UNIVERSITY OF COLORADO COLORADO SPRINGS
INSTITUTIONAL REVIEW BOARD (IRB)
ADDENDUM: RESEARCH INVOLVING PRISONERS
For IRB Use Only
IRB#________________ Date Received _____________________
Date Approved ___________
Please use this addendum to address the regulatory requirements for conducting any research
procedures while conducting research with prisoners.
Additional information related to this addendum can be referenced in 45 CFR 46.301-306 and
the IRB Standard Operating Procedures Special Topics: XXV.
Definitions:
Prisoner – An individual involuntarily confined or detained in a penal institution, including those
sentenced to such an institution under criminal or civil statute, those detained in other facilities
as an alternative to criminal prosecution or incarceration in a penal institution, and those
detained pending arraignment, trial, or sentencing. (45 CFR 46.303)
Minimal Risk – 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. (45 CFR 46.3.3(d)) Note: This differs from the definition of minimal risk for
other research.
General Questions
1. How will prisoners be involved in this research protocol?
a. Prisoners will be recruited and consented for procedures while
incarcerated
b. In the case of a participant’s release and subsequent reincarceration, the participant will NOT be re-consented and
research treatment will continue.
c. Prisoner data only will be included in secondary data use (e.g.
record review) only.
Yes
No
Yes
No
Yes
No
2. Please justify why prisoners should be included in this research:
Safeguard Evaluation
Responses to the following questions will allow evaluation regarding safeguards being in place
to protect the rights and welfare of prisoners and assist the IRB in determining that the research
fulfills all the requirements of 45 CFR 46.305(a).
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3. Are there any possible advantages to the prisoners through their participation in the
research (when compared to the general living conditions, medical care, quality of food,
amenities, and opportunity for earnings in prison) that are of such a magnitude that their
ability to weigh the risks of the research against the value of such advantages is
compromised?
4. Are the risks involved in the research commensurate with risks that
Yes
No
would be accepted by non-prisoner volunteers?
5. Are the procedures for the selection of subjects within the prison fair to
Yes
No
all prisoners and immune from arbitrary intervention by prison
authorities or prisoners? Note: Unless the PI provides a justification
in writing for following some other procedure, control subjects must be
selected randomly from the group of available subjects who meet the
study inclusion criteria.
6. Is information presented in language that is understandable to the subject population?
Note: The consent form and process must reflect language and an approach that will be
comprehensible to this subject population that is at risk for lower reading levels.
7. How will you assure that the parole board will not take into account a prisoner’s participation
in the research while making parole decisions?
8. Is each prisoner clearly informed in advance that participation in the research will have no
effect on their parole?
9. As there may be a need for follow-up examination or care after the end of the study, please
provide the IRB with sufficient information below to make the required determination under
45 CFR 46.305(a)(7).
a. What are the potential complications that may result from participation in the
research?
b. What is the possible duration of such complications?
c. What are the types of examinations and care that would typically be needed for
such complications?
d. Describe the provisions for such examinations and care to subjects after their
participation in the research has ended.
10. If research requires follow-up beyond the period of incarceration,
Yes
No
have provisions been made for locating the individual following
release?
a. If yes, please explain:
Prisoner Research Category
11. Indicate which one of the following five categories best describes the involvement of
prisoners in this research category:
Category i: 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.
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Category ii: 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 subjects.
Category iii: Research on conditions particularly affecting prisoners as a class
(e.g., vaccine trials and other research on hepatitis that is 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 (DHHS) has consulted with the appropriate
experts including experts in penology, medicine, and ethics and published notice in
the Federal Register, of his or her intent to approve such research.
Category iv: Research on practices, both innovative and accepted, that have the
intent and reasonable probability of improving the health or well-being of the
subjects.
Category v: Epidemiology Studies Only:
In accordance with the federal regulations, the IRB has the authority to waive the
requirement that the research activities fit categories i-iv listed above if the
proposed research meets all of the following specific criteria:
1. The research involves epidemiologic studies in which the sole purposes are:
a. To describe the prevalence or incidence of a disease by identifying all
cases or,
b. To study potential risk factor associations for a disease and
2. The IRB has determined that items 3-9 of this form have been appropriately
addressed and has determined:
a. The research presents no more than minimal risk and no more than
inconvenience to the subjects, and
b. Prisoners are not a particular focus of the research.
12. Please provide justification for the category you have selected above (i-iv or epidemiology
waiver).
Inclusion of prisoners as research subjects may not commence until all approvals are
complete.
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