SS_Assurance ID.IRB Certification.Exemption Declaration Form 0990-0263_03.17.21

Supporting Statement for the Assurance Identification/IRB
Certification/Declaration of Exemption Form

Background
The Office for Human Research Protections (OHRP) is requesting a 3-year extension of
the Protection of Human Subjects: Assurance Identification/IRB/Institutional Review
Board Certification/Declaration of Exemption Form, OMB No. 0990-0263. The purpose
of the form is to provide a simplified procedure for institutions engaged in research
conducted or supported by the Department of Health and Human Services (HHS) to
satisfy the requirements of HHS regulations for the protection of human subjects at 45
CFR 46.103 for assurance identification, and IRB certification, and declaration of exempt
status. The respondents for this collection are institutions engaged in research involving
human subjects where the research is supported by HHS. Institutional use of the form is
also relied upon by other federal departments and agencies that have codified or follow
the Federal Policy for the Protection of Human Subjects (the Common Rule, which is
codified for HHS at 45 CFR part 46, subpart A).

A.

Justification
In this supporting statement, the term “pre-2018 Common Rule (or pre-2018
Requirements)” refers to subpart A of 45 CFR part 46 (i.e., the Common Rule) as
published in the 2016 edition of the Code of Federal Regulations. The pre-2018
Requirements were originally promulgated in 1991 and subsequently amended on June
23, 2005 (70 FR 36325).
The term “2018 Common Rule (or 2018 Requirements)” refers to the revised Common
Rule as published in the July 19, 2018 edition of the Code of Federal Regulations. The
2018 Requirements were originally published on January 19, 2017 (82 FR 7149) and
further amended on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497).

1.

Need and Legal Basis

Section 491(a) of Pub. L. 99-158 states that the Secretary of HHS shall by regulation
require that each entity applying for HHS support (e.g., a grant, contract, or cooperative
agreement) to conduct research involving human subjects submit to HHS an assurance
satisfactory to the Secretary that it has established an IRB to review the research in order
to protect the rights of the human subjects of such research. IRBs are boards, committees,
or groups formally designated by an entity to review, approve, and conduct continuing
oversight of research involving human subjects. The pertinent authorizing legislation is
provided in Attachment 1.a., (42 U.S.C. 289).
Pursuant to the requirement of the Public Law, HHS has promulgated regulations under
45 CFR part 46. These regulations require that, before engaging in HHS-conducted or supported research that is not exempt under 45 CFR 46.101(b) (pre-2018 Requirements)
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and 45 CFR 46.103 (2018 Requirements) or waived under 45 CFR 46.101(i), each
institution must:
(1) Hold an applicable OHRP-approved written assurance of compliance
with the regulations [45 CFR 46.103(a)]; and either
(2) Certify to the awarding HHS agency that the application or proposal
for research has been reviewed and approved by an IRB [45 CFR
46.103(b) and (f) in the pre-2018 Requirements], or
(3) Certify to the awarding HHS agency that each proposed research study
has been reviewed and approved by an IRB [45 CFR 46.103(a) and (d) in
the 2018 Requirements].
Pre-2018 Requirements
Common Rule Department or Agency Signatories:
Number
Department or Agency
1
Department of Agriculture
2
Department of Energy
3
National Aeronautics and Space Administration
4
Department of Commerce
5
Agency for International Development
6
Department of Housing and Urban Development
7
Department of Justice
8
Department of Defense
9
Department of Education
10
Department of Veterans Affairs
11
Environmental Protection Agency
12
Department of Health and Human Services
13
National Science Foundation
14
Department of Transportation
15
Consumer Product Safety Commission

CFR Citation
7 CFR Part 1c
10 CFR Part 745
14 CFR Part 1230
15 CFR Part 27
22 CFR Part 225
24 CFR Part 60
28 CFR Part 60
32 CFR Part 219
34 CFR Partm97
38 CFR Part 16
40 CFR Part 26
45 CFR Part 46
45 CFR Part 690
49 CFR Part 11
16 CFR Part 1028

Common Rule Department or Agency Executive Order or Statutory Mandate:
Number
Department or Agency
EO/Statutory Mandate
1
Department of Homeland Security
Pub. L. 108-458, title VIII, section
8306
2
Social Security Administration
Pub. L. 103-296, Section 106
3
Office of the Director of National
Executive Order 12333
Intelligence
4
Central Intelligence
Executive Order 12333
Agency

2018 Requirements
Common Rule Department or Agency Signatories1:
1

Department of Justice intends to become an official signatory.

2

Number
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

Department or Agency
Department of Homeland Security
Department of Agriculture
Department of Energy
National Aeronautics and Space Administration
Department of Commerce
Social Security Administration
Agency for International Development
Department of Housing and Urban Development
Department of Labor
Department of Defense
Department of Education
Department of Veterans Affairs
Environmental Protection Agency
Department of Health and Human Services
National Science Foundation
Department of Transportation
Consumer Product Safety Commission

CFR Citation
6 CFR Part 46
7 CFR Part 1c
10 CFR Part 745
14 CFR Part 1230
15 CFR Part 27
20 CFR Part 431
22 CFR Part 225
24 CFR Part 60
29 CFR Part 21
32 CFR Part 219
34 CFR Part 97
38 CFR Part 16
40 CFR Part 26
45 CFR Part 46
45 CFR Part 690
49 CFR Part 11
16 CFR Part 1028

Common Rule Department or Agency Via Executive Order:
Number
Department or Agency
EO/Statutory Mandate
1
Office of the Director of National
Executive Order 12333
Intelligence
2
Central Intelligence Agency
Executive Order 12333
2.

Information Users
Information obtained on the authority of 45 CFR 46.103(b) and (f) of the pre-2018
Requirements and the authority of 45 CFR 46.103(a) and (d) of the 2018 Requirements is
provided by the holder of an acceptable assurance as affirmation that (1) the
institution/organization has established adequate administrative policies and procedures
for protecting the rights and welfare of human subjects in research and (2) it accepts this
responsibility.

3.

Improved Information Technology
Institutions submitting a Federalwide Assurance (FWA) will electronically submit all
information for initial FWAs, or updates and renewals of existing FWAs, including the
signature of the signatory official, via the internet using an interactive page on the OHRP
website. OHRP’s technology permits it to accept electronic signatures, eliminating the
need for submission of paperwork, except for the rare instance in which an institution
lacks the ability to submit the FWA electronically. Between January 1, 2020 and
November 16, 2020, OHRP approved 3,003 FWAs, and all were submitted electronically.
OHRP anticipates that nearly all institutions will continue to submit FWA information
via the internet.
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4.

Duplication of Similar Information
The Assurance Identification/IRB Certification/Declaration of Exemption Form does not
duplicate any other information collection effort that OHRP is aware of.

5.

Small Businesses
Funding of research activities involving human subjects extends to small businesses. The
committee that developed the Common Rule considered ways to reduce the burden on
small businesses or organizations that receive federal support and determined that it is not
feasible to do so. However, organizations that do not already have approved assurances
that would apply to proposed research (likely to be small organizations) do not have to
certify IRB review until it is requested, and generally only when an award is expected to
be made.

6.

Less Frequent Collection
Reporting of IRB approval is required with the submission of an application or proposal,
or proposed research study, or at such later date as specified by the agency/department
sponsoring the research. Institutions without an approved assurance covering the research
shall certify within 30 days after receipt of a request for such a certification from the
Common Rule department or agency that the application or proposal, or proposed
research study, has been approved by an IRB. This is necessary to ensure that federally
supported research involving human subjects is subjected to the continuing IRB review
and approval that is required at least once per year (unless the research does not require
continuing review as permitted for some research in 45 CFR 46.109(f)(1) of the 2018
Requirements). The obligation to protect human subjects is an ongoing responsibility and
not a one-time effort. In general, continuing review is required because changes in
research protocols, new scientific or medical findings or innovations, as well as
preliminary results or ongoing research, may change the degree of risks to the subjects.
Reporting the date of continuing review and approval with the application describing
those changes notifies the funding department/agency of IRB approval of the altered
protocol.

7.

Special Circumstances
None.

8.

Federal Register Notice/Outside Consultation
Public comments were solicited for a 60-day comment period in the Federal Register (86
FR 4100) on January 15, 2021. No comments were submitted.

9.

Payment/Gift to Respondents
No payment or gifts are provided to respondents.
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10.

Confidentiality
The reporting of IRB review is a part of the grant or contract file and is available in many
cases under the Freedom of Information Act. In the past, the information collected under
an assurance was considered releasable under the Freedom of Information Act (FOIA).
However, OHRP no longer requires public requesters to submit a FOIA request in order
to obtain non-public assurance information.

11.

Sensitive Questions
No sensitive information is collected on the form.

12.

Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Specific burden estimates for the Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form are provided below.

Estimated Annualized Burden in Hours for IRB Certification Burden
Number of
Number of
Hours per
Form name
Respondents Responses
Response
per
Respondent
Protection of Human
14,000
2
0.5
Subjects: Assurance
Identification/IRB
Certification/Declaration of
Exemption

Response
Burden
Hours
14,000

Institutions seeking support for human subjects research are required by 45 CFR
46.103(f) of the Pre-2018 Requirements and 45 CFR 46.103(d) of the 2018 Requirements
to certify that each application or proposal, or proposed research study, has been
reviewed and approved by an IRB. The estimate of the number of respondents is based on
the current number of institutions with an active OHRP-approved FWA; 13,687 (as of
11/16/2020), and projecting that the number may increase to 14,000. We estimate that
there will be an average of 2 certifications per institution annually (14,000 x 2 = 28,000)
and that each certification will require 30 minutes to complete, accounting for the
estimated 14,000 response burden hours. This represents no change in annual burden
hours compared to the previously approved burden.
12 b. Annualized Cost Burden Estimate
OHRP staff estimates an average submitter’s hourly wage rate of $40 per hour. The total
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annual costs for reading and understanding instructions and entering the information on
the form are estimated to be $560,000 (14,000 burden hours x $40/hour = $560,000). The
estimated burden dollars did not change compared to the previously approved burden.
Total Estimated Annualized Burden Table
Total Burden
Hourly
Total Burden
Hours
Wage Rate
Dollars
Form name
Protection of Human
14,000
$40/hour
$560,000
Subjects: Assurance
Identification/IRB
Certification/Declaration of
Exemption

13.

Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the
instructions and complete the form.

14.

Cost to the Federal Government
The estimated annual federal cost of reviewing certifications of IRB approval required
under HHS regulations at 45 CFR 46.103 is $467,000.

15.

Program or Burden Changes
The annual burden will be $560,000, which will be no change compared to the prior
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.

Certification Exceptions to Certification for Paperwork Reduction Act
Submissions
No exception is requested.

B.

Justification of Information Employing Statistical Methods
Not applicable.
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LIST OF ATTACHMENTS
Attachment 1 - Legal Authorities
a. 42 U.S.C. Section 289
b. 56 F.R. 28003 (Common Rule), i.e., Pre-2018 Requirements
c. 45 CFR Part 46, Subpart A (i.e., 2018 Requirements)
Attachment 2 – Protection of Human Subjects: Assurance Identification/IRB
Certification/Declaration of Exemption Form - OMB 0990-0263

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Attachment 1.a. - Legal Authorities

42 U.S.C. Section 289
TITLE 42 – The Public Health and Welfare
CHAPTER 6A – PUBLIC HEALTH SERVICE
SUBCHAPTER III – NATIONAL RESEARCH INSTITUTES
Part H – General Provisions

INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
Sec. 491. [289](a) The Secretary shall by regulation require that each entity which applies for a
grant, contract, or cooperative agreement under this Act for any project or program which
involves the conduct of biomedical or behavioral research involving human subjects submit in or
with its application for such grant, contract, or cooperative agreement assurances satisfactory to
the Secretary that it has established (in accordance with regulations which the Secretary shall
prescribe) a board (to be known as an Institutional Review Board) to review biomedical and
behavioral research involving human subjects conducted at or supported by such entity in order
to protect the rights of the human subjects of such research.
(b)(1) The Secretary shall establish a program within the Department of Health and Human
Services under which requests for clarification and guidance with respect to ethical issues raised
in connection with biomedical and behavioral research involving human subjects are responded
to promptly and appropriately.
(2) The Secretary shall establish a process for the prompt and appropriate response to
information provided to the Director of NIH respecting incidences of violations of the rights of
human subjects of research for which funds have been made available under this Act. The
process shall include procedures for the receiving of reports of such information from recipients
of funds under this Act and taking appropriate action with respect to such violations.
(July 1, 1944, ch. 373, title IV, Sec. 491, as added Pub.L. 99-158, Sec. 2, Nov. 20, 1985, 99 Stat.
873.)

Attachment 1.b. - Legal Authorities

56 FR 28003 (i.e., Pre2018Requirements)

Attachment 1.c. - Legal Authorities

45 CFR 46 (i.e., 2018 Requirements)
An official version of the 2018 Requirements in 45 CFR 46 of the July 19, 2018 edition of the eCode of Federal Regulations can be accessed at: https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.
46&r=PART&ty=HTML

Attachment 2
Proposed OMB No. 0990-0263

Protection of Human Subjects:
Assurance Identification/Certification/
Declaration of Exemption