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FDA Updates Guidance On Informed Consent In Drug And Device Trials

 
• By Elizabeth Orr

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 doctor in his office showing an informed consent document and pointing to the signature line.
• Source: Shutterstock

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 the study, explain potential risks and benefits, and discuss compensation...

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