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

Studies cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.