Federal regulations require that additional safeguards are put into place for the protection of prisoners involved in research.
A "prisoner" is defined to mean 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.
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.
Permitted Research with Prisoners: Biomedical or behavioral research may involve prisoners as subjects only if the proposed research involves one of the following four categories:
- 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 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 inconvenience to the 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; research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults.
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.
Studies using prisoners as subjects and involving one of the four categories of permitted research areas will be approved only if:
- 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 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 a particular research project.
- The information about the study is presented in language understandable to the subject 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.
- 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.