Prisoner is defined in 45 CFR 46.303(c) as “any individual involuntarily confined or detained in a penal institution.” The term encompasses individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples include juvenile detention facilities, residential facilities for court-ordered substance abuse treatment, treatment centers for parolees who are detained as a condition of parole, and municipal and county jails.
The review process for research with prisoners takes longer due to additional regulations and protections. In addition to review by the Duke Campus’ Prisoner IRB, research with prisoners may need to be reviewed by a State’s Department of Corrections or a department of juvenile justice. If research is funded by the Department of Health and Human Services, approval from the Secretary of Health and Human Services must be secured.
NOTE: A screening for exemption cannot be used for research on prisoners.
Categories of Permissible Research Involving Prisoners
Research involving prisoners is permissible only in one of the four categories. In the first two categories listed, the study must be no more than minimal risk and no more than inconvenience to the prisoners.
- The study of the possible causes, effects, and processes of incarceration, and of criminal behavior,
- The study of prisons as institutional structures or of prisoners as incarcerated persons.
In the next two categories, approval by the Secretary of Health and Human Services will be sought if the research is either funded by or conducted by the HHS. The Secretary will consult participant experts and will publish in the Federal Register a notice of intent to approve the study.
- Research on conditions particularly affecting prisoners as a class. Examples include vaccine trials; research on hepatitis; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults.
- Research on innovative or accepted practices that have the intent and reasonable probability of improve the health or well-being of prisoners, when the research requires the assignment of prisoners to control groups which may not benefit from the research.
Along with these requirements, research with prisoners must meet all the following requirements:
- Any possible advantages for the prisoner in joining the research are not of a magnitude that could affect his or her ability to weigh the risks of the research against the value of receiving such advantages, such as improvements in living conditions, quality of food, and opportunities for earnings in prison;
- Risks involved in the research are commensurate with risks that would be accepted by non-prisoner participants;
- Procedures for the selection of participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal researcher provides the IRB with written justification for following some other procedures, control participants must be selected randomly from the group of available prisoners that meet the characteristics needed for that particular research proposal;
- 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
- The information in the consent procedures must be presented in a way that is understandable to the prisoners.
If a research participant becomes a prisoner during the course of the research study and the research was not reviewed and approved by the IRB in accordance with the requirements and policies above, the following must occur:
- The researcher must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-participant must be suspended immediately (see exception below).
- Upon receipt of the researcher's report that a previously enrolled research participant has become a prisoner, if the researcher wishes to have the prisoner participant continue to participate in the research, the IRB must promptly re-review the proposal.
- OHRP allows one exception to the requirement that all research with the now-incarcerated prisoner-participant must cease until further review: if the researcher asserts that it is in the best interest of the prisoner to remain in the study while incarcerated, the participant may continue to participate in the research until all requirements for reviewing research with prisoners are satisfied.
If researchers anticipate that some participants of the study population are likely to become incarcerated during the course of the study, the IRB may review the research prospectively as research involving prisoners.