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PRISONERS

Prisoners detained under criminal or civil statue in any prescribed facility may be under constraints that could affect their ability to make truly voluntary and uncoerced decisions whether or not to participate in proposed research.  Therefore, DHHS has instituted additional regulations to provide safeguards for the protection of prisoner subjects of research. The regulations affect not only the CRP review of projects, but also what sorts or research an investigator can undertake using prisoners as subjects.

Research involving prisoners as subjects may include ONLY the following:

1. The study of possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the std presents no ore than minimal risk and no more than inconvenience to the subjects;

2. The study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;

3. Research on conditions particularly affecting prisoners as a class, provided that the study may proceed only after the Secretary of DHHS has consulted with appropriate experts and published notice in the Federal Register of intent to approve the research; and

4. Research on practices, both innovative and accepted, which have the intent and reasonable ;probability of improving the health or well-being of the subject.

Research on conditions that particularly affect prisoners includes, for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults.  Where research intend to improve the health or well-being of prisoners proposes to use control groups that may not benefit from the research, the work may proceed only after the Secretary of DHHS has consulted appropriate experts and published notice in the Federal Register of intent to approve the research. Other than these categories of investigation, regulations permit no research involving the use of prisoners as subjects.

The approval of research involving prisoners as subjects requires an IRB whose membership includes at least one prisoner. Since CRP cannot meet this requirement, all research involving prisoners must be reviewed both by CRP and by an IRB serving the facility or facilities housing the prisoner subjects.  Approval of a project will not be final util CRP receives a copy of the approval document from the facility IRB.

In addition to the criteria of review that CRP ordinarily uses, the regulations prescribe additional review criteria for the use of prisoner subjects.  Advantages accruing to the prisoner through participate in the research must not be great enough to impair the prisoner’s ability to weigh the risks of the research against the value of such advantages.  The advantages in question may include general living conditions, medical care, quality of food, amenities, and opportunity for earnings. Moreover, the risks must compare with those acceptable to non prisoner volunteers.  Selection procedures must be fair to all prisoners and immune to arbitrary intervention by prison authorities and other prisoners.  Control groups must come from a random selection within the qualified subject population.