The U.S. Food and Drug Administration (FDA) has issued a final rule that authorizes some experimental human clinical trials to operate without first obtaining informed consent from participants. The new rule, which took effect on Jan. 22, 2024, allows clinical investigations that pose no more than a “minimal risk” and have appropriate safeguards to protect the rights, safety and welfare of its human subjects to be exempt from the requirement to obtain prior informed consent from them.
Informed consent can only be withheld from human participants in clinical trials that pose no more than a minimal risk. The FDA defines minimal risk as…
… means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Robert Califf, MD, commissioner of the FDA, wrote:
The rule change was originally proposed in November 2018 and, while the majority of the 50 public comments were in support of the rule change, the new rule was not implemented until December 2023.
