Certificates of Confidentiality (CoC)

CoCs allow researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands. Certificates are issued by NIH and other Department of Health and Human Services (HHS) agencies to researchers to help protect the privacy of human subjects enrolled in sensitive, health-related research.

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New to System If you are a new COC requestor, need a refresher, or are new to NIH’s Electronic Application System (new in 2015).

Already Submitted If you have already submitted a request to NIH through our new request system (launched Aprli 2015).

Extend or Amend If you need to Extend or Amend and EXISTING Certificate from NIH.

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Which Projects Are Eligible for COCs?

Certificates of confidentiality are only issued for research projects that are:

Collecting subject names or other identifying characteristics, on a sensitive research topic
Approved by an Institutional Review Board (IRB) operating under a Federalwide assurance (FWA) issued by the DHHS Office of Human Research Protections (OHRP) or with the approval of the FDA.
On a topic that is within the HHS health related research mission
Storing research data in the United States
Allowable under federal regulations
Federal funding is not required but issuance is at the discretion of the issuing agency

For more info, see Frequently Asked Questions Section C: Eligibility for a Certificate