III.10

Research Involving Prisoners

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PURPOSE

1. This policy and procedure describes the review process for research involving prisoners.

SCOPE

2. This policy and procedure is applicable to investigators, CPHS Members and ORSC Staff.

DEFINITIONS

3. Definitions:

3.1. Prisoner: Prisoner means any individual involuntarily confined or detained in a penal institution, including individuals sentenced to such an institution under a criminal or civil statue, 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.

3.2. Minimal Risk: Minimal risk for a prisoner means that 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.

POLICY

4. It is the policy of UTHealth that prisoners are a vulnerable population and require additional protections to be in place when such persons are included in research. Research reviewed and approved by CPHS shall not involve prisoners as subjects unless inclusion of prisoners has been approved according to this policy.

5. If the subject population has an increased potential to become prisoners and the Principal Investigator will be interacting, intervening or collecting identifiable private information during the possible incarceration, CPHS may review the research under this policy.

6. CPHS Membership: For review and approval of research involving prisoners, CPHS membership should, in addition to the standard membership described in policy and procedure CPHS Membership, meet the following criteria:

6.1. A majority of the CPHS shall have no association with the prison(s) involved, apart from their membership on the CPHS.

6.2. At least one member of the CPHS must be a prisoner, or a prisoner representative with appropriate background and experience to serve as an advocate, except that where a particular research project is reviewed by more than one IRB, only one IRB need satisfy this requirement.

6.3. At the convened CPHS meeting reviewing research involving prisoners (including initial review, continuing review, review of protocol modifications, and review of unanticipated problems involving risks to participants or others), the prisoner or prisoner representative must be present as a voting member.

7. Permitted Research Involving Prisoners: The CPHS may approve research only if it finds that the research falls under one of the following categories:

1. A 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; or,
2. A 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; or,
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) ;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 participant.
5. Epidemiologic studies whose sole purposes are either (i) to describe the prevalence or incidence of a disease by identifying all cases or (ii) to study potential risk factor associations for a disease.

PROCEDURE

7.2. Submission: In addition to the submission requirements for initial review described in policy and procedure, Initial Review, the PI must submit a completed form Research Involving Prisoners and documentation of approval from the detention or correctional facility involved to CPHS.

7.3. Assigning Reviewers: ORSC Staff will schedule initial review for all research involving prisoners for review at a Full Board meeting. ORSC Staff will ensure that the subcommittee that reviews the research has at least one prisoner advocate.

8. Review Process: In addition to the criteria for approval outlined in policy and procedure Initial Review, CPHS has additional responsibilities when reviewing research involving prisoners. CPHS must determine that:

1. The research represents one of the categories of research permissible under Item 7 above.
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 non-prisoner volunteers.
4. 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 Investigator provides to CPHS justification in writing for following some other procedures, control participants 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 participant 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.
7. Where the CPHS 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.

8.2. For research under OHRP oversight, CPHS shall inform the PI that no prisoners may be enrolled into the study until the CPHS receives confirmation from OHRP.

9. Documentation: CPHS shall document the category under with the research is permissible and how each of the above criteria for additional protection are met. This shall include protocol-specific information justifying each CPHS finding.

10. Special Circumstances

10.1. Incarceration of Subject in Research Not Approved Under this Policy: Should a subject become incarcerated when enrolled in research study that was not originally reviewed and approved for prisoners, the PI must promptly notify CPHS of the event. The PI must cease all research interactions with the now incarcerated prisoner-subject until all of the requirements of this policy have been satisfied. If the Principal Investigator asserts that it is in the best interests of the participant to remain in the research study while incarcerated, the Chairperson may determine that the participant may continue to participate in the research while CPHS ensures that the requirements of this policy are satisfied.

10.2. Research including prisoners and non-prisoner populations - CPHS may approve a research proposal for non-prisoner populations until all the criteria in this policy are satisfied.

10.3. Research Involving Children who are Prisoners - When a prisoner is also a minor (e.g. an adolescent detained in a juvenile detention facility is a prisoner), CPHS will follow the policy and procedure for Research Involving Prisoners as well as Research Involving Children.

11. Reporting: If research involving prisoners is conducted or supported by DHHS, the ORSC Staff will inform the OHRP that the CPHS has reviewed and approved the research. The letter shall contain all the items describe in Research Involving Prisoners – Template Letter to OHRP.

RESPONSIBILITY

12. The Principal Investigator is responsible for informing CPHS when research involves prisoners and submitting a completed Research Involving Prisoners Form.

13. CPHS is responsible for ensuring that research involving prisoners meets the requirements of this policy.

14. ORSC Staff is responsible for prompt notification of OHRP of research involving prisoners.

Applicable Regulations and Guidelines

1. 45 CFR 46.111(b)
2. 45 CFR 46 Subpart C – Additional DHHS Protections Pertaining to Biomedical and Behavioral research Involving Prisoners as Subjects
3. 21 CFR 56.111(b)
4. OHRP Guidance on the Involvement of Prisoners in Research

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