American Diabetes Association Scott E. Campbell, PhD Vice President, Research Programs Alexandria, VA Association of American Medical Colleges Darrell G. Kirch, MD President & CEO Washington, DC Association of Clinical Research Professionals James Thomasell, CPA 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 Deputy Director for Health Policy 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* Elyse Summers Acting Division Director Division of Education and Development 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 Special Advisor University of Texas Health Science Center Houston, TX Society of Research Administrators International Edward Gabriele Representative Arlington, VA