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FDA Updates Guidance On Informed Consent In Drug And Device Trials
The revision adds additional discussion of coercion and patient compensation, as well as a new FAQ discussing special situations. It was coauthored by the Office of Clinical Policy, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.
A newly finalized guidance document from the US Food and Drug Administration details the agency’s preferred approach to ensuring compliance with informed consent guidelines during device and drug clinical trials.
“Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors” addresses basic elements of informed consent, including how to describe...
