Research Involving Prisoners as Subjects

The regulations define “prisoner” as:

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 (45 CFR 46.303(c)).

Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action such as arraignment or trial.

Common examples of the application of the regulatory definition of prisoner are:

  • Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.
  • Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners; however, individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to non-penal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners.
  • Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners.
  • Probationers and individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population. Institutions may consult with U.S. Office of Human Research Protections (OHRP) when questions arise about research involving these populations.

For any Federal Grant/U.S. Department of Health and Human Services (HHS)-conducted or -supported research involving prisoners, the institution(s) engaged in the research must certify to the Secretary (through OHRP) that the Institutional Review Board (IRB) reviewed the research and made seven findings – as required by the regulations (45 CFR 46.305(c) and 46.306(a)(1)).

In addition to the requirements of subpart A, subpart C of the HHS regulations at 45 CFR part 46 identifies more requirements for research involving prisoners. 

References and Additional Guidance

U.S. Office of Human Research Protections (OHRP): section 45 CFR 46, subpart C.

OHRP: “Prisoner Research - FAQs