Research Involving Prisoners
The federal regulations governing human subjects in research
45 CFR 46, Subpart C provide additional safeguards for
the protection of research subjects who are prisoners
because the constraints associated with incarceration
may affect the individual’s ability to make a truly voluntary
and uncoerced decision regarding participation in research.
The additional protections apply to research subjects
who are prisoners at the time of enrollment in the research
as well as research subjects who become prisoners after
they enroll in the research.
Prisoner
is defined in the regulations as “any individual
involuntarily confined or detained in a penal institution.”
OHRP extends the definition to “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.” Of
note, research studies that involve adolescents detained
in a juvenile detention facility are subject to these
additional protections as well as the additional protections
for children.
IRB Review of Research that Involves
Prisoners as Subjects
IRB
Membership
In
order for an IRB to review and approve research that involves
prisoners, the membership of the IRB must include at least
one member who is or has been a prisoner, or a prisoner
representative (someone who has a close working knowledge,
understanding and appreciation of prison conditions from
the perspective of the prisoner). Since the Partners Human
Research Committee (PHRC) does not meet these special
membership requirements, Partners has executed an IRB
Authorization Agreement with the Harvard School of Public
Health that allows the PHRC to utilize the HSPH IRB for
review of research involving prisoners. When a protocol
involving prisoners as subjects is being reviewed by more
than one IRB because the protocol is being conducted at
multiple sites, only one IRB must satisfy the special
membership requirements for research involving prisoners
as subjects.
Expedited
Review
Research
involving prisoners may be reviewed through the expedited
review procedure if the research is no more than minimal
risk and meets the criteria for expedited review found
at 45 CFR 46.110 and 21 CFR 56.110. However the definition
of minimal risk for prisoner research at 45 CFR 46.303(d)
differs from the definition of minimal risk for other
research, contained in 45 CFR 46, subpart A, 45 CFR 46.102(i).
For
research involving prisoners, “minimal risk” is defined
at 45 CFR 46.303(d) as follows: “Minimal risk 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.” The HSPH IRB is
responsible for determining whether the research is minimal
risk and whether the research is eligible for review through
the expedited review procedure.
Research
Exempt from the Requirements of 45 CFR 46
The
exemptions at 45 CFR 46.101(b) do not
apply to research involving prisoners. For more information,
refer to http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101.
Submission of Research Studies that Include Planned
Enrollment of Prisoners as Subjects
When the study population includes prisoners,
the study must undergo review by the HSPH IRB. Investigators
must complete and submit the following to the Partners
Human Research Office:
The
Partners Human Research Office will forward the submission
to the HSPH IRB with a request to review on its behalf.
The HSPH IRB is responsible for the initial and continuing
review of the study, and for notifying the principal investigator
and the Partners HRC of IRB review actions.
When
changes to an ongoing PHRC-approved protocol include extending
the study population to include prisoners, investigators
must follow the PHRC procedures for submitting proposed
changes (amendments) for PHRC approval. The amendment
submission must include the following:
-
PHRC amendment form;
-
Revised PHRC Protocol Summary;
-
Revised detailed protocol;
-
Harvard School of Public Health’s Vulnerable
Subjects Worksheet and
-
Other revised documents, as applicable, to the amendment.
As
with new submissions, the PHRC will forward the amendment
and related review materials to the HSPH IRB for review.
Once the study is approved to include enrollment of prisoners
as subjects, the HSPH IRB becomes the IRB of record for
the study. The HSPH is responsible for continuing review
of the study, and for notifying the principal investigator
and the Partners HRC of IRB review actions.
When
A Subject Becomes a Prisoner While Participating in an
IRB-approved
Research Study
When
a subject becomes a prisoner while participating in a
research study approved by the PHRC, all research interactions
and interventions with the subject and/or collection of
identifiable private information about the subject must
cease until the requirements of the federal regulations
have been satisfied with respect to the relevant protocol
unless the principal investigator asserts and the
IRB Chairperson agrees that it is in the best interests
of the subject to remain in the research study while incarcerated.
In such cases, the subject may continue in the research
until the requirements of the federal regulations are
satisfied.
When
a subject becomes a prisoner, the investigator must notify
the PHRC immediately of the situation. The notification
should be in writing and should include whether the subject’s
participation will end as a result of his/her incarceration
or whether permission is being requested for the subject
to continue in the research because it is in his/her best
interests.
When
requesting permission for the subject to continue in the
research, address the following:
- the
prospect of direct benefit to the individual subject;
- the
importance of the intervention or procedure to the individual
subject’s health or well-being
- the
availability of the intervention or procedure outside
of the research context; and
- how
the intervention or procedure can be performed safely
while the individual is a prisoner.
The
investigator must follow the amendment process described
above to include the prisoner as a subject in the research.
Once approved, the HSPH IRB will become the IRB of record
for the study.
Research
Involving Prisoners
Version Date: August 25, 2005
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