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IRB-HSR > FAQ > How do I apply for a Certificate of Confidentiality?

 

 

 

 

 

 

How do I apply for a Certificate of Confidentiality?

A Certificate of Confidentiality (COC) is issued by either the National Institutes of Health (NIH) or the Food and Drug Administration (FDA).  Investigators may apply for a COC to protect identifiable research information from forced disclosure.  A COC allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

COCs can be applied for through either the NIH or the FDA regardless of funding.  COCs are issued through the FDA if the study involves an Investigational New Drug (IND) Authorization, or is otherwise FDA regulated.  NIH issues most other COCs.

Whether or not a COC is necessary depends on the sensitivity of the research data and the potential impact it may have on subjects should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation).  Examples of sensitive research data include:

  • Genetic Information
  • Information of psychological well-being of participants
  • Information on participants' sexual attitudes, preferences or practices
  • Data on substance abuse or other illegal risk behaviors

Information on how to apply for a Certificate of Confidentiality may be found at http://grants.nih.gov/grants/policy/coc/contacts.htm

You will need to scroll down to the link for the FDA
FDA Certificate of Confidentiality application instructions