Subpart C Research Certification Form

OMB No. XXX
Approved for use through XXXXX
Office for Human Research Protections Subpart C Certification Form
In compliance with 45 CFR 46.305(c), an institution responsible for the conduct of research
conducted or supported by the U.S. Department of Health and Human Services (HHS) involving
prisoners as subjects must certify to the Secretary, through the Office for Human Research
Protections [OHRP], that the institutional review board (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).
To submit a subpart C certification to OHRP, the institution must submit a completed copy of
this certification form with a copy of the research proposal and relevant materials, including: the
IRB-approved protocol, including consent forms; any IRB application forms required by the
IRB; and other pertinent information requested or required by the IRB to be considered during
IRB review.
Note: If an IRB considers the grant application during its review of the study, only submit the
portions of the grant application relevant to subpart C review for the purposes of subpart C
certification. Do not submit the entire grant.
Requests should be emailed to [email protected]. If an institution is unable to submit
information electronically, please call 240-453-8141 to discuss an alternative submission
process.
Name of Institution:

Address of Institution:

Contact Information:

Name:
Title:
Phone:
Email:

Grant Number(s):
Funding Agency:
Funding Institution’s
Program Officer:
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is [Insert OMB control # once OMB provides]. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The time required to complete this information collection is estimated to average 60 minutes per response. If you have
comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health &
Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201,Attention: PRA Reports Clearance
Officer.

OMB No. XXX
Approved for use through XXXXX
OHRP Assurance #, if
applicable:
IRB Registration # for
Reviewing IRB:

Study Information
Study Title:

Name/Degree of Principal
Investigator(s):
Brief Summary of
Protocol, and a studyspecific rationale as to
why the research
represents the permissible
category of prisoner
research (below):

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is [Insert OMB control # once OMB provides]. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The time required to complete this information collection is estimated to average 60 minutes per response. If you have
comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health &
Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201,Attention: PRA Reports Clearance
Officer.

OMB No. XXX
Approved for use through XXXXX

Date of IRB Subpart C
Approval:
List of Institutions
Relying on this IRB for
Subpart C Review and
Certification, and
Assurance Numbers:

Select
One

Permissible Research Category

☐

45 CFR 46.306(a)(2)(i): 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

☐

45 CFR 46.306(a)(2)(ii): 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

☐

45 CFR 46.306(a)(2)(iii): Research on conditions particularly affecting prisoners as
a class (for example, 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 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.

☐

45 CFR 46.306(a)(2)(iv): Research on practices, both innovative and accepted,
which have the intent and reasonable probability of improving the health or wellbeing of the 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 has consulted with appropriate experts, including experts in penology,
medicine, and ethics, and published notice, in the FEDERAL REGISTER, of the intent
to approve such research.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is [Insert OMB control # once OMB provides]. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The time required to complete this information collection is estimated to average 60 minutes per response. If you have
comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health &
Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201,Attention: PRA Reports Clearance
Officer.

OMB No. XXX
Approved for use through XXXXX
Select
One
☐

Permissible Research Category
Epidemiological Waiver: (68 FR 36929) Research conducted or supported by
DHHS that involves epidemiologic studies that meet the following criteria:
(1) In which the sole purposes are:
(i) To describe the prevalence or incidence of a disease by identifying
all cases, or
(ii) To study potential risk factor associations for a disease, and
(2) Where the institution responsible for the conduct of the research certifies
to the Office for Human Research Protections, DHHS, acting on behalf of the
Secretary, that the IRB approved the research and fulfilled its duties under 45
CFR 46.305(a)(2)–(7) and determined and documented that
(i) The research presents no more than minimal risk and no more than
inconvenience to the prisoner-subjects, and
(ii) Prisoners are not a particular focus of the research.

Certification
☐

This research has been approved by an IRB that 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), or qualifies for the epidemiological waiver.

Date:

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is [Insert OMB control # once OMB provides]. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The time required to complete this information collection is estimated to average 60 minutes per response. If you have
comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health &
Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201,Attention: PRA Reports Clearance
Officer.