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Research Involving Prisoners
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The Federal Policy for the Protection of Human Subjects, 45 CFR 46,
Subpart C, includes additional protections for research involving
prisoners. Responses to the following additional IRB criteria must be
included in the IRB Initial Application (MS
Word doc ).
(1) The research under review represents one of the categories of
research permissible described below;
(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 nonprisoner 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.
Permissible Categories for research involving prisoners
(A) 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;
(B) 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;
(C) 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 psychological problems such as alcoholism, drug addiction, and
sexual assaults); or
(D) research on practices, both innovative and accepted, which have
the intent and reasonable probability of improving the health or
well-being of the subject. In cases in which those studies require the
assignment of prisoners in a manner consistent with protocols approved
by the IRB to control groups which may not benefit from the research.
