Supporting Statement_0990-0260_June 2021

Supporting Statement for Protection of Human Subjects: Assurance
of Compliance with Federal Policy/IRB Review/IRB
Recordkeeping/Informed Consent/Consent Documentation
Background
The Office for Human Research Protections is requesting a three-year extension of information
requirements in OMB No. 0990-0260, Protection of Human Subjects: Assurance of Compliance
with Federal Policy/Institutional Review Board (IRB) Review/IRB Recordkee ping/Informed
Consent/Consent Documentation.
The Federal Policy for the Protection of Human Subjects (also known as the Common Rule)
adopted in June 1991 (56 FR 28001) establishes Federal policy for the protection of human
subjects involved in Federally conducted or supported research. The Common Rule requires
applicant and awardee institutions to establish procedures to report, disclose and maintain
required information, including related to informed consent and assurance of the establishment of
an IRB. The principal respondents for the information collection requirements in OMB No.
0990-0260 are IRBs.

A.

Justification

1.

Need and legal basis

Section 491(a) of Public Law (P.L.) 99-158 states that,
The Secretary shall by regulation require that each entity which applies for a grant,
contract, or cooperative agreement under this chapter 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.
The pertinent authorizing legislation is 42 U.S.C. 289.

1

On June 18, 1991, fifteen Federal departments and agencies, including HHS, adopted the
Common Rule (56 FR 28001). HHS codification of the Common Rule is found at 45 CFR
46.
Pursuant to the requirement in P.L. 99-158, HHS promulgated regulations at 45 CFR part
46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The June 18,
1991 adoption of the common Federal Policy (56 FR 28001) by 15 departments and
agencies, including HHS, implements a recommendation of the President’s Commission
for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
which was established on November 9, 1974, by Pub. L. 95-622. The Common Rule is
based on HHS regulations at 45 CFR part 46, subpart A, the basic HHS Policy fo r the
Protection of Human Subjects published on January 26, 1981 (46 FR 8366).
As the Common Rule is based on the HHS regulations implementing P.L.99 -158, the
Common Rule echoes the same requirements set forth in this law in that it requires each
institution engaged in research involving human subjects conducted or supported by any
of the Common Rule departments or agencies to provide a written assurance satisfactory
to the department or agency head that the institution, among other things, has established
an IRB to review such research. The purpose of the IRB review is to ensure that the
rights and welfare of human research subjects are adequately protected. To that end, the
Common Rule requires that appropriate minutes of IRB meetings be maintained as
documentation of the IRB review and approval and that an institution certify IRB review
and approval to the departments and agencies conducting or supporting the research.
The Common Rule provides additional protections for human research subjects by
including requirements for obtaining and documenting informed consent of the subjects.
The Common Rule requires that informed consent to be sought from, and documented for,
each subject, to the extent required by Sections 116 and 117, for all research to which the
Common Rule applies.
On January 19, 2017, HHS and fifteen other Federal departments and agencies, revised
the Common Rule to modernize, strengthen and make it more effective (82 FR 7149). The
revised Common Rule includes some additional information collections, including:
regarding the information that must be given to prospective research subjects as part of
the informed consent process; allowing investigators to seek broad consent from a
subject for storage, maintenance and secondary research use of identifiable private
information and identifiable biospecimen; expanding the type of IRB activities for which
records must be prepared and documented; and, adding a requirement to post consent
forms for Common Rule department or agency-conducted or -supported clinical trials.
In this supporting statement, the term “pre-2018 Common Rule (or pre-2018

2

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 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
published on January 19, 2017 (82 FR 7149) were amended on January 22, 2018 (83 FR
2885) and June 19, 2018 (83 FR 28497).
.
The Federal departments and agencies that follow the Pre-2018 Requirements and the 2018
Requirements are listed below.
Pre-2018 Requirements
Common Rule Department or Agency Signatories:
Number
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

Department or Agency
Department of Agriculture
Department of Energy
National Aeronautics and Space Administration
Department of Commerce
Agency for International Development
Department of Housing and Urban Development
Department of Justice
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
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

3

4

Central Intelligence Agency

Executive Order 12333

2018 Requirements
Common Rule Department or Agency Signatories 1:
Number
Department or Agency
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

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.

Purpose and Use of the Information
Information reported to the Federal departments and agencies under the Common Rule with
respect to a satisfactory assurance is used to ensure that an institution engaged in

1

Department of Justice intends to become an official signatory.

4

nonexempt research involving human subjects conducted or supported by a Common Rule
department or agency has (1) established adequate administrative policies and procedures
for protecting the rights and welfare of human subjects in research, and (2) accepts that
responsibility. Other reporting requirements are used to: assess whether th e institution is
following the established procedures; ensure that Federal funds are not expended for
unapproved human subjects research; and, determine if the approved status of an awarded
grant, contract, or cooperative agreement should be reviewed, with the ultimate goal of
maintaining or increasing human subject protections.
The following information collections required by the Common Rule are included in this
information collection request:
Section 103(b)(5) [Pre-2018 Requirements]/108(a)(4) [2018 Requirements] Reporting Specifies certain situations which must be reported by the investigator and/or other institutional
official(s) to the IRB, appropriate institutional officials, the department or agency head, and
OHRP, HHS, or any successor office, or the equivalent office within the appropriate Federal
department or agency.
Purpose: To ensure that the IRB and individuals responsible for the protection of human
subjects are made aware of situations occurring during the research that trigger the need for
them to take further action in discharging their responsibilities to protect the rights and
welfare of human subjects participating in federally-conducted or –supported research.
Section 109(d) [Pre-2018 and 2018 Requirements] Disclosure - Specifies the procedures
for an IRB to notify the investigators and institutions in writing of its decision to approve
or disapprove proposed research activities, or of modifications required to secure IRB
approval of the research activities.
Purpose: Provides individuals responsible for conducting the research with the information
necessary to initiate the research or to take required actions before initiation of the research
is permitted.
Section 113 [Pre-2018 and 2018 Requirements] Reporting - Specifies that any suspension or
termination of IRB approval must be reported to the investigator, appropriate institutional
officials, and the department or agency head and that such reports include a statement of
the reasons for the IRB’s action.
Purpose: To ensure that individuals responsible for the protection of human subjects are
made aware of IRB actions regarding the research that trigger the need for them to take
further action in discharging their responsibilities to protect the rights and welfare of
human subjects participating in federally-conducted or –supported research.

5

Section 115(a) [Pre-2018 and 2018 Requirements] Recordkeeping - Specifies the
documentation of IRB activities, including: copies of all research proposals reviewed;
minutes of IRB meetings; records of continuing review activities [including the rationale
for conducting continuing review of research that otherwise would not require continuing
review as described in section 109(f)(1) of the 2018 Requirements]; copies of all
correspondence between the IRB and the investigators; a list of IRB members in the same
detail as described in section 103(b)(3) [Pre-2018 Requirements]/108(a)(2) [2018
Requirements]; written procedures for the IRB in the same detail as described in section
103(b)(4) and (5) [Pre-2018 Requirements]/108(a)(3) and (4) [2018 Requirements;
statements of significant new findings provided to subjects, as required by section
116(b)(5) [Pre-2018 Requirements]/116(c)(5) [2018 Requirements]; the rationale for an
expedited reviewer’s determination under section 110(b)(1)(i) [2018 Requirements] that
research appearing on the expedited review list described in section 110(a) [2018
Requirements] is more than minimal risk; and, documentation specifying the
responsibilities that an institution and an organization operating an IRB each will undertake
to ensure compliance with the requirements as described in section 103(e) [2018
Requirements]. Section 115(b) [Pre-2018 and 2018 Requirements] stipulate that records
required by the Common Rule must be retained for at least three years, and records relating
to research that is conducted must be retained for at least three years after completion of the
research. All records shall be accessible for inspection and copying by authorized
representatives of the department or agency conducting or supporting the research at
reasonable times and in a reasonable manner.
Adequate documentation of IRB activities also requires records of IRB determinatio ns
required by subparts B, C, and D: i.e., (1) in subpart B, the conditions under 45 CFR 46.
204 (Research involving pregnant women or fetuses.), 45 CFR 46.205 (Research involving
neonates.), 45 CFR 46.206 (Research involving, after delivery, the placenta, the dead fetus
or fetal material.), and 45 CFR 46.207 (Research not otherwise approvable which presents
an opportunity to understand, prevent, or alleviate a serious problem affecting the health or
welfare of pregnant women, fetuses, or neonates.), are met; (2) in subpart C, the conditions
under 45 CFR 46.305 (Additional duties of the Institutional Review Boards where
prisoners are involved.) and 45 CFR 46.306 (Permitted research involving prisoners.), are
met; and, (3) in subpart D, the conditions under 45 CFR 46.404 (Research not involving
greater than minimal risk), 45 CFR 46.405 (Research involving greater than minimal risk
but presenting the prospect of direct benefit to the individual subjects.), 45 CFR 46.406
(Research involving greater than minimal risk and no prospect of direct benefit to
individual subjects, but likely to yield generalizable knowledge about the subject’s disorder
or condition.), and 45 CFR 46.407 (Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem affecting the health or
welfare of children.), are met.

6

Purpose: Provides a means for verification by the Common Rule departments and
agencies that substantive regulatory requirements for operation of IRBs and conduct of
research involving human subjects have been fulfilled.
Section 116 (a) and (b) [Pre-2018 Requirements]/116(b), (c) and (d) Disclosure - Specifies
the general requirements for, and basic elements of, informed consent in section 116 (a)
[Pre-2018 Requirements]/116(b) [2018 Requirements]. Additional elements of informed
consent, when appropriate, are found in section 116(b) [Pre-2018 Requirements]/116(c)
[2018 Requirements]. Section 116(d) [2018 Requirements] specifies elements of broad
consent for the storage, maintenance, and secondary research use of identifiable private
information or identifiable biospecimens.
Purpose: Provides human subjects with information on which to base their independent
decisions regarding whether or not they choose to take the risks involved in the research in
light of the potential benefits which may result.
Section 116(h) [2018 Requirements] Disclosure – Specifies that for each clinical trial
conducted or supported by a Federal department or agency, one IRB-approved consent
form must be posted on a publicly available Federal website.
Purpose: Improves the quality of consent forms in federally funded research by assuring
that the forms eventually would become subject to public scrutiny and provide useful
models for others.
Section 117 Disclosure - Specifies how informed consent is to be documented.
Purpose: Provides verification that the human research subjects have been provided
information on which to base their independent decisions regarding whether or not they
choose to take the risks involved in the research in light of the potential benefits which may
result.
Section 117(c)(2) [Pre-2018 and 2018 Requirements] Disclosure – Specifies that in cases
in which the informed consent documentation is waived, the IRB may require the
investigator to provide subjects or legally authorized representativ es with a written
statement regarding he research.
Purpose: Provides subjects with written information about the research in cases when the
subjects have not signed an informed consent form (that would include information about
the research).
3.

Improved Information Technology

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The Common Rule imposes no technological or standard format requirements for
respondents. We encourage automated technology if possible.
4.

Efforts to Identify Duplication
The Common Rule establishes the only Federal standards for the performance of federally
conducted or supported research involving human subjects.

5.

Small Businesses
Support 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 was
not feasible to do so. Institutions not having on file approved assurances for the proposed
research (likely to be small organizations) generally do not have to certify IRB review until
certification is requested by the agency or department sponsoring the research generally
only when an award is expected to be made.

6.

Consequences of Collecting the Information Less Frequently
The reporting of IRB approval is required with the submission of an application or proposal
for research funding, or at such later date as specified by the federal department or agency
sponsoring the research. This is necessary to ensure that federally -conducted or -supported
research involving human subjects is subjected to the continuing IRB review and approval
that is required by the Common Rule at least once per year, except as described in section
109(f) of the 2018 Requirements, as the obligation to protect human subjects is an ongoing
responsibility and not a one-time effort. 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 or the subjects’ willingness to continue
participation in the research; therefore, IRB review is required to be co nducted at least
annually so that the rights and welfare of the human research subjects are protected
throughout the research project. Reporting of the date of that review, and approval with the
application describing any changes, notifies the department or agency conducting or
supporting the research of IRB approval of the continued compliance of the protocol.
Within HHS, the FWA form approved by OMB for use through August 31, 2023 (OMB
No. 0990-0278) must be renewed every five years instead of every three years prior to June
2011. Other reporting requirements in the Common Rule are on occasion.
The regulations require that minutes of each IRB meeting be taken and kept. The IRB’s
continuing review, as indicated above, is required annually. Less frequent review would
compromise protection of research subjects.

8

7.

Special Circumstances
There are no special circumstances.

8.

Federal Register Notice/Outside Consultation
Public comments were solicited in the Federal Register on April 14, 2021 (86 FR 19627)
for a 60-day period. No comments were submitted.

9.

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

10.

Assurance of Confidentiality
The database used to maintain and store IRB registration information, known as the Human
Assurance Tracking System (HATS), uses Microsoft SQL Server tables stored on a server
that is hosted and maintained by the Center for Information Technology, National Institutes
of Health. The HATS application screens and associated IRB registration tables/server
utilize a username/password and appropriate session variables to access and modify the
IRB registration data. Without the appropriate username/password, unauthorized users will
not gain access to the IRB registration database. IRB registration database tab les will never
be provided outside of OHRP. Requests for IRB registration information from the database
are fulfilled via printed reports or disk files containing extracted information.
The public can access some IRB registration information from the internet, e.g., IRB
organization and its IRB(s) name, number and location (city and state or country) and
expiration date) via the internet search screens found on the OHRP website at
http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc. The public would need to contact
OHRP to request non-public IRB registration information (e.g., the name or contact
information of an IRB organization’s head official, contact person, or IRB chairperson).

11.

Sensitive Questions
None of the information collection requirements in the Common Rule are of a sensitive
nature.

12.

Estimates of Annualized Burden Hours and Cost
Burden estimates for reporting to OHRP: unanticipated problems involving risks to
subjects or others; serious or continuing noncompliance with 45 CFR part 46 or the

9

determinations or requirements of the IRB; and, suspension or termination of IRB approval
of research as required in section 103(b)(5) of the pre-2018 Requirements and section
108(a)(4) of the 2018 Requirements are accounted for in an OHRP new information
collection request submission (Incident Report Form) currently pending OMB approval.
Burden estimates for IRB review and certification requirements in section 103(f) of the
pre2018 and 2018 Requirements are accounted for in an OHRP information collection
request submission to OMB for re-approval of Control Number 0990-0263 (Approved for
use through June 30, 2021). Burden estimates regarding IRB establishment and IRB
membership provisions in sections 103(b)(2) and 107 of the pre-2018 Requirements and
sections 107 and 108 of the 2018 Requirements are accounted for in the OHRP information
collection request submission to OMB that was approved in Control Number 0990-0279
(Approved for use through February 28, 2022).
12a.

Annualized Hour Burden Estimate
Respondents to this information collection include IRBs, investigators and other
persons or entities subject to the Common Rule requirements. As of February 23,
2021, there are 5,063 active IRB organizations with 5,943 IRBs registered with
OHRP. We are rounding the active registered IRBs to be 6,000.
The burden tables are organized to include specific regulatory provisions in each
row for Pre-2018 Requirements and/or 2018 Requirements information
collections. Table 1 regulatory provisions are identified as a reporting bu rden,
table 2 regulatory provisions are identified as a recordkeeping burden and table 3
regulatory provisions are identified as a third-party disclosure burden.

Table 1-Estimated Annual Reporting Burden
No of
Common Rule Provision No. of
Total
Respondents Responses Annual
per
Responses
Respondent
.103(b)(5), .113 [Pre2018
5,200
1
5,200
Requirements]/.108(a)(4),
.113 [2018
Requirements] - Incident
Reporting, Suspension or
Termination of IRB
approval Reporting
TOTAL

5,200

10

Average Total
Burden
Hours
per
Response
1
5,200

5,200

\
Table 2 –Estimated Annual IRB Recordkeeping Burden
No of
Common Rule
No. of
Total Annual Average
Responses
Burden
Provision
Respondents
Responses
per
per
Respondent
Response
.115 [Pre-2018
6,000
16
96,000
12
and
2018
Requirement] –
Preparation and
documentation
of IRB
activities
TOTAL
96,000

Total
Hours

1,152,000

1,152,000

Table 3 – Estimated Annual Third-Party Disclosure Burden
No of
No. of
Respondents Disclosures
per
Respondent
.109(d) [Pre-2018
6,000
25
and
2018
Requirements] –
Written
notification
of
IRB approval or
disapproval
of
research

11

Total
Annual
Disclosures

Average
Burden per
Disclosure

150,000

0.5

Total
Hours

75,000

.46.116(a) and (b)
(Pre-2018
Requirements)/
.46.116 (b), (c)
and (d) [2018
Requirements] –
Elements of
informed consent
and broad consent

6,000

25

150,000

0.5

75,000

.46.116(h) – [2018
Requirements] –
Posting clinical
trial consent form

100

3

300

0.5

150

.117(a) [Pre-2018
and
2018
Requirements] –
Documentation of
informed consent
.117(c)(2) [Pre2018 and 2018
Requirements] –
Written statement
about the research
when informed
consent

6,000

25

150,000

0.5

75,000

6,000

10

60,000

1

60,000

Total
Annual
Disclosures

Average
Burden per
Disclosure

No of
No. of
Respondents Disclosures
per
Respondent
documentation is
waived
TOTAL
12b.

510,300

Annualized Estimated Cost Burden

12

Total
Hours

285,150

We estimate an average hourly wage of $43 per hour. When multiplied by the
total number of burden hours (1,442,350), we estimate the information collection
costs respondents an average of $62,021,050 annually.
13.

Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents.

14.

Annualized Cost to the Federal Government
We estimate that cost to the Federal government for the collection of information will be
1,992,000.

15.

Program or Burden Changes
The information collection reflects changes, for Pre-2018 Requirements and 2018
Requirements. The burden hours increased by 304,120 hours and $35,611,450.

16.

Publication and Tabulation Dates
There are no plans to publish or tabulate the information.

17.

Expiration Date
Display of OMB expiration date is appropriate.

18.

Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

LIST OF ATTACHMENTS
Attachment 1 - Legal Authorities
a. 42 U.S.C. Section 289
b. 56 F.R. 28001 (Common Rule)
c. 45 CFR part 46

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- Legal Authorities
Attachment 1
a. 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 violatio ns.
(July 1, 1944, ch. 373, title IV, Sec. 491, as added Pub.L. 99 -158, Sec. 2, Nov. 20, 1985, 99 Stat.
873.)

- Legal Authorities
Attachment 1
a. 56 F.R. 28001 (Common Rule), Pre-2018
Requirements
b. HHS 2018 Requirements, Access here:
https://www.ecfr.gov/cgibin/retrieveECFR?
gp=&SID=83cd09e1c0f5
c6937cd9d7513160fc3f&pitd=20180719&n
=pt45.1.46&r=PART&ty=HTML

- Legal Authorities
Attachment 1
c. 45 CFR part 46
Access here: https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=2018
07
19&n=pt45.1.46&r=PART&ty=HTML