Both tiers are responsible for ensuring that individual researchers and their research institutions comply with federal laws and regulations for protecting human subjects. At the federal level are the NIH’s OPRR and the FDA. At the local level, institutional review boards (IRB)—that is, review panels that are usually associated with a particular university or other research institution—are responsible for implementing federal human subject protection requirements for research conducted at or supported by their institutions. The Common Rule requires research institutions receiving federal support and federal agencies conducting research to establish IRBs to review research proposals for risk of harm to human subjects and to perform other duties to protect human research subjects. Therefore, FDA’s and OPRR’s monitoring and enforcement efforts include review of results of IRB operations, clinical trials, and allegations of researcher misconduct. To this end, FDA conducts on-site inspections of individual drug studies. Fda Can Impose Penalties for Serious Violations

FDA has used four types of actions to enforce its regulations: (1) obtaining a promise from a researcher to abide by FDA requirements for conducting drug research, (2) invoking a range of restrictions on a researcher’s use of investigational drugs, (3) disqualifying a researcher from the use of investigational drugs, and (4) criminally prosecuting a researcher. First, pressure from heavy workloads and competing priorities can weaken IRB oversight. Given the many pressures that can weaken the effectiveness of the protection system, continued vigilance is critical to ensuring that subjects are protected from harm.
Why GAO Did This Study

GAO discussed the Department of Health and Human Services' (HHS) efforts to protect human research subjects, focusing on the prevention, monitoring, and enforcement activities of the National Institutes of Health's Office for Protection from Research Risks (OPRR) and the Food and Drug Administration (FDA).

What GAO Found

GAO noted that: (1) to ensure the protection of human research subjects, the agencies require researchers to make assurance agreements that they will comply with federal human subject protection requirements and uphold ethical standards; (2) the agencies also use institutional review boards (IRB), local review panels that review research plans to ensure that human subjects are protected; (3) both FDA and OPRR conduct on-site visits and inspections, clinical trials, investigations of allegations of researcher misconduct, and IRB reviews to identify violations of protection requirements; (4) to enforce the regulations, FDA and OPRR have requested modifications to research plans, restricted researchers' use of drugs, disqualified, suspended, or criminally prosecuted researchers; and (5) oversight effectiveness is hampered by heavy IRB workloads and competing priorities, organizational conflicts-of-interest, limited site visits and inspections, and pressures resulting from differing perceptions on the need for research versus treatment.