“On the Legal and Ethical Frontline”
Friday, September 11, 2009
7:00-8:00 am – Registration and Continental Breakfast
8:00 am- 5:15 pm – Forum Program

This forum will focus on specific applications and interpretations of federal regulations protecting human subjects in biomedical and behavioral research. The program will showcase academic and government experts who will address ‘field’ tested concepts and methods that facilitate the balance between the ethical principles of the Belmont Report with the mandates of regulation. With this balance realized, the result is a culture that promotes the approval and conduct of research activities that are maximally compliant, and provide the utmost safety for the subjects who volunteer in our studies. Representatives from the Office for Human Research Protections (OHRP), the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and academia will provide federal regulatory updates and clarification of key policy issues.

The forum features a Keynote Address by Dr. John Marburger, Former Director of the Office of Science and Technology Policy in the Executive Office of the President, Former Director of Brookhaven National Laboratory, and Third President of the State University of New York (SUNY) at Stony Brook.

The forum is a multifaceted education program that provides 15 unique breakout sessions, and 3 Plenary Sessions

• Federal Update: What’s New from the Feds?
• 9/11 and Hurricane Katrina: Challenges and Lessons Learned
• Ask the Feds

The plenary session “9/11 and Hurricane Katrina: Challenges and Lessons Learned” will include Dr. Benjamin Luft, Edmund D. Pellegrino Professor of Medicine, SUNY Stony Brook, Dr. Robyn Gershon, Associate Dean for Research, Columbia University, and Dr. Joseph L. Breault, IRB Chair, Ochsner Health System, New Orleans, who have hands on experience, extensive knowledge, and practical solutions about this topic.

The forum provides information for the novice researcher as well as the experienced IRB chair. Topics during this one day forum will offer a wide variety of learning opportunities for all those interested in the protection of human research subjects, such as:

• Fundamentals of Human Subjects Protections
• Nuts and Bolts of Protocol Review and IRB Minutes
• Unanticipated Problems and Adverse Events: Recognizing and Reporting
• Incidental Findings: What is the Expectation?
• Genetic Information Nondiscrimination Act
• Different Roles for Different Reviewers
• Going, Being, and Staying Electronic
• Informed Consent (It Ain’t Just a Form!)
• Current Trends in IRB Case Law
• Back to the Future: New Ethical Guidelines in Stem Cell Research
• Mock Institutional Review Board Review
• Psychodynamics of an IRB Meeting
• Distinguishing between “Exempt” and “Not Human Subjects” Research
• What’s new in HIPAA?
• Data Security: Avoiding Your Worst Nightmare!

This forum should be of special interest to those persons currently serving, or about to begin serving, as IRB members, as well as to institutional officials, human research administrators, legal counsel, research investigators, research staff, IRB staff, patient advocates, research sponsors, public health officials, privacy officials, compliance officers, laypersons, research sponsors, and contract research professionals. Make plans now to join us in spectacular New York City – and enjoy the restaurants, theaters, plays, Rockefeller Center, and shopping opportunities. You will go home singing “I love NEW YORK”!!