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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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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

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