Supporting Statement_FWA 0990-0278_30-Day PRA _07.23.2020

Supporting Statement for the Federalwide Assurance (FWA)
Background
The Office for Human Research Protections (OHRP) is requesting a three-year extension of the
OMB No. 0990-0278, Federalwide Assurance (FWA) for the Protection of Human Subjects
Form, currently approved through July 31, 2020, with no changes in the collected information.
The purpose of the FWA 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
assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act) (42
U.S.C. 289); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103.
The respondents for this collection are research institutions engaged in HHS-conducted or –
supported research involving human subjects.
A.

Justification
1. Need and Legal Basis
Section 491(a) of the PHS Act states that the Secretary shall by regulation require that
each entity applying for HHS support to conduct research involving human subjects
submit to HHS “assurances” satisfactory to the Secretary that it has established an
institutional review board (IRB) to review the research in order to protect the rights
and welfare of the human subjects of such research.
Pursuant to the requirements of the PHS Act, HHS has promulgated regulations for
the protection of human subjects at 45 CFR part 46. These regulations require that
each institution engaged in research which is covered by the regulations and which is
conducted or supported by HHS provide written assurance satisfactory to the
Secretary that it will comply with the requirements set forth in the regulations
[45 CFR 46.103(a)]. In lieu of requiring submission of an assurance, each of the 16
other departments and agencies that have adopted the Federal Policy for the
Protection of Human Subjects (the Federal Policy) shall accept the existence of a
current assurance, appropriate for the research in question, on file with, and approved
for Federalwide use by, the Office for Human Research Protections (OHRP)
[45 CFR 46.103(a)].
In accordance with HHS regulations at 45 CFR 46.103(b), assurances applicable to
HHS-conducted or supported research shall at a minimum include:
(a) A statement of principles governing the institution in the discharge of its
responsibilities for protecting the rights and welfare of human subjects of
research conducted at or sponsored by the institution, regardless of whether
the research is subject to Federal regulations [45 CFR 46.103(b)(1)].
(b) Designation of one or more IRBs established in accordance with the
requirements of the HHS regulations [45 CFR 46.103(b)(2)].
(c) A list of IRB members identified by name, qualifications, and affiliations

[45 CFR 46.103(b)(3)].
(d) Written procedures which the IRB will follow for conducting its reviews of
research [45 CFR 46.103(b)(4)].
(e) Written procedures for ensuring prompt reporting to the IRB, appropriate
institutional officials, and the Secretary of (i) any unanticipated problems
involving risks to subjects or others or any serious or continuing
noncompliance with 45 CFR part 46 or the requirements or determinations of
the IRB; and (ii) any suspension or termination of IRB approval
[45 CFR 46.103(b)(5)].
The assurance must be executed by an individual authorized to act for the institution
and to assume on behalf of the institution the obligations imposed by the HHS
regulations, and must be filed in such form and manner as the Secretary prescribes
[45 CFR 46.103(c)].
OHRP is the HHS component charged with fulfilling the statutory mandates of these
provisions of the PHS Act and enforcing HHS regulations at 45 CFR part 46. The
FWA provides a simplified assurance process that replaced the prior assurance
mechanisms used by OHRP, all of which were more complicated and burdensome
than the FWA. The information collected by OHRP through the FWA is the
minimum necessary to satisfy the assurance requirements of the PHS Act and the
requirements of HHS regulations at 45 CFR 46.103.
2. Information Users
The FWA collects the following information for the following purposes:
(a) The legal name, location and the current OHRP-approved assurance number
(if the institution already has an FWA) of the institution filing the FWA.
Purpose: OHRP uses this information to identify the specific institution to
which the FWA will apply. OHRP will make available the names and
locations of institutions holding an approved FWA to all components of HHS
that support research involving human subjects so that these components can
confirm that a particular institution holds an approved assurance satisfactory
to the Secretary before making an award to support research involving human
subjects.
(b) A list of components over which the institution submitting the FWA has legal
authority that operate under a different name; and any alternate names under
which the institution operates.
Purpose: Sec 2 (a) above

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(c) A checkbox indicating the statement of principles (Belmont Report,
Declaration of Helsinki, or other) that govern the institution in the discharge
of its responsibilities for protecting the rights and welfare of human subjects
of research conducted at or sponsored by the institution, regardless of whether
the research is subject to Federal regulation. When only the “Other” box is
checked, the institution is asked to submit a copy of the statement of
principles with the FWA form.
Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at
45 CFR 46.103(b)(1).
(d) An optional checkbox which allows U.S. institutions to elect voluntarily to
apply either 45 CFR part 46 and all its subparts, or just 45 CFR part 46,
subpart A (also known as the Common Rule, or the Federal Policy for the
Protection of Human Subjects), to all of its research regardless of the source
of support for the research.
Purpose: OHRP uses this information to define precisely the applicability of
the FWA.
(e) For the FWA of International (Non-U.S.) Institutions, a checkbox is to be
completed indicating the procedural standards that the institution will apply to
its U.S. federally supported research, in addition to the Federal Policy for the
Protection of Human Subjects.
Purpose: OHRP obtains this information in order to be informed of whether
an international institution applies another procedural standard to the conduct
of U.S. federally supported research, in addition to the Federal Policy for the
Protection of Human Subjects.
(f) A list of internal IRBs, by name and registration number, that an institution
will rely upon to review the research to which the FWA applies; or, if the
institution has no internal IRB the external IRB, by name and registration
number that the institution will rely upon, or if only multiple external IRBs are
relied upon, the name and registration number of the external IRB that
reviews the largest percentage of research to which the FWA applies.
Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at
45 CFR 46.103(b)(2).

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(g) The name, degree(s) or suffix, institutional title, address, telephone number,
facsimile number, and e-mail address of the human protections administrator
(i.e., the person who can serve as primary point of contact for the institution’s
system for protecting human subjects).
Purpose: This information is collected so that OHRP has a central point of
contact at the institution for questions and issues related to the FWA and the
institution’s procedures for protecting human subjects. The information can
be used by OHRP to disseminate important information and announcements
related to human subject protections issues and provides a means for
enhancing communication between OHRP and institutions engaged in
research conducted or supported by HHS. The information also will facilitate
OHRP’s ability to conduct (i) its compliance oversight program that responds
to allegations or indications of noncompliance with the HHS regulations at 45
CFR part 46 and the terms of the assurance; and (ii) its education program for
providing clarification and guidance concerning ethical issues related to
human subjects research.
(h) The name, degree(s) or suffix, institutional title, address, telephone number,
facsimile number, and e-mail address of the signatory official (i.e., the official
legally authorized to represent the institution). The signatory official must
assure that human subjects research to which the FWA applies is conducted in
accordance with the terms of assurance and sign and date the FWA. The
signatory official must electronically sign the FWA using the electronic
submission system available through the OHRP Web site at
http://ohrp.cit.nih.gov/efile/, unless the institution lacks the ability to submit
its FWA electronically.
Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at 45 CFR 46.103(c).
The information can be used by OHRP to disseminate important information
and announcements related to human subject protections issues and to provide
a means for enhancing communication between OHRP and institutions
engaged in research conducted or supported by HHS. The information also
will facilitate OHRP’s ability to conduct (i) its compliance oversight program
that responds to allegations or indications of noncompliance with the HHS
regulations at 45 CFR part 46 and the terms of the assurance; and (ii) its
education program for providing clarification and guidance concerning ethical
issues related to human subjects research.
OHRP, upon request, will make available information collected in the FWA to other
Federal departments and agencies that have adopted the Federal Policy and find the
FWA appropriate for the human subjects research which they conduct or support.
This will enable such departments and agencies to confirm that a particular institution
holds an applicable assurance approved for Federalwide use before making an award
to that institution to support research involving human subjects. The other Federal
departments and agencies will also be able to use this information to contact
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appropriate institutional officials for questions and issues related to the human
subjects research conducted or supported by these departments and agencies at the
institution.
OHRP provides two supplemental sample forms that may be used by institutions
submitting or holding FWAs, but are not collected routinely by OHRP. The first
form is an IRB Authorization Agreement. When an institution holding an OHRPapproved FWA relies upon an IRB operated by another organization or institution to
review HHS-conducted research, the institution holding the FWA must execute an
IRB Authorization Agreement with the organization operating the IRB. This
agreement defines in writing the circumstances under which the IRB will be used by
the institution submitting the FWA and both the signatory official of the institution
submitting the FWA and the signatory official of the organization operating the IRB
must sign the IRB Authorization form. The form is kept on file by both institutions
and is to be made available to OHRP upon request. Institutions are free to modify the
form or develop their own form to cover an IRB Authorization arrangement.
The second supplemental form is an Individual Investigator Agreement. An
institution with an approved FWA may use this form to extend the applicability of the
FWA to individual investigators who are not otherwise employees or agents of an
assured institution. The form defines in writing the circumstances under which the
collaborating investigator is covered by the institution’s FWA. The purpose of the
form is to provide a simplified mechanism that allows an institution with an FWA to
extend the applicability of its FWA to cover collaborating investigators, in lieu of
OHRP requiring that each such individual investigator submit a separate FWA
document. The form is kept on file by the FWA institution and is to be made
available to OHRP upon request. Institutions are free to modify the form or develop
their own form to cover a collaborating individual investigator.
3. Improved Information Technology
Institutions submitting a 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 has the technology that permits OHRP to accept electronic signatures of
Signatory Officials for the FWA. This eliminates the need for submission of any
paperwork, except for rare institutions that lack the ability to submit their FWAs
electronically. Between September 1, 2014 and February 10, 2017, OHRP approved
7,624 FWAs and 7,623 of these FWAs were submitted electronically. OHRP
anticipates that virtually all institutions will continue to submit FWA information
electronically via the internet.
4. Duplication of Similar Information
The FWA does not duplicate any other information collection by OHRP.
5. Small Businesses
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The information collected through the FWA represents the minimum amount of
information necessary to satisfy the assurance requirements of the PHS Act and HHS
regulations at 45 CFR 46.103. The information collection will not have a significant
economic impact on a substantial number of small entities. Furthermore, the
simplified assurance procedure provided by the FWA reduces burdens on small
entities by (i) eliminating the need for multiple assurance submissions (previously,
OHRP in most cases required submission of a separate assurance, called a Single
Project Assurance, for each HHS grant, contract, and cooperative agreement
supporting human subjects research that was awarded to a small entity); and (ii)
making it easier for small entities to identify and rely upon IRBs of other institutions.
The FWA also facilitates collaboration between small businesses and large academic
institutions.
6. Less Frequent Collection
Institutions are required to update the FWA within 90 days after changes occur
regarding the legal name of the institution, the Human Protections Administrator or
the Signatory Official. Each institution must renew its FWA every 5 years, even if no
changes have occurred, in order to maintain an active FWA.
7. Special Circumstances
None.
8. Federal Register Notice/Outside Consultation
Comments were requested related to this information collection during a 60-day
period in the Federal Register issue that was published on April 24, 2020 (85 FR, No.
80, p 23051). No public comments were submitted during the comment period.
9. Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
10. Confidentiality
The information collected under the FWA in the past was considered releasable under
the Freedom of Information Act (FOIA). However, currently OHRP no longer
require public requesters to submit a FOIA request in order to obtain non-public
FWA information.
The database used to track FWA data, referred to as the Human Assurance Tracking
System (HATS) uses Microsoft SQL Server tables stored on a server that are
maintained by the Center for Information Technology, National Institutes of Health.
The HATS application screens and associated FWA tables/server utilize a
username/password and appropriate session variables to access and modify the FWA
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data. Without the appropriate username/password, unauthorized users will not gain
access to the FWA database. FWA database tables will never be provided outside of
OHRP. Requests for FWA information are fulfilled via printed reports or disk files
containing extracted information.
The public can retrieve data from FWA database tables via the internet search screens
found on the OHRP website at https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc..
This link provides read only access to the name, location, and FWA assurance
number of institutions holding an active OHRP-approved FWA. Information
provided to the public via the OHRP website does not include the names and contact
information of the FWA signatory official or human protections administrator
identified in the FWA form. This information is accessible to appropriate
representatives of the other Federal departments and agencies that have adopted the
Federal Policy via a secure internet connection requiring a username and password.
The public would need to contact OHRP to obtain this information. Of note, the
public and other agencies do not have the ability to modify the FWA database tables.
11. Sensitive Questions
No sensitive information is being collected by the FWA.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Burden estimates with respect to the assurance requirements under HHS regulations
at 45 CFR 46.103 were accounted for under the Paperwork Reduction Act
Submission to OMB that was approved under Control Number 0990-0260. Specific
burden estimates for the FWA form only are provided below.
The information being requested in the FWA form should be readily available to any
institution engaged in human subjects research conducted or supported by HHS as
part of its normal operating practices.
Estimated Annualized Burden in Hours Table
Form name

Number of
Respondents

Federalwide
Assurance
(FWA)

14,000

Number of
Responses per
Respondent
2.0

Hours per
Response

Response
Burden Hours

0.50

14,000

The estimate of the number of respondents is based upon the current (as of 2/27/2020)
number of OHRP-approved FWAs (13,395) and projecting that the number may
increase to 14,000.
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The estimate of the number of responses per respondent is based upon the assumption
that an institution will need to submit an initial FWA, or update or renew a previously
approved FWA, on average every six months.
The estimate of the hours per response assumes that virtually all respondents will
complete the FWA form via the internet on an interactive page on the OHRP website.
The time estimate includes an estimate of the time needed to (i) read and understand
the instructions for completing the FWA; (ii) read and understand the FWA terms of
assurance; and (iii) enter the information requested on the FWA form. The estimate
assumes that completing a new FWA, or updating or renewing an existing FWA, on
average, will be completed in 0.50 hours.
12 b. Annualized Cost Burden Estimate
OHRP staff estimates an average submitter’s hourly wage rate of $40 per hour (for
institutional officials, administrators, administrative staff). The total annual costs for
reading and understanding instructions and terms of assurance and entering the
information via the internet are estimated to be 14,000 burden hours X $40/hour =
$560,000.
Estimated Annualized Burden in Dollars Table
Type of
Respondent

Total Burden
Hours

Hourly
Wage Rate

Total Respondent
Costs

Federalwide
Assurance FWA
Total

14000

$40.00

$560,000
$560,000

13. Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the
Terms of Assurance and to complete the FWA form.
14. Cost to Federal Government
The estimated annual Federal costs for reviewing assurances required under HHS
regulations at 45 CFR 46.103 is $400,000
15. Program or Burden Changes
The annual burden will continue to be 14,000 hours. There is no program or
adjustment change.

16. Publication and Tabulation Dates
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The list of institutions holding an approved FWA will be posted, and updated daily,
on the OHRP website.
17. Expiration Date
OHRP is not seeking approval to not show the expiration date.
18. Certification Statement
Item (i) of the certification statement on page 2 of OMB 83-I is not applicable and,
therefore, is not being certified.

B.

Justification of Information Employing Statistical Methods
Not Applicable

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LIST OF ATTACHMENTS
Attachment 1 – Legal Authorities
a. Section 491 of the Public Health Service Act
b. Title 45 Code of Federal Regulations Part 46
Attachment 2 – FWA Terms of Assurance
a. Proposed Terms
Attachment 3 – FWA Form
a. Proposed Form
Attachment 4 – Instructions for completing the FWA form
a. Proposed Instructions
Attachment 5 – Supplemental sample forms
a. IRB Authorization Agreement
b. Individual Investigator Agreement
Attachment 6 – Form 83-I

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