This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. This guidance, when finalized, will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.  Read More