OHRP RESEARCH COMMUNITY FORUM:
On the Legal and Ethical Frontline
The Graduate Center 365 Fifth Avenue New York, NY 10016 Friday, September 11, 2009
Respect for Persons Beneficence
Justice
AGENDA
7:00 – 8:00 8:00 – 8:15 REGISTRATION & CONTINENTAL BREAKFAST Welcome and Introductions Jerry Menikoff, MD, JD; Director, Office for Human Research Protections Gillian Small, PhD; Vice Chancellor for Research, City University of New York David Hirsh, PhD; Executive Vice President for Research, Columbia University Gail Habicht, PhD; Vice President for Research, SUNY Stony Brook
8:15 – 9:00
KEYNOTE ADDRESS Is the IRB Model Sustainable? Dr. John H. Marburger, III, Former Director, Office of Science and Technology Policy, Executive Office of the President; Former Director, Brookhaven National Laboratory; Past President, SUNY Stony Brook, and currently Professor, Department of Physics and Astronomy, SUNY Stony Brook
9:00 – 10:15
FEDERAL UPDATE What’s New from the Feds? In this session, participants will learn straight from OHRP, FDA, and NIH representatives about the latest, hot-off-the-presses activities in human subjects protections ongoing at these key federal agencies, including any new guidances, policies, and other initiatives that have a direct impact on the various role-players involved in the protection of human research volunteers. Melody H. Lin, PhD; Deputy Director, Office for Human Research Protections Sara Goldkind, MD, MA; Senior Bioethicist, Food and Drug Administration Marianna J. Bledsoe, MA; Deputy Associate Director, National Institutes of Health
10:15 – 10:30
BREAK
10:30 – 11:30
PLENARY SESSION A 9/11 and Hurricane Katrina: Challenges and Lessons Learned The events of 9/11 and Hurricane Katrina challenged IRBs and researchers alike. Panelists will discuss their experiences with conducting research immediately following a disaster, including the tribulations of IRB review, and how an IRB copes, faced with the disaster that hits home. Benjamin Luft, MD; Edmund D. Pellegrino Professor of Medicine, SUNY Stony Brook Robyn Gershon, DrPH; Associate Dean for Research, Columbia University Joseph Breault, MD, ScD, MPH, MS, CIP; IRB Chair, Ochsner Health System
11:30 – 11:45 11:45 - 12:45
TRAVEL TIME BREAKOUT SESSION A (A1) Fundamentals of Human Subjects Protections [Fundamentals Track] An overview of the basic framework of the human subjects protections regulations and the ethical principles of The Belmont Report will be provided. Topics of discussion will include IRB membership, IRB functions and operations, IRB record keeping, IRB review of research, expedited review procedures, suspension and termination of IRB approval of research, general requirements for informed consent, and documentation of informed consent. Melody H. Lin, PhD; Deputy Director, OHRP (A2) Nuts and Bolts of Protocol Review and IRB Minutes [Getting Things Done Track] If you find yourself wondering how to conduct a good protocol review, Ada Sue is here for you. Want to know what has to be in your minutes and what is the best way to prepare them? Ada Sue is here for you. Ada Sue Selwitz, MA; Director, Office of Research Integrity, University of Kentucky (A3) Unanticipated Problems and Adverse Events: Recognizing and Reporting [Researcher Track] Unanticipated problems (UP) can occur in any study, social behavioral or biomedical. As an investigator, you will learn how to recognize when one occurs and what to do about it. As an IRB member, you will appreciate decision processes that should be used to assess the UP, and as an IRB administrator or Institutional Official, you will understand your reporting requirements (including what information should be in the report) to OHRP, FDA (if applicable), and sponsors. Marti Benedict, RN, BSN; IRB Administrator and Chief Compliance Officer for Research, SUNY Upstate Medical University Jeffrey Cohen, PhD; President, HRP, Associates
11:45 - 12:45
(A4) Incidental Findings: What Is the Expectation? [Legal/Ethical Track] When should researchers be required to share findings with research subjects or their physicians? When is this a bad idea? Learn about incidental findings and current practical and ethical considerations related to consent and disclosure. David Strauss, MD; IRB Chair, New York State Psychiatric Institute; Professor, Columbia University (A5) Genetic Information Non-Discrimination Act (GINA) [Advanced/Hot Topics Track] GINA is a new Federal law that prohibits discrimination in health coverage and employment based on genetic information. GINA, together with already existing nondiscrimination provisions of HIPAA, generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or an individual's family members, or using such information for decisions regarding coverage, rates, or preexisting conditions. This session is designed to help clarify GINA issues. Jeffrey Botkin, MD, MPH; Associate Vice President for Research Integrity, Professor of Pediatrics and Medical Ethics, University of Utah
12:45 – 1:45 1:45 – 2:45
LUNCH BREAKOUT SESSION B (B1) Different Roles for Different Reviewers [Fundamentals Track] This session will explore the responsibilities of IRB members when they serve different roles for the various types of reviews conducted by an IRB (such as, full committee reviews, expedited reviews, facilitative reviews, new protocols, renewals/continuing reviews, modifications, unanticipated problems). Brenda Ruotolo, BA, CIP, CIM; Associate IRB Director, Columbia University (B2) Going, Being, and Staying Electronic [Getting Things Done Track] Moving from paper to electronic systems is not just about turning on a switch. This session will be of interest to all members of your human research protections program, discussing experiences and common misconceptions of investigators, challenges that face the IRB office before and after the switch is turned on, impact on IRB member reviews (content and timeliness), and the transparencies that 'going electronic' permits from the Compliance Office/Institutional Official perspectives. Judy Matuk, MS; Institutional Official, Assistant Vice President for Research Compliance, SUNY Stony Brook Andrew Olmsted, MBA; Director, IRBNet (B3) Informed Consent: It Ain’t Just A Form [Researcher Track] Often investigators are under the assumption that the informed consent form is all that is required to enable the subject to make an informed decision. In many studies, a continuous informed consent process is more appropriate. There are also situations where re-consent is necessary. This session will discuss the concept of informed consent as a process. TBA
1:45 – 2:45
(B4) Current Trends in IRB Case Law [Legal/Ethical Track] In this session, Dr. Menikoff will trace the history of litigation involving human subjects protections and institutions, IRB staff, and IRB members. Dr. Menikoff will discuss several high-profile and notable examples in IRB case law and their relative significance (or lack thereof). Jerry Menikoff, MD, JD; Director, OHRP (B5) Back to the Future: New Ethical Guidelines in Stem Cell Research [Advanced/Hot Topics Track] On March 9, 2009, President Barack Obama issued Executive Order (EO) 13505, entitled "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells." What are the practical implications to researchers, research administrators, and IRBs of this action as well as NIH's Policy Guidelines? In this session, come learn from an expert: Dr. Pearl O'Rourke, who brings a broad perspective to this issue from her extensive experience in both crafting and implementing federal stem cell policy guidelines over multiple Presidential administrations. Pearl O’Rourke, MD; Director, Human Research Affairs, Partners HealthCare System
2:45 – 3:00 3:00 – 4:00
TRAVEL TIME AND COFFEE BREAKOUT SESSION C (C1) Mock IRB Review [Fundamentals Track] This session will present an IRB application containing both biomedical and social and behavioral issues and will simulate a convened review by an IRB. The IRB will represent a duly constituted IRB with appropriate membership. Samuel Aymer, PhD; Professor, Hunter College, CUNY Father David Kossey, IRB Community Member, Baruch College & CUNY-Wide IRBs Stephanie Musso, RN, MSN, CHP; Privacy Officer, SUNY Stony Brook Michael Pearl, MD; Professor; Director, Gynecologic Oncology; IRB Chair, SUNY Stony Brook Vicki Raveis, PhD; Co-Director, Aging and Public Health Program, Columbia University
Moderator: Elyse Summers, JD; Acting Director, Division of Education and Development, OHRP
(C2) Psychodynamics of an IRB Meeting [Getting Things Done Track] Have you ever felt frustrated trying to manage an IRB meeting because members just do not seem to "click." Discussions dragged on and on with no resolution? Members argued, but never came to consensus? This session delves into the psychological dynamics of IRB's, how a Chair can manage the diverse personalities of IRB members and how IRB members can work collaboratively with each other to facilitate an efficient and effective IRB meeting. Cheryl Savini, CIP; IRB Manager, Columbia University Hannah Rothstein, PhD; IRB Chair, Professor, Baruch College, CUNY
3:00 – 4:00
(C3) Distinguishing between “Exempt” and “Not Human Subjects” Research [Researcher Track] Researchers are often confused about which research projects must be submitted to the IRB. In this session participants will learn to distinguish between studies that meet the regulatory definition of exempt and those that do not meet the regulatory definition of research with human subjects. Discussion will also include guidance on institution-specific submission policies. Ada Sue Selwitz, MA; Director, Office of Research Integrity, University of Kentucky Patricia MacCubbin, MS; Executive Director, Office of Research Conduct, CUNY (C4) What’s New in HIPAA? [Legal/Ethical Track] It's hard to believe that the law (1996) that resulted in the HIPAA privacy regulations is now officially a "teenager" and that the deadline (2003) for HIPAA compliance has long passed. Learn the latest information on HIPAA from Dr. Pearl O'Rourke, who has dealt with HIPAA in her positions both inside and outside the federal government. Pearl O’Rourke, MD; Director, Human Research Affairs, Partners HealthCare System (C5) Data Security: Avoiding Your Worst Nightmare! [Advanced/Hot Topics Track] With incredibly rapid advances in information technology come the ever present data security nightmares. This session will discuss data protection techniques that should – or must – be considered for research containing identifiable human subjects information. After this session, you will sleep better! Elizabeth White, MBA, MPH; Department of Energy, Program Manager, Protection of Human Research Subjects Carl Cammarata, BS; Chief Information Security Officer, CUNY
4:00 – 5:00
PLENARY SESSION B Ask the Feds You've got questions and we've got answers! After spending the day participating in a wide variety of sessions on an even wider variety of issues, you probably still have some unanswered questions. This session will provide attendees with a final opportunity to pose your burning questions to our Federal agency representatives, in a plenary forum where their answers may go beyond helping just you to also helping your colleagues who may just find themselves with the same or similar questions. Marianna J. Bledsoe, MA; Deputy Associate Director, NIH Sara Goldkind, MD, MA; Senior Bioethicist, FDA Jerry Menikoff, MD, JD; Director, OHRP
5:00 – 5:15 5:15 – 6:30
CLOSING REMARKS RECEPTION Meet the Speakers and Your Colleagues
OHRP is not providing funding for any refreshments or food associated with this event. The co-sponsors of this OHRP Research Community Forum will not be selling any educational materials associated with this event to make a profit.