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. The Office of Human Research Protections strongly suggests that expedited review procedures NOT be used for research involving prisoners. Therefore, research with prisoners must be reviewed by the Institutional Review Board as full.
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.
Additional Duties of the IRB Where Prisoners are Involved
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:
- the research under review represents one of the categories of research permissible under 45 CFR 46.306(a)(2);
- any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
- the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
- procedures for the selection of participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control participants must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
- the information is presented in language which is understandable to the participant population;
- adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
- where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
Research must meet all of the IRB's requirements. In addition:
- Consent forms, under voluntary nature, must include a statement that the decision whether or not to participate will not affect parole or probation.
- In the recruitment permission letter, the Warden or Director must include a statement that the decision whether or not to participate will not affect parole or probation.
- The researcher must be aware that the prison or facility may have their own IRB to which the researcher must apply.
If a Participant Becomes a Prisoner During the Course of a Study
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.
Participants on Parole or Probation
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.
Update 2/7/2017: Added OHRP's recommendation about review type