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Research Involving Vulnerable Populations

Because prisoners may not be free to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, the regulations require additional safeguards for the protection of prisoners in research. These safeguards are found in 45 CFR 46, Subpart C. Subpart C applies to all research that includes any individual who is or becomes a prisoner while participating in a research study. 

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Definitions Specific to Subpart C (46.303):

Prisoner - any individual involuntarily confined or detained in a penal institution encompassing:

  • 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
  • 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."

* This definition is different from the definition of minimal risk found in 46.102

No exemptions found in 46.101(b) apply to research under Subpart C (research involving prisoners).

Roles and Responsibilities of NIH Staff in Reviewing and Funding Research Involving Prisoners

  • The SRG conducts a review of the proposed research. Reviewers may choose to comment on the additional protections for prisoners in their critiques. Unacceptable risks and/or inadequate protections for prisoner subjects must be identified as Unacceptable Human Subjects Protections in the Summary Statement.
  • When appropriate, Program Staff communicates with the PI and provides information and resources describing:
    • The responsibilities of the PI when conducting research involving prisoners
    • The proper process for IRB review and approval
    • The need for documented approval from OHRP prior to the initiation of any research involving prisoners
    • Program Staff communicates with Grants Management Staff after OHRP issues its approval, in writing, of the proposed research.
  • If an award is made prior to documentation of OHRP approval, Grants Management Staff must restrict research involving prisoners on the Notice of Grant Award. Restrictions are lifted by Grants Management Staff in a revised NGA after Program Staff has notified them that OHRP has provided documentation of approval for the proposed research.

Roles and Responsibilities of the Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) is responsible for ensuring the protection of prisoners as research subjects. In fulfilling this obligation, OHRP has three major roles:

  • Approve the institutional certification that the research has been reviewed and approved by a properly constituted IRB (46.305);
  • Determine that the proposed research falls within one of the categories of permissible research (46.306). This may include consultations with appropriate experts and publication of intent to approve the research in the Federal Register; and
  • Provide guidance documents to clarify the requirements of the Federal regulations and the steps that funding agencies and research institutions should take to comply with the regulations
  • Clarification of Subpart C requirements
  • Definition of "prisoner"
  • Information that should be provided by an institution for review and approval by OHRP
  • Three of the questions addressed in this document are:
  1. What to do if research subjects become prisoners during the study:
    • The PI should notify the IRB immediately, and the prisoner should be temporarily withdrawn from the study until all of the requirements of Subpart C have been met

    • OHRP has allowed one important exception to the requirement that the prisoner be temporarily withdrawn from the study:
      In special circumstances in which the PI asserts that it is in the best interest of the subject to remain in the study while incarcerated, the IRB Chairperson may determine that the subject may continue to participate in the research until the requirements of Subpart C are satisfied.
  2. How to meet regulatory requirements for child prisoners:
    • An adolescent detained in a juvenile detention facility IS considered a prisoner. In most cases such as this, the requirements of both Subpart C and Subpart D must be met.
  3. Who to contact for additional information:
    • OHRP Prisoner Research Contact Person at (240) 453-6900 (phone) or (240) 453-6909 (fax)

Roles and Responsibilities of Awardee Institutions in the Protection of Prisoner-Subjects

Under 46.305(c), the awardee institution must certify to OHRP that the IRB has made all of the findings required under 46.305(a).

NIH conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution and to the NIH.

IRB Requirements (46.304 and 46.305)

  • Any time an IRB reviews research that falls under Subpart C, it must submit its findings to the Secretary, via OHRP, for approval (46.305(c) and 46.306(a)(2))
  • IRBs reviewing research subject to Subpart C must be constituted in a particular manner. In addition to the requirements of 46.107,
    • The majority of the IRB members cannot have any association with the prison(s) involved in the research apart from their membership on the IRB
    • At least one member of the IRB must be a prisoner or a prisoner representative (e.g. a prison chaplain). If a project is reviewed by more than one IRB, only one IRB must include a prisoner or prisoner representative.
  • In order to approve research involving prisoners, the IRB must make the following findings:
  1. The proposed research meets the requirements for one of the categories of permitted research;
  2. Any possible advantages or compensation to the prisoner for participation in research, when compared to the general living conditions and opportunities in the prison, are not so great that they impair the prisoner's ability to evaluate the risks and benefits of the research in the limited choice environment of the prison;
  3. The risks involved in the research are commensurate with risks that non-prisoner volunteers would accept;
  4. Procedures for the selection or recruitment of subjects are fair to all prisoners and cannot be arbitrarily influenced by prison authorities or prisoners. Unless the PI provides the IRB with written justification for following 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 that 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. When the IRB deems it necessary, provisions have been made for follow-up examinations or care after for participants after the end of their participation, taking into account the varying sentence lengths, and participants will be informed of this fact


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