“Prisoner” is defined by DHHS regulations at 45 CFR 46.303(c) as “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.”
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.” DHHS-funded research involving prisoners must be approved by both the 51ԹϺ 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; studies 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.
Any investigator planning research involving prisoners is encouraged to review the current regulations for other requirements before submitting the project IRB for review. If a subject in an ongoing research study becomes a prisoner, the researcher must report this to the IRB immediately so that the IRB can review the protocol again with a prisoner representative present and with an eye to the special conditions of being a prisoner.
The definition of minimal risk for research involving prisoners can be found at 45 CFR 46.303(d). This definition, promulgated in 1978, differs from the definition of minimal risk in subpart A of 45 CFR 46. See 45 CFR 46. 102(i).
For research involving prisoners, the definition of minimal risk requires reference to physical or psychological harm, as opposed to harm or discomfort, to risks normally encountered in the daily lives, or routine medical, dental or psychological examination of healthy persons.
Definition of Minimal Risk in Prisoner Research 45 CFR 46.303(d)
“Minimal risk” 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.
Definition of Minimal Risk in 45 CFR part 46, subpart A, 45 CFR 46.102(i)
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.