This guidance document provides information to assist researchers planning to conduct research with individuals who are incarcerated and/or individuals on parole or probation.  This document also provides instruction on what to do if a participant becomes incarcerated during the course of a study. 

A prisoner is 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 (§46.303(c)).

The federal regulations (45 CFR 46 Subpart C) require additional protections for incarcerated individuals participating as research subjects.  Additional protections are extended to prisoners because these individuals could be under constraints which could affect their ability to make a truly voluntary decision to participate in research.

IRB Process for Research Involving Prisoners

If your target population involves individuals who are incarcerated, follow these steps:

  1. If the correctional facility is under the purview of the Oregon Department of Corrections (DOC), complete the DOC application and consult with them regarding feasibility before submitting an application to the OSU IRB. Please see the DOC website for additional information.
  2. Submit an initial application to the OSU IRB for Full Board review.
  3. Once the DOC has approved your application, forward a copy to the OSU IRB.

Permitted Research Involving Prisoners

An IRB may approve research involving prisoners provided that the following requirements are satisfied (§46.305(a)):

  1. For DHHS-supported research[1], the research under review must fall within one of the following four categories of research permitted under §46.306(a)(2)
    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 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 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 
    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 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.
  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 Board 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 Board 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.

Incarceration of an Enrolled Subject

If a participant becomes incarcerated during the course of a study, it is the responsibility of the PI to notify the IRB.  The incarceration of a research subject should be promptly reported to the IRB as an unanticipated problem.  The PI should work with the IRB to determine if the participant must be withdrawn from the research or if the study will be re-reviewed by the full Board to ensure that the research is in compliance with the regulations.  All research activities with the recently incarcerated individual should cease unless stopping an intervention would negatively impact the health or welfare of the participant. 

Individuals on Probation or Parole

While the federal regulations do not have specific provisions for individuals on probation or parole, OSU’s IRB has determined that these individuals are part of a vulnerable population and additional considerations should be taken when deciding to include these individuals in research.  When submitting a protocol that includes individuals on probation or parole the following documentation should be included with your submission:

• A letter of support from the subject’s probation or parole officer

• A statement in the informed consent document clearly indicating that their decision to participate in the research will have no impact on the individual’s probation or parole. 

Expedited Review

Research involving individuals who are incarcerated may be reviewed by an expedited procedure under the following three circumstances:

  1. Minor changes in previously approved research during the period (of one year of less) for which approval is authorized
  2. Continuing review of research previously approved by the convened IRB as follows:
    1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
    2. where no subjects have been enrolled and no additional risks have been identified; or
    3. where the remaining research activities are limited to data analysis.
    4. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

OHRP Prisoner Research FAQs

Additional IRB Responsibilities When Reviewing Research Involving Prisoners 

• Board Composition: When the IRB reviews research involving prisoners the composition of the Board must have at least one member that is a prisoner, or a prisoner representative with appropriate background or experience to serve in that capacity and a majority of the Board (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the Board.

• Certification Letter to OHRP:  When the IRB approves research involving prisoners that is DHHS-supported the IRB must submit a letter to the Office of Human Research Protections certifying that the research was approved in accordance with Subpart C and provide information about the research including a copy of the documents approved by the IRB, a copy of the HHS application for funding and documentation of specific findings under Subpart C. 

 

 

[1] References to the Secretary of Health and Human Services and the Certification Letter to OHRP do not apply to studies without DHHS funding.  All other regulations apply regardless of funding source.