When reviewing federally supported research involving prisoners an IRB must have?

Updated July 1, 2021

Introduction

The University IRB adheres to the regulatory requirements for research which involves a prisoner as outlined in 45 CFR 46 Subpart C. Federal regulations consider prisoners to be a vulnerable population. For research conducted or supported by DHHS or other federal agencies, under Subpart C (45CFR46.301-306) the regulations require additional safeguards for their protection in human research. (See IRB Policy Manual definitions for definition of "prisoner.") The University opts to apply Subpart C to all research involving prisoners regardless of funding.

Research involving prisoners requires researcher form Population: Prisoners.

Subpart C: Requirements for IRB Review and Approval

Defining "Prisoner"

The regulatory definition of prisoner (i.e., any individual involuntarily confined or detained in a penal institution) is intended to encompass:

• individuals sentenced to a penal 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.

Individuals are considered prisoners if they are in a penal institution, such as a prison or jail, or other institution when their ability to leave the institution is restricted. Prisoners may be convicted felons or may be untried persons who are detained pending judicial action such as arraignment or trial. A child or youth detained in a juvenile detention facility is considered a prisoner.

The University IRB applies the regulatory definition of prisoner as follows:

• Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners.
  NOTE: This does not include individuals who are receiving non-residential court-ordered substance abuse treatment who reside in the community.
• Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners.
  NOTE: This does not include individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to non-penal institutions for treatment because their illness makes them a danger to themselves or others.
• Parolees who are detained in a treatment center as a condition of parole are prisoners.
  NOTE: Persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners.
• Probationers and individuals wearing monitoring devices are generally not considered prisoners.
  NOTE: University and affiliate researchers planning research with such individuals are advised to consult the RIO for guidance. The RIO may consult with the DHHS OHRP.

Composition of the IRB for Review of Prisoner Research (§46.304)

When a fully convened IRB reviews a research project involving prisoners as participants, the IRB will satisfy the requirements for composition of the IRB as described in the Common Rule and these two additional requirements:

• Most IRB members will not be associated with the prisons involved, apart from their membership on the IRB.
• At least one member of the IRB will be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity.

The University IRB uses a prisoner representative for review of all research involving prisoners. This includes initial review, continuing review, full-board modifications, and reportable unexpected or unanticipated problems. The prisoner representative is listed as an alternative IRB member who:

• attends IRB meetings as a voting member when prisoner research is on the agenda for review by a convened IRB, and
• reviews prisoner research that meets the criteria for review by expedited procedures.

Consistent with any changes to the IRB rosters, the IRB will notify the DHHS OHRP of any change in the IRB roster involving the addition, removal, or substitution of the prisoner representative by providing the name and qualifications of the prisoner representative. The IRB will maintain the CV of the prisoner representative.

Requirements for IRB Approval of Prisoner Research (§46.305)

The following requirements apply to new projects, and continuing review and amendments for approved projects whether reviewed at a convened IRB meeting or by expedited procedures. 

The University does not exempt any federally funded prisoner research from IRB review. Note: policy, entitled 201. Exempt Research and Vulnerable Populations offers application of Flex policy for research that is non-federally funded, minimal risk conducting prisoner research involving records, samples, or other materials.

In addition to the criteria for IRB approval under the Common Rule, The IRB will approve the research only if it finds and documents that:

• The research under review represents one of four permissible categories (§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 participants is permissible.
  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 participants is permissible.
  3. Research on conditions particularly affecting prisoners as a class (e.g., vaccine trials, research on hepatitis, which is much more prevalent in prisons than elsewhere, research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) is permissible.
     NOTE: When such research is conducted or supported by the DHHS, the research may not proceed without verification of consultation by the DHHS Secretary with experts in penology, medicine, and ethics; and publication of the Secretary's intent to approve the research in the Federal Register.
  4. Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of participants.
     NOTE: If such studies require the assignment of prisoners to control groups which may not benefit from the research, the study may not proceed without verification of consultation by the DHHS Secretary with experts in penology, medicine, and ethics; and publication of the Secretary's intent to approve the research in the Federal Register.
• Any possible advantages accruing to the prisoner through 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 so great as to impair a participant's ability to weigh the risks of the research against the value of these advantages.
• The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
• Procedures for the selection of prisoner-participants are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. NOTE: Control participants must be selected randomly from the group of available prisoners who meet the characteristics needed for the research project.
• Information about the research and research participation is presented in language which is understandable to the participant population.
• Researchers provide the IRB with adequate assurance that:
  • parole boards will not consider 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.
• If the IRB finds there may be a need, researchers will make adequate provisions for follow-up examination or care of participants after the end of their participation, considering the varying lengths of individual prisoners' sentences. Researchers will inform participants of these provisions.

Appropriate Consent Process

The information will be presented in language that is understandable to prisoners. Each prisoner will be informed in advance that participation in the research will have no effect on his or her parole. Prisoners who are competent have the fundamental right to decide whether to participate in research. In case of a request to waive or alter the consent document, the IRB reviews the research and makes the appropriate findings regarding the waiver or alteration of informed consent requirements. Research involving prisoners may be approved with a waiver or alteration of informed consent. However, even if informed consent is waived or altered, subpart C of 45 CFR part 46 still requires that the subjects be clearly informed in advance that participation in the research will have no effect on their parole if such notification is relevant.

Additional Requirements for Prisoner Research Funded by DHHS (§46.306)

If a study utilizing prisoners as research participants is federally funded, the Director of Regulatory Affairs or designee will send a letter to the Office for Human Research Protections (OHRP) indicating it has approved a study that will include prisoners, the category the study fits into as well as how the study satisfies the six criteria noted under the regulations. A research study is not permitted to commence for DHHS supported research until written approval is received from OHRP on behalf of the DHHS Secretary under the provisions of 45 CFR 46.306(a)(2).

• The IRB will implement or require the researchers implement other duties as required by this section of the Code and as assigned by the DHHS Secretary.
• The University will certify to the DHHS Secretary, in the form and manner required, that the duties of the IRB required under Subpart C have been fulfilled.

If a participant becomes a prisoner after enrollment in a research study the investigator should notify the IRB immediately. Either the prisoner-subject must be withdrawn from study participation; or the IRB must, at the earliest opportunity, re-review the research protocol and consent form in accordance with the listed requirements. The IRB can either (a) approve the involvement of the prisoner-subject in the research or (b) determine that this subject must be withdrawn from the research. Note that if the subject-prisoner is withdrawn from study participation, s/he must be fully informed of the reason for such action.

Can you research on prisoners?

Which example of research with prisoners would be allowable under the regulations?