Supporting Statement_Sub C Research Certification Form PRA New ICR_04.14.2020

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 approval of the Department of
Health and Human Services (HHS) Subpart C Research Certification Form. This form will
facilitate the collection of information relevant to an institutional request for OHRP authorization
of research involving prisoners; the information in the form will be entered into OHRP’s prisoner
research database, and will be used by OHRP to draft a response certification letter back to the
institution. This is a new information collection request.
The Subpart C Research Certification Form will provide institutions with a simplified,
standardized procedure for submitting subpart C research certification requests to OHRP in order
to obtain authorization to include prisoners in human subjects research. The form will also
simplify the internal process used by OHRP to review and record such certifications in the
prisoner research database, which is then used to draft the OHRP response certification letter
back to the institution, resulting in faster processing while reducing unnecessary and burdensome
staff time.
The respondents for this collection are institutions or organizations operating Institutional
Review Boards (IRBs) that have approved enrollment, or are planning to approve enrollment, of
prisoners in human subjects research conducted or supported by HHS.

A.

Justification
1. Need and Legal Basis
Section 491(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.
45 CFR part 46, subpart C, 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
permissibly may be involved (see 45 CFR 46.306(a)(2)) and a later-added
epidemiological waiver which functions as a narrow fifth category of permissible
research. An IRB reviewing proposed research under 45 CFR 46.306(a)(2) involving
prisoners must make seven findings, including the finding that the proposed research
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represents one of the permissible categories of research under section 46.306(a)(2).
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 made the seven findings required under 45 CFR 46.305(a); 45 CFR
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 practice, the institution must send OHRP a certification
request letter, which must include the name and address of the institution, specific
identification of the research protocol, and relevant materials for review. After
reviewing the materials, OHRP determines whether the research conforms to a
permissible category of research, and issues a letter concurring or non-concurring
with the institution’s cited provision. The concurrence from OHRP authorizes the
inclusion of prisoner-subjects in human subjects research, and allows the release of
HHS funding for such research.
In order to review a certification request regarding research subject to subpart C, and
under its authority at 45 CFR 46.115(b), OHRP requires the responsible institution to
submit to OHRP a copy of the research proposal so that OHRP can determine
whether the proposed research involves one of the categories of research permissible
under 45 CFR 46.306(a)(2). 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 to be collected
In order 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 of institution, and name, title or position, mailing address, phone
number, and electronic mail address of the contact person providing the
certification information.
(Note: submitting the following information for the contact person is optional:
title or position)

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Purpose: OHRP will use this information to communicate with the institution
directly to ask questions, forward information, and send electronic mail to the
institution through that contact person.
(b) Relevant grant number, granting institution, and name 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) IRB Registration number
Purpose: OHRP uses this information to identify the specific IRB which
performed 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. Institutions
that only serve as an IRB will not have this number.
(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) 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.
(h) 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
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46.306(a)(2) or falls within the epidemiological waiver, and that the IRB has
made the determinations required by 45 CFR part 46.305(a)(2)-(7).
Purpose: This certification is required by 45 CFR 46.305(c).
(i) Names of institutions (and associated institutional Assurance numbers) 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 certifying IRB is acting as the IRB of record on
behalf of multiple institutions, this provides clarity regarding which institutions
have fulfilled the certification requirement.
3.

Improved Information Technology
OHRP’s current practice is to require that subpart C certifications be submitted
electronically. This practice will be continued, and the subpart C certification will be
submitted to [email protected]. If an institution or organization lacks the ability to
submit a subpart C certification electronically, it should contact OHRP and may send
its certification information in writing to OHRP.

4. Duplication of Similar Information
There is no duplication of similar information relevant to this information collection.
OHRP is the only entity overseeing application of 45 CFR part 46 to HHS-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 OHRP 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 human subjects research interaction or intervention with prisoners. The
certification must be resubmitted only if there is a change in the IRB-approved
category of permissible research (45 CFR 46.305(a)).
7. Special Circumstances
None.
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8. Federal Register Notice/Outside Consultation
Public Comments were solicited for a 60-day period in the Federal Register published
on September 13, 2019 (84 FR178, p. 48359) on this proposed collection. 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 database information. The information
from the form in the database is not affirmatively made public due to policy
considerations; it will only be made public to the extent required by the FOIA in
response to a FOIA request.
The Subpart C Certification Form does not collect information that is subject to the
Privacy Act; all information collected is about institutions (entities). Although the
names and contact information described in 2(a), (b), and (e) identify particular
individuals, each individual is merely serving as an institution’s point of contact or
Principal Investigator. The described purposes for which such names and contact
information are used concern or affect only the institutions.
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 human subjects
research to OHRP. In 2018, 100 percent of the respondents submitted their
certification information electronically.
The burden is estimated to average one hour per Subpart C Certification Form. If on
average 80 previous respondents submit certifications each year, the total annual
burden hours are projected to be 80 hours.

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Estimated Annualized Burden Table
No.
Average Burden
Type of
No. of
Responses
per Response (in
Respondent Respondents
per
hours)
Respondent
Subpart C
Certification
40
2
1
Forrm
Total

Total
Burden
Hours
80

80

The estimate of the hours per response assumes that all respondents will complete the
Subpart C Certification Form and email it to [email protected]. The time estimate
includes an estimate of the time needed to (i) read and understand the instructions for
completing the IRB Registration Form; (ii) collect the information to complete the
form; and (iii) enter the information requested on the IRB Registration Form. Based
on OHRP’s experience in processing current subpart C certifications, most of the
respondents will be administrative staff persons within organizations and institutions.
The hourly wage is estimated to be $17.41 and the total burden cost is estimated to be
$1,392.80.

Type of
Respondent
Subpart C
Certification
Form

Total Estimated Annualized Burden Table
No. of
No.
Hourly Wage
Respondents Responses per
Rate
Respondents
40
2
$17.41

Total
Burden
Dollars
$1,392.80

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 for reviewing and accepting Subpart C
Certification Forms is $42,914.00.
15. Program or Burden Changes
This is the initial request, therefore there are no changes to note.
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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. Section 289 of the Public Health Service Act
b. Title 45 Code of Federal Regulations Part 46, Subpart C
Attachment 2- Subpart C Research Certification Form

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