Prisoners
Prisoners are considered vulnerable because they are in a restrictive, institutional environment that affords little opportunity for making choices, earning money, communicating with outsiders, or obtaining medical care. The National Commission for the Protection of Human Subjects found that prisoners often volunteer for medical research as a means of access to a competent medical examination, because health care may be inadequate in some prisons.
Because their autonomy is limited, prisoners may participate only in certain categories of research, and special precautions are needed to assure that their consent to participate in the research is both knowing and voluntary (45 CFR 46.302).
Categories of Research in Which Prisoners May Participate
Prisoners may participate in the following permissible categories of research:
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Studies of the possible causes, effects, and process of incarceration and criminal behavior, if those studies present no more than minimal risk or inconvenience to the subjects;
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Studies of prisons as institutions, or of prisoners as incarcerated persons, if those studies present no more than minimal risk or inconvenience to the subjects;
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Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
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Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research.