Supporting Statement for the Institutional Review Board (IRB) Registration Form and for Institutional Review Boards: Registratio

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Supporting Statement for the Department of Health and Human Services
(HHS) Subpart C Certification Form
Background
The Office for Human Research Protections (OHRP) is requesting a three-year extension,
without changes, for the currently approved collection for the OMB No. 0990-0473, HHS
Subpart C Certification Form. The current form is approved through October 31, 2026. The
purpose of the form is to provide a simplified, standardized procedure for institutions to
electronically submit subpart C research certifications to OHRP in order to meet the regulatory
requirements for including prisoners in non-exempt human subjects research that is conducted or
supported by HHS. The form also simplifies the internal process used by OHRP to review and
record such certifications, resulting in faster processing while reducing unnecessary and
burdensome staff time. Respondents for this collection are institutions or organizations
operating Institutional Review Boards (IRBs) that have enrolled or are planning to enroll
prisoners in human subjects research conducted or supported by HHS.

A.

Justification
1. Need and Legal Basis
Section 491[289](a) of the PHS Act states that the Secretary of HHS shall by
regulation require that each entity applying for a grant, contract, or cooperative
agreement to conduct research involving human subjects submit to HHS assurances
satisfactory to the Secretary that it has established an IRB to review research in order
to protect the rights of the human subjects of such research. The Secretary of HHS
has delegated this statutory authority to the Assistant Secretary of Health, and to
OHRP. OHRP is responsible for interpreting and enforcing the HHS protection of
human subjects regulations at 45 CFR 46 1.
Subpart C, 45 CFR part 46, provides “Additional Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as Subjects.” Subpart C
provides four permissible categories of HHS-conducted or –supported research in
which prisoners may be involved (45 CFR 46.306(a)(2)); an epidemiological waiver
was added later, and functions as a narrow fifth category of permissible research. In
approving such research, an IRB reviewing research involving prisoners to which
Subpart C applies must make seven findings, including the finding that the proposed
research represents one of the permissible categories of research under section
46.306(a)(2) (45 CFR 46.305(a)). Pursuant to 45 CFR 46.305(c), an institution that

The pre-2018 HHS Protection of Human Subjects Regulations (or pre-2018 Requirements), codified at subpart A,
45 CFR part 46 (as amended), were originally promulgated in 1991 (56 FR 28012, 28022) and amended on June 23,
2005 (70 FR 36325). The 2018 HHS Protection of Human Subjects Regulations (or 2018 Requirements), codified at
subpart A, 45 CFR part 46 (as amended), were originally published on January 19, 2017 (82 FR 7149), and amended
on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497).
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intends to conduct HHS-supported research involving prisoners as subjects must
certify to the Secretary (through OHRP) that the IRB has approved the research in
accordance with section 46.305(a) Section 46.305(c) states that “The institution shall
certify to the Secretary, in such form and manner as the Secretary may require, that
the duties of the [IRB] under this section have been fulfilled.”
2. Information Users
In order to standardize and facilitate the processing and recordation of such
certifications, the Subpart C Certification Form requests the following
information, for the following purposes:
(a) The name and address of the IRB of record institution, name(s) of institutions
relying on the IRB of record, and the name, title or position, mailing address,
phone number, and electronic mail address of the contact person for the
institution or organization providing the certification information.
(Note: submitting the following information for the contact person is
optional: title or position)
Purpose: OHRP will use this information to communicate with the IRB of
record institution directly to ask questions and forward information and send
electronic mail to that contact person. In cases in which the reviewing IRB is
acting as the IRB of record on behalf of multiple institutions, clarity
regarding to which institutions the certification applies.
(b)

Relevant grant number, granting institution, and name and email
address of granting institution’s program officer.
Purpose: This information serves to specifically identify the study at issue,
and provide contact information for future correspondence for questions or
notification of final disposition.
(c) OHRP Assurance number
Purpose: OHRP collects this information to be able to contact the
institutional official at the site(s) engaged in human subjects research, if
necessary.

(d) IRB Registration number
Purpose: OHRP uses this information to identify the specific IRB which
conducted the subpart C review.
(e) Study title, name of Principal Investigator(s), and brief summary of the
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protocol
Purpose: OHRP uses this information to identify the research study,
responsible investigator(s), and the research context.
(f) Dates of IRB approval under Subpart C
Purpose: The dates of initial and/or Subpart C review and verify IRB review
and approval, as required by 45 CFR 46.111 and 46.305(a).
(g) IRB risk determination of minimal risk or greater than minimal risk
Purpose: the IRB risk determination of minimal risk or greater than minimal
risk is necessary in order for OHRP to, if appropriate, revise the permissible
45 CFR 46.306(a)(2) category of research from the one designated by the
reviewing IRB. Section 46.306(a)(2) allows four permissible categories of
subpart C research. Sections 46.305(a)(2)(i) and (ii) apply only to minimal
risk research, while sections 46.305(a)(2)(iii) and (iv) do not have a risk
limit. In circumstances in which the IRB erroneously placed the research
study in categories 46.306(a)(2)(iii) or (iv) and OHRP determines that the
elements of those categories are not satisfied and that the study may be more
appropriately categorized as 46.305(a)(2)(i) and (ii), OHRP may change the
study’s category determination. In order to do so, OHRP must know the
IRB’s determination of risk level to ensure the study does not exceed the
limitations for the revised category.
(h) The applicable permissible category or categories of research, and a
rationale as to why the research represents the specified category.
Purpose: In compliance with 45 CFR 46.305(a), the IRB must determine
that the proposed research represents a permissible category of research
under 45 CFR 46.306(a)(2), or satisfies criteria for the epidemiological
waiver.
(i) Certification that the research has been approved by an IRB that has adhered
to all responsibilities prescribed for IRBs under subpart C, that the research
under review represents one of the categories of permissible research under
45 CFR 46.306(a)(2) or falls within the epidemiological waiver, and that the
IRB has made the determinations required by 45 CFR 46.305(a)(2)-(7).
Purpose: This certification is required by 45 CFR 46.305(c), and by the
terms of the epidemiological waiver.
3.

Improved Information Technology
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OHRP use information technology to allow for electronic completion and submission
of the collected information on the Subpart C Certification form that is automatically
transferred to a database. If an institution is unable to submit the information
electronically, it can contact OHRP by phone, 240-453-8141 or email,
[email protected], to discuss an alternative submission process.
To send a subpart C certification request to OHRP, the institution must complete and
submit the Subpart C Certification form,
https://oash.force.com/ohrpwebforms/s/prisoner-web-form in conjunction with a
copy of the research proposal. 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 portions of the grant application relevant to subpart C review.
4. Duplication of Similar Information
There is no duplication of similar information relevant to this information collection.
OHRP is the only entity exercising regulatory oversight of the Subpart C certification
requirement for SuHHS-conducted or -supported research involving prisoners.
5. Small Businesses
The information collection through the Subpart C Certification Form is simple and
straightforward and represents the minimum amount of information necessary to
satisfy the Subpart C certification requirements. The information collection will not
have a significant economic impact on a substantial number of small entities.
6. Less Frequent Collection
The Subpart C Certification Form must be submitted prior to any HHS-conducted or supported non-exempt human subjects research interaction or intervention with
prisoners. The certification must be resubmitted only if there is a change in the IRBapproved category of permissible research (45 CFR 46.305(a)).
7. Special Circumstances
None.
8. Federal Register Notice/Outside Consultation
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A notice announcing a 60-day period for public comments on this information
collection was published in the Federal Register (91 FR 40543) on July 2, 2026. The
comment period ended on August 31, 2026. There were no comments submitted.
9. Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
10. Confidentiality
The public is required to submit a Freedom of Information Act (FOIA) request to
request non-public Subpart C Certification Form information.
11. Sensitive Questions
No sensitive information is being collected on the Subpart C Certification form.
12. Burden Estimate (Total Hours & Wages)
The estimate of the number of respondents is based upon the current number of
institutions certifying HHS-conducted or -supported subpart C human subjects
research to OHRP. In 2025, OHRP received fifty-one certifications from thirty-eight
institutions or organizations and one hundred percent of the respondents submitted
their certification information electronically. We project that annually, forty
institutions will submit certifications. Most respondents will submit the form twice
annually, however some respondents may submit the form 3 times annually.
Consistent with 5 CFR 1320.5(a)(1)(iv)(5), therefore, we believe this estimate
represents the total annual reporting and recordkeeping burden that will result from
the collection of information.
The burden is estimated to average one hour per Subpart C Certification Form and the
total annual burden hours are projected to be eighty-five.
12a. Estimated Annualized Burden Hours
Form name
Respondents
Number of
Number of
Respondents
Responses per
Respondent
Subpart C
Institutions or
40
2.13
Certification
Organizations
Form
operating
Institutional
Review Boards
(IRBs)
Total
5

Average Burden
per Response (in
hours)
1.0

Total Burden
hours
85

85

We expect that respondents will be research staff persons (to include IRB
administrators and Human Protection Administrators), at organizations and
institutions. The hourly wage is estimated to be an average $55.80 and the total
estimated annualized burden cost is estimated to be $2,681.25
12b. Estimated Annualized Burden Costs
Form Name
Number of
Burden
Respondents
Hours
Subpart C
40
85
Certification
Form
Total

Hourly Wage
$55.80

Total Respondent
Costs
$4,743.00
$4,743.00

The total annualized cost for completing the HHS Subpart C Certification form
is $14,229.
OHRP estimates an average submitter’s hourly wage rate of $55.80 per hour (for
institutional officials, administrators, administrative staff). This is based on the 2026
OPM hourly pay tables and is equivalent to a GS 12, step 5. The total annual costs for
completing and submitting certification information electronically is estimated to be
85 burden hours X $55.80/hour = $4,743 plus a 200% fully loaded rate of $9,486
accounting for benefits, etc.
(85 burden hours X 55.80/hour) = $4,743 plus a 200% fully loaded rate of $9,486 that
accounts for benefits, etc.
$4,743 + $9,486= $14,229
13. Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the
instructions and to complete the Subpart C Certification Form.
14. Cost to Federal Government
The estimated annual Federal costs is $137,701: $54,701 for reviewing and accepting
Subpart C certifications and $87,000 for operating the database.
15. Program or Burden Changes
The burden calculation has been adjusted to account for the number of institutions
that submitted for certifications, average responses per institution annually, and the
time required to complete a certification. We estimate that an average of forty
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institutions will submit certifications: thirty-five of the institutions will submit two
certifications (35 x 2= 70); five of the forty institutions will submit three certifications
(5 x 3= 15); and that each certification will require 1 hour to complete, accounting for
the estimated 85 response burden hours. This represents an increase in annual burden
hours of 20 hours compared to the previously approved burden. The change accounts
for agency adjustments based on data on the number of institutions that submitted
certifications.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish or tabulate the information.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
No exception is requested.

B. Justification of Information Employing Statistical Methods
Not Applicable

LIST OF ATTACHMENTS
Attachment 1 – Legal Authorities
a. 42 U.S.C Section 289
b. 45 CFR 46 (pre-2018 Requirements)
c. 45 CFR 46 (2018 Requirements)

Attachment 2 – Subpart C Certification Form

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