meet the conditions of the Common Rule (outlined previously) but also must have among its membership a prisoner or prisoner representative.

Further, the IRB must find that the research proposal meets both the Common Rule requirements as well as additional requirements specific to the prisoner setting. These additional requirements are as follows:

  • the research is within one of the four permissible categories of research for prisoners;

  • benefits that accrue as a result of the prisoner’s participation should not be so great in comparison to what is available in the correctional environment that the ability to provide informed consent is impaired;

  • risks are commensurate with those that would be accepted by nonprisoner volunteers;

  • selection procedures are fair and not subject to arbitrary intervention by either prison authorities or other prisoners;

  • the consent form is written in language that is easily understood by the prisoner;

  • the person’s participation in the research project will not be a consideration in parole or probation decisions; and

  • adequate provisions are made for follow-up care, should it be needed, once the research study ends.24

OHRP Certification

Once the IRB has found that the research meets the criteria described previously and approves the study, OHRP certification must be obtained for research in Categories i through iv and for epidemiological waivers as well (Table 3-1). If the OHRP certifies that the category is appropriate and that the criteria have been met, the research is approved. This certification step adds an average of 3–4 weeks to the review process.

Report of the SACHRP Subcommittee

In 2003, the SACHRP asked its Subpart C Subcommittee to review the text and application of Subpart C, primarily to determine whether the current DHHS interpretation and application of Subpart C’s requirements should be modified. Among the topics the subcommittee addressed were:

  • the definition of the term prisoner under Subpart C;


45 C.F.R. § 46.305(a).

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