Subpart C: Prisoners as Research Subjects

Beyond the Common Rule contained in Subpart A, additional subparts of 45 C.F.R. Part 46 provide further and more specific protection for certain particularly vulnerable populations: pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects,” the focus of this project, was first finalized in 1978. These additional protections were developed in response to the National Commission’s Report and Recommendations: Research Involving Prisoners (NCPHSBBR, 1976). They represent further safeguards that must be met when conducting research with this vulnerable population group. To date, Subpart C has only been adopted by the DHHS, the CIA, and the SSA.

Key Definitions Within Subpart C

Subpart C defines a prisoner as any person who is “involuntarily confined or detained in a penal institution” as a result of violating a criminal or civil statute, a person who is committed to other facilities as an alternative to criminal prosecution or incarceration, or someone who is detained pending arraignment, trial, or sentencing.18 Research with this population must present no more than minimal risk. Here, that is defined as:

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.19

Subpart C identifies four categories of research that are permitted with prisoners.

  1. 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 subjects;

  2. 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 subjects;

  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 psychologi-

18

45 C.F.R. § 46.303(c).

19

45 C.F.R. § 46.303(d).



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