Subject: Special Categories of Research: Prisoners

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review and approve all research involving prisoners with additional ethical and regulatory considerations applicable to prisoners under 45 CFR 46, Subpart C, ^[1] and other applicable Federal, State, and Local laws. ^[2]

1. Composition of Institutional Review Boards where prisoners are involved.
   1. In addition to satisfying the requirements of IRB Policy VI.A, ^[3] the Institutional Review Board, carrying out responsibilities under this part with respect to research covered by this policy, will also meet the following specific requirements:
   2. 1. A majority of the Board (exclusive of prisoner members) will have no association with the prison(s) involved, apart from their membership on the Board.
      2. At least one member of the Board will 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 Board only one Board need satisfy this requirement. ^[4]
2. Additional duties of the IRB where prisoners are involved.
   1. In addition to all other responsibilities in this section, the IRB will review research covered by this policy and approve such research only if it finds that:
   2. 1. The research under review represents one of the categories of research permissible under Section III of this policy.
      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;
      3. The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
      4. 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;
      5. The information is presented in language which is understandable to the subject population;
      6. 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
      7. 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.
   3. The IRB will carry out such other duties as may be assigned by the Secretary of DHHS.
   4. The institution will certify to the Secretary of DHHS, in such form and manner as the Secretary may require, that the duties of the IRB under this section have been fulfilled. ^[5]
3. Permitted research involving prisoners.
   1. Biomedical or behavioral research may involve prisoners as subjects only if:
   2. 1. Mayo Clinic has certified to the Secretary of DHHS that the IRB has approved the research under this policy; and
      2. In the judgment of the Secretary of DHHS the proposed research involves solely the following:
      3. 1. Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk for prisoners and no more than inconvenience to the subjects;
         2. 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;
         3. 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 of DHHS has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his/her intent to approve such research; or
         4. 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 of DHHS 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. ^[6]
         5. Research that has as its sole purpose
         6. 1. To describe the prevalence or incidence of a disease by identifying all cases, or
            2. To study potential risk factor associations for a disease. ^[7], ^[8]
4. Exemptions.
   1. Exemption from review of research involving prisoners is not allowed. ^[9]

^[1] 45 CFR 46 Subpart C

^[2] 21 CFR 56.111 (b)

^[3] IRB Policy VI.A

^[4] 45 CFR 46.304

^[5] 45 CFR 46.305

^[6] 45 CFR 46.306

^[7] 45 CFR 46.101(i)

^[8] Waiver of the Applicability of Certain Provisions of Department of Health and Human Services Regulations for Protection of Human Research Subjects for Department of Health and Human Services Conducted or Supported Epidemiologic Research Involving Prisoners as Subjects, 68 FR 36929

^[9] 45 CFR 46.101(i), Footnote 1