This draft document was created by the US Food & Drug Administration (FDA). It aims to provide Institutional Review Boards (IRBs), clinical investigators, and sponsors with general guidance on the FDA's requirements for informed consent.
Informed consent is often mistakenly viewed as synonymous with obtaining a participant's signature on the consent form. This definition, however, does not consider other key parts of the consent process such as adequately informing the participant about a clinical trial, facilitating their understanding of the information, and providing the opportunity to ask questions and consider whether to participate. To be legally effective, the informed consent process must satisfy the general requirements under 21 CFR 50.20 and include the relevant elements of informed consent described at 21 CFR 50.25. Importantly, informed consent is an ongoing exchange of information throughout the clinical trial lifecycle, adapting to new safety information or protocol changes in the study.
This final guideline document presents general guidance on FDA's regulatory requirement for the informed consent process as well as a discussion of the roles and responsibilities of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.
2. Summary of the consent process
3. FDA informed consent requirements and discussion
4. Responsibilities for informed consent
5. Frequently asked questions
Important notice: This guidance represents the current thinking of the FDA on this topic. It does not establish any rights for any person and is not legally binding. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.