GUIDANCE DOCUMENT
Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff November 2019
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2019-D-3592
- Docket Number:
- FDA-2019-D-3592
- Issued by:
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Guidance Issuing OfficeOffice of PolicyCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Tobacco ProductsCenter for Food Safety and Applied NutritionCenter for Veterinary MedicineOffice of the Chief Scientist
This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC).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 and 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.