FDA Finalizes Guidance on Informed Consent in Clinical Investigations: Ensuring Compliance and Patient Rights
Providing clarity on patient rights for informed consent in clinical investigations, the US Food and Drug Administration (FDA) has issued its final guiding document as of August 15, 2023. Titled ‘Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors’ (final guidance), this decisive documentation finalizes, with new examples and minuscule updates and alterations, the FDA’s…