88 FR 157 pgs. 55703-55705 - Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
Type: NOTICEVolume: 88Number: 157Pages: 55703 - 55705
Pages: 55703, 55704, 55705Docket number: [Docket No. FDA-2006-D-0031]
FR document: [FR Doc. 2023-17594 Filed 8-15-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 This guidance finalizes the draft guidance entitled, "Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors," issued on July 15, 2014, and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."
[top] 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.
• 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, kevin.prohaska@fda.hhs.gov.
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
Footnotes:
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 ).
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.
Footnotes:
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 ).
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
[top] 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
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]
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