Certificates of Confidentiality
Certificates of Confidentiality provide protection against the forced disclosure of certain identifying information about research participants. The Certificates can be obtained from the National Institutes of Health (NIH). All new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. (Previously, researchers had to proactively apply to the NIH for a CoC, and only if the study was collecting sensitive information from participants.) For more information about the change in policy, please see this notice. For information about required consent language, please see the IRB guidance here.
Detailed information about Certificates of Confidentiality is available via:
A PI must apply for a Certificate of Confidentiality from the NIH, not the Emory IRB; however, Emory’s Institutional Official must sign an assurance before the NIH will review the request. (The Institutional Official is the signatory on Emory’s Federal Wide Assurance).
- Once you have the assurance form ready to be signed, DO NOT send the form directly to the Emory Institutional Official. Instead, email the IRB analyst who is responsible for your study. If you are unsure who the analyst is, you may call the IRB to find out, or you can send the CoC application directly to the IRB’s main email address (email@example.com).
- In addition, the Emory IRB needs to know that a study includes plans to obtain a Certificate of Confidentiality, or that it has obtained one that is in effect. In most cases, the PI should communicate this information to the Emory IRB as part of an application for approval (at initial submission, continuing review, or as an amendment request).
For additional information on these requirements please consult with the IRB guidance here.