
[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55703-55705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 This guidance finalizes the draft guidance 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

[[Page 55704]]

     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected].

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; 
https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf). 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; https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/2018-00997.pdf) 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; https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf).
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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 https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards, and 87 FR 58752 
at https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research).
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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 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    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


