Drug Resistance, the first pan-European group established to assure a common standard of care for patients in all European states.

Paul Ndebele, PhD, obtained his doctorate degree in research ethics from the University of KwaZulu-Natal. Dr. Ndebele serves as the director of the Medical Research Council Zimbabwe with prior appointments as bioethics contractor at the Division of AIDS, NIH; assistant director of research ethics, Office of Research and Development, University of Botswana; deputy director in the Centre for Bioethics at the University of Malawi, College of Medicine; and assistant visiting professor at the Centre for Ethics in the Life Sciences, Michigan State University. He has participated in several bioethics programs including Fogarty African Bioethics Program at The Johns Hopkins University, The South African Research Ethics Training Initiative, The Centre for Bioethics in Eastern and

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Susan E. Lederer, PhD, is the Robert Turell Professor of the History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health, and was appointed chair of the department of medical history and bioethics in 2008. A historian of medicine and biomedical ethics, Professor Lederer received her doctorate in the history of science and medicine at the University of Wisconsin Madison. Before coming to the University of Wisconsin, Professor Lederer taught in the department of humanities at the Pennsylvania State University College of Medicine, and in the section of medical history at Yale University School of Medicine. In 1994, she was appointed by President Clinton to the Advisory Committee on Human Radiation Experiments, and contributed to the Committee’s report on the radiation research sponsored by the federal government between 1944 and 1974. She also served on presidential commissions for the German government that were charged with exploring the conduct of human experimentation during the period of National Socialism. Professor Lederer’s books include Subjected to Science: Human Experimentation in America Before the Second World War (Johns Hopkins University Press, 1995); Frankenstein: Penetrating the Secrets of Nature (Rutgers University Press, 2002); and Flesh and Blood: A Cultural History of Transplantation and Transfusion in Twentieth-Century America (Oxford University Press, 2008).

nature. These experiences have provided her with insight on the complexities of protecting participants involved in research within institutions with varying interests and goals. One of her main areas of focus has been on the challenges of protecting participants involved in collaborative research partnerships within culturallyand ethnically-diverse research contexts, specifically, Native American tribal members as potential research participants.

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Southern Africa, the College of Medicine (University of Malawi), the Center for Ethics in the Humanities and Life Sciences (Michigan State University), and as a visiting scholar at the Erasmus Mundus Bioethics Programme, Padova University, Italy. He has published widely on research ethics issues.

Camille Nebeker, EdD, MS, is an assistant professor in the department of family and preventive medicine at the University of California, San Diego where she also serves on the IRB, and as director of the Collaborative to Advance Professional and Research Integrity. Her undergraduate education was in public health with graduate studies in human development and education from San Diego State University. Dr. Nebeker’s research has received continuous support since 2002, and is designed to advance ethical and responsible research practices in biomedical, social, and behavioral sciences. Dr. Nebeker leads Project Building Research Integrity and Capacity and the Project Research Ethics: A CaPROMISE Initiative. Both projects focus on developing research competencies in research support staff with little to no formal education in research who play key roles in the conduct of community-engaged research. She is also conducting research to explore the ethical dimensions of pervasive imaging and computing technologies in health-related research.

Dr. Nebeker consults nationally and internationally on matters pertaining to research compliance, scientific integrity, and applied research ethics.

P. Pearl O’Rourke, MD, is the director of human research affairs at Partners HealthCare, and 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 human embryonic stem cell research. Dr. O’Rourke’s career began as a pediatric critical care physician at Boston Children’s Hospital, and then as the director of the Pediatric Intensive Care Unit at Children’s Hospital, University of Washington. She did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation.

Following a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy from 1997 to 2000, she was the deputy director of the Office of Science Policy in the Office of the Director at the NIH, where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Dr. O’Rourke has been actively involved with PRIM&R as both a member and past chair of the Board of Directors, and she is a member of the 2014 AER Conference CCPC. Laura Odwazny, JD, MA, is a senior attorney with the Office of the General Counsel, DHHS. Ms. Odwazny’s primary client is OHRP, which interprets and enforces the DHHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the Presidential Commission for the Study of Bioethical Issues, the DHHS Office on Women’s Health, and the DHHS Office of Global Affairs. Throughout her 14 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within DHHS, including the Office of the Assistant Secretary for Health, the Program Support Center Division of Freedom of Information Act Services, the Health Resources and Services Administration, the Substance Abuse and Mental Health Administration, and the ORI. Prior to her employment with DHHS, Ms. Odwazny served as a law clerk to the Superior Court of Pennsylvania and the Supreme Court p rim&r’ s 20 1 4 2 adv ad vanci ancing ng eeti thhical cal re rese s eaarc rch h ccon onffeerreennccee

of Pennsylvania. Ms. Odwazny is a graduate of the University of Chicago and the University of Pittsburgh School of Law, and received a master’s degree in bioethics through the History and Philosophy of Science Department at the University of Pittsburgh.

Ms. Odwazny is a member of the CCPC for the 2014 AER Conference.

Holly L. Peay, MS, CGC, is the director of the DuchenneConnect Registry and senior vice president of community engagement for Parent Project Muscular Dystrophy. Ms. Peay is the principal investigator of the DuchenneConnect Patient Centered Outcomes Research (PCOR)-net Patient-Powered Research Network.

She is a personal services contractor/investigator at the social/ behavioral research branch of the National Human Genome Research Institute (NHGRI), a social/behavioral research consultant to the US Military HIV Research Program, and has an adjunct faculty appointment at Johns Hopkins Bloomberg School of Public Health. Ms. Peay has more than 15 years of experience spanning clinical genetic counseling, education, advocacy, and social/behavioral research. Her research focuses on patient and caregiver decision making, informed consent, and adaptation. She serves on numerous committees and working groups, including cochairing the PCORnet Rare Disease Task Force, membership on the ClinGen Steering Committee and ClinGen Ethics Committee, and the Executive Committee for the Johns Hopkins/NHGRI Genetic Counseling Graduate Program. Ms. Peay received her master’s degree in genetic counseling from the University of South Carolina School of Medicine and her bachelors of science in biomedical ethics from the University of Virginia. She anticipates a PhD in social science (medicine) from Leiden University Medical Centre early in 2015.

Michael Rosenblatt, MD, is the executive vice president and chief medical officer of Merck & Co., Inc. Dr. Rosenblatt was dean of Tufts University School of Medicine, the George R. Minot Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center (BIDMC), the president of BIDMC from 1999 to 2001, and the Harvard faculty dean and senior vice president for academic programs at BIDMC. Dr. Rosenblatt also served as director of the Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, where he led a medical education organization for MD, PhD, and MD-PhD training. He was senior vice president for research at Merck Sharp & Dohme Research Laboratories, where he coled the worldwide development team for alendronate, and he headed Merck Research’s worldwide University and Industry Relations Department. Dr. Rosenblatt is the recipient of the Fuller Albright Award for his work on parathyroid hormone, the Vincent du Vigneaud Award in peptide chemistry and biology, and the Chairman’s Award from Merck. From 1981 to 1984, he served as chief of the endocrine unit at Massachusetts General Hospital (MGH). He has testified before a Senate hearing on US biomedical research priorities in 1997 and, in 2011, served as a consultant to the US President’s Council of Advisors on Science and Technology. Dr. Rosenblatt received his undergraduate degree from Columbia University and his MD from Harvard. His internship, residency, and endocrinology training were all at MGH. Karen H. Rothenberg, JD, MPA, serves as senior advisor on genomics and society to the director of the National Human Genome Research Institute, and a visiting scholar in the department of bioethics at the Clinical Center at the NIH. She is

Mark A. Rothstein, JD, is the Herbert F. Boehl Chair of Law and Medicine and director of the Institute for Bioethics, Health Policy, and Law at the University of Louisville School of Medicine.

Professor Rothstein has concentrated his recent research on health privacy, bioethics, genetics, public health, and employment law. He is a past president of the American Society of Law, Medicine and Ethics, an elected member of the American Law Institute, and an elected fellow of The Hastings Center. He currently serves as department editor for public health ethics of the American Journal of Public Health, and also writes a regular column on bioethics for the Journal of Law, Medicine and Ethics.

Professor Rothstein is the author or editor of 19 books and more than 200 book chapters and articles. Among his many honors, he is a recipient of the 2013 Louis D. Brandeis Privacy Award from Patient Privacy Rights.

Charmaine D. M. Royal, PhD, MS, is associate professor of African and African American studies and director of the Center on Genomics, Race, Identity, Difference at Duke University. Dr. Royal’s research, scholarship, and teaching focus on ethical, psychosocial, and societal issues in genetics and genomics, particularly intersections with constructs of race, ethnicity, and ancestry. Dr. Royal serves on several committees and boards, including the Bioethics Advisory Committee of the March of Dimes Foundation, Editorial Board for the American Journal of Bioethics, Expert Panel for WHO’s Grand Challenges in Genomics for Public Health in Developing Countries Project, and the Independent Expert Committee for the Human Heredity and Health in Africa Initiative. She was chair of the Social Issues Committee of the American Society of Human Genetics and a former member of the Board of Directors of PRIM&R. Dr. Royal received a master’s in genetic counseling and a doctorate in human genetics from Howard University. She completed postgraduate training in bioethics and ethical, legal, and social implications research at the National Human Genome Research Institute of the NIH and in epidemiology and behavioral medicine at Howard University Cancer Center.

Joe V. Selby, MD, MPH, is the first executive director of the Patient-Centered Outcomes Research Institute (PCORI), where he works to identify and address strategic issues and opportunities

for PCORI and to implement and administer the research agenda authorized by the PCORI Board of Governors. Building on the work of the board, Dr. Selby leads the continuing development of PCORI as a research organization, overseeing the implementation of its research agenda, external communications, and work to establish effective ongoing, two-way engagement channels with PCORI’s key stakeholder groups, beginning with patients. Dr. Selby joined PCORI from Kaiser Permanente, Northern California, where he was a researcher for 27 years and director of the division of research for the last 13 years. Dr. Selby has authored more than 220 peer-reviewed articles. He was elected to membership in the IOM in 2009. Dr. Selby received his medical degree from Northwestern University; his training in family medicine from Contra Costa County Family Medicine Program, Martinez, California; and his MPH from the University of California, Berkeley. He served as a commissioned officer in the PHS with the National Health Services Corp from 1976-1983, and received the Commissioned Officer’s Award in 1981.

Nelson K. Sewankambo, MBChB, MSc, MMED, FRCP, Doctor of Laws, Honoris Causa, is a professor of medicine and the head principal of Makerere University College of Health Sciences, a position he took after serving as dean of Makerere University Medical School for 11 years. He has devoted the last 13 years of professional life to the advancement of medical education, research, and capacity development. Professor Sewankambo has been a very active member of the National AIDS Research Committee, a Uganda National IRB for AIDS Research, and a member on data and safety monitoring boards, including one for the Human Immunoglobulin HIV Trial. He is very active in health research in HIV/AIDS. Professor Sewankambo has participated on various discussion groups and planning meetings of the NIH and Fogarty International Center, and provided guidance on the agenda for the second Global Forum on Bioethics in Research in 2000. He was a member of the Nuffield Council Working Party on Ethics of Healthcare-Related Research in Developing Countries from 1999 to 2002, and has participated in the development of the Working Group on Ethics Guidelines for Global Health Training workshops, and the process of developing guidelines on ethical conduct of global health education.

Saul M. Shiffman, PhD, is a research professor of clinical and health psychology, psychiatry, and pharmaceutical sciences at the University of Pittsburgh. Dr. Shiffman helped develop and systematize the methodological framework of ecological momentary assessment, and the use of diaries and ambulatory assessment for real-world, real-time data collection using mobile electronic devices. Dr. Shiffman’s own research has applied European Medicines Agency methods to the study of addiction, stress and coping, diet, and cardiovascular health. He has consulted on many projects using mobile devices to collect data, and is also engaged in the development of interventions delivered by mobile devices. Dr. Shiffman was a co-founder of invivodata, a company that provided electronic diary facilities for clinical research in the pharmaceutical and device industry. He has published more than 350 scientific papers, and is a fellow of the American Psychological Association, the American Psychological Society, the Society for Behavioral Medicine, and the Academy of Behavioral Medicine Research. Dr. Shiffman has served on advisory panels to several institutes at NIH, the American Cancer Society, and the Center for the Advancement of Health.

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the Marjorie Cook Professor of Law, founding director of the Law and Health Care Program, and former dean of the University of Maryland Carey School of Law. Professor Rothenberg is also a visiting professor at Johns Hopkins Berman Institute of Bioethics. Over the last two decades, her research has focused on the ethical, legal, and social implications of genetic testing and research, including the legislative approaches to genetic information in the health insurance and employment context, the impact of genetic research on racial and ethnic populations and women’s health care, and the use of genetic information in the courtroom. Professor Rothenberg’s current research includes the use of theatre as an innovative tool to identify and encourage discussion of the unique ethical, legal, and social issues posed by emerging technologies in healthcare. She co-authored, with Lynn Wein Bush, the book, The Drama of DNA: Narrative Genomics (Oxford University Press 2014), and has authored numerous articles. She received her BA from Princeton University, her MPA from Princeton’s Woodrow Wilson School of Public and International Affairs, and her JD from the University of Virginia School of Law.

Plenary and Keynote Biographies Recognition Conference Information

faculty

faculty

Veronica Spencer is Henrietta Lacks’ great granddaughter.

Inspired by Henrietta Lacks’ story, she is currently studying to become a registered nurse at Baltimore City Community College.

Ms. Spencer represents the Henrietta Lacks family on the National Institute of the Science’s panel that reviews applications to conduct research using the HeLa genome. Ms. Spencer is also a mentor at The Johns Hopkins University Henrietta Lacks Dunbar Health Science Scholarship and Mentoring Program. She assists with formatting a national lesson plan based off her great grandmother’s amazing contributions to science, and is a very active member of the Lacks Family HeLa Foundation.

Walter L. Straus, MD, MPH, is the global director for scientific affairs-vaccines at Merck Research Laboratories, Merck & Co, Inc., where he leads a team that conducts research in vaccine-preventable and other infectious diseases, as well as oncology. The work spans early discovery through postlicensure assessments, and he has involvement in issues ranging from molecular epidemiology, to development of patient-reported outcome measures for use in clinical trials, through to assessment of the safety and effectiveness of marketed products. Additionally, Dr. Straus’ team is involved in epidemiologic assessment of disease in areas of the world normally outside the sphere that has historically characterized pharmaceutical development. This activity has led to his involvement in internal discussions about proper research ethical considerations for research in developing countries. Dr. Straus is a former epidemic intelligence service officer at the CDC, and has served as a consultant to the WHO and other non-governmental organizations. His primary focus is upon ensuring appropriate research protection for vaccine research in developing countries. He serves as a technical consultant to the Agency for Healthcare Research and Quality Center for Education and Research on Therapeutics at the University of Alabama, and holds an adjunct appointment with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania. Dr. Straus is a member of PRIM&R’s Board of Directors, previously serving as chair.

David H. Strauss, MD, is director of 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 Human Subjects Research. He co-chairs Columbia University’s Standing Committee on the Conduct of Research, and previously served as co-director of the Ethics, Public Policy, and Human Rights Core of the current HIV Center for Clinical and Behavioral Studies. Dr. Strauss is a past recipient of two NIH grants on research ethics training and the enhancement of human subjects oversight for psychiatric research. He is a former member of SACHRP, and completed work as co-chair of its Subcommittee on the Inclusion of Individuals with Impaired Decision-Making in Research. Dr. Strauss practices psychiatry, psychotherapy, and psychopharmacology, and lectures and consults widely on research and professional ethics. Dr. Strauss is a member of PRIM&R’s Board of Directors, and has been a co-chair of PRIM&R’s AER Conference CCPC for the past three years.

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Jeremy Sugarman, MD, MPH, MA, is the Harvey M. Meyerhoff Professor of Bioethics and Medicine and deputy director for medicine of the Berman Institute of Bioethics at The Johns Hopkins University. He is an internationally recognized leader in the field of biomedical ethics with particular expertise in the application of empirical methods and evidence-based standards for the evaluation and analysis of bioethical issues.

Dr. Sugarman is the author of more than 200 articles, reviews, and book chapters. He has also edited or co-edited four books.

He has worked with the White House Advisory Committee on Human Radiation Experiments, the National Bioethics Advisory Commission, the Presidential Commission for the Study of Bioethical Issues, and the Maryland Stem Cell Research Commission. In addition, he chairs the Ethics Working Group of the HIV Prevention Trials Network and is the ethics officer for the Resuscitation Outcomes Consortium. Dr. Sugarman has been elected as a member of the American Society for Clinical Investigation, the Association of American Physicians, and the IOM. He is also a fellow of the AAAS and The Hastings Center. Dr. Sugarman is a member of PRIM&R’s Board of Directors and the 2014 AER Conference CCPC. Anne L. Taylor, MD, is currently the senior vice president for faculty affairs and career development for Columbia University Medical Center and vice dean for academic affairs at Columbia University’s College of Physicians and Surgeons. She received her medical degree from the University of Chicago’s Pritzker School of Medicine and completed her internship, residency, and a two-year clinical cardiology fellowship at the University of Chicago Medical Center. Her research training was conducted at Johns Hopkins Hospital and the University of Iowa. She was assistant professor of internal medicine/cardiology at the University of Texas, Southwestern Medical Center in Dallas, where she also served as director of echocardiopraphy at Parkland Memorial Hospital.

From 1990 to 1997, Dr. Taylor was an associate professor of internal medicine/cardiology at Case Western Reserve University and chief cardiology at the Cleveland VA Medical Center. In 1997, she was appointed vice chair for women’s health programs in the department of medicine in Case Western University. From 2000 to 2007, Dr. Taylor was professor of medicine/cardiology and associate dean of faculty affair at the University of Minnesota Medical School. She joined the faculty at Columbia University in November 2007. Dr. Taylor’s interests include cardiovascular disease in African-Americans and women, the transfer of principles of cardiovascular disease prevention from academia to the community, and professional development for faculty. Dr. Taylor was a chair of the Steering Committee for the African-American Heart Failure Trial, a national multi-center trial of nitric oxide enhancing therapy in congestive heart failure.

Alan Wertheimer, PhD, is a senior research scholar in the Department of Bioethics at 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 for Advanced Study at Princeton University, and the Program in Ethics and the Professions at Harvard University. Prior to joining NIH, Dr. Wertheimer’s work focused on political philosophy and philosophy of law. His work now focuses on issues in research ethics. He is a member of the 2014 AER Conference CCPC.

John T. Wilbanks is the chief commons officer at Sage Bionetworks where he works to promote the use of technology to pool medical data. Mr. Wilbanks is also a senior fellow at Faster Cures and founder of Consent to Research. He co-founded the Access to Research campaign, which increased accessibility to results of federally funded scientific research, and he started the bioinformatics company, Incellico, which became a part of Selventa in 2003. Mr. Wilbanks serves on the board of directors for Impact Story and the tranSMART Foundation, and on the advisory boards for Boundless Learning, Curious, GenoSpace, and Patients Like Me. Mr. Wilbanks served as a senior fellow at the Ewing Marion Kauffman Foundation, senior advisor for big data to the National Coordination Office, and has past affiliations with Massachusetts Institute of Technology’s Project on Mathematics and Computation, which hosts Creative Commons, a nonprofit organization enabling knowledge sharing through free legal tools. Mr. Wilbanks worked with Harvard University’s Berkman Center for Internet & Society, the World Wide Web Consortium, the US House of Representatives, and Creative Commons.

He has numerous publications on data sharing, and a chapter titled “I Have Seen the Paradigm Shift, And It Is Us,” in The Fourth Paradigm: Data-Intensive Scientific Discovery (Microsoft Research, 2009). Mr. Wilbanks received a BA in philosophy from Tulane University and studied modern letters at the Sorbonne.

Sabune Joane Winkler, JD, is the director of regulatory affairs operations within the Harvard Catalyst, Clinical and Translational Science Center at Harvard Medical School (HMS).

Ms. Winkler is responsible for reducing legal, regulatory, and administrative and policy barriers in biomedical and clinical research through identifying opportunities for improvement as well as establishing and making transparent adoptable best practices. In her current position, Ms. Winkler successfully drafted and delivered major contracts such as reliance agreements among the HMS affiliated IRBs, IACUCs, and IBCs, all unprecedented in scope. She champions a master IRB reliance agreement and framework, allowing consolidated IRB review for clinical and social behavioral research among 22 Harvard teaching hospitals, including the Broad Institute and Massachusetts Institute of Technology and other institutions in New England and California. This IRB agreement was adopted and utilized as a model nationally by a number of institutions and awarded the Health Improvement Institute’s 2011 Award for Best Practice in Human Research. While in the Office of General Counsel at Beth Israel Deaconess Medical Center, Ms. Winkler’s diverse law practice involved transactional, corporate, tax, employment, and policy work. Her practice focused on research ethics, human subjects protection, animal research, compliance, and biotechnology (negotiating industry-sponsored research agreements and licensing). Ms. Winkler held an adjunct faculty position at Emmanuel College where she chaired the research contracts course for graduate students and was a fellow in the Division of Medical Ethics at HMS. Ms. Winkler graduated from Northeastern University School of Law with a JD and earned a BA in Asian studies from Bates College.

Jeri Lacks Whye is the granddaughter of Henrietta Lacks and the daughter of Henrietta’s middle child, David “Sonny” Lacks.

Along with other family members, Ms. Lacks Whye travels the country giving an insightful account of her grandmother’s important contribution to science. As the granddaughter of an amazing African American woman, one that has left a

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Darrell P. Wheeler, PhD, MPH, ACSW, is professor and dean at Loyola University Chicago School of Social Work. Dr. Wheeler has more than 25 years of experience in clinical, academic, and community practice, and has held faculty positions at Columbia University, the University of North Carolina at Greensboro, and Hunter College (City University of New York) Silberman School of Social Work. His research and publications focus on the identification and exploration of individual and communal resiliency in HIV prevention and intervention among African American and Black gay, bisexual, and transgender communities. Dr. Wheeler obtained his BA in sociology at Cornell College, MSW in health and mental health from Howard University, and MPH in health administration and PhD in social work from the University of Pittsburgh. Currently, he is working on studies pertaining to Black men who have sex with men (MSM) and HIV intervention and/ or prevention including: Black Men Exploring, a CDC funded trial evaluating the efficacy of a locally developed behavioral intervention (principal investigator), and HPTN-073, a NIH funded study examining the pre-exposure prophylaxis among Black MSM in the United States (protocol chair). He is member of the Office of AIDS Research Advisory Council and the president of the National Association of Social Workers.

legacy to the world, Ms. Lacks Whye also discusses the highly acclaimed, nonfiction book, The Immortal Life of Henrietta Lacks, by Rebecca Skloot. Ms. Lacks Whye is a graduate of Villa Julie College and Coppin State University. She works in the Baltimore judiciary system in the domestic violence unit, and is a native of Baltimore, Maryland. Ms. Lacks Whye enjoys spending time with her family, traveling, and keeping the legacy of her grandmother alive.

Posters Selected for Presentation Recognition Conference Information PRIM&R is pleased to present the Annual Poster Presentation at the 2014 AER Conference. The posters will be on display throughout the meeting in The Conference Connection located in Exhibit Hall FG. Please see page 7 of this guide for information on The Conference Connection’s hours. In addition, don’t miss these dedicated times to hear from the poster authors: • I nnovations in… series on December 5 from 11:15 AM to 12:30 PM: Nine exemplary posters were selected for presentation in this panel series.

•M eet and greet with the poster authors: Visit The Conference Connection on December 5 from 1:45 to 2:30 PM to talk with the poster authors about their important work.

Many thanks are owed to the Poster Abstract Sub-Committee for coordinating this conference event.

The posters are grouped by theme, and a map of the posters can be found on page 80 of this guide.

posters

BIOBANKING AND GENOMICS RESEARCH 1. Overcoming Challenges in Providing Biospecimens for Commercial Use Cris Wells, EdD, MBA, RT(R)(M), CCRP Arizona State University Julie Robbins, RN, BSN, CCM, CCRC Battelle 2. Biobank-Related Survey Uncovers Recognition Divergence Between Medical and Non-Medical Hospital Workers Masayuki Yoshida, MD; Masumi Ai, MD, PhD; Eiichiro Kanda; Hitoshi Kuwana; Yuka Ozasa, PhD, RN; Miwa Suzuki, RN, NMW, PhD; Naoko Nii Tokyo Medical and Dental University 3. Obtaining Biorepository “Front Door” Consent in the Pre-Op Anesthesia Clinic to Benefit Patients, Protocols, and Pre-Op Staff Sonya L. Dalton-Salahuddi; Nicole Sieffert, BA, CRCC MD Anderson Cancer Center 4. No Laughing Matter: Comic Assent for Biobanking Leah R. Eisenberg, JD, MA University of Arkansas for Medical Sciences Rose Anderson Mayo Clinic

COMMUNITY ENGAGEMENT 5. Translational Health Research Initiative: An Inter-Organizational Partnership Model for Fostering Research Integrity Paula Garcia McAllister, PhD, CIP Northern Arizona Healthcare

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6. A New Option for Obtaining Community Consultation in Emergency Research George Perdrizet, MD, PhD Kent Hospital, Care New England Organization

EDUCATION AND TRAINING 7. Stronger Together: Creating a CIP® Study Group that Incorporates Multiple Institutions Sarah Marie Huban, MA, CIP, CHRC; Sarah Clark-Worley Children’s Healthcare of Atlanta 8. Evaluating Social Media Research: Ethical Considerations for IRBs Fredeswinda Rivera-Ocasio, MBA InterAmerican University of Puerto Rico 9. Perspectives on the Training and Development of New IRB Administrators Maisie R. Pascual, MS University of Pennsylvania 10. A Pilot Study on the Effectiveness of the “Navigating Clinical Research” Training Course Dorean J. Flores, CIP; Tina Chuck; Richard Ramdeo North Shore-Long Island Jewish Health System 11. Establishment of a Diploma Program in Research Methodology and Ethics in Sudan Sara Lavinia Brair, MBBS, MD Al Neelain University, Khartoum, Sudan Henry Silverman, MD, MA University of Maryland School of Medicine 12. CIP® Demographics Maeve E. Luthin, JD PRIM&R

13. Developing Timely and Appealing Human Subject Protection Refresher Education Using Education Program Participation, Unanticipated Problem & Internal Audit Data Susan A. Corl, MSW, MPH, CIP, CCRP; Matthew D. Stafford, BA Boston Children’s Hospital 14. Introduction to Ethics: Bringing Humanity Into the Healthcare Classroom Mary E. Cataletto, MD Winthrop University Hospital 15. Expanding Education for Increased Understanding: An In-Depth Research Coordinator Training Michele Antisdel, MBA/CCRP; Amy Blakeslee, CIP; Donna LaCivita; Jean Larson, MBA; Monika Lau; Jennifer Reese, MS, CIP Yale University

17. Development of a Searchable, Hyperlinked Resource Guide for IRB Staff Christine S. Epps, BS University of South Florida 18. I RB Navigation: A Resource for New Investigators Anna Johansson, PhD; Michele Hacker, ScD; James Rodrigue, PhD; Randy Mason, MBA Beth Israel Deaconess Medical Center 19. Ensuring Protection of Study Participant Personally Identifiable Information Katie B. Speanburg, EdM; Sean Owen, CISSP, CAP, CRISC Abt Associates 20. Tiered Education: Updating Course Offerings Based on Experience and Feedback Steven J. Austin, JD, LLM; Judith Birk, JD; Diana Miller, MS; Katherine Sasamoto; Brian Seabolt University of Michigan Medical School 21. New Board Member Education: Developing a Collective Approach to New Board Member Education to Address Individual Needs Steven J. Austin, JD, LLM; Diana Miller, MS; Katherine Sasamoto; Jennifer Rasmussen; Pat Gordon, BS; Bethany Vibbart University of Michigan Medical School

23. Assessment of Research Ethics Training Workshop Involving Sudanese Investigators Shaza Abas, BDS, MSc, PhD; Shahd Osman, MBBS, IFME, Msc.EPID University of Khartoum, Khartoum, Sudan Henry Silverman, MD, MA University of Maryland School of Medicine 24. Sharing SI IND/IDE Resources: A Contributory Network Model of Scalable Adoptable IND/IDE Support Services across Massachusetts Academic Institutions?

Sabune Joane Winkler, JD Harvard Catalyst, The Harvard Clinical and Translational Science Center Stanley Estime, MSCI, CIP Harvard School of Public Health Leigh Read, CIP Joslin Diabetes Center Emily Ouellett, JD; Sarah White, MPH Partners HealthCare Ashley Pysczynski, CIP Boston Children’s Hospital Joanna Greene; Hila Bernstein, MS Harvard Catalyst, The Harvard Clinical and Translational Science Center Emily Eldh, CIP Dana-Farber Cancer Institute Barbara E. Bierer, MD Brigham and Women’s Hospital; Harvard Medical School

ETHICS & RISK 25. Use of Electronic Health Records as a Recruitment Tool: Methods to Protect Privacy Sandra L. Alfano, PharmD, FASHP, CIP; Silvio Inzucchi, MD; Cathleen Montano, JD, CIP Yale University 26. Knowledge and Perceptions of Adults from the Middle East Regarding their Rights as Participants in Research Hillary Anne Edwards, MPH; Tamer Hifnawy, MD, DrPH; Manal Mohamed Anwar, MD; Dalia Yahia, MD; Dalia Zahran, PhD; Henry Silverman, MD, MA University of Maryland, Baltimore 27. Protecting Highly Sensitive and Identifiable Data for Research on Vulnerable Populations Natalie M. Matthews, MSW; Brooke Spellman; Teresa Doksum Abt Associates

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16. Implementation of a Research Compliance Training Program Within a Community Health Center Jessica A. Ripton, MPH; Marcy Gelman; Jessica LaCroix Fenway Health, The Fenway Institute

22. IRB Collaborative: Continuing to Build and Refine an Online Library of Audiovisual Educational Materials Steven J. Austin, JD, LLM; Judith Birk, JD; Diana Miller, MS; Brian Seabolt, University of Michigan Medical School

Posters Selected for Presentation Recognition Conference Information 28. The Ordinary Life Experiences Rating Scale: Development of a New Instrument to Measure Minimal Risk in the Context of OHRP Terminology Evan Harrington, PhD The Chicago School of Professional Psychology 29. Social Network Analysis on Sensitive Issues: A Human Subjects Research Case Study Anita Balgopal, PhD; Emily Dworkin; Ron Banks University of Illinois at Urbana-Champaign

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30. Investigating Human Subjects Issues in Patient-Centered Outcomes Research Katherine Bevans, PhD; Amanda Brodt; Emily Moore; Alison Rein; Juliana Tillema Children’s Hospital of Philadelphia 100. The Association of IRB Delays and Tolerance for Research Malfeasance Among Student Researchers Evan Harrington, PhD The Chicago School of Professional Psychology

GLOBAL RESEARCH 31. Distribution of IRBs in India Simon George Trivandrum Medical College 32. Upholding the Ideal of “Dual Approval” for Externally-Sponsored Research: A Reality Check Isolde Birdthistle; Marika McAdam; Monika Milinauskyte; Olivia Nuccio; Thoai Ngo Marie Stopes International 33. Global Justice and Health Systems Research in Low- and Middle-Income Countries Bridget Pratt, PhD; Adnan Hyder, MD Johns Hopkins Berman Institute of Bioethics 34. An Intervention for Improving Understanding of Clinical Trial Procedures Among Low Literacy Populations: An Intervention within a Microbicide Trial in Malawi Paul Ndebele, PhD; Douglas Wassenaar; Esther Munalula Medical Research Council of Zimbabwe 102. An IRB Mentorship Programme as a Means of Increasing Ethics Review Capacity in Institutions Rosemary Musesengwa, BSc, MPH, CRA; Abigail Rugare Kangwende, MD, MPH Medical Research Council

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INFORMED CONSENT 35. Perceptions of Pregnant Women With Low Educational Attainment About Informed Consent After Registering Into Randomized Controlled Trial in India: A Qualitative Study Ramya Shenoy, MDS, MBA, PGDBEME Manipal College of Dental Sciences, Mangalore, Manipal University 37. Pre-Procedure Consent Process vs.

Post-Procedure Consent Process for Biorepository Sample Acquisition: A Prospective Survey at the Time of Pre-Admission Yasmin Isler, PhD; Lee Booze-Battle, MPA, CIP; Lynnea Lau, MPH, CIP ProMedica Toledo Hospital 38. Impact of Research Ethics and GCPs Training on Bangladeshi Doctors Mohammed Abul Kalam, MA, PhD, MSc Siam Health Care 39. Research with Incarcerated Youth: Helping Vulnerable Research Subjects Understand Assent Sharon Zack, MS; Tim Smith, Leanne Heaton Westat 40. Implementing Post-Approval Monitoring to Better Protect Human Research Participants Joshua Fedewa, CIP; Jessica Macha, CIP; Erin Lynch; Andrea Slay; Catherine Powers, MBA, CCRC, CIP Ann & Robert H. Lurie Children’s Hospital of Chicago

IRB OPERATIONS 41. Out With the Old, in With the New: Replacing an Outdated IRB Process With a New Electronic Software Management Tool Anita E. Pascoe, MS, CIP; Shelby Moench, BA, CIP Intermountain Healthcare 42. Establishing a Framework for Student Research in a Non-Academic Setting Anita E. Pascoe, MS, CIP; Shelby Moench, BA, CIP Intermountain Healthcare 44. Finding Regulatory Flexibility with a Decentralized Exempt Reviewer Process Mariette Marsh, MPA, CIP University of Arizona 45. Creating a Process for Use of Central IRBs Hallie Kassan, MS, CIP North Shore-Long Island Jewish Health System

46. Decreasing Time from Submission to Exempt Determination Through the Use of a Submission Checklist Meredith L. Burcyk; Jon Newlin, CIP; Emily Chumas North Shore-Long Island Jewish Health System

55. Research Concerns and Complaints: A Programmatic Approach Laurie Herraiz, RD, CCRP, CIP; Joan Doherty, JD; Lisa Denney, CCRP, CIP University of California San Francisco

47. Enhanced IRB/Research Ethics Committee Collaborative Review Through Videoconferencing Daima Bukini, BSc, MD; Richard Waddell; Muhsin Aboud; Susan Adams; Eligius Lyamuya, MD, MMED, PhD; Joyce Masalu, DDS, MPH, PhD; Elizabeth Bankert, MA; Lorri Wettemann, CCRC, CIP Geisel School of Medicine at Dartmouth College

56. Designing and Implementing a Quality Management System Dawn Pope, BA, CIP WIRB-Copernicus Group

48. IRB Processes for Reconciling Consent Form Injury Language With Executed Sponsor Contracts Patrick Stanko, BA, CIP; Emma Meagher; Renee Crews University of Pennsylvania

50. Implementation of a Cloud-Based IRB Material Distribution System Susan Ebert, MS, RD, CIP The Ohio State University 51. Tackling Complex Modification Submissions: One Institution’s Approach to the Development of Improved Resources for the IRB and the Research Community D. Hoon Chung, MPH; Megan Kasimatis Singleton, JD, MBE, CIP; Tracy Ziolek, MS, CIP; Christine Davison, MBE, CIP University of Pennsylvania 52. University of California (UC) IRB Reliance Registry: Facilitating Human Subject Review for Multi-Campus Studies in the UC System Colleen Kohashi, MA, CIP; Adrienne Tanner, CIP; Tani L. Prestage, MPA, MA, CIP; Dragana Nikolajevic, MPA, MSc University of California, Berkeley

58. I mproving IRB Processes Through Kaizen and Value Stream Mapping: A Case Study Michael W. Willis, Jr.; Sherry Seabock Copernicus Group IRB 59. Check Your Expiration Date: An IRB Process for Ensuring Timely Submission of Renewal Applications Ellen Bedard, MS, CIP; Cathleen Montano, JD, CIP; Jan Hewett, BSN, JD; Jean H. Larson, MBA Yale University 60. Doing Less With Less: A Process for Evaluating IRB Tasks Cathleen Montano, JD, CIP; Jan L. Hewett, BSN, JD; Jeri Barney, JD, MS; Jean H. Larson, MBA Yale University 61. The FYI Process: Reporting and Evaluating Unanticipated Problems Involving Risks to Subjects or Others and Serious Adverse Events Jean H. Larson, MBA; Jeri Barney, JD, MS; Cathleen Montano, JD, CIP; Jan L. Hewett, BSN, JD Yale University 62. How Different IRB-of-Record Model Requirements Can Impact Fluidity in Research Operations Jan L. Hewett, BSN, JD; Jean H. Larson, MBA Yale University

53. PRIM&R IRB Workload and Salary Survey Maeve E. Luthin, JD PRIM&R

63. Implementing a Comprehensive Customer Service Program at an IRB Megan Aiken, BA, CIP Copernicus Group IRB

54. Challenges in Review of Pediatric Transplantation Research Ashley E. Pysczynski, CIP, Robleinscky Dominguez, BS; Anna Mitchell, BA; Maureen Pimentel, CPNP; Matthew D. Stafford, BA; Amir Taghinia, MD Boston Children’s Hospital

64. Preparing and Training Your Workforce to Be Ready for E-Submission Systems Royell C. Sullivan, BA; Helen Panageas, CIP; Paul Thompson; Andrew Hadaway New York University School of Medicine

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49. The Intangible Effects of “Going Paperless”: IRB Staff Outcomes One Year After Implementing an Electronic Work Management System Elicia D. Preslan, MS; Dawn Anderson Virginia Commonwealth University

57. Strengthening Non-Governmental Organization and IRB Cooperation Through the Establishment of Joint Working Groups on Ethical Issues Marika McAdam; Isolde Birdthistle Marie Stopes International

Posters Selected for Presentation Recognition Conference Information 65. Creating a Reliable Method for Reviewing Emergency Uses of Investigational Drugs, Biologics, and Devices Michelle Grienauer, JD, MPH; Tara C. Polek, PhD; Dominic Chiarelli, JD; Kelly Hebner, JD; Laurie Bolton, JD Seattle Children’s Research Institute

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66. Database of Genotypes and Phenotypes and National Database for Autism Research Certification Process Improvements Tara C. Polek, PhD; Michelle Grienauer, JD, MPH; Dominic Chiarelli, JD Seattle Children’s Research Institute

74. Using Visual and Data Technology to Inform IRB Operations Judith Birk, JD; Caleb Smith; Vasu Ramani University of Michigan 75. Righting Research Wrongs: How US IRBs Respond to Participant Complaints, Concerns, and Injuries Kristen Underhill, JD, DPhil Yale University Stephanie Boegeman, BS, MA; Celia B. Fisher, PhD Fordham University

67. Simple Method to Track IRB Metrics Without an Electronic System Joshua Fedewa, CIP; Catherine Powers, MBA, CCRC, CIP Ann & Robert H. Lurie Children’s Hospital of Chicago

76. Streamlining an Expedited Review Process of Minor Changes in Previously Approved Research Ishita Modi, BS, MLT; Michael Brown; Raffaella Hart, CIP Biomedical Research Alliance of New York

68. Crossing Over: The Bridge Connecting Staff Julie T. Martin, RN, MEd, CCRP; Christine Epps, BS; Brandy Hutchinson, BS, CIP University of South Florida

77. Improving Public Relations for Your IRB: What Would Don Draper Do? Ilene F. Wilets, PhD, CIP New York State Psychiatric Institute; Columbia University

69. A Cup of Joe and a Chat? That Could Be Exempt… Under Certain Circumstances: A Story of an Exemption Category 7 Monika Lau, MEd, CIP; Cathleen Montano, JD, CIP; Jean H. Larson, MBA; Carrie McDaniel, CIP; Brandy Dionne, BS, CIP Yale University

78. Establishing a Central IRB: Triumphs and Tribulations Denelle Reilly; Renee Holt, RN, JD, MPH; Danielle Harden; Michele Andrasik; James Kublin Fred Hutchinson Cancer Research Center

70. Decreasing the Time to Activation for Clinical Research Studies Ann Rodavitch, MA; Paul Sabbatini, MD; Collette Houston, BA; Joseph Larkin; Joseph Lengfellner; Roger Wilson, MD; Katherine Fain, MPA, CCRP; Gary Dranch; Michael Ayerov; Elsa Hwang, MA, MPH, CCRP Memorial Sloan Kettering 71. Internal Centralized IRB for Multi-Site Community Healthcare Network Lana Gevorkyan, BS, CM, CCRP; Jodi Reetz, BS McLaren Healthcare 72. Pillars of PRIM&R Project: Effects of an In-Meeting Intervention on Meeting Length, Approval Time, and Member Satisfaction Jeanelle L. Graham, BS, MPH; Sharol Jacobson, PhD, MEd, BSN University of Alabama At Tuscaloosa 73. IRB Meeting Minutes: Transforming the Process to Improve Workflow Royell C. Sullivan, BA; Aaron Rogoff, MA; Marina Godina, RN, CCRP, CIP; Helen Panageas, CIP; New York University School of Medicine

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103. A Protocol Navigation Training Program at the NIH Marcia L. Vital, MS; Beverly Barham, RN, MSN, CCRC NIH

QUALITY ASSURANCE/QUALITY IMPROVEMENT 79. Using Lean Methods to Improve Efficiency of IRB Review Maria Lebedeva, PhD; Kyaani Robinson New England Veterans Engineering Resource Center & VA Boston Healthcare System 80. IRB Members and Researchers: A Quality Improvement Survey Kathleen A Seabolt, CIM, CIC Phoenix Children’s Hospital 81. Human Research Compliance: A Journey Not Just a Destination for One VA Medical Center Sheron L. Salyer, DNSc, RNC, CHRC; Virginia Wiley, MSN, MBA, RN; Jeannie Helton, BS VA Tennessee Valley Healthcare System 82. An Integrated QA Program for Human Subjects Protections Patricia A. Mendoza, BA, BSN, RN, CCRC, CHRC; Mary Clancy, MSN, CCRC, CIP; Edward A. Jones; Catherine Simmons, BS, BSN, RN Houston Methodist Research Institute

83. Institutional Culture and Implications for IRB Panel Member Recruiting, Retention, Time Management, and Education Enid A. Virago, PhD, CIP, CCRP; Joanna Lyons, RN, DEd The Pennsylvania State University 84. The Impact of Submission Assistance on IRB Review Turnaround Time Lisa Gabel, CIP; Leslie M. Howes, MPH, CIP; Stanley Estime, MSCI, CIP; Alyssa Speier, MS, CIP; Delia Wolf, MD, JD, MSCI Harvard School of Public Health 85. QA in the Design of Data, Specimen, and Measurement Collection in Fielding Epidemiology Research Projects: A QA Tool Elizabeth O’Connell, RN, BSN, PMP; Kerry James, MPH; Pamela Schwingl, PhD; Christie Barker-Cummings, DrPH Social & Scientific Systems

87. Research Quality Improvement Team: Monitoring Research Compliance in a Decentralized Research Model Laura Miller, MSHA, CIP; Kathy Ababio, BS; Marie Blake; Anuja Mathai Inova Healthcare Services 88. Lean Thinking and the Use of Huddle Boards to Identify Opportunities for Improvement Melissa Schlenker, MS, CCRC, CIP; Tara L. Moore WellSpan Health 89. Common Findings from an Initial Year of Post-Approval Monitoring of Research Protocols and its Impact on Organizational and IRB Policies and Procedures Jessica Macha, CIP; Catherine Powers, MBA, CCRC, CIP; Vita Land, MD Ann & Robert H. Lurie Children’s Hospital of Chicago 90. Joining Forces: Using Education and QA to Reduce For-Cause Audits Julie T. Martin, RN, MEd, CCRP; Christine Epps, BS; Brandy Hutchinson, BS, CIP University of South Florida

92. The FDA Is Coming: Where’s My Liaison?

Jeri Barney, JD, MS; Jan Hewett, BSN, JD; Jessica A. Randall, MA, CIP Yale University 93. Ensuring Institutional Compliance With ClinicalTrials.gov Registration and Reporting Requirements Leah Silbert, MPH, CIP, CCRP; Keren Dunn, BS, CIP; Eifaang Li, DVM, MPH, CIP Cedars-Sinai Medical Center 94. Investigator Single Site Compliance with ClinicalTrials.gov Consent and Website Posting Requirements: The First Two Years Debra G. Tice, MS; Tinatin Kiguradze; Michael Kelley, BS, CIP; Eileen Yates, MS, CIP; Heather Gipson, JD, MA; Jeff Lunt; Barb Ferry; Monalee Shah; Sigmund Weitzman; Steven Belknap; Dennis West, PhD, CIP Northwestern University 95. Creating Data Security Guidance and Policy at the University of California, Berkeley Colleen Kohashi, MA, CIP; Adrienne Tanner, CIP University of California, Berkeley

SPECIAL POPULATIONS 96. Research Subjects Want to Know: An IRB Asks Investigators to Consider Dissemination Strategies Susan Z. Kornetsky, MPH Boston Children’s Hospital Elizabeth Witte Harvard Medical School Barbara E. Bierer, MD Brigham and Women’s Hospital; Harvard Medical School Lingling Guo Harvard Catalyst, The Harvard Clinical and Translational Science Center Matthew D. Stafford, BA Boston Children’s Hospital Sabune Joane Winkler, JD Harvard Catalyst, The Harvard Clinical and Translational Science Center 97. Shifting Responsibilities: Transitioning from Signed Assent to Attestation of Affirmative Assent Mary E. Cataletto, MD; Kathleen Corneliess; Igal Fligman; Naomi Moskowitz-Brooks; Phillip Scimeca; Aniket Saha; Linda Skelly; Mark Weinblatt Winthrop University Hospital

91. Developing a Proactive QA/QI Program Jessica A. Randall, MA, CIP; Jerri Barney, JD, MS; Jan L. Hewett, BSN, JD Yale University

selected for Innovations In... series

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86. Use of Flow Charts to Guide Data Collection and Administrative Responsibilities in Epidemiologic Field Studies Elizabeth O’Connell, RN, BSN, PMP; Thomasina Austin, BS; Moniquea Wiggins, BA; Kerry James, MPH; Pamela Schwingl, PhD; Christie BarkerCummings, DrPH Social & Scientific Systems

REGULATIONS AND GUIDANCE

Posters Selected for Presentation Recognition Conference Information 98. Improving Quality One Child at a Time: Formal and Informal Feedback Loops Improve Determination of Capacity and Discussion during the Informed Consent Process Mary E.Cataletto, MD; Kathleen Corneliess; Igal Fligman; Naomi Moskowitz-Brooks; Philip Scimeca; Aniket Saha; Linda Skelly; Mark Weinblatt Winthrop University Hospital 99. Is “Vulnerable Population” Actually Vulnerable? Rethinking for Concept of “Vulnerability” in Human Research Soyoung Yoo Asan Medical Center

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101. To Protect “Vulnerable Populations,” or to Address “Vulnerabilities”?

Towards a New Paradigm in Human Research Participant Protections Nabeel Mangadan Konath, M.K., MBBS, MHSc Public Health and Bioethics Consultant, India 104. Inaccurate Reporting of HIV Prevention Research: A Look at the Zimbabwean Experiences Melody Elizabeth Phiri; Rosemary Musesengwa, BSc, MPH, CRA; Richard M. Kanengoni, Bsc, CRA; Fadzai Chidakwa, BSc, CRA. Medical Research Council of Zimbabwe

*Please note that the inclusion of posters featuring commercial products should not be considered an endorsement by PRIM&R.

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Biobanking and Genomics Research: 1-4 Community Engagement: 5-6 Education and Training: 7-24 Ethics & Risk: 25-30, 100 Global Research: 31-34, 102 Informed Consent: 35-40 IRB Operations: 41-78, 103 QA/QI: 79-91 Regulations and Guidance: 92-95 Special Populations: 96-99, 101, 104

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selected for Innovations In... series

Posters Selected for Innovations in… Series This year, nine exemplary posters have been selected for presentation in our Innovations in… series on December 5 from 11:15 AM to 12:30 PM. The Innovations in… series is composed of three concurrent sessions on cutting-edge topics and, during these sessions, research professionals will present their work in the field of human subjects protections and provide audience members with concrete strategies designed to improve the effectiveness of their HRPPs/IRBs. The posters that will be presented during each panel are listed below along with the full text of the abstract. These nine posters will also be on display in The Conference Connection. number of doctor’s visits in the last year, non-native English speakers did show a higher comprehension score when the comic assent was used. Also, overall, the comic assent was preferred, and rated as more interesting to read.

POSTER 4 No Laughing Matter: Comic Assent for Biobanking Presenter: Leah R. Eisenberg, JD, MA University of Arkansas for Medical Sciences

Additional Information: Rather than just adding illustrations to existing text, we developed a narrative flow which shows a group of peers discussing biobank participation. This assent is also novel because it focuses on biobank participation rather than engagement in a typical clinical trial. Consent for biobanking is a complex issue because participants are typically asked to give broad consent for unspecified future research.

Problem Statement: Sections of the US Code of Federal Regulations pertaining to protection of human research subjects state that “the IRB shall determine that adequate provisions are made for soliciting the assent of the children.”

45 CFR §46.408(a) (2010). Assent is defined as “a child’s affirmative agreement to participate in research.” 45 CFR §46.402(b) (2010). The phrase “adequate provisions” has not been clarified by any regulating body, although the age, maturity, and psychological state of the children involved should be considered. Assent does not carry the same requirements as the informed consent given by adults; it is meant to give the child a voice about participating in research, particularly since research is not a clinical need. Although there is not a lot of data about children’s understanding of assent, the studies that have looked at comprehension suggest that children do not fully understand the information presented to them.

Description of Research: In order for the concept of assent to be meaningful, it is critical that minors are given enough information to understand the consequences of participating in research. The last several years have seen a rise in graphic novels depicting medical experiences and graphic stories used for patient education purposes, both of which have proven successful. Graphics have not been utilized in the context of assent, though. Will the engaging nature of an illustrated document improve minors’ interest in and comprehension of a research assent document? An interdisciplinary team comprised of individuals with expertise in design, illustration, ethics, research, genetics, and law developed a comic assent for children ages 12-18 enrolling in a research biobank. The comic assent was compared to a text-based assent in a study that assessed preference and comprehension among 267 adolescents. While there were no significant differences in comprehension scores based on participant age, sex, or

POSTER 34 An Intervention for Improving Understanding of Clinical Trial Procedures Among Low Literacy Populations: An Intervention Within a Microbicide Trial in Malawi Presenter: Paul Ndebele, PhD Medical Research Council of Zimbabwe Problem Statement: Several authors have reported or discussed some difficulties that research participants face in understanding clinical trial concepts. An intervention aimed at improving trial participants understanding was developed as a follow-up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding, and placebo use. In the empirical study involving 203 participants, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study.

Description of the Research Methods: The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a PowerPoint presentation. The intervention narrative used daily examples from the field of agriculture to explain concepts and their justification. Malawi has an agro-based economy.

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Innovations A: Innovations in Communication with Research Subjects Ballroom III Moderator: Susan S. Fish, PharmD, MPH

Posters Selected for Recognition Conference Innovations in…Information Series Results: Thirteen of the 18 women in the intervention arm obtained high scores (above 75%) during the post-intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001).

Conclusions: Evaluation of the intervention suggests that it was useful in improving understanding of the key concepts (randomisation, double-blinding, placebo use, and personal implications of these) under study. The study findings suggest that if information on scientific procedures is provided in a meaningful, structured, locally relevant, and complete way, it is possible to facilitate adequate understanding.

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Limitations: While the intervention was tested among real trial participants, it is possible that there were several confounding variables that could not be controlled.

Next Steps: There is need to further test this intervention in an active clinical trial setting using participants that are in the process of considering participation in a real trial in order to test impact on both short-term recall and long-term memory. This will also assist in answering the question of whether improving understanding may affect willingness to participate in a trial.

POSTER 37 Pre-Procedure Consent Process vs. Post-Procedure Consent Process for Biorepository Sample Acquisition: A Prospective Survey at the Time of Pre-Admission Presenter: Yasmin Isler, PhD ProMedica Toleda Hospital Background: In the last 10 years there has been an influx of biorepositories collecting human biological specimens for use in various types of research. One crucial component often overlooked is the consent process. It is proposed that the consent process would best serve the participant and the biorepositories when consent is obtained prior to the procedure(s). There are perceived limitations and downfalls to the post-procedure consenting process as it takes place when a patient is more vulnerable. Currently, federal regulations do not specifically mention this topic, nor do they offer guidance.

Methods: This qualitative/quantitative pilot research began on April 1, 2013, and evaluated participants’ perspectives regarding the importance of informed consent timing. The study aim was to determine which consenting process was favorable to patients, to ensure that patients were informed, and to establish a trend among different gender and age groups. Fifty patients were enrolled and were given a survey. Question types were limited in variability to provide ease of data analysis. The surveyed population consisted of adult male and female patients undergoing procedures to remove diagnosed or potentially pre-cancerous or cancerous human biological specimens. Eligible subjects were those who qualified to participate in the Academic Health Center Biorepository (AHCBR) during the advanced admission program (AAP).

Results: All 50 participants completed the survey (100% response). Ninety-two percent of the patients surveyed were female and 8% were male. Ninety-two percent responded as being

very informed during the consenting process, 6% felt somewhat informed, and 2% felt not very informed. One hundred percent felt they had sufficient decision time. Ninety-six percent reported that they preferred to be consented during their AAP appointment.

Two percent reported post-operatively or either for the consent timing. Ninety-eight percent of the patients consented were first time donors to a biorepository. One hundred percent of the patients consented agreed to participate with the AHCBR. Conclusions: Overall, the participants felt very informed during the consenting process. The participants also felt that the AAP appointment time was the best time to be presented with the opportunity to participate in the AHCBR program.

Limitations: Although the response rate was good, males were underrepresented due to the population consisting mostly of gynecological patients. This also presented some limitations to the age group that was surveyed. It is anticipated that other institutions and potential biorepository donors will benefit from employing a pre-procedural consent process as a standard practice.

••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Innovations B: Innovations in Respecting and Protecting Research Subjects Exhibit Hall E Moderator: Alan Wertheimer, PhD POSTER 22 IRB Collaborative: Continuing to Build and Refine an Online Library of Audiovisual Educational Materials Presenter: Judith Birk, JD University of Michigan Medical School Introduction: Maintaining a fresh continuing education program is a necessity and a challenge for IRBs; existing members need to remain topically current and new members are required to absorb large volumes of information. Now in its second year, an IRB Collaborative continues to develop multimedia educational material addressing a range of human subjects research–related topics.

To date, the Collaborative’s multimedia library offers nearly 40 voiceover slideshows, and new offerings are added as frequently as twice per month.

Methods: Presentations vary in duration and level of detail.

Material is displayed in a visually interesting manner in order to hold the viewer’s attention. Most consist of broad overviews of their subject matter, gathering key points within three- to fiveminute summaries. To explore certain topics more thoroughly, midsize presentations may run up to 10 minutes in length and may comprise two or more parts. For example, a recent two-part series on writing informed consent documents devotes a total of nearly 20 minutes to outlining and illustrating techniques for creating readable and comprehensible consent documents. To ensure accuracy and clarity, each presentation undergoes significant vetting and revision. In most instances, IRB’s technical writer begins by drafting a voiceover script, generally about 400 words in length. This draft is reviewed by the IRB’s director, assistant director, and senior education and regulatory coordinator—as well as other IRB staff identified as subject matter experts. After revising the script, the technical writer records the voiceover and pairs it with a slide set. Now in its near-final format, the multimedia

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presentation is previewed at an IRB staff meeting. If IRB office staff recommends corrections or improvements, the technical writer revises the presentation. Finally, the presentation is released to select institutional leadership and the IRB membership. In the rare event of any further recommended changes, the technical writer revises the presentation a final time before posting it on the IRB’s website for public viewing.

consist of items with relatively low skew. Psychometric properties are reported.

Conclusion: Researchers and IRB members commend the program for conveying useful messages in brief snapshot formats that are clear and consistent. To respond to institutional needs, the Collaborative periodically queries board members and IRB office staff to collect new topical areas for development.

Limitations: Volunteer sample, more testing is needed for validity.

POSTER 28 The Ordinary Life Experiences Rating Scale: Development of a New Instrument to Measure Minimal Risk in the Context of OHRP Terminology Presenter: Evan Harrington, PhD The Chicago School of Professional Psychology

Research Question: How do participants’ reactions to research compare with minimal risk benchmarks, and can they be directly measured?

Description of the Research Methods: A pool of items was developed in an effort to tap a variety of ordinary life experiences that may cause psychological distress. Fifty-one items involving distress-causing situations were generated, covering such themes as social embarrassment (accidentally hurting another’s feelings), environmental nuisances (e.g., waiting on a long line in a loud office), and loss (e.g., having a beloved pet pass away).

Participants were asked to rate each item on an 11-point scale, anchored by “Not at All Distressing” to “Intensely Distressing.”

The scale was administered to a volunteer sample through a web-based application. Links for the web survey were posted on www.socialpsychology.org and similar sites for the promotion of online research. A total of 225 usable surveys were returned, though many surveys had multiple missing data points, making the effective sample size for most analyses 211.

Results: Distress ratings ranged from a mean of 9.10 (unexpected breakup of romantic partner) to 1.96 (how distressing was THIS survey?). Each item was reviewed for skew, and those with very high skew were removed. Ultimately, a list of 15 items were reserved to reflect a broad cross-section of stressors, including items related to OHRP benchmarking for minimal risk, and to

Next Steps: Results will be published to make the scale widely available.

POSTER 75 Righting Research Wrongs: How US IRBs Respond to Participant Complaints, Concerns, and Injuries Presenter: Celia Fisher, PhD Fordham University Problem Statement: Under US federal regulations, individuals providing informed consent to participate in research must receive information regarding whom to contact in case of a researchrelated injury or complaint. Informed consent protocols routinely direct participants to contact IRBs with concerns, but there has been little empirical study of participants’ research-related grievances and the strategies that institutions use to resolve them. Formal resolution methods such as litigation and insurance are often unavailable or inadequate for addressing the range of research participants and research-related disputes. Research is needed to understand alternative venues for resolving researchrelated conflicts. This project presents an empirical study of the dispute resolution mechanisms that US research institutions use to address participant complaints, concerns, and injuries.

Methods: This poster presents results of 30 in-depth interviews with IRB chairs and directors at federally funded US hospitals and academic institutions. Interviews took place during 2013-14 and elicited data on frequency and types of research-related complaints, institutional practices for responding to participants’ concerns, options for complaint resolution, involvement of legal counsel, availability of compensation for injuries, and institutional experiences with research-related litigation.

Results: Interviews identified a range of participant complaints and institutional practices for resolution, as well as concerns about accessibility, conflicts of interest, and gaps in federal guidance.

Across institutions, IRB personnel suggested that effective institutional dispute resolution practices can protect participants, minimize exposure to litigation, and safeguard relationships with participant communities. Interviewees described institutional practices using procedural justice themes, such as voice, transparency, courtesy, neutrality, and providing participants and research staff opportunities to be heard. Uptake of dispute resolution processes by participants, however, may be low due to discomfort or lack of knowledge; process evaluation was rare; and process development typically did not solicit input from participant or community representatives.

Limitations: This study used qualitative methods and a relatively small sample size; inclusion was limited to hospitals and academic centers; and findings cannot provide generalizable numerical

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Problem Statement: Federal regulations, at 45 CFR 46.102(i), define “minimal risk” as research where “the probability and magnitude of harm or discomfort…are not greater in and of themselves than those ordinarily encountered in daily life…or routine physical…tests.” The OHRP IRB Guidebook (last updated in 1993), provides a descriptive benchmark by suggesting that the point of comparison should be that of a routine physical examination involving a blood draw. Psychological risks are inherently subjective, and IRB committees are tasked with judging how participants will react to research. To date there is no instrument or scale available to compare participants’ reactions to minimal risk benchmarks. The present study seeks to ameliorate this problem.

Conclusion: The resulting scale can be used by researchers in any area of socio-behavioral research to compare how participants felt about their own participation as compared to OHRP benchmark stressors such as blood draws.

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Posters Selected for Recognition Conference Innovations in…Information Series estimates of the frequency and types of participant complaints or dispute resolution mechanisms across institutions.

with new THRIVE members to see if their belief systems could be adequately incorporated into the model.

Conclusions/Next Steps: Research institutions provide a variety of ways for resolving participants’ concerns, complaints, and injuries, although these mechanisms may be underutilized by participants. This field may benefit from consulting research on workplace grievances and medical malpractice disputes.

Further research is needed to understand how participants and investigators experience research-related disputes.

••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Innovations C: Innovations in Institutional Collaborations Ballroom I & II Moderator: Moira A. Keane, MA, CIP

Conclusion/Next Steps: As collaborative research continues to grow in our region, we see lasting partnerships supported by the THRIVE model. Future goals include improving research integrity and reducing research misconduct across institutions. It has been particularly useful in smoothing the path for researchers to attain review board approval from multiple IRBs. Other institutions seeking to develop partnerships with community organizations would be advised to embrace a community-engaged model, such as recommended by the Presidential Commission for the Study of Bioethical Issues (2011). Our program is in the process of developing a toolkit to assist other institutions interested in implementing this model.

POSTER 5 Translational Health Research Initiative (THRIVE): An Inter-Organizational Partnership Model for Fostering Research Integrity Presenter: Paula Garcia McAllister, PhD, CIP Northern Arizona Healthcare

POSTER 24 Sharing SI IND/IDE Resources: A Contributory Network Model of Scalable Adoptable IND/IDE Support Services across Massachusetts Academic Institutions?

Presenter: Sabune Joane Winkler, JD Harvard Catalyst, The Harvard Clinical and Translational Science Center

Program Description: When different organizations with different values systems collaborate on research that is vital to the community, complications due to cultural differences, competing or disconnected research goals, and varying ethical standards among different disciplines can arise. Collaborative research among various institutional and community researchers raises questions about the research priorities of the various stakeholders; data confidentiality, ownership, and management; dissemination of findings; and perceptions of research misconduct (Harding, et al, 2012). This program is a partnership between a university and a regional community hospital that serves multiple Native American tribes and other sensitive populations. THRIVE partners represent a university, a hospital system, a biomedical/genomics center, and several Native American tribes whose mission is to address issues around research misconduct and the responsible conduct of research.

Problem Statement: Academic institutions are faced with how best to support SIs, individuals who serve as both the clinical investigator and the sponsor, when conducting investigational drug and device research. An ideal model of institutional support for SIs is one that provides necessary education of the SI’s responsibilities and facilitates regulatory and institutional compliance. However, institutions struggle with identifying and providing access to services necessary to navigate the complex and challenging IND/ IDE requirements. Many do not have a centralized IND/IDE office but rather only have access to limited resources and expertise embodied in different individuals/departments across the institution.

The result is that academic centers have various models of IND/ IDE support based on numerous factors such as institution size, type of research conducted, organizational structure, budget, and number of SI held INDs/IDEs. For an institution considering a deployment of new or improved IND/IDE services, functions have been classified, and individual institutional models have been identified. However, three of the major missing components are identifying 1) how many employees are required to effectuate various IND/IDE support models; 2) required types of expertise/skill sets/background that would constitute an effective IND/IDE support model; and 3) how institutions without resources may regionally create basic toolkits and share education and learning.

Problem Statement: Complications in conducting ethical healthcare research can be due to: 1) involvement of multiple IRBs representing a variety of institutions and multi-cultural communities; 2) data management and dissemination of research involving electronic health records, multi-use biosamples, and other sensitive information; and 3) publication and dissemination of research findings that comply with diverse stakeholders’ interests, including Native American tribes.

Method: The THRIVE project aimed to alleviate these complications and develop a model for building consensus among various stakeholders. THRIVE conducted a communityengaged investigation that involved interviews, observations, and focus groups with THRIVE members to determine cross-cultural differences and similarities within and between cultural groups (i.e., the various research stakeholders) in terms of beliefs and behaviors relating to research integrity. This project allowed us to produce a model that 1) accounted for various stakeholder interests and beliefs, and 2) provided a roadmap for arriving at consensus on contentious issues. This project was evaluated by testing the model

Method: To assist institutions in providing support for SIs in meeting regulatory requirements for their ongoing and/or new research studies, 13 volunteer experts from eight different academic and hospital institutions met to share resources, education, and experiences. Given the diversity of the institutional structures and cross-departmental functions, we were able through discussion and surveys to cross-map the models and functions with the human resource component to elucidate a diverse range of scalable and adaptable tools, education that any institution can adopt, and access to enable IND/IDE support functions within their own institutions and networks.

Result: A contributory network, sharing policy, form development, and educational resources elucidated the diversity in the

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provision of institutional assistance to IND/IDE holders and offered compelling benefits to SIs and institutions by extending services to, expanding learning of, and assistance to employees to be more productive and responsive.

Scalability: Through this effort, institutions seeking models to manage IND/IDE obligations can access our resources and implement their own network model to co-create value, instill a collective identity, and ultimately deliver high quality IND/IDE support services seamlessly.

POSTER 52 University of California (UC) IRB Reliance Registry: Facilitating Human Subject Review for Multi-campus Studies in the UC System Presenter: Colleen Kohashi, MA, CIP University of California, Berkeley

Description of the Program: This poster describes The Registry’s development process, the benefits to the campuses that it has generated, and remaining and on-going challenges of using an online tool to facilitate a single IRB review for multi-site studies in a large research university system. The existence of the MOU and the online Registry promotes collaboration not just among researchers at multiple campuses but also among the IRB staff across the system. In just two years since its pilot launch, there are around 1,500 researchers working on 428 studies using The Registry. That is a 146% increase over a two year period compared to the total number of all multi-site studies conducted under the MOU during the period of six years (2005-2012). The process of developing and adopting The Registry tool also brought to light several existing contradictions and differences between IRB procedures and requirements at different campuses, and as a result promoted the implementation of more standardized and streamlined IRB procedures among participating campuses.

These streamlined procedures have, in turn, further reduced faculty burden and decreased the time for IRB reviews of multi-site studies.

Suggestions for Implementation: The poster will map the complexities of a reliance system, and will illustrate how the process that was implemented streamlined some of those complexities and decreased investigators’ administrative burden associated with multiple IRB reviews of a study. It will also offer lessons learned and tips for the design and implementation of similar systems.

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posters

Program Statement: A university system, comprising of 10 campuses including seven R1 universities, six medical schools, and a national lab, recognized the benefit to its investigators of a single IRB review for collaborative human subject research involving multiple campuses. Starting in 2005, the 10 campuses plus one laboratory signed their first Memorandum of Understanding (MOU) agreeing to rely on each other’s IRB reviews. In 2012, the system developed an online system, “The Registry,” which facilitates documentation, communication between IRBs, and tracking of the status of multisite human subject studies. In creating The Registry, the goals were to encourage greater collaborations amongst campuses, to make it easier for researchers to collaborate while fulfilling multi-campus

IRB requirements, to decrease IRB workload, and to efficiently track reliances for IRBs and the Office of the President.

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

Please visit Supporters and Exhibitors in The Conference Connection, located in Exhibit Hall FG on Level 100 of the Baltimore Convention Center. The Conference Connection hours are provided on page 7, and a map is included on page 98.

Platinum Supporters The Collaborative Institutional Training Initiative (CITI) Program at the University of Miami 305.243.7970 | www.citiprogram.org Booths: 119 and 218

The CITI Program at the University of Miami offers customizable, 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. PRIM&R would like to thank The CITI Program for supporting this year’s Global Research Scholarship Program. More information can be found on page 11 of this guide.

supporters & exhibitors

Evisions 714.824.5252 | www.evisions.com/research Booths: 219 and 318

The Evisions Research Suite, which includes Cayuse 424, Cayuse SP, and Cayuse IRB, comes from a company with over 15 years of experience in research administration. Our customers drive everything we do–-research, solutions, service and support–-when you work with us, you are part of the Evisions team. PRIM&R would like to thank Evisions for supporting this year’s conference mobile app. Please see page 4 of this guide for more information on how to access the conference mobile app.

Schulman Associates IRB 513.761.4100 | www.sairb.com Booths: 109 and 208

Schulman Associates IRB provides high quality, rigorous IRB reviews for all phases of research in North America via streamlined processes, customized technology, and responsive customer service. We offer dedicated IRB services for research institutions and also offer clinical quality assurance and human research protections consulting via our partner Provision Research Compliance Services. PRIM&R would like to thank Schulman Associates IRB for supporting this year’s conference wireless internet access and the onsite charging station located in the Pratt Street Lobby.

WIRB-Copernicus Group (WCG) 609.945.0101 | www.wcgclinical.com Booths: 209, 308, and 309

WCG is the world’s largest and most trusted provider of regulatory and ethical review services for human research. The pioneer of independent ethical review, WCG continues to drive ingenuity in the clinical research space. Today, WCG’s solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials. PRIM&R would like to thank WCG for supporting this year’s conference lanyards.

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Gold Supporter FTI Consulting 410.224.8770 | www.fticonsulting.com/hc Booths: 126 and 128

FTI Consulting’s Clinical Research and Compliance Practice provides a comprehensive array of healthcare related research and compliance support services including, but not limited to: research billing, human subjects protections, conflicts of interest, research administration, scientific misconduct, grants management, and good clinical practices. PRIM&R would like to thank FTI Consulting for supporting this year’s conference pens.

Silver Supporters Huron Consulting Group 312.583.8700 | www.huronconsultinggroup.com Booths: 118 and 120

At Huron, we help our clients create the best HRPPs. Huron is the only provider combining the industry’s leading HRPP regulatory and process experts with the #1 IRB enterprise software solution, Click® IRB. Working with Huron, your research organization will improve principal investigator satisfaction, strengthen compliance, and increase organizational efficiency.

PRIM&R would like to thank Huron Consulting Group for supporting breakfast on December 5 in The Conference Connection in Exhibit Hall FG.

InfoEd Global would like to welcome you to PRIM&R’s 2014 AER Conference. There are many new and exciting things happening in the world around us in eRA. We supply world class Enterprise Software to manage research electronically from cradle to grave. We hope to get the chance to meet all of you; please stop by our booths during the conference. PRIM&R would like to thank InfoEd Global for supporting the boxed lunches on December 7.

The PEER Consulting Group (PEER) 551.265.2040 | www.peercg.com Booths: 115 and 214

PEER helps institutions, researchers, and sponsors enhance performance, excellence, and efficiency in research. PEER consists of three divisions: Associates for IRB/HRPP Solutions (AIS), Associates for Clinical Trials (ACT) Management, and Associates for Research Compliance (ARC). The group is complemented with a team of over 70 consultants who have extensive expertise in all areas of research administration and clinical trial management.

PRIM&R would like to thank PEER for supporting the boxed lunches on December 6.

Quorum Review IRB 206.448.4082 | www.quorumreview.com Booths: 215 and 314

Quorum Review IRB is a privately-held, independent ethics review board fully accredited by AAHRPP. Our mission is to safeguard the rights and well-being of research participants. With 15 board meetings a week, we provide sponsors, clinical research organizations, institutions, and sites with reliable, responsive service to support efficient study start-up and management.

PRIM&R would like to thank Quorum Review IRB for supporting the Common Ground Networking Luncheon with the Supporters and Exhibitors on December 5 in The Conference Connection in Exhibit Hall FG. d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

supporters & exhibitors

InfoEd Global 800.727.6427 | www.infoedglobal.com Booths: 319 and 321

Supporters & Exhibitors Bronze Supporters HRP Consulting Group, Inc. 347.862.9321 | www.thehrpconsultinggroup.com Booths: 221 and 223

HRP Consulting Group is a leading provider of human subjects protections consulting services 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; retention plan; HRP monitor; accreditation assistance; and assistance responding to federal agencies. PRIM&R would like to thank HRP Consulting Group, Inc. for supporting the morning coffee break on December 6 in The Conference Connection in Exhibit Hall FG.

EnterpriseWeb LLC and the Ideate Research Management Suite 646.502.8062 | www.enterpriseweb.com Booths: 229 and 328

supporters & exhibitors

Ideate is a comprehensive suite of research management applications, which are quick to deploy, easy to use, and highly customizable. The research suite includes: pre- and post-award grants, human ethics, animal studies, radiation safety, biosafety, profile management, funding opportunities, etc. Ideate’s smart research apps reduce administrative burden, while facilitating automated compliance. Ideate offers on-premise perpetual licenses and Cloud subscriptions.

PRIM&R would like to thank EnterpriseWeb LLC and the Ideate Research Management Suite for supporting the afternoon coffee break on December 5 in The Conference Connection in Exhibit Hall FG.

iMedRIS Data Corporation 909.798.9100 | www.imedris.com Booths: 210, 212, and 325

iMedRIS Data Corporation provides research institutions with web-based integrated research information systems to streamline clinical trial reporting. Our exceptional product iRIS, remains the industry forerunner of clinical research software with modules such as eProposal Assistant (Pre-Award), IRB Assistant, and IACUC Assistant. PRIM&R would like to thank iMedRIS Data Corporation for supporting the morning coffee break on December 5 in The Conference Connection in Exhibit Hall FG.

IRBNet, A WIRB-Copernicus Group Company 617.758.4202 | www.irbnet.org Booths: 311, 313, and 315

IRBNet is the leading compliance and research oversight solution for institutions. Developed in 2001 as part of a NIH Enhancement Grant, IRBNet supports over 2,500 research sites and review boards and over 125,000 research professionals in the successful and efficient management of research involving humans, animals, and recombinant DNA. PRIM&R would like to thank IRBNet for supporting the morning coffee break on December 7 in The Conference Connection in Exhibit Hall FG.

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Exhibitors

Alion Science and Technology 410.507.2036 | www.alionhrpp.com Booth: 312

Alion’s HRPP service offering aligns a set of nationallyrecognized subject matter experts in human subjects protections with a distinct vision for ensuring the welfare of research participants. The Alion HRPP Accreditation Program offers comprehensive accreditation services for organizations involved in conducting, managing, or reviewing research involving humans.

AAHRPP, Inc. 202.783.1112 | www.aahrpp.org Booth: 227

AAHRPP works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

Mentor IRB by

IRB & Grants Management Software

Apex Ethical Services offers unique state-of-the-art and cost-efficient products to help your HRPP and IRB become more knowledgeable, functional, and efficient. Apex Ethical Services’ landmark IRB educational product, IRB EasyEdTM, designed for brief educational sessions at IRB meetings, will begin publication and distribution to clients in January 2015.

Aspire IRB, A WIRB-Copernicus Group Company 619.469.0108 | www.aspire-irb.com Booth: 310

Aspire IRB was founded in 2004 by a group of CIP-certified women dedicated to making a difference in healthcare through human subjects protections. The first female and minority-led independent IRB, Aspire is recognized for the timeliness and efficiency of its service, and the quality of its communication with clients.

Mentor IRB and Mentor IACUC: Research Compliance Solutions, by Axiom Education, is a full featured, fully customizable protocol management system for Human Subjects and Animal Research that supports automatic agenda creation, multi-part forms, post-approval reporting, notification templates, and reviewer assignments. Both systems also support student submitted protocols with named supervisor approval workflow.

The Bioethics Program of Union Graduate College and Icahn School of Medicine at Mount Sinai 518.631.9860 | www.bioethics.union.edu Booth: 129

Jointly offered by Union Graduate College and the Icahn School of Medicine at Mount Sinai, the Bioethics Program provides competency- and skills-based education in clinical ethics, research ethics, and bioethics policy. The program uses a hybrid approach to teach bioethics. Students take a mixture of online and onsite courses, which are taught by internationally recognized experts in the field, and includes the use of case studies, supervised exercises, and innovative real-world simulations.

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supporters & exhibitors

Apex Ethical Services, LLC 517.290.3965 | www.apexethical.com Booth: 320

Axiom Education 203.242.3070 | www.axiomeducation.com Booth: 224

Supporters & Exhibitors

Chesapeake IRB 410.884.2900 | www.chesapeakeirb.com Booth: 220

Chesapeake IRB has been providing central independent IRB services since 1993. Chesapeake IRB, AAHRPP accredited since 2004, has a history of creating innovative and adaptive solutions in response to changing research and regulatory environments. We offer a 21 CFR Part 11 compliant, electronic IRB platform (CIRBI) that streamlines protocol submissions and decreases investigator review turnaround times resulting in faster subject enrollments.

supporters & exhibitors

CIP® Program 617.423.4112 | www.primr.org/certification/cip Booth: 113

The CIP® program, PRIM&R’s certification initiative, was developed for individuals participating in and overseeing the daily activities of IRBs. The credential establishes and promotes standards for professional knowledge, and supports adherence to regulatory requirements, best practices, and ethical standards.

More than 2,500 individuals have become certified since the inception of the program in 1999.

Complion, Inc 800.615.9077 | www.complion.com Booth: 225

Complion’s mission is to transform the way clinical trial regulatory documentation is created and maintained, thus fostering greater regulatory compliance. By re-engineering cumbersome compliance processes, Complion seeks to unleash medical innovators to better focus on advancements that improve patient outcomes and enhance the reputations of institutions and investigators.

Hummingbird IRB 855.447.2123 | www.hummingbirdirb.com Booth: 226

Hummingbird IRB, fully accredited by AAHRPP, has brought together the IRB community’s most experienced and trusted board and staff members to provide efficient central IRB services for academic and commercial clients. Hummingbird IRB offers specialty boards in Oncology, Respiratory, Central Nervous System, Rheumatology, Infectious Disease, Devices, Integrative Medicine, and Phase I Trials.

Infonetica Ltd. 888.222.1253 | www.infonetica.net Booth: 228

Infonetica is a world leader in web-based software for IRBs, Clinical Research Management, Human Tissue Tracking, and Online Training. We created the national web-based ethics application and approval systems in the United Kingdom, Australia, and New Zealand. Our Ethics Review Manager is used by health institutions and universities in the United Kingdom, United States, and Canada.

IntegReview IRB 512.326.3001 | www.integreview.com Booth: 121

IntegReview IRB has continually maintained high standards of quality, ethical integrity, and regard for human safety while being responsive to customer demands and needs for prompt, thorough, and professional IRB services with daily meetings since 1999. IntegReview IRB provides an online 21 CFR Part 11 compliant document management system and is fully accredited

by AAHRPP since 2007.

IRBManager 888.871.7575 | www.irbmanager.com Booth: 123 The Health Care Compliance Association (HCCA) 888.580.8373 | www.hcca-info.org Booth: 213

HCCA is a member based organization for compliance professionals in the healthcare field. Our events, products, and resources offer education for those looking to be certified in healthcare compliance, or just for those looking to keep their compliance department updated with the latest news. HCCA currently has over 9,500 members, and has over 6,500 individuals actively certified through its seven certification programs. p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

With its award-winning IRBManager offering, Tech Software continues to deliver best-of-breed solutions for research oversight and compliance. A modern cloud solution, IRBManager supports your compliance needs from IRB and IBC to IACUC and export control, including electronic submissions, online reviews, agendas and minutes, and reporting. IRBManager builds on Tech Software’s 30-year history of providing solutions that meet and exceed industry norms while delivering user-friendliness and configurability second to none.

Iritzi 800.557.9962 | www.iritzi.com Booths: 322 and 324

Iritzi teamed up with some of the foremost professionals in their fields, their institutions, and review boards to develop a better, trackable social method for IRBs today. Iritzi takes a fresh look at the review process and the research behind it. Central hubs give IRB professionals and administrators the easy access they need—to everything!

Johns Hopkins Berman Institute of Bioethics 410.614.5550 | www.bioethicsinstitute.org Booth: 124

The Johns Hopkins Berman Institute of Bioethics is an internationally-renowned home for research, scholarship, education, and service in bioethics. Over the past two decades, the Berman Institute has identified, explored, and addressed the diverse ethical challenges involved in advancing science and human health. Follow us on Twitter: @bermaninstitute

MaGil IRB 731.624.4584 | www.magilirb.com Booth: 122

MaGil IRB is a full service, AAHRPP-accredited IRB offering expeditious, quality review at a competitive price. We offer an average turnaround time of two to four days for exempt and expedited reviews and one week for full board reviews.

MaGil IRB is 100% paperless and all submission forms can be completed and submitted online.

MŌDERAS 518.412.2020 | www.moderas.org Booth: 323

MŌDERAS specializes in web-based electronic research administration solutions developed on the open-source Kuali Coeus platform. Move beyond software selection with a fully modular, end-to-end solution that doesn’t sacrifice functionality to be cost-effective. Stop by our booth to learn more about our best-in-breed applications.

Key Solutions, Inc. 888.871.7575 | www.keyusa.com Booth: 211

Key Solutions is the Integrated Research Administration and Compliance Software leader. Products include: Human Subjects (IRB), Bio Safety (IBC), Animal Subjects (IACUC), Chemical Safety (CSC), Radiation Safety (RSC), Stem Cell, Animal Resource Management, Animal Health Records, PostApproval Monitoring, Conflict of Interest (COI), Sponsor Project Administration (SPA), and Grant Management Systems.

Kuali Coeus 617.253.8048 | www.kuali.org/kc Booth: 125

Kuali Coeus creates, maintains, and supports the most robust electronic solution to manage all components of research administration including IRB, IACUC, and conflicts of interest while fostering best practices by joining innovative technology with the knowledge base of a national consortium of research stakeholders.

NCI’s Central IRB (CIRB) 888.657.3711 | https://ncicirb.org Booth: 326

The NCI’s CIRB is a free service for institutions participating in the NCI’s National Clinical Trial Network and Experimental Therapeutics Clinical Trial Network. Comprised of national experts in oncology, the three NCI CIRBs focus their reviews on adult late-phase emphasis trials, adult early-phase emphasis trials, and pediatric trials.

Novelution 212.864.1653 | www.novelution.com Booth: 329

Novelution provides tailor-made research management software, including Pre- and Post-Award, IRB, IACUC, Space Management, and other modules our partners need to support their research administration. Our software is custom-built rather than customconfigured; as such, we have unlimited flexibility to create an ideal system for each partner.

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supporters & exhibitors

National Cancer Institute Central IRB Initiative

Supporters & Exhibitors

OHRP 240.453.6900 | www.hhs.gov/ohrp Booth: 327

The Department of Health and Human Services’ (DHHS’) OHRP oversees the protection of human subjects for DHHS-conducted or supported research activities and accomplishes its mission through assurances, policy and guidance development, compliance oversight, education, and the quality improvement program. Staff will be available to discuss ethical principles, regulations, policy guidance, and educational resources.

RosterTech™ 801.585.3492 | www.rostertech.com

supporters & exhibitors

Booth: 111

RosterTech™ delivers cost-effective, customizable solutions for research compliance and training programs. “Built by trainers for trainers,” RosterTech™ provides efficient registration, tracking, certification, and reporting for your institution and federal funding agencies. RosterTech™ fully integrates with existing software platforms enabling centralized data management and instructional content in a secure environment.

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Seton Hall Law 973.642.8500 | law.shu.edu Booth: 127 Seton Hall Law now offers Online Graduate Certificates, created specifically for non-lawyers, in Clinical Research and the Law. Explore regulatory, ethical, and compliance issues relevant to individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and IRBs.

University of Maryland, Baltimore (UMB) 410.706.3100 | www.graduate.umaryland.edu/research-ethics Booth: 222 UMB is a 71-acre research and technology complex located in Baltimore, MD. UMB is Maryland’s only public health, law, and human services university. Seven professional and graduate schools train the majority of the state’s physicians, graduate nurses, dentists, lawyers, social workers, and pharmacists.

Board of Directors Conference Information Officers

Members

Alexander M. Capron Chair University of Southern California

Barbara E. Bierer Brigham and Women’s Hospital; Harvard Medical School

Susan Z. Kornetsky Vice Chair Boston Children’s Hospital

Cynthia A. Gómez San Francisco State University

about PRIM&R

Robert J. Levine Yale University

A. Cornelius Baker FHI 360

Joseph J. Byrne Tufts University (Emeritus)

Leonard Glantz Boston University

Christine Grady NIH Serves in Personal Capacity

Tanise L. Jackson Florida Agricultural and Mechanical University

Moira A. Keane University of Minnesota Retired

Christian E. Newcomer AAALAC International

Judy Norsigian Our Bodies, Ourselves

P. Pearl O’Rourke Partners HealthCare

Ada Sue Selwitz University of Kentucky

Barbara Stanley Columbia University

Walter L. Straus Merck & Co., Inc.

Hugh H. Tilson University of North Carolina at Chapel Hill

Elisa A. Hurley PRIM&R Ex officio

Susan S. Fish Secretary Boston University

Heather H. Pierce Association of American Medical Colleges

David A. Borasky, Jr. Treasurer Copernicus Group IRB

David H. Strauss Columbia University

Jeremy Sugarman The Johns Hopkins University

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Staff

Avery Avrakotos Education and Policy Manager

Ashley Brewer Conference Assistant

Joanna Cardinal Assistant Director for Membership and IT Operations

Mariellen Diemand Associate Director for Conferences

Mason Drastal Registration and Operations Assistant

Meredith Elkins Director of Marketing and Communications

Megan Frame Membership Coordinator

Elizabeth Geer Program and Membership Assistant

Kimberly Hensle Lowrance Managing Director

Elisa A. Hurley Executive Director

Jen Levine-Fried Staff Accountant

Maeve Luthin Professional Development Manager

Anne Meade Senior Manager for Website and Social Media

Alysa Perry Program Coordinator

Marley Thrasher Director of Education and Professional Development

about PRIM&R

Caroline Slymon Executive Coordinator

Alexandra Shlimovich Webinar and Publications Specialist

Meghan Timmel Communications Coordinator

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Conference Information PRIM&R established the CIP® credential in 1999, and since then, more than 2,500 individuals have become certified.

Certification improves human subjects protections and promotes ethical research practices and programs by recognizing that those charged with their administration have demonstrated an advanced level of knowledge, understanding, and experience.

The CIP® credential…

• Promotes the ethical conduct of research by strengthening the professional administration of HRPPs • Validates an individual’s professional experience and mastery of the body of knowledge determined by national experts to be essential to competent HRPP and IRB administrative practices • Encourages personal growth and professional development • Strengthens the quality of HRPPs by certifying a cadre of committed and educated individuals As the CIP® credential has gained visibility, the number of employers seeking candidates with this certifications continues to grow. Those who have obtained the credential report greater job satisfaction, workplace recognition, and personal pride. To support individuals who are considering obtaining the CIP® credential or those who are actively preparing for the exam, PRIM&R offers an overview session during the AER Conference, described below. Facebook and LinkedIn groups of peers are also available for exam preparation assistance, support, and mentoring.

CIP® Exams Examinations are conducted during two periods of two weeks each in the spring and fall. The 2015 examination dates will be: • Spring testing period: March 7-21 Application deadline: January 15 • Fall testing period: September 12-26 Application deadline: August 1 CIP® Recertification Participation in the 2014 AER Conference qualifies as continuing education for the purpose of CIP® recertification. A maximum of 18.75 credit hours issued by a recognized accrediting body are available for the 2014 AER Conference.

CIP® at the 2014 AER Conference • A22: The CIP® Credential: What’s it About?

Friday, December 5, 2:45-4:00 PM, in Room 319 This session is for individuals interested in learning about earning the CIP® credential.

• CIP® Continental Breakfast Saturday, December 6, 7:00-8:00 AM, in Room 314-317 This session is for anyone interested in becoming certified, or those already certified and who would like to network with other CIPs. • CIP® Program Booth Visit the CIP® Program booth in The Conference Connection to learn more about the credential and connect with CIP Council Members. The Conference Connection hours are listed on page 7, and a map is included on page 105.

A special thank you to the Council for Certified IRB Professionals (CCIP) about PRIM&R

PRIM&R would like to thank the current members of the CCIP for their dedication to the program:

Greg Lim Chair

Erica Heath Vice Chair

Barbara Bigby

Jerry Castellano

David Forster p rim&r’ s 20 Bambi Grilley Ross LoDico 14 2 adv ad vanci ancing ng eeti thhical cal re rese sHickey eaarc rch h ccon onffeerreennBarbara ccee p rim&r’s 20 1 3 adv anci ng e th i cal re s e a rc h c on f e r e n c e

Gary Chadwick

Susan Delano

Lori Roesch

Carla Scioneaux

In Memoriam

Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, an active and valued leader in the field of human subjects protections and proud family man, passed away on October 2, 2014.

Among his many accomplishments, Dr. Gyi founded Chesapeake Research Review, Inc, an independent IRB, in 1993, and served as its CEO for more than 20 years. During his time at Chesapeake IRB, Dr. Gyi helped raise important questions about the growing role of central IRBs. Dr. Gyi was also instrumental in the creation of the CIP® credential. Gary Chadwick, PharmD, MPH, another of the credential’s founders, spoke to Dr. Gyi’s contributions: “He was one of the first persons I tapped to get the CIP® credential off the ground back in 1999. I saw first-hand his dedication and extensive knowledge, which, when put with his easy-going nature and great sense of humor and fun, produced outstanding results and spurred others to excel.”

Dr. Gyi also offered his expertise on the issues related to human subjects protections to SACHRP, for which he served as a member from 2003 to 2006. Later, he was also a member of SACHRP’s Subpart A Subcommittee, charged with reviewing and making recommendations related to the regulations found in 45 CFR 46 Subpart A. Throughout his career, Dr. Gyi was a sought-after speaker both nationally and abroad. His ability to capture the spirit of human subjects protections served as a passionate reminder to all about the importance of such work.

Dr. Gyi’s unique ability to elucidate the importance of human subjects protections has ensured that his legacy will endure.

The dedication and commitment with which he spoke about human subjects protections left an indelible impression on

Dr. Gyi will also long be remembered for his spirit and attitude, as Dr. Chadwick attested: “Felix was an absolute joy to be around—he always had a kind word and was supportive of family and friends. His generosity was boundless—he personally hosted many a dinner and reception for ‘official functions’ of organizations that didn’t have the funds to support this important professional networking or provide amenities.”

Immediately prior to his death, Dr. Gyi was elected to the PRIM&R Board of Directors. While Dr. Gyi was not aware that he had been elected to the Board at the time of his passing, he knew of his nomination and indicated that he was eager to contribute. The PRIM&R Board and staff were looking forward to welcoming Dr. Gyi to the Board, and feel a deep the sense of sorrow that he will not be joining in January.

Ethical, humble, and generous, Dr. Gyi was an extraordinary leader, whose impact can be felt in the way the regulations governing the conduct of research with human subjects are interpreted and operationalized throughout the research enterprise. He touched the lives of many in the field and his wisdom, warmth, and humanity will be deeply missed.

To honor and recognize Dr. Gyi’s service to PRIM&R, the CIP® credential, and the human research protections community, PRIM&R is establishing the Felix Gyi Memorial CIP® Scholarship that will benefit those who cannot afford to sit for the CIP® exam or to recertify. Details about the Fund can be found at www.primr.org/felixgyi.

Please join us as we formally announce the creation of the Felix Gyi Memorial CIP® Scholarship on December 6 at 8:10 AM in Exhibit Hall E.

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about PRIM&R

Dr. Gyi also served alongside Gary Chadwick, Susan Delano, and others as an inaugural member of the Council for Certification of IRB Professionals (CCIP). Ms. Delano reflected: “He could always be relied on for his sound judgment and in-depth knowledge of the complex regulations and guidance governing research involving human subjects. He demonstrated a deep commitment to the ethical conduct of research and the welfare of research subjects. His positive attitude, generous spirit, and sense of humor were very much appreciated by his fellow Council members and the IRB community.”

the countless individuals who had the privilege to hear him present over the years were struck by the dedication and commitment with which he spoke about human subjects protections.

Maps Level 100: Supporters & Exhibitors, Poster Gallery in The Conference Connection Supporters & Exhibitors Poster Gallery Key

Booth

Biobanking and Genomics Research: 1-4 Community Engagement: 5-6 Education and Training: 7-24 Ethics & Risk: 25-30, 100 See page 80 for Global Research: 31-34, 102 enlarged detail of Informed Consent: 35-40 poster gallery IRB Operations: 41-78, 103 QA/QI: 79-91 Regulations and Guidance: 92-95 Special Populations: 96-99, 101, 104

Organization

109, 208 111 113 115, 214 118, 120 119, 218

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Schulman Associates IRB Rostertech CIP® Program The PEER Consulting Group Huron Consulting Group Collaborative Institutional Training Initiative IntegReview IRB MaGil IRB IRBManager Johns Hopkins Berman Institute of Bioethics Kuali Coeus FTI Consulting Seton Hall University School of Law Union Graduate College

200

PRIM&R Pavilion

209, 308, 309 210, 212, 325 211 213 215, 314 219, 318 220 221, 223 222 224 225 226 227 228 229, 328

WIRB-Copernicus Group iMedRIS Data Corporation Key Solutions Health Care Compliance Association Quorum Review IRB Evisions Chesapeake IRB HRP Consulting Group, Inc. University of Maryland, Baltimore Axiom Education Complion Hummingbird IRB AAHRPP Infonetica EnterpriseWeb LLC and the Ideate Framework

310 311, 313, 315 312 319, 321 320 322, 324 323 326 327 329

Aspire IRB IRBNet Alion Science and Technology InfoEd Global Apex Ethical Services, LLC Iritzi MŌDERAS NCI Central IRB OHRP Novelution

121 122 123 124

maps

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75

74

69

70

71

72

73

68

67

66

65

64

59

60

61

62

63

58

57

56

55

54

49

50

51

52

53

48 39

47

46

45

44

40

41

42 35

38 100

37 31

32

33

102 34

30 21

29 22

28 23

27 24

26 25

20 11

19 12

18 13

17 14

16 15

10

9

8

7

6

1

2

3

4

5

128

129

228

229

328

329

126

127

226

227

326

327

124

125

224

225

324

325

122

123

222

223

322

323

120

121

220

221

320

321

118

119

218

219

318

319

115

214

215

314

315

113

212

213

312

313

111

210

211

310

311

109

208

209

308

309

Demo Area

200

Lower Lobby

E

ESC Escalator S

p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

Elevator

Stairs

S

Charles St. Lobby

Pratt Street

Level 100: Exhibition Halls

Elevator

Stairs

ESC Escalator

E

Charles Street

Hall E

d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

maps

Hall FG

• Breakfast & lunch • Coffee breaks • Supporters • Exhibitors • Posters • PRIM&R Pavilion

The Conference Connection

General Session, Plenaries

Lower Lobby

Howard Street

E Elevator

C Stairs

Coffee

Terrace Terrace

Help Desk

Skywalk to Hilton

p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

Camden Terrace

Camden Lobby

Business Center

Registration

Charging Station

Pratt Street Lobby

Bookstore

Internet Cafe

Howard Street

Level 300: Session Rooms Charles Street ESC Escalator

S

Terrace

Terrace

maps

Maps

Level 400: Ballrooms

VIP Suite West

VIP Suite East

Ballrooms I & II Plenary Room

Ballroom IV Breakout

Ballroom III Plenary Room

maps

d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

notes

Notes

p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

Notes

notes

d e c e m b e r 5 - 7, b a lt i m or e , m a ry l a n d

notes

Notes

p rim&r’ s 20 1 4 ad v anci ng e th i cal re s e a rc h c on f e r e n c e

Schedule at a Glance

7:00-8:30 AM 8:30 AM 4:30-6:00 PM

Continental Breakfast Pre-Conference Programs Pre-Conference Programs Networking Reception

Ballroom III See schedule for room locations Camden Lobby

Friday, December 5 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 7:00-8:00 AM 7:00-8:00 AM 7:00-8:00 AM 8:00-8:15 AM 8:15-8:30 AM 8:30-9:15 AM 9:15-9:30 AM 9:30-10:45 AM 10:45-11:15 AM 11:15 AM-12:30 PM 12:45-1:45 PM 12:45-2:00 PM 1:45-2:05 PM 1:45-2:30 PM 1:45-2:30 PM 2:10-2:30 PM 2:45-4:00 PM 4:00-4:15 PM 4:15-5:30 PM 5:30-6:45 PM

Continental Breakfast Continental Breakfast to Welcome First-Time Attendees Affinity Group Peer-to-Peer Networking Continental Breakfast Welcome from the Conference Co-Chairs Welcome from PRIM&R’s Executive Director Keynote Address: John T. Wilbanks Break Panels I, II, III Coffee break Innovations in… Series Common Ground Networking Lunch with the Supporters and Exhibitors Research Ethics Book Group Lunch Demonstration of PRIM&R’s Ethical Research Oversight Course Meet and Greet the 2014 AER Conference Poster Authors Meet and Greet the Conference Supporters and Exhibitors Demonstration of PRIM&R’s Knowledge Center Didactic Sessions and Workshops Series A Coffee break Panels IV, V, VI 2014 AER Conference Welcome Reception

Exhibit Hall FG Room 314-317 Room 309-310 Exhibit Hall E Exhibit Hall E Exhibit Hall E

See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG Room 314-317 Exhibit Hall FG Exhibit Hall FG Exhibit Hall FG Exhibit Hall FG See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG

Sunday, December 7 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Continental Breakfast Welcome from the Conference Co-Chairs Membership Update Keynote Address: Susan E. Lederer, PhD Break Didactic Sessions and Workshop Series D Coffee Break Didactic Sessions and Workshops Series E Lunch The Uncomfortable Conversation: Talking about Diversity Lunch Living Room Conversation: An Update on the Henrietta Lacks Case

Exhibit Hall FG Exhibit Hall E Exhibit Hall E Exhibit Hall E

See schedule for room locations Exhibit Hall FG See schedule for room locations Exhibit Hall FG Room 328 Exhibit Hall E

Baltimore, MD

7:00-8:00 AM 8:00-8:15 AM 8:15-8:30 AM 8:30-9:15 AM 9:15-9:30 AM 9:30-10:45 AM 10:45-11:15 AM 11:15 AM-12:30 PM 12:45-1:45 PM 12:45-1:45 PM 2:00-3:15 PM

n

Continental Breakfast Exhibit Hall FG CIP® Continental Breakfast Room 314-317 Welcome from the Conference Co-Chairs Exhibit Hall E Presentation of the ARENA Legacy and Distinguished Service Awards and Exhibit Hall E Announcement of the Felix Gyi Memorial CIP® Scholarship Keynote Address: Anthony S. Fauci, MD Exhibit Hall E Break

Panels VII, VIII, IX See schedule for room locations Coffee break Exhibit Hall FG Didactic Sessions and Workshops Series B See schedule for room locations Lunch Exhibit Hall FG Affinity Group Peer-to-Peer Networking Lunch Room 314-317 Policy and Practice Recommendations for Ethical Sharing and Room 336 Use of Biospecimens/Data Speed Mentoring Exhibit Hall FG Meet and Greet the Conference Supporters and Exhibitors, and View the Exhibit Hall FG 2014 AER Conference Poster Presentations Didactic Sessions and Workshops Series C See schedule for room locations The Drama of DNA: An Interactive Play (Light refreshments will be served.

Ballroom I & II Show starts at approximately 4:45 PM.) Young Professionals Networking Reception Pratt Street Ale House

December 5-7

7:00-8:00 AM

7:00-8:00 AM

8:00-8:10 AM

8:10-8:30 AM

8:30-9:15 AM

9:15-9:30 AM

9:30-10:45 AM

10:45-11:15 AM

11:15 AM-12:30 PM

12:45-1:45 PM

12:45-1:45 PM

1:30-2:45 PM

1:45-2:45 PM

1:45-2:45 PM

3:00-4:15 PM

4:30-6:00 PM

6:30-8:30 PM

n

Saturday, December 6 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

PRIM&R’s 2014 Advancing Ethical Research Conference

Thursday, December 4 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •