American Diabetes Association Scott E. Campbell, PhD Vice President, Research Programs Alexandria, VA Association of American Medical Colleges Jordan J. Cohen, MD President Washington, DC Association of Clinical Research Professionals Thomas Adams, CAE Chief Executive Officer Virginia, VA Biotechnology Industry Organization James Greenwood President Federal Govt Relations/ Bioethics Council Washington, DC Consortium of Independent IRBs John Isidor, JD CEO, Schulman Associates IRB Cincinnati, OH Consortium of Social Science Associations Angela L. Sharpe, MG Associate Director for Government Affairs Washington, DC DIA Foundation, Inc Irwin G. Martin, PhD Acting President Horsham, PA Federation of American Societies for Experimental Biology Guy C. Fogleman Executive Director Bethesda, MD * Ex-officio member

Health Improvement Institute* Peter G. Goldschmidt, MD President Bethesda, MD Medical Device Manufacturers Association Mark B.Leahey Executive Director Washington, DC National Association of IRB Managers, Inc. Thomas Ball M.Div., CIM Executive Director Atlanta, GA National Health Council Scott E. Campbell, PhD Vice President, Research Programs American Diabetes Association Alexandria, VA (representing both organizations) Office for Human Research Protections* Shirley Hicks Director, Division of Education Rockville, MD Pharmaceutical Research and Manufacturers of America (PhRMA) Billy Tauzin President & CEO Washington, DC Public Responsibility in Medicine & Research (PRIM&R) Paula Knudson, CIP Executive Coordinator University of Texas Health Science Center Houston, TX Society of Research Administrators International Edward Gabriele Representative Arlington, VA