USA – 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…