Prisoners as Subjects
The use of prisoners as subjects is severely limited since such subjects' ability to voluntarily consent is limited by the "coercive nature of the environment."
Prisoner means any person involuntarily confined or detained in a penal institution. The term also includes persons detained in other facilities (e.g., group homes, work release centers) by statute or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as persons detained pending arraignment, trial, or sentencing.
DHHS funded research involving prisoners must be approved by both the local IRB and the funding department/agency head. The research must be limited to 'minimal risk' studies of criminal behavior and incarceration, penal institutions and prisoners as a social class; research on conditions affecting prisoners--including social and psychological problems--only if approved by the department/agency head after expert consultation; and therapeutic research, with control groups also requiring the department/agency head's approval. Unfunded and non-HHS supported research does not require approval by the federal agency. All research involving prisoners will require full committee review.
'Minimal Risk' in prisoner research is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Any researcher planning research involving prisoners is encouraged to review the current regulations for other requirements before submitting the Summary Safeguard Statement for review. These regulations are in Subpart C of 45 CFR 46, and are available from on the web at the OHRP site.
If a subject in an ongoing research study becomes a prisoner, the researcher must report this to the IRB immediately so the IRB can review the protocol again with a prisoner representative present and an eye to the special conditions of being a prisoner.