Informed Consent Should Address Standard Of Care Risks, US FDA’s Califf Says

 
• By Michael McCaughan

US FDA Commissioner Robert Califf offers some thoughts on improving the informed consent process during a Patient Engagement Advisory Committee meeting that reflect concerns informed consent documents are too long and complex, but also do not address everything that may be important to patients.

Information gaps still exist in informed consent documents, even though they are long and legalistic, FDA Commissioner Robert Califf said. (Shutterstock)

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