The NIH System of Oversight of Human Gene Transfer Research: Optimizing Science, Safety and Ethics
	Annual Meeting of the American Society for Gene Therapy Seattle, Washington May 30, 2007
	Segment I – The Fundamentals of Oversight: NIH and Local Review
	Introduction to the NIH Office of Biotechnology Activities and the Resources OBA Offers Investigators Allan Shipp Director of Outreach NIH Office of Biotechnology Activities (OBA)
	Overview of the Policy and Biosafety Framework for Human Gene Transfer Research: The NIH Guidelines for Research Involving Recombinant DNA Molecules Kathryn Harris, Ph.D., RBP Senior Outreach and Education Specialist (Contractor) NIH OBA
	Institutional Biosafety Committees (IBCs): The Linchpin of Local Oversight Allan Shipp Director of Outreach NIH OBA
	The “What, When and How” of Submitting Human Gene Transfer Protocols to the NIH OBA for Review by the Recombinant DNA Advisory Committee (RAC) Jacqueline Corrigan-Curay, M.D., J.D. Acting Executive Secretary, RAC NIH OBA
	Safety and Annual Reporting; What to Report and How to Get the Most out of GeMCRIS, NIH OBA’s Electronic Safety Reporting System Jacqueline Corrigan-Curay, M.D., J.D. Acting Executive Secretary, RAC NIH OBA
	Segment II – Views from the Field
	Biosafety Review of Human Gene Transfer: From Preclinical Studies to Human Trials David J. Weber, M.D., M.P.H. Professor of Medicine, Pediatrics, and Epidemiology Division of Infectious Diseases Schools of Medicine and Public Health University of North Carolina , Chapel Hill
	An Investigator’s Perspective: How to Prepare for RAC Review John Zaia, M.D. Professor and Chair, Department of Virology City of Hope
	Informed Consent in Human Gene Transfer Trials Nancy King, J.D. Professor, Department of Social Sciences and Health Policy Director, Program in Bioethics, Health, and Society Wake Forest University School of Medicine