Supporting Statement - Renewed HHS Subpart C Certification Form_May 2023

Supporting Statement for the Department of Health and Human Services
(HHS) Subpart C Research Certification Form
Background
The Office for Human Research Protections (OHRP) is requesting a three-year extension of
OMB No. 0990-0473, the HHS Subpart C Research Certification Form, currently approved
through July 31, 2023. This information collection request includes three new information
elements (Name(s) of Institutions Relying on the IRB of Record; Program Officer’s Email
Address; and the IRB Determination Regarding the Risk Level of the Study) and clarification in
two information elements (Name and address of the IRB of Record Institution; and Contact
information for the IRB of record) on the current Subpart C Research Certification Form.
The purpose of the Subpart C Research Certification Form is to provide a simplified,
standardized procedure for institutions to 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 information collection are institutions or organizations which operate the
IRB of record that approved the research, or the non-institutional IRBs that serve as the IRB of
record.

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 and welfare 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 part 46 1.
Subpart C, 45 CFR part 46, provides “Additional Protections Pertaining to

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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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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)); a waiver was later added in
2003 under 46.101(i) for epidemiological studies which satisfy certain criteria and
involve prisoners as subjects (https://www.govinfo.gov/content/pkg/FR-2003-0620/html/03-15580.htm). This “epidemiological waiver” 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 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.”
Under OHRP’s current implementation of this certification requirement, 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. For purposes of certification, the term "research
proposal" includes:
•
•
•

the IRB-approved protocol and consent forms, if any;
any IRB application forms required by the IRB; and
any other information requested or required by the IRB to be considered during
IRB review

2. Information Users
To standardize and facilitate the processing and recordation of such certifications,
the Subpart C Research Certification Form requests the following information, for
the following purposes:
(a) The name and address of the institution that operates the IRB of record which
approved the research (or the name and address of the non-institutional IRB
that serves as the IRB of record), 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 institution
or the IRB of record directly to ask questions, forward information, and send
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electronic mail to that contact person.
(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 granting institution contact information for future correspondence for
questions or notification of final disposition.
(c)

IRB Registration number
Purpose: OHRP uses this information to identify the specific IRB which
conducted the subpart C review. OHRP posts a list of registered IRBs on its
website, including the name and location of each IRB and the name and
location of the organization operating the IRB.

(d) OHRP Assurance number
Purpose: OHRP collects this information to be able to contact the institutional
official at the site engaged in human subjects research, if necessary.
(e) Study title, name and degree of Principal Investigator, and brief summary of
the protocol
Purpose: OHRP uses this information to identify the research study,
responsible investigator, and the research context.
(f) Dates of IRB approval under Subpart C
Purpose: The dates of initial and/or Subpart C review 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 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 46.306(a)(2)(i) and (ii) apply only to minimal risk research,
while (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 46.306(a)(2)(i) and
(ii), OHRP may change the study’s category determination. 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.
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(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.
(j) Names of institutions relying on the reviewing IRB as the IRB of record for the
subpart C review and certification of this study.
Purpose: In cases in which the reviewing IRB is acting as the IRB of record on
behalf of multiple institutions, this provides clarity regarding to which
institutions the certification applies.
3.

Improved Information Technology
OHRP uses information technology to allow for electronic completion and
submission of the collected information on the Subpart C Certification form which is
automatically transferred to a database. If an institution or organization 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.

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 HHS-conducted or -supported non-exempt 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.
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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
Public comments were solicited for a 60-day period in the Federal Register published
on March 16, 2023 (88 FR 16275). No comments were 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.
The information in this database is not public and will only be made available to the
public through a FOIA request.
11. Sensitive Questions
No sensitive information is being collected by 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 non-exempt human
subjects research to OHRP. In 2021, OHRP received fifty certifications from twentynine institutions or organizations and one hundred percent of the respondents
submitted their certification information electronically. We project that annually;
thirty institutions will submit certifications: twenty-five of the institutions will submit
two certifications and five of the thirty institutions will submit three certifications.
The burden is estimated to average one hour per Subpart C Certification Form and the
total annual burden hours are projected to be sixty-five.
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12a. Estimated Annualized Burden Hours
Form name
Number of
Number of
Respondents
Responses
per
Respondent
Subpart C
25
2
Certification
Form
Subpart C
5
3
Certification
Form
Total

Average
Burden per
Response
(in hours)
1.0

Total Burden
hours

1.0

15

50

65

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 $41.35 and the total
estimated annualized burden cost is estimated to be $2,681.25.
12b. Estimated Annualized Burden Costs
Form Name
Number of
Burden Hours
Respondents
Subpart C
Certification
Form
Subpart C
Certification
Form
Total

Hourly Wage

25

50

$41.25

Total
Respondent
Costs
$2,062.50

5

15

$41.25

$618.75

$2,681.25

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 Government cost 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 annual burden estimates changed compared to the current burden estimates. The changes
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are due to agency adjustments. The total annual burden in the current OMB-approved
information collection (eighty hours and $1,392.80, respectively) is projected to be sixty-five
hours and $2,681.25, respectively, in this information collection request.

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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