Notice2023-00974
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects and Institutional Review Boards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 12 (Thursday, January 19, 2023)</title>
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[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3415-3417]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00974]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0403]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Protection of Human
Subjects and Institutional Review Boards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by February 21, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0130. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#c8989a899bbca9aeae88aeaca9e6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="742426352700151212341210155a1c1c075a131b02">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Protection of Human Subjects; Informed Consent; and Institutional
Review Boards--21 CFR Parts 50 and 56
OMB Control Number 0910-0130--Extension
This information collection supports Agency regulations pertaining
to the protection of human subjects, informed consent, and
responsibilities of institutional review boards (IRBs) as set forth in
parts 50 and 56 (21 CFR parts 50 and 56). Parts 50 and 56 apply to all
clinical investigations regulated by FDA under sections 505(i) and
520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)
and 360j(g), respectively), as well as clinical investigations that
support applications for research or marketing permits for products
regulated by FDA. The regulations in parts 50 and 56 are intended to
protect the rights and safety of subjects involved in such
investigations. The regulations also contain the standards for
composition, operation, and responsibilities of IRBs that review
clinical investigations regulated by FDA.
21 CFR Part 50--Protection of Human Subjects
Provisions in part 50 provide for the protection of human subjects
involved in FDA-regulated clinical investigations. With few exceptions,
no investigator may involve a human being as a subject in FDA-regulated
research unless the investigator has obtained the legally effective
informed consent of the subject or the subject's legally authorized
representative. Basic elements of informed consent are set forth in
Sec. 50.25 (21 CFR 50.25) and include, among other things: (1) a
statement of the purpose and duration of a subject's participation in
the research; (2) a description of the procedures to be followed; (3)
identification of any experimental procedures; (4) a description of
risks, benefits, and appropriate alternative procedures or treatments;
(5) a description of extent to which confidentiality of records
identifying the subject will be maintained; (6) certain contact
information; and (7) a statement that participation is voluntary and
may be discontinued at any time. Additional elements set forth in Sec.
50.25 are required in the informed consent as appropriate. Exceptions
to these requirements are governed by 21 CFR 50.23, which requires both
investigator and physician to certify in writing that necessary
elements for exception from general requirements have been satisfied;
and Sec. 50.24 (21 CFR 50.24), which covers exception from informed
consent requirements for emergency research. In accordance with Sec.
50.27 (21 CFR 50.27) informed consent must be documented, except as
provided in Sec. 56.109(c) (21 CFR 56.109(c)), which provides for an
IRB to waive documentation of informed consent in certain
circumstances.
Informed consent must be documented using a written consent form
approved by the IRB and signed and dated by the subject or the
subject's legally authorized representative at the
[[Page 3416]]
time of consent. For each clinical investigation reviewed by an IRB, we
believe there will typically be one associated written consent form
developed by an investigator. In some cases, investigators will seek
IRB approval of changes in the research and/or consent form after
initial IRB approval. For some multi-institutional clinical
investigations, the IRB of each institution involved may separately
conduct initial and continuing review of the research, including review
of the written consent form to determine whether it is in accordance
with Sec. 50.25. However, in cases where a multi-institutional
clinical investigation uses a single IRB review process, there may only
be one IRB conducting such reviews. Additional safeguards are required
for children, as prescribed in subpart D (21 CFR 50.50 through 50.56)
of the regulations.
21 CFR Part 56--Institutional Review Boards
The general standards for the composition, operation, and
responsibilities of an IRB are set forth in part 56. IRBs serve in an
oversight capacity by reviewing, among other things, informed consent
documents and protocols for FDA-regulated studies, to make findings
required to approve research, and document IRB actions. Part 56 also
regulates the administrative activities of IRBs reviewing FDA-regulated
research including, among other things, identification of types of IRB
records that must be prepared and maintained. Required recordkeeping
includes documentation pertaining to written procedures, proposals
reviewed, committee membership, meeting minutes, actions taken by the
IRB, correspondence, as well as other functional and operational
aspects of the IRB. Finally, the regulations describe administrative
actions for noncompliance, including both disqualification of IRBs or
IRB parent institutions, as well as reinstatement and alternative and
additional actions.
Description of Respondents: Respondents to the information
collection are IRBs that review and approve clinical investigations
regulated by FDA and clinical investigators of such research who obtain
informed consent of human subjects prior to research participation.
In the Federal Register of June 24, 2022 (87 FR 37867), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the annual burden for the collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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56.113; suspension or termination of research. 2,520 1 2,520 0.5 (30 minutes)........................ 1,260
56.120(a); IRB response to lesser 7 1 7 10...................................... 70
administration actions for noncompliance.
56.123; reinstatement of an IRB or an 1 1 1 5....................................... 5
institution.
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Total..................................... .............. .............. .............. ........................................ 1,335
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on available data, there are approximately 2,520 IRBs
overseeing FDA-regulated clinical research. We have organized the table
summarizing estimated annual reporting burden to list only one
requirement per row recognizing that some provisions may also include
recordkeeping or third-party disclosure tasks. We believe we have
accounted for all burden cumulatively across the information collection
activity tables and invite comments on our estimates.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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50.24; exceptions from informed consent for 8 3 24 1....................................... 24
emergency research.
50.27; documentation of informed consent...... 2,520 40 100,800 0.5 (30 minutes)........................ 50,400
56.115; IRB records (documentation of IRB 2,520 14.6 36,792 40...................................... 1,471,680
activities).
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Total..................................... .............. .............. .............. ........................................ 1,522,104
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We characterize activities associated with Sec. Sec. 50.24 and
50.27 as recordkeeping burden. We assume each of the 2,520 IRBs meets
an average of 14.6 times annually and assume 40 hours of person-time
per meeting are required to meet the IRB recordkeeping requirements of
Sec. 56.115. We also assume most recordkeeping is completed
electronically.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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50.25; elements of informed consent.......... 2,520 40 100,800 0.5 (30 minutes)....................... 50,400
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56.109(d); written statement about minimal 2,520 2 5,040 0.5 (30 minutes)....................... 2,520
risk research when documentation of informed
consent is waived.
56.109(e); written notification to approve or 2,520 40 100,800 0.5 (30 minutes)....................... 50,400
disapprove research.
56.109(g); IRB written statement about public 8 2 16 1...................................... 16
disclosures to sponsor of emergency research
under Sec. 50.24.
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Total.................................... .............. ................ .............. ....................................... 103,336
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We characterize activities associated with Sec. Sec. 50.25 and
56.109(d) and (e) as disclosure burden. We estimate that eight IRBs per
year will receive a request to review emergency research under Sec.
50.24, thus requiring written notification under Sec. 56.109(g) from
the IRB to the sponsor. We estimate that it will take an IRB
approximately 1 hour to prepare each written statement, for a total of
2 hours per study. The total annual third-party disclosure burden for
IRBs to fulfill this requirement is estimated at 16 hours.
Dated: January 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00974 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P
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