Scientific Research:

Continued Vigilance Critical to Protecting Human Subjects

T-HEHS-96-102: Published: Mar 12, 1996. Publicly Released: Mar 12, 1996.

Additional Materials:

Contact:

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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). 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.

Sep 3, 2020

Aug 31, 2020

Aug 11, 2020

Jul 30, 2020

Jul 28, 2020

  • science icon, source: National Cancer Institute

    Science & Tech Spotlight:

    Contact Tracing Apps
    GAO-20-666SP: Published: Jul 28, 2020. Publicly Released: Jul 28, 2020.

Jul 7, 2020

Jun 30, 2020

  • science icon, source: National Cancer Institute

    Science & Tech Spotlight:

    E-cigarettes
    GAO-20-610SP: Published: Jun 30, 2020. Publicly Released: Jun 30, 2020.

Jun 4, 2020

  • science icon, source: National Cancer Institute

    Science & Tech Spotlight:

    COVID-19 Modeling
    GAO-20-582SP: Published: Jun 4, 2020. Publicly Released: Jun 4, 2020.

May 28, 2020

  • science icon, source: National Cancer Institute

    Science & Tech Spotlight:

    Quantum Technologies
    GAO-20-527SP: Published: May 28, 2020. Publicly Released: May 28, 2020.

May 26, 2020

Looking for more? Browse all our products here