Since the implementation of the 21st Century Cures Act, several changes have been made to the types of protections Certificates of Confidentiality (CoC) offer, and to the limitations they impose on any future data sharing. Additionally, more HHS agencies are issuing automatic CoCs for studies they fund (as NIH has been doing for several years). As a result, new guidance has been added to the Investigator’s Manual. Study teams working with an automatic, or ‘deemed’ CoC as a result of funding and any study team considering applying for a discretionary CoC are encouraged to carefully review this guidance.
New Certificate of Confidentiality Guidance
April 29, 2024