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UC Comment Letters

UC Office of the President

UC Comments on Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff: Availability (FDA-2019-D-3592)

Abstract

This comment letter responds to the FDA’s draft guidance on Certificates of Confidentiality (CoCs) for protecting identifiable, sensitive information collected in human subjects research. UC supports the guidance’s privacy protections and streamlined CoC process but requests greater clarity on what qualifies as sensitive information, when individual investigators may obtain CoCs, appropriate informed consent language, and the circumstances and options associated with FDA denial of discretionary CoCs.


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