Inasmuch as prisoners may be under constraints because of their incarceration, which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate in research, Federal regulations require additional protections for prisoners under subpart of C of 45 CFR 46.
Research involving prisoners as participants does not qualify for exempt review.
Prisoner means 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.
Adolescents detained in juvenile detention centers or other court-mandated residential programs are considered prisoners.
Minimal risk (for prisoners) 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.
When an IRB is reviewing a protocol in which a prisoner is a participant, the IRB must make, in addition to other requirements under 45 CFR 46, subpart A, seven additional findings under 45 CFR 46.305(a), as follows:
Research must meet all of the IRB's requirements. In addition:
If a human participant involved in ongoing research becomes a prisoner during the course of a study, and the relevant research proposal was not reviewed and approved by the IRB in accordance with the requirements for research involving prisoners under subpart C of 45 CFR part 46, the investigator must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-participant must be suspended immediately, except under certain circumstances.
While individuals on parole or probation are not considered prisoners by OHRP's definition (above), they are still part of a vulnerable population which may experience increased risks due to the parole or probation assignment. As such, Marywood University's IRB must ensure that adequate protections are in place for these individuals.
While the IRB requires a recruitment permission letter from the appropriate director, such permission must include a statement addressing the fact that the participants are not considered prisoners according to OHRP's federal definition. The permission letter, as well as the consent form, must also state that the decision whether or not to participate will not affect parole or probation.