• studies that involve exposing subjects to potentially noxious biological or chemical agents merely for the purpose of determining and/or evaluating human reactions to such agents; and

  • biomedical studies that would enroll more prisoners than nonprisoners, unless a federal-level review authorizes the study.

Once the IRB determines that a study involving prisoners offers more potential benefits than risks and does not fall within one of the categories of impermissible research noted above, it must determine the appropriate safeguards and monitoring. The types and levels of safeguards and monitoring required depend on the nature of the correctional setting, the extent of restrictions imposed on prisoners in that setting, and the degree to which the proposed research poses risk to the health or well-being of the prisoner-subjects.

Box 6-1 presents the kinds of special design and implementation safeguards and special monitoring safeguards that an IRB might mandate for particular research protocols. In the examples that follow, research involving low risk and conducted in less-restrictive settings may be approvable without the IRB imposing any special safeguards; however, additional special safeguards from Box 6-1 may be necessary for prisoner research that involves greater risk and is planned for more restrictive settings. Stronger safeguards would also be needed in those extremely limited circumstances when it would be ethically permissible to utilize a greater proportion of prisoners than nonprisoners.

The safeguards in Box 6-1 are designed to be responsive to specific ethical (and in some instances, practical) considerations in research with prisoners. The obvious general principle is that as the level of research risk increases and as greater restrictions on liberty appear in a particular correctional setting, additional safeguards should be used. With respect to design safeguards, D1 (federal certificates of confidentiality) is responsive to the concern that correctional settings may pose greater challenges to privacy and confidentiality. D2 (50 percent ceiling) is designed to prevent investigators from capitalizing on prisoners as a captive population and to ensure that prisoners do not bear an undue share of the burdens of research in higher risk studies. D3 (prohibiting incentives for recruitment quotas), D4 (availability of control-arm standard-of-care medications and treatments to nonresearch participants), and D6 (adequate prison health services) are viewed as protections against potentially coercive conditions. D5 (openness of the research setting) is responsive to the concern that, compared with nonprisoner research subjects, prisoners may generally be at greater risk of experiencing harmful effects of research because of limited access to researchers. D7 (30-day review presentation to IRB) provides an extra safeguard to evaluate high-risk studies once they have begun.



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