Certificates of Confidentiality (CoC) are issued to protect the privacy of research participants by prohibiting disclosure of identifiable, sensitive research information. NIH-funded research that collects or uses identifiable, sensitive information is automatically deemed to be issued a CoC, so NIH recipients do not need to request a CoC. NIH also has a program for issuing CoCs for research not funded by NIH (research by non-NIH HHS agencies and other federal departments and agencies or non-federally funded research).
Some federal agencies and departments maintain their own CoC request system. For research that is non-NIH and not in one of the organizations where the agency maintains its own CoC system, researchers may request a discretionary CoC through NIH. This includes investigators whose research is funded by an HHS agency, other than NIH, CDC, FDA, HRSA, IHS, or SAMHSA, or a non-HHS federal department or agency.
To facilitate the request, evaluation, management, and issuance of CoCs, eRA maintains the Certificate of Confidentiality Request system at NIH. Researchers conducting studies on a topic that is within the NIH mission or HHS health-related research mission can use this system to request a CoC for research with human subjects. The system asks a series of qualifying questions about the research, and if the answers indicate that the research may qualify for a CoC, the researcher enters data about the research and performance sites and submits the CoC request.
After additional email verification and attestation by the Institutional Official, the Principal Investigator and Institutional Official receive confirmation of submission, and NIH CoC Coordinators evaluate and process the request. If approved, the requestor receives a PDF copy of the certificate via email.