Federal regulations require that IRBs give special consideration to protecting the welfare of vulnerable subjects. Title 45 CFR Part 46, Subpart C provides for "Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects."
IRB Member's Role
When reviewing protocols that propose to enroll prisoners, IRB members must pay particular attention to the additional regulatory requirements outlined in Subpart C. When the IRB reviews protocols proposing to enroll prisoners, the prisoner advocate must be present at the IRB meeting at which the protocol is discussed. The prisoner advocate serves as a voting member of the IRB when such protocols are reviewed.
In order to approve the enrollment of prisoners, each IRB member must assess a protocol to determine whether it meets the following conditions specified in Subpart C. Protocols that do not meet the following conditions cannot enroll prisoners.
- The research under review represents one of the categories of research permissible under 46.306(a)(2) (See below for descriptions of these categories)
- 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;
- The information is presented in language which is 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; 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.
In addition to determining whether a protocol meets the above conditions, IRB members also must assess the proposed project to determine whether it fits into one of the categories described below. Enrollment of prisoners cannot be approved if the proposed project does not fit into one of the allowable 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 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 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; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; 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. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research.
The Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
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 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.