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FDA Removes Informed Consent Protections from Some Human Clinical Trials

FDA Removes Informed Consent Protections from Some Human Clinical Trials

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 […]

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