FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators, and Institutional Review Boards

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document entitled, Key Information and Facilitating Understanding in Informed Consent. The draft guidance is intended specifically for sponsors, investigators, and institutional review boards (IRBs) involved with clinical trials. As the FDA explains, the draft guidance aims to align FDA regulations on human subject protections and IRBs with the updated Common Rule, a set of ethical standards for human research in the U.S. It aims to improve how participants are informed, requiring that the informed consent process starts with key information about the research and is presented clearly to aid understanding.

Here are some of the highlights:

Adding a “Key Information” Section to Informed Consent Forms

The FDA’s draft guidance proposes adding a requirement for informed consent forms used in connection with FDA-regulated clinical investigations to begin with a “key information” section. The FDA’s definition of “key information” would mirror that in the Common Rule, which defines this term to include information, “that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”

Innovative Approaches to Informed Consent Delivery

While the FDA’s guidance will require disclosure of key information if it becomes final, the guidance also proposes a flexible approach to delivering key information to prospective subjects and their representatives. Specifically, the draft guidance states that the FDA would, “encourage interested parties to develop innovative ways and utilize available technologies to provide key information.” As examples of “innovative ways” to provide key information, the FDA proposes “consulting in advance with patient advocacy groups,” or “using alternative media, such as illustrations, video, and electronic tablets.” The purpose of the key information is to let prospective subjects know why they would, or would not, want to participate in a trial.

Key Information Requirements

Similarly, while what constitutes “key information” will vary between clinical trials, the FDA’s draft guidance offers some examples of the types of disclosures that may be necessary. For example, the FDA suggests that informed consent disclosures may need to provide information on the following topics, “in a concise and focused way that facilitates comprehension”:

• Voluntary Participation and the Right to Discontinue Participation

• Purpose of the Research, Expected Duration, and Procedures to Be Followed

• Reasonably Foreseeable Risks and Discomforts

• Reasonably Expected Benefits

• Appropriate Alternative Procedures

• Compensation and Medical Treatments for Research-Related Injuries

• Costs Related to Subject Participation

The FDA’s suggested topics are neither exclusive nor mandatory. As with many other aspects of FDA compliance, a custom-tailored approach is required. The public comment period for this draft guidance has closed. The FDA is currently reviewing the feedback received. Stakeholders are advised to stay informed on updates and final publication details through the FDA's official communications.

Contact Us

Medical device and pharmaceutical manufacturers should prioritize reviewing the FDA’s draft guidance in light of their existing informed consent processes to ensure alignment with evolving compliance standards. Contact Gardner Law for help in reviewing your informed consent documents, identifying key information, and providing strategic guidance throughout the process.