Submitting Protocols with Special Populations/Concerns

Special Population: Prisoners

 Click on the topic below for more information about:

• Why are prisoners a "special population?"
• Scope of the definition of "prisoner."
• Special protections for prisoners
• Expedited review of studies involving prisoners

• One of the three "subparts" of the federal code that focus on particular populations of subjects that may be especially vulnerable as research participants concern prisoners (Subpart C, 45 CFR 46.301-306). In the past, prisoners were sometimes seen as a convenient population for conducting all kinds of research where their ability to refuse to participate was compromised. The regulations are intended to afford these individuals "additional DHHS protections" because of this potential and historical vulnerability.

• 46.303(c) defines "prisoner"  as "any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing."  The "residential" nature of the detention is critical; for example, someone ordered to a residential substance-abuse treatment program as an alternative to prison would be considered a prisoner, but those ordered to a similar treatment program but residing in the community would not be considered prisoners. Similarly, probationers are not considered prisoners, even if they are required to wear monitoring devices (although OHRP recognizes there may be special circumstances in that case that must be considered). Residents of a psychiatric facility who were ordered there as an alternative to imprisonment would be prisoners, but those committed involuntarily through civil action because of the risk they pose to themselves or others, would not be prisoners.

• Research involving prisoners as subjects is constrained in several ways:
• The IRB review process must include a prisoner or prisoner representative. (46.304(b)). The IRB02 has two such members who can act in this role.
• Special attention is paid to the compensation, or any "advantages" being offered for participation, to avoid potentially coercive incentives, such as access to special facilities, medical care, special consideration for parole, or earnings (46.305)(a)(2).
• The selection of prisoners should be "fair to all prisoners" and, unless otherwise approved, be done on a random basis from among potential participants. Selection and special privileges have been issues, for example, in recent "faith-based" rehabilitation programs.
• Approvable research topics is restricted to those that directly concern prisoners; these are specified as  (a) the causes, effects, and processes of incarceration, (b) prisoners as incarcerated persons, or prisons "as institutional structures;" (c) those that concern "conditions particularly affecting prisoners," such as drug addiction or sexual assaults; or (d)  those concerning practices that may improve the health or well-being of the prisoners.  [46.306]. The first two of these catergories must be minimal risk to be approved.
• The exemptions that otherwise could be applied to protocols, thus waiving the review process, do not apply to studies involving prisoners (see 46.101(i), footnote 1).

• Research with prisoners as subjects does not necessarily have to be reviewed by the convened Board, but can be given expedited review. However, given the additional protections and constraints on such research, it is much more likely that the full Board will be asked to consider the protocol.

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