What is a Certificate of Confidentiality and do I need one for my research?

Frequently Asked Question

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.

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
When applying for a COC the UW-Madison institutional official for human subjects research must co-sign the letter.  

For more information, see the below document(s).

Keywords:FAQ, COC stigmatizing, Certificates of Confidentiality   Doc ID:22800
Owner:Faye L.Group:Health Sciences IRBs
Created:2012-02-22 14:01 CDTUpdated:2015-11-17 13:21 CDT
Sites:Health Sciences IRBs
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