Institutional Review Board Manual
Special Population Requirements
Prisoners: Special Provisions and Requirements
In as much as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and un-coerced decision whether or not to participate as subjects in research, additional safeguards are imposed for their protection.
"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.
Exempt: There are no categories of research involving prisoners as subjects that are exempt.
All categories of research eligible for Expedited Review approval are applicable.
Permitted Research Involving Prisoners:
Biomedical or behavioral research may involve prisoners as subjects only if the proposed research involves solely the following:
- Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
- Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to subjects;
- Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults); or
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well‑being of the subject.
Research that fall into one of the above categories may be approved only if the Institutional Review Board (IRB) finds that all of the following are applicable:
- 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 subjects 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 subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
- 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.