Download Appendix B

Protocol #________
HRRB Appendix B
Research Involving Prisoners, Probationers, and Parolees as Participants
45 CFR 46 Subpart C; UCR SOP Section 10.3
Using prisoners as research participants requires special attention to assure that consent is wholly voluntary, that
prisoners are given the opportunity to consult legal counsel, and that prisoners are made fully aware of the risks of
their participation, including possible risks from other prisoners. Therefore, such research is covered by
additional and specific protections under federal and state laws. This supplement helps the HRRB to assess the
risks and assure that research procedures comply with these special regulations.
1. Who are your research participants? (Please check all that apply)
Probationers
Parolees
Prisoners (means 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.) [45 CFR 46.303(c)]
2. Please check the category below that best represents the nature of the research and the degree of risk and
benefit to which the prisoners in this study will be exposed. (More than one category may be indicated, such
as when a protocol involves both a study group and a control group.)
Note: The definition of minimal risk for prisoners is slightly different than the definition for other participants. The
definition of minimal risk for research involving prisoners is given in 46.303(d), and is 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.
Category 1: The study of the possible causes, effects, and processes of incarceration, and of criminal
behavior, where the study presents no more than minimal risk and no more than an inconvenience to the
participants. [45 CFR 46.306(a)(2)(i)]
Category 2: The study of prisons as institutional structures or of prisoners as incarcerated persons, where
the study presents no more than minimal risk and no more than inconvenience to the participants. [45 CFR
46.306(a)(2)(ii)]
Category 3: The study of conditions particularly affecting prisoners as a class (for example, research on
social and psychological problems such as alcoholism, drug addiction, and sexual assaults). For DHHSfunded research, OHRP has consulted with appropriate experts, including experts in penology, medicine,
and ethics, and published notice, in the Federal Register, of its intent to approve such research. [45 CFR
46.306(a)(2)(ii)]
Category 4: The study of practices, both innovative and accepted, which have the intent and reasonable
probability of improving the health or well-being of the participant. For DHHS-funded research, which
requires the assignment of prisoners in a manner consistent with protocols approved by the HRRB to
control groups which may not benefit from the research, the study may proceed only after OHRP has
consulted with appropriate experts, including experts in penology, medicine, and ethics, and published
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notice, in the Federal Register, of its intent to approve such research. [45 CFR 46.306(a)(2)(iv)]. Does the
study in Category 4 involve a control group which will not receive a benefit from being in the study?
No
Yes. Additional procedures are required for approval. Contact the Office of Research Integrity at (951)
827-4811 or 6332, or [email protected], for more information.
3. Risks and Benefits
a. Are there any possible advantages accruing to the prisoner through his or her participation in the research
that - 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? [45 CFR 46.305(a)(2)]
No
Yes. Please explain:
b. Are the risks involved in the research commensurate with risks that would be accepted by persons who are
not probationers, parolees, or prisoners? [45 CFR 46.305(a)(3)]
Yes
No. Please explain:
c. Are the procedures for the selection of participants fair and immune from arbitrary intervention by oversight
authorities (e.g, parole officers, probation officers)? [45 CFR 46.305(a)(4)]
Yes
No. Please explain:
4. Informing Participants
a. Is the information presented in language that is understandable to the participant population? [45 CFR
46.305(a)(5)]
Yes
No. Please explain:
b. How will you inform your research participants that they may consult legal counsel? (Please check all that
apply)
Written consent form
Oral presentation
Information statement (when deception is being used in the study)
Other(s). Please specify:
c. How will you make your research participants aware of possible risks from other prisoners, probationers, or
parolees that may result from the participants’ participation in the study? (Please check all that apply.)
Written consent form
Oral presentation
Information statement (when deception is being used in the study)
Other(s). Please specify:
d. Does adequate assurance exist that oversight authorities will not take into account a probationer, parolee, or
prisoner’s participation in the research in making decisions regarding the participant’s legal status (e.g.,
parole or probation)? [45 CFR 46.305(a)(6)]
Yes. How will each participant be clearly informed in advance that participation in the research will
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have no effect on his or her legal status? (Please check all that apply)
Written consent form
Oral presentation
Information statement (when deception is being used in the study)
Other(s). Please specify:
No. Please explain:
e. If you or the IRB board finds a need for a follow-up study, examination, or care of the participants after
their initial participation, has adequate provision been made for such follow-up, taking into account
possible changes in the legal status of the participant and/or the length of the participant’s prison sentence
(if applicable) (e.g., parole being revoked, probation ends)? [45 CFR 46.305(a)(7)]
Yes. How will each participant be clearly informed in advance of such follow-up provisions? (Please
check all that apply)
Written consent form
Oral presentation
Information statement (when deception is being used in the study)
Other(s). Please specify:
No. How will each participant be clearly informed in advance that there will not be any follow-up
provisions? (Please check all that apply)
Written consent form
Oral presentation
Information statement (when deception is being used in the study)
Other(s). Please specify: