Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff November 2020

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-3592
• Issued by: Office of the Commissioner, Office of Policy, Legislation, and International Affairs, Office of Policy; Center for Biologics Evaluation and Research; Center for Drug Evaluation and Research; Center for Devices and Radiological Health; Center for Tobacco Products; Center for Food Safety and Applied Nutrition; Center for Veterinary Medicine; Office of the Commissioner, Office of the Chief Scientist

This guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled to disclose identifiable, sensitive information about the research participant, created or compiled for purposes of the human subject research. As amended, the statute broadened the protections by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies.

The 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 this 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 this 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.

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