Revision of FDA’s Informed Consent Rule for Clinical Trials

Introduction to the New Regulation

The United States Food and Drug Administration (FDA) has recently enacted a definitive regulation permitting certain experimental clinical trials on humans to proceed without the necessity of acquiring informed consent from the participants beforehand. This regulation, which became effective on January 22, 2024, applies to clinical studies deemed to only involve “minimal risk” and incorporates adequate measures to safeguard the participants’ rights, safety, and welfare, exempting them from the prerequisite of prior informed consent.

Definition of Minimal Risk

The criterion for what constitutes a “minimal risk” in these trials is strictly defined by the FDA. The term “minimal risk” is characterized as situations where the likelihood and extent of potential harm or discomfort expected in the research do not exceed those ordinarily experienced in daily life or during standard physical or psychological evaluations or tests.

FDA Commissioner’s Perspective