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Recommendations for Study Sponsors on Informed Consent Documents

The 21st Century Cures Act, passed in 2017, required that OHRP and FDA harmonize their regulations so that all human subject research is effectively being conducted under the same rules. While the new Common Rule, effective on January 21, 2019, does not apply to FDA-regulated research, FDA has already made clear their intent to update their own regulations to become consistent with these changes. This document summarizes the regulatory changes that apply to informed consent documents  to provide extra-regulatory and informal guidance where helpful, to help sponsors update informed consent document templates to be compliant with the new regulations.