FDA Sets New Certificate of Confidentiality Application Process for Nonfederal Trials
Sponsors of nonfederally funded clinical trials can request a certificate of confidentiality (CoC) that protects them from being compelled to disclose participants’ private information, according to a final FDA guidance released last week.
A CoC specifically prohibits an investigator or sponsor from releasing a participant’s identifiable, sensitive information — including biospecimens — to anyone not connected to the trial so that they cannot be compelled to disclose the information in any kind of legal proceeding or litigation.
However, it does not protect investigators or sponsors from any federal, state or local laws already on the books that require disclosure. The CoC also does not apply to information that is necessary for a participant’s medical treatment, released with the consent of the participant or used for the purposes of other scientific research conducted under federal human research subject protections.
While federally funded trials are required to have a CoC, trials not sponsored by a federal agency are not, but they may apply for one if they are conducting research regulated by the FDA, says the guidance.
Other entities involved in a trial, such as CROs or academic institutions, are also bound by CoCs, but the FDA recommends that only sponsors or sponsor-investigators submit requests for them to avoid duplicate requests.
The final guidance includes the same provisions as the draft released in November 2019 with the exception of two points suggested in public comments on the draft: clarification of the definition of “identifiable, sensitive information” and an additional paragraph noting that it is within a trial’s IRB authority to require a CoC as a condition of approval.
Read the final guidance at https://bit.ly/3pMzqLX.