Prisoners are another of the three classes that are deemed so vulnerable to exploitation in research that there are special rules protecting them. In the past, prisoners were viewed as a convenient research population. They are housed in a single location, constitute a large and relatively stable population, and live a routine life. Unfortunately, all the things that make a prison and prisoners a convenient research population also make prisoners ripe for exploitation. The concern that Subpart C, and this policy based on Subpart C, attempt to address is whether prisoners have any real choice in participation in research, or whether incarceration prohibits free choice.
The following applies to all research involving prisoners, regardless of funding source. The requirements in this section are consistent with Subpart C of 45 CFR 46, which applies to the Department of Health and Human Services (DHHS)-funded research.
This policy applies to all research conducted under the auspices of SEKESC involving prisoners as subjects. Even though the SEKESC-IRB may approve a research protocol involving prisoners as subjects according to this policy, investigators are still subject to any applicable state or local law. (45 CFR 46.301)
SEKESC-IRB also applies Subpart C to persons who otherwise have limited civil freedoms, such as those under court order or on parole. These populations often require extra considerations for privacy and confidentiality. For instance, additional precautions may be required to ensure nothing incriminating could affect a participant’s legal status.
Because prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and non-coerced decision whether or not to participate as subjects in research, it is the purpose of this policy to provide additional safeguards for the protection of prisoners involved in research activities to which this subpart is applicable (45 CFR 46.302).
- Prisoner – 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 – 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.
Composition of the IRB
In addition to satisfying the general requirements detailed in the IRB section of this manual, when reviewing research involving prisoners, the IRB must also meet the following requirements:
- A majority of the IRB (exclusive of prisoner members) must have no association with the prison(s) involved, apart from their membership on the IRB.
- At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one IRB, only one IRB need satisfy this requirement.
Additional Duties of the IRB
In addition to all other responsibilities prescribed for IRB in the SEKESC-IRB Board and IRB Review Process sections of this manual, the IRB will review research involving prisoners and approve such research only if it finds that:
- The research falls into one of the following permitted categories (45 CFR 46.306): (a) 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 subject; (b) 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 on the subjects; (c) research on conditions particularly affecting prisoners as a class (for example, research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults); (d) research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.
- 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 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 Board 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 subjects 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 subjects of this fact.
Waiver for Epidemiology Research
The Secretary of DHHS has waived the applicability of 45 CFR 46.305(a)(l) and 46.306(a)(2) for certain research conducted or supported by DHHS that involves epidemiologic studies that meet the following criteria:
- In which the sole purposes are: (a) To describe the prevalence or incidence of a disease by identifying all cases, or (b) to study potential risk factor associations for a disease, and
- Where the IRB has approved the research and fulfilled its duties under 45 CFR 46.305(a)(2)-(7) and determined and documented that (a) the research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and (b) prisoners are not a particular focus of the research.
The specific type of epidemiological research subject to the waiver involves no more than minimal risk and no more than inconvenience to the human subject participants. The waiver would allow the conduct of minimal risk research that does not now fall within the categories set out in 45 CFR 46.306(a)(2). The range of studies to which the waiver would apply includes epidemiological research related to chronic diseases, injuries, and environmental health. This type of research uses epidemiologic methods (such as interviews and collection of biologic specimens) that generally entail no more than minimal risk to the subjects. In order for a study to be approved under this waiver, the IRB would. need to ensure that, among other things, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.