Certificate of Confidentiality Guidance

A Certificate of Confidentiality (CoC) provides additional protections to investigators and the institution against compulsory disclosure of identifying information about subjects enrolled in research that collects identifiable, sensitive information.

How to obtain a Certificate of Confidentiality

CoC requirements and request processes vary by sponsor. For example, research funded by the NIH is automatically protected with a CoC and there is no need to request one. Access the NIH CoC guidance for information about the process for other federal sponsors and non-federally sponsored research.

CoC requests that utilize the online CoC request system will need to identify the designated institutional official, who will also need to sign the Certificate of Confidentiality Assurance for all CoC requests:

  • For research managed under the Duke University Health System Human Research Protection Program, this is Geeta Swamy (geeta.swamy@duke.edu)
  • For research managed under the Campus Institutional Review Board (IRB),  please contact the Campus IRB at campusIRB@duke.edu

Review the following policies (as applicable to your project oversite) for additional information: