FDA Revises Policy for Certificates of Confidentiality

The FDA issued a new draft guidance that would formalize its current process for issuing discretionary Certificates of Confidentiality (CoCs) for commercial sponsors that seek to prohibit disclosure of identifiable information about a research participant.

In the past, a CoC protected a researcher from being compelled to disclose identifiable information about a research participant. The 21st Century Cures Act changed that by prohibiting CoC holders from disclosing such information unless a specific exemption applies.

The FDA typically approves about 150 such requests a year and doesn’t expect that number to change, although the agency warned sponsors that recent technological innovations make it easy for other parties to easily deduce a patient’s identity from deidentified data of a trial, including genomic data and biospecimens.