What is a Certificate of Confidentiality?
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. Learn more about CoCs.
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
Applying for a CoC
NIH uses an on-line Application system for all CoC requests to NIH. See below for more information.
|Select the area that applies to you||Process|
|If you are a new COC requestor, need a refresher, or are new to NIH's Electronic Application System (new in 2015)||
Step 1: Identify where to apply
Step 2: Learn what is required for an application
Step 3: Apply for a new Certificate from NIH
|If you have already submitted a request to NIH through our new request system (launched April 2015)||
|If you need to Extend or Amend an EXISTING Certificate from NIH||See who to contact|