HHS Subpart C Certification Form

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OMB No. 0990-0473
Approved for use through XXXXXXXX

U.S. Department of Health and Human Services (HHS)
Subpart C Certification Form
In compliance with 45 CFR 46.305(c), an institution that intends to conduct HHS-supported research involving
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 rese arch represents one of the
permissible categories of research under 45 CFR 46.306(a)(2).
OHRP requires the electronic submission of Subpart C certification requests. 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.
Do not print and scan the certification form for submission. Fill the form out electronically, and email a
copy of the electronically filled-out form as an attachment.
To submit a subpart C certification request to OHRP, the institution must submit a completed copy of this
certification form in conjunction with a copy of the research proposal in order to determine whether the
appropriate findings have been made. The term “research proposal” includes:
•
•
•

the IRB-approved protocol, including consent forms;
any IRB application forms required by the IRB; and
any other 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.
Administrative Information
Name of the
Institution that
Operates the IRB
of Record, or the
Non-institutional
IRB that Serves as
the IRB of Record:

Click or tap here to enter text.

Address of the
Institution that
Operates the IRB
of Record, or the
Non-institutional

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IRB that Serves as
the IRB of Record:
Name(s) of
Institutions Relying
on the IRB of
Record:

Contact
Information for the
Individual
Submitting the
Certification:

Name: Click or tap here to enter text.
Title: Click or tap here to enter text.
Phone: Click or tap here to enter text.
Email: Click or tap here to enter text.

Relevant Grant
Number(s):

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Funding Agency:

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Granting
Institution’s
Program Officer:

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Program Officer’s
Email Address:
OHRP Assurance #:

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IRB Registration #
for Reviewing IRB:

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Study Information
Study Title: Click or tap here to enter text.
Name of Principal Investigator(s): Click or tap here to enter text.
Brief Summary of Protocol:
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Date(s) of IRB meeting(s) in which protocol was considered, including the dates of initial IRB review
and subpart C review:
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What was the IRB’s determination regarding the risk level of this study?:
☐ Greater than minimal risk
☐

Minimal risk

Permissible Categories of Research
This institution certifies that the IRB has determined that the research under review represents one of the
categories of research permissible under §46.306(a)(2) or meets the criteria for use of the epidemiological
waiver (45 CFR 46.305(a)(1) and 68 FR 36929):
Select
One

Permissible Activity Description

☐

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 well-being 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.

Select
One
☐

Permissible Activity Description
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, tha t
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.

Certifications (both boxes must be selected before submitting this form)
The institution further certifies the following:
Select
Both

Required Certifications

☐

That the research has been approved by an IRB that has adhered to all other responsibilities
prescribed for Institutional Review Boards under subpart C (45 CFR 46.305(a)(1)).

☐

That an IRB has made the determinations required by 45 CFR 46.305(a)(2)-(7).

The time required to complete this information collection is estimated to average one hour per response,
including the time to review instructions, gather the data needed, and complete and review the information
collection. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden to: OS Reports Clearance Officer, Room 503, 200
Independence Avenue, SW., Washington, DC 20201. Do not return the completed form to this address.