A Certificate of Confidentiality (COC) is issued by either the National Institutes of Health (NIH) or the Food and Drug Administration (FDA).
Effective December 13, 2016, DHHS enacted new provisions that automatically provide a Certificate of Confidentiality for any study funded by the Federal government that will collect identifiable sensitive information. No application for a Certificate of Confidentiality is required and no Certificate will be provided by the Federal Government.
If your protocol is not funded by the NIH and involves an investigational drug, device or biologic, you should make your application for the Certificate of Confidentiality to the FDA. You may submit the application to the FDA prior to receiving IRB approval of the protocol. See information below on how to submit an application to the FDA.
If your application does NOT involve an investigational drug, device or biologic and the study is not funded by the Federal Government you should make your application to the NIH. The application cannot be submitted to the NIH until you have IRB approval of the protocol. See information below on how to submit an application to the NIH.
Tools and information provided by the NIH:
The FDA is authorized to issue a Certificate Confidentiality for studies with an IND or IDE that do not have any other HHS funding.
For information about how to apply to the FDA for a Certificate of Confidentiality, please refer to this link for the most up-to-date FDA contact information. Note there are different contacts; a contact person for drugs and a different contact for biologics: Certificate of Confidentiality to the FDA