Scientific Research

Experiments ranging from the 40-year Tuskegee study, in which treatment was withheld from black men with syphilis, to the recently disclosed Cold War radiation experiments have revealed breakdowns in the protection of human subjects in government research. Questions have been raised about whether study participants understood what they would be subjected to and had an adequate opportunity to decline to participate. GAO found that better oversight of tens of thousands of research projects funded by the Department of Health and Human Services and drug studies regulated by the Food and Drug Administration appears to have reduced the likelihood of serious abuses of human subjects. The conspicuous activity of local institutional review boards and human subject protection efforts by federal agencies have heightened the research community's awareness of ethical conduct standards, increased compliance with federal regulations, and served as deterrents to abuse of subjects' rights and welfare. However, little data exist that directly measure the effectiveness of human subject protection regulations. At the same time, no practical level of oversight can guarantee that each researcher will protect subjects with complete integrity. Time, resource, and other pressures threaten to reduce the effectiveness of local review board and federal agency oversight. As a result, continued vigilance over human subject research must remain a priority for the research community and the oversight agencies. GAO summarized this report in testimony before Congress; see: Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, by Sarah F. Jaggar, Director of Health Financing and Public Health Issues, before the Senate Committee on Governmental Affairs. GAO/T-HEHS-96-102, Mar. 12 (nine pages).

GAO found that: (1) federal efforts to prevent the abuse of human research subjects include establishing institutional review boards, educating the research community, and requiring written commitments from researchers to comply with standards for the protection of human subjects; (2) although these efforts work to prevent harm to participants in most experimental studies, the effectiveness of those standards in ensuring compliance has not been systematically studied; (3) federal monitoring activities for the protection of human research subjects include on-site inspections and reviews of study documentation, institutional review board operations, and allegations of misconduct; (4) actions to enforce the human research subject protection requirements include research restrictions, researcher disqualification, criminal prosecution, and suspensions from conducting further research; and (5) the oversight procedures are impaired by institutional review boards' heavy workloads and competing demands, limited funds for on-site inspections, the complexity and volume of research under review, and reliance on researchers' self-assurances that they are complying with requirements.