Last Revised: 10.2015
Prior Version: 7.2007
Special Populations in Research
Prisoners as Research Subjects
Introduction
The inclusion of individuals in a research protocol who are considered “prisoners” requires
special ethical considerations and additional regulatory requirements to safeguard their interests
and protect them from harm. Prisoners constitute a research population who are at risk for
coercion due to their legal status or confinement. Prisoners may be under constraints because of
their incarceration, which could affect the ability to make a truly voluntary decision with respect
to participation as subjects in research.
Definition
Prisoner is “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.”
Interment in a facility for psychiatric illness or substance abuse is considered to meet the
criteria for incarceration if the commitment has been made as an alternative to a criminal
prosecution or incarceration. However, an individual in mental health or substance abuse facility
is not considered incarcerated if he/she has voluntarily committed him/herself or has been civilly
committed.

Probationers and parolees – who are not incarcerated – are not classified as prisoners
even though they are under criminal justice supervision. Probation and parole are not
considered incarceration.
Minimal Risk for Prisoners 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
examinations of healthy persons.
Policy
A research protocol is considered to include prisoners when:

prisoners are the target population that will be recruited; or
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the subject is a prisoner at the time of enrollment; or
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a currently enrolled subject becomes incarcerated during the course of the study.
When a research protocol involves the inclusion of prisoners, the IRB will review the research
in accordance with institutional policy, as well as in accordance with OHRP regulations as well
as with 45 CFR 46 Subpart C (additional protections pertaining to research involving prisoners).
Additional rules as determined by federal, state, county, and local regulations may also apply.
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When a prisoner is a child (e.g., an adolescent detained in a juvenile detention facility is a
prisoner), the IRB policy regarding enrollment of children, 45 CFR 46 Subpart D will be applied.
Federal regulations allow for certain categories of research involving prisoners to be reviewed
via expedited procedures. The IRB Office, IRB Chair, and/or Vice Chair will determine if a
protocol involving prisoners can be reviewed via expedited review or if it is required to be
reviewed at a convened IRB meeting. If a protocol involving prisoners is designated for
expedited review, the IRB prisoner representative member will be assigned as the primary or
secondary reviewer.
None of the exemption categories in the HHS regulations for research involving human subjects
at 45 CFR 46.101(b) apply to research involving prisoners.
When research is conducted within the Bureau of Prisons, implementation of Bureau
programmatic or operational initiatives made through pilot projects is not considered to be
research.
i.
Additional Requirements for New Protocols Recruiting Prisoners as Subjects
Prisoner Checklist: To document the above requirements have been met, investigators
must complete and a reviewer checklist that includes prisoner requirements via iRIS.
Research Protocol: In addition to the standard research protocol requirements, a protocol
involving prisoners must clearly articulate that it meets all applicable criteria under 45
CFR 46 Subpart C. The protocol must state the following:
a)
Clarification about how the proposed research represents one of the following
categories of research permissible for inclusion of prisoners (45 CFR
46.306(a)(2)):

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 participants.

A 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 participants.

Research on conditions particularly affecting prisoners as a class (e.g.,
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) provided that the study may proceed only after the Secretary of
DHHS (through OHRP) has consulted with appropriate experts including
experts in penology, medicine, and ethics and published notice, in the
Federal Register, of his intent to approve such research.

Research on practices, both innovative and accepted, which have the intent
and reasonable probability of improving the health or well-being of the
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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, the study may
proceed only after the Secretary of DHHS (through OHRP) has consulted
with appropriate experts including experts in penology, medicine, and
ethics and published notice, in the Federal Register, of his intent to
approve such research.
Epidemiologic studies that meet the following criteria:
o The sole purposes are one of the following:
 To describe the prevalence or incidence of a disease by
identifying all cases.
 To study potential risk factor associations for a disease.
o The research presents no more than minimal risk and no more than
inconvenience to the prisoner-subjects, and
o Prisoners are not a particular focus of the research.
b)
Discussion 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. There must also be a confirmation that these advantages are not of such a
magnitude that the prisoner’s ability to weigh the risks of the research against the
value of such advantages in the limited choice environment of the prisoner is
impaired.
c)
Discussion about the risks involved in the research and justification about how the
risks are commensurate with risks that would be accepted by non-prisoner
volunteers.
d)
Detail regarding procedures for selection of prisoners, including justification for
selection procedures to ensure that selection is fair to all prisoners and immune
from arbitrary intervention by prison authorities or prisoners. If a control
population is needed, controls must be selected from the group of available
prisoners who meet the characteristics needed for that particular research project,
unless the principal investigator provides to the IRB justification in writing for
following some other procedures.
e)
Discussion of the process for obtaining informed consent and study procedures to
ensure that the information is presented in language that is understandable to the
subject population.
f)
Adequate assurance in the protocol to affirm that parole boards will not take into
account a prisoner’s participation in the research in making decisions regarding
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parole, and that each prisoner is clearly informed in advance that participation in
the research will have no effect on his or her parole.
g)
If the IRB finds there may be a need for follow-up examination or care of
participants after the end of their participation, adequate provision must also be
made for such examination or care, taking into account the varying lengths of
individual prisoners’ sentences, and for informing participants of this fact.
Informed Consent: The informed consent document as well as any study materials must
be presented in a language that is understandable to the subject population. The consent
form must also clearly address any risks of participation, voluntary nature of participation
and state that participation in the research will not have any effect on a prisoner’s parole.
In certain limited circumstances, informed consent may be waived or altered by an IRB
according to 45 CFR 46.116. However, even if informed consent is waived or altered,
subpart C of 45 CFR part 46 still requires that the subjects be clearly informed in advance
that participation in the research will have no effect on their parole, if such notification is
relevant.
ii.
Additional requirements if a research subject becomes a prisoner
If a subject becomes a prisoner after enrolling in a research study, the investigator is
responsible for immediately reporting the event in writing to the IRB on an
“Unanticipated Problem/Protocol Deviation” form (NOTE: This is not required if the
study was previously approved by the IRB for prisoner participation.). The investigator
should provide detail on the subject and the incarceration, as well as the extent of the
subject’s participation in the research trial up to becoming a prisoner, what remaining
study activities the subject has to complete and the plan for either inclusion or exclusion
of the subject from further research activities.
If the study was not previously reviewed and approved by the IRB in accordance with the
requirements of 45 CFR 46 Subpart C, all research interactions and interventions with,
and obtaining identifiable private information from the prisoner must cease until the
requirements of Subpart C are satisfied. This is necessary because it is unlikely that
initial IRB review of the research and the informed consent documents contemplated the
constraints imposed by the possible future incarceration of the subject. If the
investigators would like the subject to continue in participation in the research, an
amendment must be submitted with revisions to the protocol and consent form to detail
how continuation of the prisoner meets applicable criteria under 45 CFR 46 Subpart C
(see section A: “Additional Requirements for New Protocols Enrolling Prisoners as
Subjects” above).
The convened IRB will review the current research protocol in which the subject is
enrolled, taking into special consideration the additional ethical and regulatory concerns
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for a prisoner involved in research as per Section C of this policy “Additional IRB
Requirements” noted below.
In special circumstances in which the investigator asserts that it is in the best interest of
the subject to remain in the research study while incarcerated, the subject may continue to
participate in the research until the requirements of subpart C are satisfied. The
investigator must promptly notify the IRB of this occurrence, so that the IRB can rereview the study. Note that in these circumstances, some of the findings required by 45
CFR 46.305(a) may not be applicable; for example, the finding required under 45 CFR
46.305(a)(4) regarding the selection of subjects within the prison may not be applicable,
if the subject was recruited outside of an incarcerated context. The IRB should document
findings of non-applicability accordingly.
If research interactions and interventions or obtaining identifiable private information
will not occur during the incarceration, IRB review and approval under the prisoner rules
is not required.
iii.
Additional IRB Requirements
For all new protocols that proposed to recruit prisoners as research subjects, or propose to
include individuals who subsequently become incarcerated during the course of an active
research trial, the IRB will review the protocols to determine if the inclusion is
appropriate in accordance with OHRP 45 CFR 46 Subpart C.
In order to review research involving prisoners, the IRB will note appropriate constitution
(45 CFR 46.304 (a) and (b))by affirming the following:
a)
A majority of the IRB (exclusive of prisoner members) shall have no association
with the prison(s) involved, apart from their membership on the IRB.
b)
At least one member of the IRB must be a prisoner, or a prisoner representative
with appropriate background and experience to serve in that capacity, except that,
where a particular research project is reviewed by more than one IRB, then only
one IRB needs to satisfy this requirement. If a prisoner representative is selected
to serve on the IRB, the person must have a close working knowledge,
understanding and appreciation of prison conditions from the perspective of a
prisoner. Suitable individuals could include present or former prisoners; prison
chaplains; prison psychologists, prison social workers, or other prison service
providers; persons who have conducted advocacy for the rights of prisoners; or
any individuals who are qualified to represent the rights and welfare of prisoners
by virtue of appropriate background and experience.
The IRB will meet the special composition requirements for all types of review for the
protocol: initial review, continuing review, review of protocol amendments, review of
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reports of adverse events or unanticipated problems involving risk to participants or
others, or in the event an individual becomes a prisoner while participating in a research
protocol.
The IRB must also find that the proposed research meets the requirements of 45 CFR
46.305, including that the research represents one of the categories of permissible
research under 45 CFR 46.306. OHRP notes that in order to make some of these seven
findings and meet the requirements of subpart A of 45 CFR part 46, the IRB must be
familiar with the specific conditions in the local prison(s) or jail site(s) that are pertinent
to subject protections, before approving the proposal for the local site (45 CFR
46.107(a)).
In order to approve research involving prisoners, the IRB must find that the proposed
research falls into one of the permissible categories of research (45 CFR 46.306), and
make six other findings under 45 CFR 46.305. The meeting minutes must document the
IRB’s discussion of these elements and affirm that the research meets the regulatory
criteria. Additionally, the minutes must reference that a majority of the IRB (exclusive
of prisoner member/representative) has no association with the prison(s) involved and a
qualified prisoner representative was present and voted on the protocol.
iv.
Prisoner Certification Letter to OHRP
An institution that intends to conduct research supported by the U.S. Department of
Health and Human Services (DHHS) that will involve prisoners as subjects must certify
to the Secretary (through OHRP) that the IRB has made the seven findings required under
45 CFR 46.305(a), including the finding that the proposed research represents one of the
permissible categories of research under 45 CFR 46.306(a)(2).
The institution must send OHRP a certification letter, to that effect, which should include
the name and address of the institution and specific identification of the research
protocol, including the relevant grant number. For DHHS-funded research, the Research
Compliance Officer certifies to OHRP the duties of the IRB have been fulfilled.
The OHRP requires the responsible institution to submit a copy of the research proposal
so OHRP can determine whether the proposed research involves one of the categories of
research permissible under 45 CFR 46.306(a)(2), and if so, which one. This will include:

The IRB-approved protocol.

Any relevant DHHS grant application or proposal.
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Any IRB application forms required by the IRB.

Any other information requested or required by the IRB to be considered during
initial IRB review.
The IRB will also include the following information in its certification letter to OHRP to
facilitate processing:
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OHRP Assurance number.
IRB registration number.
Date(s) of IRB Meeting(s) in which protocol was considered, including a brief
chronology that encompasses the date of initial IRB review and date of Subpart C
review.
v.
Other Approvals that May be Required
There may be other approvals required depending on the policies and procedures for the
correctional facility at which the research will take place (e.g., Federal Bureau of Prisons,
Ohio Department of Rehabilitation and Corrections, County jail, etc). It is the
investigator’s responsibility to determine what additional requirements must be met prior
to conducting research that involves prisoners.
vi.
For research conducted within the Bureau of Prisons
a)
The organization, IRB, and researchers and research staff must follow the
requirements of 28 CFR 512, including:
 The project must not involve medical experimentation, cosmetic research, or
pharmaceutical testing.
 The research design must be compatible with both the operation of prison
facilities and protection of human subjects. The researcher must observe the
rules of the institution or office in which the research is conducted.
 Any researcher who is a non-employee of the Bureau must sign a statement in
which the researcher agrees to adhere to the provisions of 28 CFR 512.
All research proposals will be reviewed by the Bureau Research Review
Board.
b)
The researcher must have academic preparation or experience in the area of study of the
proposed research.
c)
The project must have an adequate research design and contribute to the advancement of
knowledge about corrections.
d)
When submitting a research proposal, the applicant shall provide the following
information:
 A summary statement, which includes:
o Names and current affiliations of the researchers.
o Title of the study.
o Purpose of the study.
o Location of the study.
o Methods to be employed.
o Anticipated results.
o Duration of the study.
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o Number of participants (staff or inmates) required and amount of time
required from each.
o Indication of risk or discomfort involved as a result of participation.
A comprehensive statement, which includes:
o Review of related literature.
o Detailed description of the research method.
o Significance of anticipated results and their contribution to the
advancement of knowledge.
o Specific resources required from the Bureau of Prisons.
o Description of all possible risks, discomforts, and benefits to individual
participants or a class of participants, and a discussion of the likelihood
that the risks and discomforts will actually occur.
o Description of steps taken to minimize any risks.
A Description of physical or administrative procedures to be followed to:
o Ensure the security of any individually identifiable data that are being
collected for the study.
o Destroy research records or remove individual identifiers from those
records when the research has been completed.
A Description of any anticipated effects of the research study on
organizational programs and operations.
Relevant research materials such as vitae, endorsements, sample consent
statements, questionnaires, and interview schedules.
A statement regarding assurances and certification required by 28 CFR 46, if
applicable.
e)
The research design shall take into account:
 The selection of participants within any one organization must be equitable.
 Incentives may not be offered to help persuade inmate participants to
participate. However, soft drinks and snacks to be consumed at the test setting
may be offered.
 Reasonable accommodations such as nominal monetary recompense for time
and effort may be offered to non-confined research participants who are both:
o No longer in Bureau of Prisons custody, and
o Participating in authorized research being conducted by Bureau
employees or contractors.
f)
The informed consent form shall include the required elements of disclosure:
 Identification of the researchers.
 Anticipated uses of the results of the research.
 A statement that participation is completely voluntary and that the participant
may withdraw consent and end participation in the project at any time without
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
g)
penalty or prejudice (the inmate will be returned to regular assignment or
activity by staff as soon as practicable).
A statement regarding the confidentiality of the research information and
exceptions to any guarantees of confidentiality required by federal or state
law. For example, a researcher may not guarantee confidentiality when the
participant indicates intent to commit future criminal conduct or harm himself
or herself or someone else, or, if the participant is an inmate, indicates intent
to leave the facility without authorization.
A statement that participation in the research project will have no effect on the
inmate participant's release date or parole eligibility.
The research design shall maintain the confidentiality of data by the following
steps:
 A non-employee of the Bureau may receive records in a form not individually
identifiable when advance adequate written assurance that the record will be
used solely as a statistical research or reporting record is provided to the
agency.
 Except as noted in the consent statement to the participant, the researcher
must not provide research information that identifies a participant to any
person without that participant’s prior written consent to release the
information. For an additional layer of protection, an investigator should
obtain a Certificate of Confidentiality. For example, research information
identifiable to a particular individual cannot be admitted as evidence or used
for any purpose in any action, suit, or other judicial, administrative, or
legislative proceeding without the written consent of the individual to whom
the data pertain.
 Except for computerized data records maintained at an official Department of
Justice site, records that contain non-disclosable information directly traceable
to a specific person may not be stored in, or introduced into, an electronic
retrieval system.
 If the researcher is conducting a study of special interest to the Office of
Research and Evaluation (ORE) but the study is not a joint project involving
ORE, the researcher may be asked to provide ORE with the computerized
research data, not identifiable to individual participants, accompanied by
detailed documentation. These arrangements must be negotiated prior to the
beginning of the data collection phase of the project.
h) After the protocol is approved by the CWRU IRB:
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The researcher must assume responsibility for actions of any person engaged
to participate in the research project as an associate, assistant, or subcontractor
to the researcher.
At least once a year, the researcher shall provide the chief, Office of Research
and Evaluation (ORE), with a report on the progress of the research.
At least 12 working days before any report of findings is to be released, the
researcher shall distribute one copy of the report to each of the following: the
chairperson of the Bureau Research Review Board, the regional director, and
the warden of each institution that provided data or assistance. The researcher
shall include an abstract in the report of findings.
In any publication of results, the researcher shall acknowledge the Bureau's
participation in the research project.
The researcher shall expressly disclaim approval or endorsement of the
published material as an expression of the policies or views of the Bureau.
Prior to submitting for publication the results of a research project conducted
under this subpart, the researcher shall provide two copies of the material, for
informational purposes only, to the Chief, Office of Research and Evaluation,
Central Office, Bureau of Prisons.
References and/or Regulatory Citations
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45 CFR 46 Subpart C, Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Federal Bureau of Prisons website and restrictions with respect to research under 28.CFR
part 512
OHRP Guidance Document: “OHRP Guidance on Involvement of Prisoners in
Research,” May 23, 2003
OHRP Prisoner Frequently Asked Questions
State of Ohio Department of Rehabilitation and Corrections Policy and Procedure
website (with links to polices related to research approval process and human subject
research policy)
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