Prisoners are considered a vulnerable population in the regulations, and additional protections required for research involving prisoners are described under Subpart C. If the proposed research involves prisoners or individuals who may become prisoners, information should be included in the application in addition to that required by the PHS 398 Instructions. That information should include:

Risks to Subjects:

The "Human Subjects Involvement and Characteristics" should include a justification for the use of prisoners in the research that includes an explanation of why the research is particularly applicable to the population.

The categories of permitted research are described under 46.306(a)(2) and an additional category of permitted epidemiological research is described in the Federal Register. The applicant should be aware of which category applies to the proposed research, and address the issues raised by this category. The categories of permitted research are summarized under "Regulatory Requirements".

Adequacy of Protection Against Risks

The "Recruitment and Informed Consent" section should include a description of the informed consent process as well as what additional steps will be taken to minimize the opportunity for coercion or undue influence.

Potential Benefits of the Proposed Research to Subjects and Others

This section should include information about how the proposed research is particularly applicable to prisoners as required by all four categories of permitted research under 46.306(a)(2).

NOTE: No exemptions found in 46.101(b) apply to research under Subpart C (research involving prisoners).