FDA enforces compliance with its regulations through on-site inspections of IRBs, clinical investigators, and sponsors. To address these concerns about authority and autonomy, HHS established OHRP in the Office of the HHS Secretary, Office of Public Health and Science in June 2000, enhancing the status and visibility of human subjects protection activities. Recent and Planned Protection Efforts Involve Strengthening Oversight Performed by Research Institutions

HHS has taken some actions to improve the review and monitoring of clinical trials by research institutions. HHS has taken several recent actions to inform investigators about human subjects protection policies and practices. Concerns Remain Regarding the Pace and Scope of HHS’ Actions to Protect Human Subjects

Although problems with the oversight of human subjects protection have received increasing attention since the 1990s, it is only recently that HHS has made a concerted effort to address these issues. At the research institution level, HHS’ efforts to support IRBs and enhance their performance appear promising, but the subject of financing IRBs remains largely unexplored.
What GAO Found

At the federal level the Department of Health and Human Services (HHS) is seeking to better protect human subjects in biomedical research by enhancing the visibility of its human subjects protection activities, improving its monitoring of compliance with relevant regulations by institutions and investigators, and strengthening enforcement of those regulations. HHS has also issued new guidance and is collecting information to improve oversight and monitoring at the institutional level. HHS activities directed at the investigator level consist largely of educational efforts to heighten investigators' awareness of and compliance with ethical policies and practices in conducting research. Overall, HHS' actions appear promising, but GAO has some concerns about the pace and scope of HHS' efforts to ensure the safety and protection of participants in clinical trials.