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Regulatory Focus™ > News Articles > 2020 > 11 > FDA finalizes certificates of confidentiality guidance

FDA finalizes certificates of confidentiality guidance

Posted 16 November 2020 | By Michael Mezher 

FDA finalizes certificates of confidentiality guidance

The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy of clinical trial participants.
“By protecting researchers from being compelled to disclose identifiable, sensitive information about the research participants, CoCs help protect the identity of the research participants and achieve the objectives of the research,” FDA writes.
FDA explains that two recent pieces of legislation, the 21st Century Cures Act and the Public Health Service Act (PHS Act), strengthened CoC protections by prohibiting CoC holders from disclosing identifiable, sensitive information and by mandating CoCs for federally funded research.
While the guidance is focused on obtaining a discretionary CoC and the statutory requirements and responsibilities for requesting and possessing the certificate, FDA notes that the protections and responsibilities for mandatory CoCs are identical.
To determine whether a sponsor or sponsor-investigator should request a CoC, FDA says they should be able to answer “yes” to four questions, including whether the requestor is involved in human subject research in which identifiable, sensitive information is collected and whether the research involves the use or study of an FDA-regulated product. The guidance also details the information that should be submitted in a discretionary CoC request and provides sample language for the assurances that should be provided to demonstrate that the requestor understands its obligations to comply with CoC statutory requirements.
The seven-page guidance is largely the same as the draft version released for comment last November, but has been revised to include some additional information on the definition of “identifiable, sensitive information” and the role of institutional review boards (IRBs). (RELATED: How to request a certificate of confidentiality: FDA unveils draft guidance, Regulatory Focus 22 November 2019).
“There are various definitions of the phrase identifiable, sensitive information used by different government agencies and for different purposes – not all necessarily applicable in this context but which may be useful in an evaluation by the sponsor, sponsor-investigators and other researchers of whether certain information would fall within the statutory definition,” FDA explains, noting that the determination of whether information is identifiable and sensitive is up to sponsors or sponsor-investigators.
The final guidance adds a paragraph discussing the role of IRBs, noting that it is within an IRB’s purview to request that a CoC be obtained to secure IRB approval. Any disagreement between the IRB, sponsor or investigators should be worked out between the parties, FDA says.
The agency also explains that it expects that, “Most discretionary requests will be granted provided these are in compliance with the statutory requirements.”


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