Written commitments, which bind research institutions to comply with human subject protection requirements, are an important element of the protection system. By requiring individual researchers and IRBs to uphold their institution’s commitments, the system works to prevent harm to participants in most experimental studies. However, the effectiveness of the HHS human subject protection regulations in ensuring compliance by institutions and individual researchers has not been systematically studied. OPRR, the federal office within NIH that approves assurances for research funded by HHS, requires assurances to (1) include a statement of ethical conduct principles, (2) stipulate that a review board has been designated to approve and periodically review the institution’s studies, and (3) specify the review board’s membership, responsibilities, and process for reviewing and approving proposals. These institutions receive most of HHS’ funding for research with human subjects. Federal Entities’ Education of Research Community Is Another Preventive Measure

Both OPRR and FDA educate the research community on issues related to protecting human research subjects. Federal monitoring efforts for human subject protection violations include reviews of study documentation, IRB operations, and allegations of misconduct. The monitoring includes reviews of progress reports and on-site inspections. IRBs face the pressure of heavy workloads and competing professional demands. Moreover, the complexity and volume of research under review and the difficulty of ensuring that individuals truly understand the risks they may experience as research subjects can weaken the effectiveness of human subject protections.
Why GAO Did This Study

Pursuant to a congressional request, GAO reviewed the federal oversight systems for protecting human subjects in federally sponsored scientific experiments, focusing on whether the oversight procedures: (1) have reduced the likelihood of abuses of human subjects; and (2) have weaknesses that could limit their effectiveness.

What GAO Found

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.