Notice2023-17594
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
Primary source
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Published
August 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA- regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency's recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, "Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors," issued on July 15, 2014, and supersedes FDA's guidance entitled "A Guide to Informed Consent," issued in September 1998.
Full Text
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<title>Federal Register, Volume 88 Issue 157 (Wednesday, August 16, 2023)</title>
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[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55703-55705]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0031]
Informed Consent: Guidance for Institutional Review Boards,
Clinical Investigators, and Sponsors; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Informed
Consent: Guidance for Institutional Review Boards, Clinical
Investigators, and Sponsors.'' The guidance announced in this notice is
intended to assist institutional review boards (IRBs), clinical
investigators, and sponsors involved in clinical investigations of FDA-
regulated products in carrying out their responsibilities related to
informed consent. The guidance provides the Agency's recommendations
regarding informed consent and describes FDA regulatory requirements to
help assure the protection of the rights and welfare of human subjects
in clinical investigations. This guidance finalizes the draft guidance
entitled, ``Informed Consent Information Sheet: Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors,''
issued on July 15, 2014, and supersedes FDA's guidance entitled ``A
Guide to Informed Consent,'' issued in September 1998.
DATES: The announcement of the guidance is published in the Federal
Register on August 16, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2006-D-0031 for the final guidance entitled ``Informed Consent:
Guidance for Institutional Review Boards, Clinical Investigators, and
Sponsors.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
[[Page 55704]]
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Kevin A. Prohaska, Office of Clinical
Policy, Office of Clinical Practice and Policy, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5110, Silver
Spring, MD 20993-0002, 301-796-3707, <a href="/cdn-cgi/l/email-protection#157e70637c7b3b65677a7d74667e74557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="f29997849b9cdc82809d9a93819993b2949693dc9a9a81dc959d84">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Informed Consent: Guidance for Institutional Review Boards,
Clinical Investigators, and Sponsors.'' The guidance announced in this
notice is intended to assist IRBs, clinical investigators, and sponsors
involved in clinical investigations of FDA-regulated products in
carrying out their responsibilities related to informed consent. The
guidance provides the Agency's recommendations regarding informed
consent and describes FDA regulatory requirements to help assure the
protection of the rights and welfare of human subjects in clinical
investigations.
This guidance supersedes FDA's guidance entitled ``A Guide to
Informed Consent,'' issued in September 1998, and finalizes the draft
guidance entitled, ``Informed Consent Information Sheet: Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors,''
issued on July 15, 2014 (79 FR 41291). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include references and links to other
relevant guidance issued since 2014. Additionally, the document was
reorganized to first present general guidance on FDA's regulatory
requirements for informed consent and a discussion of roles of IRBs,
clinical investigators, sponsors, and FDA related to informed consent,
followed by a series of frequently asked questions. Editorial changes
were also made to improve clarity.
FDA notes that, since 2014 when we issued the draft informed
consent guidance, HHS and a number of other Federal Departments and
Agencies issued revisions to the Federal Policy for the Protection of
Human Subjects (codified for HHS at 45 CFR 46, subpart A; ``the 2018
Common Rule''). The 2018 Common Rule sets forth requirements for the
protection of human subjects involved in research that is conducted or
supported by HHS and these Federal Departments and Agencies.\1\
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\1\ A final rule to revise the Federal Policy for the Protection
of Human Subjects was issued on January 19, 2017 (82 FR 7149;
<a href="https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf">https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf</a>). That final rule was modified by an interim final rule
that delayed the effective date and general compliance date (83 FR
2885, January 22, 2018; <a href="https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/2018-00997.pdf">https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/2018-00997.pdf</a>) and a final rule that delayed the general
compliance date, while allowing use of three burden-reducing
provisions for certain research during the delay period (83 FR
28497, June 19, 2018; <a href="https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf">https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf</a>).
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FDA is currently engaged in notice and comment rulemaking to
harmonize with the 2018 Common Rule to the extent practicable and
consistent with other statutory provisions.\2\ This guidance does not
address possible future changes to FDA's informed consent regulations
that may be developed as part of these harmonization efforts. FDA may
amend this guidance to reflect such changes or to address new questions
related to informed consent.
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\2\ On September 28, 2022, FDA issued proposed rules to
harmonize certain provisions of 21 CFR parts 50 and 56 with the 2018
Common Rule to the extent practicable and consistent with other
statutory provisions (see 87 FR 58733 at <a href="https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards">https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards</a>, and 87 FR 58752
at <a href="https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research">https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research</a>).
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This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on, ``Informed Consent: Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. The use of the
word ``should'' in Agency guidance means that something is suggested or
recommended, but not required.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR parts 50 and 56 have been approved under OMB control number 0910-
0130; the collections of information in 21 CFR part 312 have been
approved under OMB control
[[Page 55705]]
number 0910-0014, and the collections of information under 21 CFR part
812 have been approved under OMB control number 0910-0078.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17594 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P
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