Summary: 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.
