Prisoners as Prisoners as Human Research SubjectsHuman Research Subjects

Presentation for IRB MembersPresentation for IRB Members

45 CFR Part 4645 CFR Part 46 - DHHS Policy for Protection

of Human Research Subjects- Subpart AAdopted January 13, 1981Revised June 18, 1991

Also know as “The Common Rule” –FederalPolicy for Protection of Human Subjects,June 18, 1991 –adopted by 17 federalagencies

Criteria For Approval of all Human Subjects Research

45 CFR Part 46.111 (Subpart A)

Minimized risks Reasonable risk/benefit relationship Equitable subject selection Informed consent process Informed consent documentation Data monitored for safety Confidentiality/privacy maintained Vulnerable populations protected

Additional Protections Additional Protections Included in 45 CFR 46Included in 45 CFR 46

Subpart B-Subpart B- Additional DHHS Protections Pertaining Additional DHHS Protections Pertaining to Research, Development, and Related Activities to Research, Development, and Related Activities Involving Pregnant Women, Fetuses, and Neonates Involving Pregnant Women, Fetuses, and Neonates (non-viable and those of uncertain viability)(non-viable and those of uncertain viability)

Subpart C-Subpart C- Additional DHHS Protections Additional DHHS Protections Pertaining to Biomedical and Behavioral Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Research Involving Prisoners as Subjects (adopted in 1981) – (adopted in 1981) – Not adopted by the FDANot adopted by the FDA

SubpartSubpart DD-- Additional DHHS Protections for Children Additional DHHS Protections for Children Involved as Subjects in Research Involved as Subjects in Research

Definition of PrisonerDefinition of Prisoner

• Any person confined or detained in a penal Any person confined or detained in a penal institution or,institution or,

• Individuals sentenced under criminal or civil Individuals sentenced under criminal or civil statutes or, statutes or,

• Individuals detained in other facilities by Individuals detained in other facilities by virtue of statute or commitment procedures virtue of statute or commitment procedures which provide alternatives to criminal which provide alternatives to criminal prosecution or incarceration or, prosecution or incarceration or,

• Individuals detained pending arraignment, Individuals detained pending arraignment, trial, or sentencing.trial, or sentencing.

Definition of Minimal Risk for Definition of Minimal Risk for Prisoner ResearchPrisoner Research

““Minimal Risk” is defined as the probability andMinimal Risk” is defined as the probability andmagnitude of magnitude of physical or psychologicalphysical or psychological harm that is harm that isnormally encountered in the daily lives, or in thenormally encountered in the daily lives, or in theroutine medical, dental, or psychological routine medical, dental, or psychological examination of examination of healthy personshealthy persons..

The definition of minimal risk for prisoners found inThe definition of minimal risk for prisoners found inSubpart C differs from the definition of minimal riskSubpart C differs from the definition of minimal riskin Subpart A of 45 CFR 46:in Subpart A of 45 CFR 46:

• focuses on physical and psychological harmfocuses on physical and psychological harm• comparison with healthy non-incarcerated populationcomparison with healthy non-incarcerated population

Allowable Research Allowable Research 45 CFR Part 46.306 (a)(2)45 CFR Part 46.306 (a)(2)

• Study of possible causes, effects, processes of incarceration Study of possible causes, effects, processes of incarceration and criminal and criminal behavior; if the study involves no more than minimal risk and no more than inconvenience to the subjects

• Study of prisons as institutional structures or prisoners as Study of prisons as institutional structures or prisoners as incarcerated persons; incarcerated persons; if the study involves no more than minimal risk and no more than inconvenience to the subjects

• Research on conditions affecting prisoners as a class; requires Research on conditions affecting prisoners as a class; requires OHRP and expert approvalOHRP and expert approval

• Research on practices (innovative and accepted) that have a Research on practices (innovative and accepted) that have a reasonable probability of improving the health or well-being of reasonable probability of improving the health or well-being of prisoners; if study involves a placebo, requires OHRP and prisoners; if study involves a placebo, requires OHRP and expert approvalexpert approval

Additional Criteria for Additional Criteria for Approval of HS Research Approval of HS Research

per Sub Part C per Sub Part C Fall within category of allowable research per Fall within category of allowable research per

46.306 (a)(2)46.306 (a)(2)

Ensure that the advantages of the research Ensure that the advantages of the research participation are not of such magnitude as to participation are not of such magnitude as to influence a prisoner’s ability to weigh risks and influence a prisoner’s ability to weigh risks and benefitsbenefits

Risks are commensurate with risk that might be Risks are commensurate with risk that might be assumed by non-prisonersassumed by non-prisoners

Selection procedures are equitable among all Selection procedures are equitable among all prisoners and immune from arbitrary influence by prisoners and immune from arbitrary influence by prison authoritiesprison authorities

Additional Criteria Additional Criteria for Approval for Approval

in Sub Part C in Sub Part C (cont.)(cont.) No influence on parole boardsNo influence on parole boards Information is in language understandable to prisonersInformation is in language understandable to prisoners Provisions are made for follow-up, if necessaryProvisions are made for follow-up, if necessary For studies supported by the Department of Health For studies supported by the Department of Health

and Human Services, the Institute must certify to the and Human Services, the Institute must certify to the Secretary (through OHRP) that the IRB has made the Secretary (through OHRP) that the IRB has made the seven findings required under 45 CFR 46.305(a), seven findings required under 45 CFR 46.305(a), including the finding that the proposed research including the finding that the proposed research represents one of the permissible categories of represents one of the permissible categories of research under 45 CFR 46.306(a)(2). For more research under 45 CFR 46.306(a)(2). For more information on this process, please refer to the information on this process, please refer to the following link: following link: http://www.hhs.gov/ohrp/special/prisoners/http://www.hhs.gov/ohrp/special/prisoners/

Other Criteria:Other Criteria:

For research conducted within the Bureau of For research conducted within the Bureau of Prisons, the project must have an adequate Prisons, the project must have an adequate research design and also contribute to the research design and also contribute to the advancement of knowledge about corrections advancement of knowledge about corrections [Department of Justice (DoJ): 28 CFR 512.11(a)[Department of Justice (DoJ): 28 CFR 512.11(a)(2)].(2)].

IRB Composition for IRB Composition for Prisoner ResearchPrisoner Research

• IRB meets all requirements of IRB meets all requirements of 46.10746.107• In addition, per 45 CFR 46.304 the composition In addition, per 45 CFR 46.304 the composition

of the IRB when reviewing prisoner research of the IRB when reviewing prisoner research must be addressed as follows:must be addressed as follows:– A majority of the Board (exclusive of prisoner A majority of the Board (exclusive of prisoner

members) shall have no association with the prisons members) shall have no association with the prisons involved, apart from their membership on the Board.involved, apart from their membership on the Board.

– At least one member of the Board shall be a prisoner, At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate or a prisoner representative with appropriate background and experience to serve in that capacity, background and experience to serve in that capacity, except that where a particular research project is except that where a particular research project is reviewed by more than one Board only one Board reviewed by more than one Board only one Board need satisfy this requirement.need satisfy this requirement.

Types of ReviewTypes of Review• It is important to note that the use of It is important to note that the use of prisoners inprisoners in biomedical research is biomedical research is

prohibitedprohibited. Biomedical research is defined by CA law as, “research relating to or . Biomedical research is defined by CA law as, “research relating to or involving biological, medical or physical science.”involving biological, medical or physical science.”

• Non-Human Subject Research: Research involving access to existing private de-Non-Human Subject Research: Research involving access to existing private de-identified information about prisoners does not constitute research involving human identified information about prisoners does not constitute research involving human subjects. Moreover, research involving existing coded information about prisoners subjects. Moreover, research involving existing coded information about prisoners does not constitute research involving human subjects if both of the following does not constitute research involving human subjects if both of the following conditions are met: conditions are met: – 1) the private information was not collected specifically for the currently 1) the private information was not collected specifically for the currently

proposed research project through an interaction or intervention with living proposed research project through an interaction or intervention with living individuals; and individuals; and

– 2) the researchers cannot readily ascertain the identity of the individuals to 2) the researchers cannot readily ascertain the identity of the individuals to whom the coded private information pertain because, for example the whom the coded private information pertain because, for example the researchers and the holder of the key enter into an agreement prohibiting the researchers and the holder of the key enter into an agreement prohibiting the release of the key under any circumstances, until the individuals are deceased.release of the key under any circumstances, until the individuals are deceased.

• Exempt Research: Per federal regulations, none of the exemption categories in the Exempt Research: Per federal regulations, none of the exemption categories in the federal regulations for research involving human subjects at 45 CFR 46.101(b) apply federal regulations for research involving human subjects at 45 CFR 46.101(b) apply to research involving prisoners to research involving prisoners

• Expedited Research: Per UCI policy, research involving access to private identifiable Expedited Research: Per UCI policy, research involving access to private identifiable information about prisoners (coded identifiers only) but not involve intervention or information about prisoners (coded identifiers only) but not involve intervention or interaction with prisoners, may be reviewed and approved under Expedited review. interaction with prisoners, may be reviewed and approved under Expedited review.

• Full Committee: Per UCI policy, research involving access to private identifiable Full Committee: Per UCI policy, research involving access to private identifiable information about prisoners (direct identifiers) or involve intervention or interaction information about prisoners (direct identifiers) or involve intervention or interaction with prisoners, requires initial Full Committee review. with prisoners, requires initial Full Committee review.

Additional Important PointsAdditional Important Points• Subpart C applies whenever any human subject in an IRB-approved Subpart C applies whenever any human subject in an IRB-approved

research protocol becomes a prisoner at any time during the study. research protocol becomes a prisoner at any time during the study.

• When a previously enrolled research subject becomes a prisoner and When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the relevant research protocol was NOT reviewed and approved by IRB in accordance with the requirements Subpart C, the researcher IRB in accordance with the requirements Subpart C, the researcher should promptly notify the IRB of this event.  All research interactions should promptly notify the IRB of this event.  All research interactions and interventions with, and obtaining identifiable private information and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the about, the now-incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the requirements of subpart C have been satisfied with respect to the relevant protocol. relevant protocol.

NOTE: NOTE: In special circumstances in which the researcher asserts that it In special circumstances in which the researcher asserts that it is in the best interests of the subject to remain in the research study is in the best interests of the subject to remain in the research study while incarcerated, the IRB Chair may determine that the subject may while incarcerated, the IRB Chair may determine that the subject may continue to participate in the research until the requirements of continue to participate in the research until the requirements of Subpart C are satisfied. Subpart C are satisfied.

• An adolescent (e.g., age 14) detained in a juvenile detention facility is An adolescent (e.g., age 14) detained in a juvenile detention facility is a prisoner therefore, the IRB would need to comply with Subpart C a prisoner therefore, the IRB would need to comply with Subpart C and Subpart D - Children.and Subpart D - Children.

Documentation – Appendix CDocumentation – Appendix C

• Investigators interested in Investigators interested in enrolling prisoners as research enrolling prisoners as research subjects must complete subjects must complete Appendix CAppendix C when completing when completing the electronic IRB Application or the electronic IRB Application or when requesting a modification when requesting a modification to an IRB-approved study. to an IRB-approved study.

Documentation – Supplemental Documentation – Supplemental Reviewer’s ChecklistReviewer’s Checklist

• The IRB Reviewer will complete a The IRB Reviewer will complete a Supplemental Reviewer’s Supplemental Reviewer’s ChecklistChecklist as part of their review, as part of their review, assessing the level of risk posed to assessing the level of risk posed to the subjects. the subjects. It is important that the It is important that the IRB Reviewer read through and IRB Reviewer read through and complete all applicable checkboxes complete all applicable checkboxes as part of the risk assessment.as part of the risk assessment.

Questions?Questions?Please contact:Please contact:

Jessica Sheldon, CIPJessica Sheldon, CIPIRB C AdministratorIRB C Administrator@ jessica.sheldon@uci.edu@ jessica.sheldon@uci.edu or 949-824-4779or 949-824-4779

Karen Allen, CIPKaren Allen, CIPDirector of Human Research Protections Director of Human Research Protections @ kallen@uci.edu @ kallen@uci.edu or 949-824-1558or 949-824-1558

This presentation was adapted from the This presentation was adapted from the InstitutionalInstitutional

Review Board: Management andReview Board: Management andFunction, Amdur and Bankert, 2002Function, Amdur and Bankert, 2002