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Human Participants in Scientific Research

In 1998, the Office of Inspector General (OIG), an office of the Department of Health and Human Services (HHS), issued a seminal set of reports on the federal system for institutional review boards (IRBs) and their effectiveness in protecting human research subjects.

Generally referred to as “Institutional Review Boards: A Time for Reform," the reports concluded that “the long-established system for protecting human research subjects has vulnerabilities that threaten its effectiveness,” and that IRBs review too much, too quickly, with too little expertise.

As most of the clinical research trials in the United States are conducted by either the pharmaceutical industries under the regulation of the Food and Drug Administration (FDA), or the Universities and Academic Medical Centers under the sponsorship of the National Institutes of Health (NIH), the report findings led the OIG to present numerous recommendations to the NIH, its Office for Protection from Research Risks (OPRR), and FDA – all of which are overseen by HHS.

A follow-up document in 2000 entitled "Protecting Human Research Subjects: Status of Recommendations" reported that while OPRR and FDA had significantly stepped up their on-site presence at research institutions since the initial reports, overall, few of the OIG’s recommended reforms had been enacted. Following is a list of the broad areas covered by the recommendations:

  • IRB flexibility and accountability
  • oversight and ongoing protections for subjects once the research has begun
  • education for research investigators and IRB members
  • mediating potential IRB conflicts of interest
  • moderating IRB workload pressures
  • reengineering the Federal oversight process.

Additional resources

Secretary's Advisory Committee on Genetics, Health, and Society (Report on Large Population Cohort Studies)

Office for Human Research Protections (US Dept of Health & Human Services)

National Institutes of Health Clinical Trial Registry