Description
This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014. This document is structured 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 related to informed consent, followed by a series of frequently asked questions.
Scope & Applicability
Product Classes
4Medical device being tested in a clinical trial.; Medical devices intended for participants during the trial.
Products for which batch/lot information is particularly important
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
drug or biological product not yet approved for marketing; Drugs used for treatment use under expanded access categories.; Drug used for treatment under expanded access; The product being provided through expanded access; Drugs provided under expanded access.
Stakeholders
10Institutional Review Board providing study approvals
Providing new information to subjects who have completed their active participation.
Person qualified to prepare translations
individual appointed for a child who is a ward of the state
individual authorized to give permission for a child
IRB cooperating with local IRBs in multicenter investigations
Required for the oral presentation when using a short form consent document.
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
Person who may give consent on behalf of a participant
Regulatory Context
Attributes
7Risk level for exception from informed consent
summary outcomes of a clinical trial shared with subjects
Condition where a subject's ability to provide legally effective consent is diminished
Subjects who do not understand English
children under the care of an agency or institution
Potential or actual conflicts that may influence the consent process
subjects likely to be susceptible to coercion
Identified Hazards
Hazards
8Substantial impact on day-to-day functioning
Summary of the known and potential risks and benefits, if any, to human participants.
Situations requiring protocol deviations to protect participants
A risk that the consent process must minimize.; risk to voluntary participation
A risk that the consent process must minimize.; risk to voluntary participation
Potential risks to subjects, embryos, or fetuses not yet identified.
Privacy risk to participants
Significant risk to be focused on in consent
Related CFR Sections (20)
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
- 21CFR56.102§ 56.102 Definitions.
As used in this part:Read full regulation →
- 21CFR50.3§ 50.3 Definitions.
As used in this part:Read full regulation →
- 21CFR50.27§ 50.27 Documentation of informed consent.
(a) Except as provided in § 56.109(c) , informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.Read full regulation →
- 21CFR56.110§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a) The Food and Drug Administration has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register.Read full regulation →
- 21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
- 21CFR50.56§ 50.56 Wards.
(a) Children who are wards of the State or any other agency, institution, or entity can be included in clinical investigations approved under § 50.53 or § 50.54 only if such clinical investigations are:Read full regulation →
- 21CFR50.55§ 50.55 Requirements for permission by parents or guardians and for assent by children.
(a) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent.Read full regulation →
- 21CFR812.35§ 812.35 Supplemental applications.
(a) Changes in investigational plan —Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR312.42§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →
- 21CFR56.108§ 56.108 IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →
- 21CFR56.109§ 56.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.Read full regulation →
- 21CFR812.100§ 812.100 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under inRead full regulation →
- 21CFR312.60§ 312.60 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs Read full regulation →
- 21CFR812.140§ 812.140 Records.
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:Read full regulation →
- 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →
- 21CFR312.8§ 312.8 Charging for investigational drugs under an IND.
(a) General criteria for charging.Read full regulation →
- 21CFR812.7§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:Read full regulation →
- 21CFR812.145§ 812.145 Inspections.
(a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, pRead full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (Status: Final)
- A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry (Status: Final)
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Status: Final)
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (Status: Final)
- Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors (Status: Draft)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)