curred before the national commission released its report (NCPHSBBR, 1976). In this report, in fact, the committee adds further protections both by expanding the population of prisoners covered by rigorous ethical rules and by recommending additional ethical safeguards. At the same time, access to research may be critical to improve the health of prisoners and the conditions in which they live, as the committee was told by prisoners during prison site visits. The task was to strike a balance between potential benefits and risks of specific research protocols. The goal is to ensure rigorous responsible research that improves the well-being of prisoners while taking great care to protect their health, well-being, and human rights.

The recommendations discussed later (and presented in Box S-1) will allow research, in limited circumstances, that might benefit prisoners. These limited circumstances cannot be captured by a rigid categorical approach but need to be rooted in an ethically relevant risk-benefit analysis that grapples with the balance between a need for protection and access to potentially beneficial research protocols. During the course of the committee’s deliberations, five themes emerged as organizing categories for the committee’s recommendations: (1) expand the definition of the term prisoner; (2) ensure universal, consistent ethical protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research with prisoners.

Expand the Definition of Prisoner

Subpart C defines a prisoner as any person who is “involuntarily confined or detained in a penal institution” as a result of violating a criminal or civil statute, detained in other facilities as an alternative to criminal prosecution or incarceration, or detained pending arraignment, trial, or sentencing (45 C.F.R § 46.303[c]). The present regulation’s emphasis on custodial detention is too narrow. Of the nearly 7 million persons under adult correctional supervision in 2004, only 2.1 million were in prisons and jails. The rest—4.9 million—were on parole and probation, groups that do not clearly fit under the definition in the current regulations (BJS, 2005c). The committee, therefore, recommends an expansion of the definition of prisoner to afford protections for a larger population of prisoners involved in human subjects research.

Recommendation: Redefine the term prisoner to expand the reach of human subjects protections. The Department of Health and Human Services and other relevant agencies that write, implement, or enforce regulations pertaining to research with prisoners should expand the definition of the term prisoner to include all settings, whether a correc-

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