Skip to content

FDA Issues Updated Informed Consent Guidance for Clinical Investigations


On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations.  The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors.  Informed consent enables prospective subjects to understand the relevant information concerning a clinical investigation while also providing them the opportunity to pose questions, deliberate on participation, and grant voluntary agreement.  The guidance emphasizes the continuation of information dissemination throughout the investigation, ensuring transparency and subject autonomy throughout the investigation’s progress.  The guidance also provides insight into various aspects of the informed consent process, from communication of new information to subjects’ rights and privacy considerations.  Additionally, the guidance highlights the regulatory framework under 21 C.F.R. § 50, which applies to a range of clinical investigations, from drugs and medical devices to food and color additives.

Under the new guidance, the consent process must not include exculpatory language requiring a subject to waive any of their legal rights or release the clinical investigation’s investigator, the sponsor, the institution, or its agents from liability for negligence.  The FDA defines “exculpatory language” as language that has the general effect of freeing an individual or entity from malpractice, negligence, blame, fault, or guilt.

In addition, the FDA requires that the information given to prospective subjects be in language understandable to the prospective subject.  The FDA’s guidance defines “understandable” as presenting information to prospective subjects in a language and at a level the subjects can comprehend, including explanations of any relevant scientific and medical terms.

The FDA’s new informed consent guidance is an updated roadmap for ethical clinical research.  It underscores the intricate process of informed consent, delineates responsibilities across an investigation’s stakeholders, and provides clarity into the FDA’s review processes.  Researchers, institutions, sponsors, and institutional review boards (IRBs) are encouraged to review and incorporate the guidance to ensure compliance and ethical practice in their clinical investigations.


, ,

FDA Issues Updated Informed Consent Guidance for Clinical Investigations Headshot

Nima Zargari

Nima uses his degrees, training, and experience to give clients thorough and diligent legal and professional advice, providing structured solutions to their intellectual property needs.

Nima received his J.D. from Loyola Law School, Los Angeles, where he worked in the Ninth Circuit Appellate Clinic, and successfully briefed a withholding of removal immigration case to the U.S. Court of Appeals for the Ninth Circuit. He also served as the editor-in-chief of Volume 40 of the Loyola of Los Angeles Entertainment Law Review.

Before attending law school, Nima earned his Ph.D. in chemistry from the University of Southern California. His graduate work focused on small molecule synthesis via palladium(II) catalysis.

Nima worked as a summer associate with the firm in 2019 and joined the firm in 2021.

View all posts published by Nima Zargari
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.
close modal