Proposed Rule2024-04377
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
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Published
March 1, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled "Key Information and Facilitating Understanding in Informed Consent." This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA's proposed rule "Protection of Human Subjects and Institutional Review Boards." FDA's proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA's proposed rule.
Full Text
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<title>Federal Register, Volume 89 Issue 42 (Friday, March 1, 2024)</title>
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[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Proposed Rules]
[Pages 15094-15096]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04377]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 50
[Docket No. FDA-2022-D-2997]
Key Information and Facilitating Understanding in Informed
Consent; Draft Guidance for Sponsors, Investigators, and Institutional
Review Boards; Availability
AGENCY: The Office for Human Research Protections, Office of the
Assistant Secretary for Health, Office of the Secretary, and the Food
and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Office for Human Research Protections, Office of the
Assistant Secretary for Health (OHRP), and the Food and Drug
Administration (FDA) are announcing the availability of a draft
guidance entitled ``Key Information and Facilitating Understanding in
Informed Consent.'' This draft guidance provides recommendations
related to two provisions of the revised Federal Policy for the
Protection of Human Subjects (the revised Common Rule) by the U.S.
Department of Health and Human Services (HHS) and identical provisions
in FDA's proposed rule ``Protection of Human Subjects and Institutional
Review Boards.'' FDA's proposed rule, if finalized, would harmonize
certain sections of FDA's regulations on human subject protections and
institutional review boards (IRBs), to the extent practicable and
consistent with other statutory provisions, with the revised Common
Rule, in accordance with the 21st Century Cures Act (Cures Act). The
guidance addresses the provisions of the revised Common Rule that
require informed consent to begin with key information about the
research and to present information in a way that facilitates
understanding and identical provisions in FDA's proposed rule.
DATES: Submit either electronic or written comments on the draft
guidance by April 30, 2024 to ensure that FDA and OHRP consider your
comment on this draft guidance before the agencies begin work on the
final version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2022-D-2997 for ``Key Information and Facilitating Understanding in
Informed
[[Page 15095]]
Consent.'' 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.
<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.'' We 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 the draft 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; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 800-
835-4709 or 240-402-8010; the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#773433253f5a30021e131619141237111316591f1f0459101801"><span class="__cf_email__" data-cfemail="064542544e2b41736f626768656346606267286e6e7528616970">[email protected]</span></a>; the Office of Clinical Policy, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993, 301-796-
8340, or the Division of Policy and Assurances, Office for Human
Research Protections, 1101 Wootton Pkwy., Suite 200, Rockville, MD
20852, 240-453-6900 or 866-447-4777; <a href="/cdn-cgi/l/email-protection#1976716b695971716a377e766f"><span class="__cf_email__" data-cfemail="bad5d2c8cafad2d2c994ddd5cc">[email protected]</span></a>. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Alyson Karesh, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6356, Silver Spring, MD 20993-0002, 301-
796-3826; James Myers, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911; Soma Kalb, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 3516, Silver Spring, MD 20993, 301-
796-5490; the Office of Clinical Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993,
301-796-8340; or the Division of Policy and Assurances, Office for
Human Research Protections, 1101 Wootton Pkwy., Suite 200, Rockville,
MD 20852, 240-453-6900 or 866-447-4777.
SUPPLEMENTARY INFORMATION:
I. Background
FDA and OHRP are announcing the availability of a draft guidance
entitled ``Key Information and Facilitating Understanding in Informed
Consent.'' This draft guidance provides recommendations related to two
provisions of the revised Common Rule and identical provisions in FDA's
proposed rule ``Protection of Human Subjects and Institutional Review
Boards'' (87 FR 58733, September 28, 2022). The FDA's proposed rule, if
finalized, would harmonize certain sections of FDA's regulations on
human subject protection and IRBs, to the extent practicable and
consistent with other statutory provisions, with the revised Common
Rule (codified by the Department of Health and Human Services at 45 CFR
part 46, subpart A), in accordance with the Cures Act (Pub. L. 114-255,
section 3023). The guidance addresses the provisions of the revised
Common Rule that require informed consent to begin with key information
about the research and to present information in a way that facilitates
understanding and identical provisions in FDA's proposed rule.
In this draft guidance, FDA and OHRP provide recommendations for
developing a key information section for clinical trials or studies,
including strategies to make consent information as a whole more
understandable for prospective research participants. We also provide a
sample approach to the key information section that is based, in part,
on research regarding patient understanding of information found in
labeling for prescription drugs. By using simple phrases and plain
language principles, as well as formatting and organizational tools,
researchers found that presenting information in a discrete bubble
format with topics organized or grouped together can facilitate
consumer understanding.\1\ In the appendix of the draft guidance, we
provide an example of a key information section using the bubble
format. We encourage interested parties, with input from IRBs, to
develop innovative ways to provide key information that will help
prospective subjects better understand the reasons why one might or
might not want to participate in research.
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\1\ Boudewyns, V., A.C. O'Donoghue, B. Kelly, et al. (2015),
``Influence of Patient Medication Information Format on
Comprehension and Application of Medication Information: A
Randomized, Controlled Experiment,'' Patient Education and
Counseling, vol. 98(12), pp. 1592-1599, <a href="https://doi.org/10.1016/j.pec.2015.07.003">https://doi.org/10.1016/j.pec.2015.07.003</a>.
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This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on ``Key Information and
Facilitating Understanding in Informed Consent.'' It does not establish
any rights for any person and is not binding on FDA, OHRP, or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.\2\
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\2\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to
its interpretation of 1 CFR 5.9(b). We note that the categorization
as such for purposes of publication in the Federal Register does not
affect the content or intent of the document. See 1 CFR 5.1(c).
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[[Page 15096]]
II. Paperwork Reduction Act of 1995
This draft guidance refers to proposed collections of information
described in FDA's September 28, 2022, proposed rule on ``Protection of
Human Subjects and Institutional Review Boards'' (87 FR 58733), which
this draft guidance is intended to interpret, and with previously
approved collections of information described in the revised Federal
Policy for the Protection of Human Subjects (the revised Common Rule).
The proposed collections of information in the proposed rule are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). As
required by the PRA, FDA has published an analysis of the information
collection provisions of the proposed rule (87 FR 58733 at 58744) and
they have been approved under OMB control number 0910-0130. The
collections of information in 45 CFR 46 and the final rule entitled,
``Federal Policy for the Protection of Human Subjects'' (Common Rule)
have been approved under OMB control number 0990-0260.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>, <a href="https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm">https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm</a>, <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm</a>, <a href="https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-clinical-policy">https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-clinical-policy</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>,
<a href="http://www.hhs.gov/ohrp/newsroom/rfc/index.html">http://www.hhs.gov/ohrp/newsroom/rfc/index.html</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: February 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04377 Filed 2-29-24; 8:45 am]
BILLING CODE 4164-01-P
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