Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff." This draft guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.