Prisoners
as Subjects
The use of prisoners as subjects is severely limited
since such subjects' ability to voluntarily consent is
limited by the "coercive nature of the environment."
Prisoner means any person involuntarily
confined or detained in a penal institution. The term
also includes persons detained in other facilities
(e.g., group homes, work release centers) by statute or
commitment procedures which provide alternatives to
criminal prosecution or incarceration in a penal
institution, as well as persons detained pending
arraignment, trial, or sentencing.
DHHS funded research involving prisoners must be
approved by both the local IRB and the funding
department/agency head. The research must be limited to
'minimal risk' studies of criminal behavior and
incarceration, penal institutions and prisoners as a
social class; research on conditions affecting
prisoners--including social and psychological
problems--only if approved by the department/agency head
after expert consultation; and therapeutic research,
with control groups also requiring the department/agency
head's approval. Unfunded and non-HHS supported
research does not require approval by the federal
agency. All research involving prisoners will require
full committee review.
'Minimal Risk' in prisoner research is 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.
Any researcher planning research involving prisoners
is encouraged to review the current regulations for
other requirements before submitting the Summary
Safeguard Statement for review. These regulations are in
Subpart C of 45 CFR 46, and are available from on the
web at
the OHRP site.
If a subject in an ongoing research study becomes a
prisoner, the researcher must report this to the IRB
immediately so the IRB can review the protocol again
with a prisoner representative present and an eye to the
special conditions of being a prisoner.
