NCJ Number
90040
Journal
Southern California Law Review Volume: 56 Issue: 4 Dated: (May 1983) Pages: 969-1000
Date Published
1983
Length
32 pages
Annotation
Prisoners should be allowed to participate in experimental research because they are capable of voluntary, informed consent.
Abstract
In May 1980, the Food and Drug Administration (FDA) proposed a ban on nontherapeutic, experimental drug research on prisoners. The FDA professed to be implementing recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Two months later, four inmates at the State Prison of Southern Michigan at Jackson filed a lawsuit challenging the FDA rule. A year after the suit was filed, the FDA stayed its rule and announced plans to repropose the regulations. The reproposal, issued on Dec. 18, 1981, attempts to answer the Jackson prisoners' challenge by avoiding the paternalism of the earlier proposal and, instead, recognizing the notion that prisoners might freely decide whether to participate in experimental research. Although the FDA reproposed only the most practicable of the Commission's recommendations, the reproposal will impose an effective moratorium on nontherapeutic, experimental research in prisons. The FDA should disregard those Commission provisions that in effect prohibit nontherapeutic research in prisons. Instead, the FDA should rely on provisions that ensure safety, fairness, and voluntariness. Moreover, the FDA should require additional safeguards for medium or high-risk experiments. A total of 203 notes are included.