Rationale This approach starts with the presumption that biomedical research should be severely restricted and is allowable only in limited circumstances. Biomedical research involving prisoners as subjects is only permitted when the potential benefit to the prisoner-participants outweighs the risk to which the subjects are exposed. Under this framework, studies that offer no benefit to potential subjects would be precluded (e.g., testing of cosmetic products).The goal of the risk-benefit analysis is to prevent prisoners from being burdened by more than their fair share of risk, while allowing access to research that has potential benefits. This is especially relevant in circumstances in which effective treatments have not been developed to address a life-threatening or life-altering condition.

The guidelines articulated above illustrate how these principles would be applied in practice. The first allowable situation involves a treatment that appears to be safe and effective based on small-scale trials. The potential benefit of an experimental intervention must be established before engaging in a risk-benefit analysis. As such, phase 1 and phase 2 studies, as defined by the FDA to determine safety and toxicity levels, would not be allowable. Since these trials are principally designed to study a drug’s safety and efficacy, potential benefits are not yet clear. In these cases, risks to the prisoner might well overshadow the uncertainty of unproven benefits. Only phase 3 studies would be allowed, since basic efficacy would already have been demonstrated.

This approach reflects the growing view that research presents not only burdens but can also present benefits that should be fairly distributed to prisoners. However, the distribution of burdens must still be considered— thus the requirement that the ratio of prisoner to nonprisoner-subjects does not exceed 50 percent. Biomedical research should involve prisoners only to provide a benefit to individual prisoner participants, not because they are a convenient source of subjects. This 50 percent limit represents the committee’s strongly held view that prisoners should not compose the majority of a biomedical study’s enrollment when nonincarcerated subjects are available. The just distribution of risks and the potential for abuse require that researchers not be permitted to unnecessarily rely on prisoners as subjects.

It should be noted that the 50 percent limit is a ceiling that should only be approached when extensive use of prisoners as subjects can be justified by potential benefit. If a disease is less common in prisons, ethical guidelines would suggest a lower proportion of prisoner-subjects. Inmates should only be part of the subject pool to the extent that the disease affects the prisoner population. A study that extensively enrolls prisoners when nonprisoner-subjects are available should be examined closely to ensure that benefit to the prisoner population, and not convenience, is the true justification.

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