FDA’s New Rule Allows for Medical Research Without Informed Consent

In an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the U.S. Food and Drug Administration (FDA) has finalized a rule allowing certain clinical trials to operate without obtaining informed consent from participants. The hitch? The study cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved. The rule was issued in late December 2023 and went into effect on Jan. 22, 2024. “We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise,” Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, wrote on his FDA blog, “Catching Up With Califf.” “This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.”...