Unlike members of the other populations described here, any person already enrolled in a research protocol could conceivably become a prisoner during his or her participation. If this occurs, the investigator must notify the OIRB immediately to discuss how to continue the research in compliance with federal and institutional requirements.

Any study that involves one or more prisoners must be reviewed by the convened IRB in compliance with the federal requirements protecting prisoners in research (i.e., 45 CFR 46 Subpart C). The reviewing IRB must include at least one member who is either a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity. Therefore, when the IRB approval of a protocol includes approval for the enrollment of prisoners, the determination letter that is sent to the investigator indicates that a prisoner representative was present during the review.

Investigators who propose enrolling (or retaining) prisoners complete the Special Population Review Form—Prisoners to provide protocol-specific information about the applicable federal and institutional requirements. One such requirement is that the investigator identify the protocol either (a) as fitting into one of the federally allowable categories for research with prisoners or (b) as fitting the requirement for waiver of the category requirement.

A prisoner is defined (45 CFR 46.303(c)) as follows:

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.