Informed Consent | FDA

Metadata

• Author: Guidance Issuing Office
• Full Title: Informed Consent | FDA
• URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent

Highlights

A recommendation that consent forms be written at an eighth grade or lower reading level was made by the working group formed by the National Cancer Institute (NCI), along with the Office for Protection from Research Risks (now the Office of Human Research Protections, OHRP) and FDA in the 1998 “Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials.” (View Highlight)

Content to be consumed by the general public should be written at an eighth grade or lower reading level