Food and Consumer Product Administration, HHS.
The Food and Drug Administration (FDA or Agency) announces the availability of final industry guidance entitled "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." The guidelines announced in this notice are intended to assist institutional review boards (IRBs), clinical investigators, and sponsors participating in clinical trials of FDA-regulated products in fulfilling their informed consent responsibilities. The guidance includes the Agency's recommendations on informed consent and describes FDA's legal requirements to ensure the protection of the rights and well-being of human subjects in clinical trials. This guideline supplements the draft guideline entitled "Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors" issued on July 15, 2014 and supersedes the FDA's guidance entitled "Guide to Informed Consent" issued in September 1998.
The guidance notice is published onfederal registeron August 16, 2023.
You may submit comments to the Agency's guidelines online or in writing at any time as follows:
Submit feedback online as follows:
•Federal eRulemaking Portal:https://www.regulations.gov.Follow the instructions for submitting feedback. Comments submitted electronically, including attachmentshttps://www.regulations.govit will be placed on the roll unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not contain confidential information that you or a third party would not want published, such as medical information, your or anyone else's social security number, or confidential business information, such as a production process. Please note that if you include your name, contact information or other information that identifies you in the body of your comments, this information will be posted tohttps://www.regulations.gov.
- If you wish to submit a comment that contains confidential information that you do not wish to be made public, please submit the comment as a written/paper submission and in the manner described (see “Written/Written Submission” and “Instructions”).
Submit written/written submissions as follows:
•Post/Hand Delivery/Courier (For written/paper entries):Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to Dockets Management staff, FDA will publish your comment, as well as any attachments, other than the information submitted, marked and designated as confidential, if submitted as described in the "Instructions."
Instructions:All submissions received must include document no. FDA-2006-D-0031 for final guidance entitled "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." Comments received are posted to the directory and, except for those submitted as "Confidential Submissions", are publicly viewable athttps://www.regulations.govor with Dockets management staff between 9 A.M. and 4 p.m., Monday through Friday, 240-402-7500.Start Printed Page 55704
• Confidential Submissions—If you wish to submit a comment that contains confidential information that you do not wish to be made public, please submit your comments as a written/paper submission only. You must submit a total of two copies. One copy contains the information you claim is confidential with a heading or cover that reads "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will consider this copy, including any confidential information claimed, when reviewing comments. The second copy, in which the claimed confidential information has been deleted/blacked out, will be publicly available and posted athttps://www.regulations.gov.Give both copies to the Dockets Management Staff. If you do not wish your name and contact information to be published, please provide this information on the cover page, not in the body of your comments, and identify this information as "confidential". Any information marked "confidential" will not be disclosed except in accordance with21 CFR 10,20and other applicable disclosure laws. For more information on FDA comments on public documents, see80 FR 56469, 18 September 2015 or see the information at:https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
role:To access the directory to read background documents or the electronic and written/print submissions received, go tohttps://www.regulations.govand enter the Docket number, in brackets in the header of this document, in the "Search" box and follow the instructions and/or go to Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You can submit feedback on any guide at any time (see21 CFR 10,115(g)(5)).
Submit written requests for separate copies of this guideline 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, Rom. 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, Rom. 5431, silver spring, MD 20993-0002. Send a sticker to help the office process your request. Watch thisMORE INFORMATIONsection for online access to the guideline.
Get started with more information
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, zilveren veer, MD 20993-0002, 301-796-3707,firstname.lastname@example.org.
End More information End Preamble Start additional information
The FDA announces the availability of an industry guidance document entitled "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." The guidelines announced in this notice are intended to assist IRBs, clinical investigators, and sponsors involved in clinical trials of FDA-regulated products in fulfilling their responsibilities regarding informed consent. The guidance includes the Agency's recommendations on informed consent and describes FDA's legal requirements to ensure the protection of the rights and well-being of human subjects in clinical trials.
This guideline supersedes the FDA guideline A Guide to Informed Consent, issued in September 1998, and supplements the draft guideline Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors", issued on 15 July 2014 (79 FR 41291). FDA considered the comments received on the draft guideline when the guideline was finalized. Changes from the draft to the final guidance include references and links to other relevant guidance issued since 2014. In addition, the document has been reorganized to first present general guidance on FDA's regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA on 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 certain other federal agencies and departments have issued revisions to the federal human protection policy (codified for HHS at45 CFR 46, subpart A; "the 2018 common rule"). The 2018 joint rule contains requirements to protect subjects involved in research conducted or supported by HHS and these federal departments and agencies.
FDA is currently preparing notices and comments to align with the 2018 Common Rule to the extent feasible and consistent with other regulatory provisions.This guidance does not address potential future changes to FDA's informed consent rules that may be developed as part of these harmonization efforts. FDA may modify these guidelines to reflect these changes or to address new informed consent questions.
This guidance is issued in accordance with the FDA's Good Practice Guidance Regulation (21 CFR 10,115). The guidance represents FDA's current thinking on "Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors." It does not establish rights for any individual and is not binding on the FDA or the public. You may use an alternative approach if it meets the requirements of applicable laws and regulations. The use of the word "shall" in the Agency's guidance means that something is suggested or recommended, but not required.
II. Red Tape Reduction Act of 1995
Although this guidance is not a compendium of information, it refers to compendiums of information previously approved by the FDA. Previously authorized information collections are subject to review by the Office of Management and Budget (OMB) under the Red Tape Reduction Act of 1995 (44 USC 3501–3521). Collections of information21 CFR parts 50In56have been approved under OMB control number 0910–0130. information collections21 CFR part 312are approved under OMB controlStart Printed Page 55705number 0910–0014 and the collections of information under21 CFR part 812are approved under OMB control number 0910–0078.
III. Electronic access
People with Internet access can get the guidance at the addresshttps://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,https://www.fda.gov/regulatory-information/search-fda-guidance-documents,ofhttps://www.regulations.gov.
Date: August 11, 2023.
Lauren K Roth,
Deputy Commissioner of Politics.
End of signature End of additional information
1. A final rule revising federal human rights policies was issued on January 19, 2017 (82 FR 7149;https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf). This final rule was modified by an interim final rule that delayed the effective date and the global compliance date (83 FR 2885, 22 Jan 2018; https://www.govinfo.gov/content/pkg/FR-2018-01-22/pdf/2018-00997.pdf) and a closing rule that postponed the general compliance date while allowing the use of three mitigation provisions for certain investigations during the delay period (83 FR 28497, June 19, 2018;https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf).
Back to the quote
2. On September 28, 2022, FDA issued proposed rules to enforce certain provisions21 CFR parts 50In56with the Common Rule of 2018 to the extent possible and in accordance with other legal provisions (see87 FR 58733beehttps://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards,In87 FR 58752beehttps://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research).
Back to the quote
[FR Doc. 2023–17594 filed 8–15–23; 8:45 am]
Informed Consent: Guidelines for Institutional Review Boards, Clinical Investigators, and Sponsors. Availability? ›
The FDA also highlights the basic elements of informed consent, including a requirement to describe the clinical investigation and the extent of the prospective subject's participation – potential risks and discomforts, an explanation of benefits, disclosing alternatives and maintaining confidentiality – describe ...What are the rules for informed consent in IRB? ›
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.Does the IRB require informed consent? ›
Informed consent from the subject and/or his legally authorized representative must be obtained prior to initiating any research activities, including screening procedures unless the IRB grants a waiver to do otherwise.Are investigators only required to obtain approval from an institutional review board for federally funded research studies True or false? ›
Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects.What are the GCP guidelines for informed consent? ›
The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers' rights.What are the 4 important ethical issues IRB guidelines address? ›
Four requirements for ethical conduct of research follow directly from this principle of respect for persons: 1) Participants must voluntarily consent to participate in research; 2) The voluntary consent obtained from participants must be informed consent; 3) Protection of privacy and confidentiality must be ...What is the common rule for the IRB? ›
The Common Rule lists categories of research exempt from the requirements for IRB approval. Any research project involving human subject though to be exempt must be submitted to the IRB for determination of exempt status.Do you need IRB approval for publicly available data? ›
The data available to the public are not individually identifiable and therefore their use and analysis would not involve human subjects. If the information or biospecimens to be used in the secondary research study are identifiable, the researcher must obtain IRB approval before the information can be accessed.What are the two exceptions to informed consent? ›
There are two well-recognized exceptions to the need for informed consent to medical treatment. The more common is a medical emergency, in which an unconscious or delirious patient cannot consent. The second is rare and involves certain court-ordered treatments or treatments and tests mandated by law.What must be approved by IRB? ›
Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.
“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.Which type of research does not need to get an IRB approval? ›
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”What is the principal investigator required to comply with the Institutional Review Board for? ›
The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process.What are the 5 conditions required for informed consent? ›
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient's role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient's ...What are the four guidelines for consent? ›
- Emphasize key elements. ...
- Allow individuals to control the level of detail they get and when. ...
- Provide individuals with clear options to say 'yes' or 'no' ...
- Be innovative and creative. ...
- Consider the consumer's perspective. ...
- Make consent a dynamic and ongoing process.
Federal regulations require investigators to obtain informed consent of the subject prior to research interventions. The informed consent form (ICF) must have written IRB approval before implementing with subjects.What are 5 main rules relating to obtaining informed consent? ›
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient's role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient's ...What is the IRB review of informed consent? ›
The IRB reviews the informed consent process to help to make sure that the study details are communicated in language that is readily understandable to the person who may volunteer to be a research subject. The informed consent process includes: Background information about why the study is being done.What are the common rule elements of informed consent for a research study? ›
These include: obtaining informed consent before involving a human subject in a research activity; only seeking informed consent under circumstances that provide the prospective subject sufficient opportunity to discuss and consider whether or not to participate; providing information to potential subjects in a way ...