New FDA Guidance on Certificates of Confidentiality

In November 2020 FDA released a Guidance to describe how sponsors and sponsor/investigators (IND holders and IDE holders) of FDA regulated, non federally-funded studies can apply to the FDA to obtain a Certificate of Confidentiality (CoC) for a specific study.

The 21st Century Cures Act simplified certain aspects of the issuance of CoCs by requiring that CoCs be issued for federally-funded human subject research that collects or uses identifiable, sensitive information (referred to in the guidance as mandatory CoCs). For non-federally funded research, issuance of CoCs is not required but may be issued at the discretion of FDA (referred to in the guidance as discretionary CoCs). FDA intends to continue receiving and considering such requests and will issue discretionary CoCs as appropriate. This guidance is intended to provide information on how to request a discretionary CoC, the statutory requirements for requesting such a CoC, and the statutory responsibilities associated with possessing a CoC. Although the mandatory CoC and the discretionary CoC are issued under different processes, the protections afforded by the issuance of either CoC are identical and the statutory responsibilities are the same.

Click here for this guidance.