IRB Prisoner Participant Form
Revised February 10, 2006
PRISONER PARTICIPANT FORM
Submit with main protocol form
Leave Blank
Protocol #: _________________
Approval Date: _____________
Expiration Date: ____________
A "prisoner" is defined by HHS regulations at 45 CFR part 46.303(c) as "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."
Name the prison, penal institution, or other facility in which prisoner participants
will be recruited or data will be collected.
CHECKLIST:
Indicate all of the statements that apply to this protocol:
Research involving no more than “minimal risk” and no more than inconvenience to
the prisoner-subjects. “Minimal risk” is defined as 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.
Research studying the possible causes, effects, and processes of incarceration, and of
criminal behavior.
Research studying prisons as institutional structures or of prisoners as incarcerated
persons.
Research on conditions particularly affecting prisoners as a class.
Research on practices, both innovative and accepted, which have the intent and
reasonable probability of improving the health or well-being of the subject.
EXPIRATION
Research that involves epidemiologic studies in which the sole
purposes areDATE:
to
describe the prevalence of a disease by identifying all cases or to study potential risk
factor associations for a disease, AND prisoners are not a particular focus of the
research.
Describe 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.
These advantages should not be 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.
Describe the risks involved in the research. The risks involved in the research
should be commensurate with risks that would be accepted by nonprisoner
volunteers.
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IRB Prisoner Participant Form
Revised February 10, 2006
Describe the procedures for the selection of subjects within the prison. These
procedures should be fair to all prisoners and immune from arbitrary intervention
by prison authorities or prisoners. If control subjects will not be randomly selected
from the group of available prisoners who meet the needed characteristics, provide
justification for following the desired procedures.
Describe how you will verify that the informed consent form and any other
pertinent information will be written in language understandable to the population.
Describe how you will ensure that parole boards do not take into account a
prisoner's participation in the research in making decisions regarding parole.
Describe how you will clearly inform each prisoner in advance that participation in
the research will have no effect on his or her parole.
Where there may be a need for follow-up examination or care of participants after
the end of their participation, describe the provisions that will be made for such
examination or care, taking into account the varying lengths of individual prisoners'
sentences, and for informing participants of this fact.
I certify that I will not proceed with this research until the protocol receives
approval from the UNCW IRB and all applicable prisoner facility IRBs, and (if the
research is HHS conducted or supported) until OHRP issues its approval in writing
to UNCW on behalf of the Secretary of HHS.
____________________________________________
Principal Investigator’s Signature
____________________________________________
Print Name
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__________________
Date