Research Involving Prisoners

Regulatory Background and Definitions

Because prisoners are a vulnerable research population, the Office of Human Research Protection (OHRP) requires and enforces additional protections (45 CFR 46 Subpart C). OHRP Guidance on the Involvement of Prisoners in Research will be useful to PIs who conduct prisoner research, or those who have enrolled a research participant who subsequently becomes incarcerated.

The California Penal Code (Sections 3500; 3501-3509.5, 3521) outlines provisions for research involving prisoners within the state. IRB policies are consistent with all federal and state regulations.

Definitions:

Prisoner means 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.

Minimal risk (prisoners): 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. Note: This definition differs from the minimal risk definition that applies to research with non-vulnerable populations.

What to do if ...

Permissible Categories of Research Involving Prisoners

Biomedical Research

California law prohibits all biomedical research on prisoners (Section 3502).

Behavioral Research

Epidemiologic Research

For more information, call the IRB 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 IRB must review prisoner research and find that the research complies with seven additional requirements [45 CFR 46.305(a)]:

1. The study satisfies the criteria for permissible research.

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 subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some 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 which 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. Where the Board 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.

Other Considerations

Investigators conducting prisoner research should carefully consider the following issues:

  • Confidentiality: There are several privacy and confidentiality issues to address in the prison environment, such as the availability of private rooms to conduct interviews and involving prison staff in any part of the study.
  • 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 consistent with those specified for prisoners in state regulations (Section 3521-3523).

IRB Composition and Review Process

The IRB must abide by federal requirements for review and approval of research involving prisoners.

 

Last updated: June 4, 2021