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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Vulnerable Subject Populations - Prisoners (Revised February 2005)

 • Brief Overview
 • Federal and State Regulations
• Definitions
•Prisoner
•Minimal Risk
 • Research Participants in Danger of Arrest
 • If an Enrolled Participant is Jailed
 • Permissible Categories Of Research
• Biomedical Research
• Behavioral Research
• Epidemiologic Research
 • Additional Requirements
 • Informed Consent
 • Other Considerations
 • IRB Composition and Duties
• Prisoner Representative
• Federal Approval Required
• Extra Review Time
 • Resources

Brief Overview

All research involving prisoners must be approved by the Committee on Human Research (CHR). CHR policies are consistent with all federal and state regulations related to prisoners as research participants. This guidance provides UCSF investigators with summaries of the applicable regulations as well as links to more detailed information if needed.

• Federal Regulations: Because prisoners are a vulnerable research population, additional protections (45 CFR 46 Subpart C) are required and enforced by the Office of Human Research Protection (OHRP) along with the basic policy for protection of human research subjects (45 CFR 46 Subpart A).
  • Recent OHRP guidance on prisoner research expands the agency’s regulatory directives. This information may be useful to investigators intending to conduct prisoner research, or those who have enrolled a research participant who has subsequently become incarcerated.



• State Regulations: Equally important to UCSF investigators, the California Penal Code (Sections 3500; 3501-3509.5, 3521) outlines provisions for research involving prisoners within the state.



• Definitions: Investigators who intend to conduct prisoner research should consider the following
  • A prisoner is defined as: “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.” [45 CFR part 46.303(c)]
  
  
  
  • Minimal risk for prisoner research [45 CFR 46.303(d)] differs from the minimal risk definition that applies to research with non-vulnerable populations [45 CFR 46.102(i)]. As shown below the definition is modified to encompass the condition of incarcerated participants:
    
    
    

    Research involves:	Minimal Risk means:
    Prisoners [45 CFR 46.303(d)]	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. Non-vulnerable Populations
    [45 CFR 46.102(i)]	The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Research Participants in Danger of Arrest

• Prospective Research Participants: If the research population includes people who are likely to be jailed during a study – and whose participation the investigator would like to continue – the study should be reviewed as prisoner research. This would include studies intending to enroll parolees, street people, addicts, and prostitutes because these individuals are more likely to be arrested than the general population.



• Application Requirements: The researcher should anticipate the likelihood of arrests and discuss what study activities will and will not continue while the participants are in jail. To include these jailed participants, the study must meet the same requirements and review standards as other studies involving prisoners.

If an Enrolled Participant is Jailed

• If a research participant is incarcerated after enrollment in a study, the participant can continue in the study only if the CHR reviews and approves the study in accordance with all requirements for research involving prisoners.
  • If the study is not already approved to include prisoners, the investigator must immediately contact the CHR at (415) 476-1814 and speak with the specialist on prisoner research.
  
  
  
  • The study will need to be modified and must be reviewed by a member of the CHR qualified to represent prisoners’ interests.

Permissible Categories of Research Involving Prisoners

• Biomedical Research: California law prohibits all biomedical research on prisoners (Section 3502). However, prisoner participation in investigational new drug (IND) research may be allowed if:
  • The treatment protocol or treatment IND meets the regulatory requirements in 21 CFR 312, regulations enforced by the Food and Drug Administration; and
  
  
  
  • The treatment is deemed to be in the prisoner's best medical interest [Section 3502.5(a)], and
  
  
  
  • The prisoner-participant has given informed consent [Section 3521].



• Behavioral Research: State [Section 3505] and federal [45 CFR 46.306(a)(2)] regulations define four categories of permissible behavioral research as follows:
  • Studies of 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.
  
  
  
  • Studies 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.
  
  
  
  • Research on conditions particularly affecting prisoners as a class, for example:
    • Vaccine trials and other research on hepatitis which is more prevalent in prisons than elsewhere;
    
    
    
    • Research on social and psychological problems (alcoholism, drug addiction, and sexual assaults)
      • The study may proceed only after the HHS Secretary (through OHRP) has consulted with appropriate experts and has published notice of approval in the Federal Register.
  
  
  
  • Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.
    • Non-therapeutic research with a control group must be approved by the CHR and subsequently reviewed by the HHS Secretary. The Secretary’s ruling, informed by consultation with experts, will be published in the Federal Register.



• Epidemiologic Research: By waiver published in the Federal Register on June 20, 2003 (68 FR 36929), prisoners may be included in research directed towards the prevalence, incidence, or risk factors for diseases that might affect prisoners.
  • The research must pose no more than a minimal risk and present no more than an inconvenience to the prisoner participant.
  
  
  
  • For further information, call the CHR at (415) 476-1814 and ask to speak with the specialist on prisoner research.

Additional Requirements

In addition to all the basic human subject protection requirements (45 CFR 46, Subpart A), the Committee on Human Research (CHR) must review prisoner research and find that the research complies with seven additional requirements [45 CFR 46.305(a)]:

Informed Consent

Prisoners who are competent have the fundamental right to decide whether or not to participate in research. UCSF requirements for informed consent are described in detail on the CHR website and these general consent requirements are consistent with those specified for prisoners in state regulations (Section 3521-3523).

Other Considerations

Investigators conducting prisoner research should carefully consider the following issues:

• Research Participation and Parole: To avoid coercion and undue influence, it must be clearly stated to the prisoner that study participation will have no effect on his/her parole.



• Confidentiality: There are several privacy and confidentiality issues to address in the prison environment:
  • The availability of private rooms to conduct prisoner interviews.
  
  
  
  • The involvement of prison staff in any part of the study.

IRB Composition and Duties

The Committee on Human Research, as the Institutional Review Board (IRB) for UCSF, SFGH, SF VAMC, and several other institutions, must abide by federal requirements for review and approval of research involving prisoners.

• IRB Composition: Research involving prisoners must be reviewed by an IRB that fulfills the following membership requirements [45 CFR 46.304]:
  • At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity.
  
  
  
  • A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB
    
    
  IMPORTANT NOTE: If a research project is reviewed by more than one IRB, only one IRB must satisfy the requirement that at least one member is a prisoner or a prisoner representative.
  
  
  • Federal Approval Required: The institution responsible for conducting federally-funded prisoner research must provide a Prisoner Certification Letter to the OHRP citing that the IRB has completed its review of permissible research and that the seven additional requirements are met.
    
    IMPORTANT NOTE: The research cannot proceed until OHRP issues written approval to the institution.
  • Extra Review Time: The availability of qualified reviewers and the requirement for federal approval mean that researchers should allow for at least a month additional time between submission and final approval of an application affecting prisoners.

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  Resources

  The Office of Human Research Protection (OHRP)

  45 CFR 46 Subpart A
  45 CFR 46 Subpart C
  OHRP guidance on prisoner research

  
  California Penal Code

  Section 3500;
  Sections 3501-3509.5,
  Sections 3521-3523

  Food and Drug Administration (FDA)

  21 CFR 312