PHIL 7570
CASE STUDIES IN RESEARCH ETHICS

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Researchers who deal with actual human subjects, tissues from humans, or information from identifiable people are all using human participants in their research. Because of serious concerns over possible abuse and the risks faced by participants the Federal government and research universities have set standards for the use of human research subjects. This session investigates the origin of these standards, informed consent practices, privacy concerns, and Institutional Review Board (IRB) procedures for clearing research with human subjects.

Required Reading:

• ORI Text: Chapter 3 (pp.31-49); free download at ORI.

• Article: Guinea Pigs in the ER: Researchers debate the ethics and logistics of performing emergency research without patients' consent. In the Chronicle of Higher Education, June 16, 2006.

• Case Studies Human Participants

Other Articles and Links:

• University of Utah Institutional Review Board (IRB)

• Report Assails FDA Oversight of Clinical Trials. New York Times, September 28, 2007.

• Gene Therapy: Questions remain on Cause of death in arthritis trial. (pdf) By Jocelyn Kaiser. Science , September 21, 2007.

• Science BC (Before Consent). On DNA research and human subjects in The Chronicle of Higher Education, March 2006. See also Blood Feud.

• Panel Suggests Using Inmates in Drug Trials. By Ian Urbina. The New York Times, August 13, 2006.

• Ethicists and Biologists Ponder the Price of Eggs. Issues concerning egg donors for stem cell research. Nature, August 10, 2006. 606-608.

• Crossing the Line? Medical research on brain-dead people raises ethical questions. The Chronicle of Higher Education, August 1, 2003.

• Rethinking Protections for Human Subjects. Point of view by C. K. Gunsalus. The Chronicle of Higher Education, November 15, 2002. See also responses to Gunsalus's article in January 3, 2003 Letters to the Editor: Protecting Subjects of Research .

• At Your Own Risk: Human Guinea Pigs. Examining risks associated with clinical trials. Time, April 22, 2002.

• Ethical and Legal Aspects of Human Subjects Research on the Internet. A report of a workshop by the AAAS, June 10-11, 1999, Washington. DC.

• IRB: Ethics and Human Research. A journal for the Hastings Center.

• Prof. Benham's Power Point on Human Participants.