AAAS Center for Science, Technology and Congress

AAAS Policy Brief:
Human Research Subject Protections

Issue Summary | AAAS Resources | Links

Reports:

• "Report on University Protections of Human Beings Who Are the Subjects of Research," June 28, 2000, Association of American Universities (pdf)
• "Report on Individual and Institutional Financial Conflict of Interest," October 2001, Association of American Universities (pdf)
• "Ethical and Policy Issues in Research Involving Human Participants," August 2001, National Bioethics Advisory Commission
• "Human Subjects Research:  HHS Takes Steps to Strengthen Protections, but Concerns Remain," May 2001, U.S. General Accounting Office
• "Protecting Subjects, Preserving Trust, Promoting Progress -- Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research," December 2001, Association of American Medical Colleges

Congressional Hearings and Legislation:

• "Protecting Human Subjects in Research:  Are Current Safeguards Adequate?" April 23, 2002, Senate Committee on Health, Education, Labor, and Pensions Hearing
• Human Research Subject Protections Act of 2002 (H.R. 4697)

Organizations:

• Alliance for Human Research Protection
• American Society of Gene Therapy
• Association for the Accreditation of Human Research Protection Programs, Inc.
• Association of American Medical Colleges
• Association of American Universities
• Biotechnology Industry Organization
• Citizens for Responsible Care and Research
• Public Responsibility in Medicine and Research
  • Applied Research Ethics National Association

Other Resources:

• "Senate Panel Reviews Adequacy of Human Research Subjects Protections," April 26, 2002, Association of American Medical Colleges
• HHS Conference on Human Subject Protection and Financial Conflict of Interest, August 15-16, 2000
• "Government Suspends Human Subjects Research," The Gazette Online, Johns Hopkins University July 23, 2001, Vol. 30, No. 40
• "Report of Internal Investigation into the Death of a Volunteer Research Subject," Johns Hopkins University
• The Institute for Human Gene Therapy, University of Pennsylvania; Information on the gene therapy clinical trial in which patient Jesse Gelsinger died
• "Adverse Events Reporting – The Tip of an Iceberg," Adil E. Shamoo.  Accountability in Research 2001; 8: 197-218.
• "How We Uncovered the Hidden Fatality in a Clinical Trial," Deborah Nelson and Rick Weiss.  The Newsletter of the National Association of Science Writers, Spring 2000; 49 (1): 1-3

Updated August 29, 2002