[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 [www.gpo.gov]
[FR Doc No: 2024-04377]


=======================================================================
-----------------------------------------------------------------------

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Consent; Draft Guidance for Sponsors, Investigators, and Institutional 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.

-----------------------------------------------------------------------

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Administration (FDA) are announcing the availability of a draft 
guidance entitled ``Key Information and Facilitating Understanding in 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 This draft guidance provides recommendations 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DATES: Submit either electronic or written comments on the draft 
guidance by April 30, 2024 to ensure that FDA and OHRP consider your 
comment on this draft guidance before the agencies begin work on the 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 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 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, [email protected]; 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; [email protected]. 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.
---------------------------------------------------------------------------

    \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, https://doi.org/10.1016/j.pec.2015.07.003.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).

---------------------------------------------------------------------------

[[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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-clinical-policy, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, 
http://www.hhs.gov/ohrp/newsroom/rfc/index.html, or https://www.regulations.gov.

    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