Under guideline 2, the 50 percent ceiling can be exceeded in exceptional circumstances, such as for conditions that solely or almost exclusively affect prisoners (for example, repetitive sexual assault; see Example 7, Chapter 6, page 167). Due to the inherent risks associated with research involving prisoners, increased oversight is needed when a biomedical study enrolls a high proportion of prisoners or when the potential benefits are expected but not yet established. Thus, the second exception requires more stringent safeguards. In this instance, the protocol would need to be submitted to an expert panel of medical and ethical scholars, whose opinions would be collected by the supervising agency and published on the agency’s Web site. The agency would then need to publicly post an opinion regarding its acceptance or rejection of the expert testimony and the reasons for either. This process is analogous to the process used under Subpart D § 407 (IOM, 204).

The preceding discussion should not be construed as an abandonment of the commission’s “primarily protective framework.” The goal of a risk-benefit framework is to maximize the safety and well-being of prisoners. As the commission emphasized, respect for persons requires that the risk of coercive practices and research abuses be negated (or at least minimized) by the use of protective measures. The commission’s approach emphasized the prevention of deleterious research protocols, but it did not properly account for potential that research can offer positive benefits to prisoner-subjects. A risk-benefit framework is still primarily concerned with preventing harm, but does so in a manner that allows for participation in research when the potential for benefit to prisoners greatly outweighs potential risks.

Risk-benefit analyses of the type illustrated here provide the bases for the kinds of specific safeguards discussed and described in greater detail in Chapter 6.


In this section, the committee lays out its expansion of the principle of justice in two ways: To include: (1) collaborative responsibility for research proposals and setting a research agenda, and (2) enhancing the welfare of the prisoner population.

Collaborative Responsibility

The conceptualization of justice has expanded since the original commission’s work. They primarily thought of justice in terms of the distribution of risks and benefits. Although this is still a legitimate concern, some recent scholarship suggests elevating collaborative responsibility under the rubric of justice.

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