Federation of American Scientists Module 1.0: Introduction
Topic: Control Efforts Subtopic: Control Efforts: Pre-2001

The concept of localized Institutional Review Boards (IRBs) evolved from hospital based scientific peer review committees that operated on an ad hoc basis and were responsible for addressing patient care-related ethical issues that arose. In the 1950's and 1960's, these local review boards became institutionalized and acquired more formal responsibilities, influenced by the National Institutes of Health (NIH) which issued regulations on human research for those receiving federal grants. This process became more widespread after a series of widely reported ethical "crises" between 1958 and 1968, including transplantation of a sheep heart and chimpanzee kidneys into humans, radiation experiments on prisoners, and most notoriously, the Tuskegee Study of Untreated Syphilis in the Negro Male. The impetus built by these revelations led to the National Research Act of 1974, which outlined protections for human subjects, and the subsequent 1978 National Commission Report and Recommendations which recognized IRBs as fundamental to a national system of protections within the scientific research process.

The Asilomar Conference of 1975 was a milestone for the scientific community on the issue of exerting self-governance of biotechnology. The conference was in response to a growing level of concern by the public and government over the scientific, ethical, and legal issues surrounding the safety of manipulating genetic material. The conferees convened to review the potential dangers of recently discovered recombinant DNA techniques to cut and splice together strands of DNA, and how experiments with recombinant DNA should be monitored and regulated. The outcome of the conference was a set of voluntary guidelines that restricted recombinant DNA research to the K12 strain of E. coli, which was believed to be disabled from generations of use in the laboratory and less likely to survive in the wild. The adoption of the guidelines not only enabled recombinant research to resume, it also diminished the fervor at the time for possible government intervention to regulate such research.

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