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Regulatory Focus™ > News Articles > 2019 > 11 > How to Request a Certificate of Confidentiality: FDA Unveils Draft Guidance

How to Request a Certificate of Confidentiality: FDA Unveils Draft Guidance

Posted 22 November 2019 | By Zachary Brennan 

How to Request a Certificate of Confidentiality: FDA Unveils Draft Guidance

The US Food and Drug Administration (FDA) on Friday released draft guidance explaining how sponsors can request certificates of confidentiality (CoCs), which can prevent researchers from being compelled to disclose identifiable, sensitive information about research participants.

For non-federally funded research, FDA says it has issued so-called “discretionary CoCs,” on a case-by-case basis since the enactment of the 21st Century Cures Act, which also made the CoCs for federally funded research mandatory.

“Given current technological capabilities, there is some support for the position that the identity of an individual participating in certain types of research is relatively easy to determine even with limited de-identified data,” the 7-page draft explains. “Genomic data also are often considered to fall automatically into the category of identifiable, sensitive information.”

FDA suggests such sponsors ask themselves four questions before submitting a request for a CoC, including: Does the human subject research collect identifiable, sensitive information; “Does the human subject research, for which a discretionary CoC is being requested, involve the use or study of a product subject to FDA’s jurisdiction and subject to FDA’s regulatory authority? Are the requestor’s research measures sufficient to protect the confidentiality of the identifiable, sensitive information?”

After FDA completes its review of a request, the guidance says the agency will send an electronic response letter to the requestor indicating whether or not the CoC has been granted. If granted, that letter will serve as the CoC.

The FDA draft follows the NIH’s institution of a policy to ensure NIH-funded investigators do not have to apply for a CoC. The CoC will be issued automatically to awards funded wholly or in part by the NIH that collect or use identifiable, sensitive information.

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

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