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Need to Extend or Amend an Existing Certificate of Confidentiality?

For non-NIH funded research, to extend or amend an existing Certificate, contact the issuing agency or NIH Institute or Center (IC)


Extensions

Should be requested if your non-NIH funded research project will extend beyond the current expiration date on your Certificate.  Please request extensions at least 3 months prior to the Certificate's expiration date and include the reason for the extension in your request (for example, we are continuing to enroll new subjects).

NOTE: if your study has completed all enrollment and data collection, there is no need to extend the Certificate.  Sensitive, identifiable research information maintained by investigators during any time a Certificate is in effect, is protected permanently.

Amendments

If there is a SIGNIFICANT change in your non-NIH funded project after the Certificate has been issued, you should request an Amendment to your Certificate.  This includes such changes as a major change in the scientific scope of the project, changes in the PI, or in the drugs to be administered.  

NIH-Funded Research If your NIH-funding will or has ended but the collection of new data from research participants will continue without NIH-funding you will need to apply for a CoC for continuity of protections using the CoC application system. If your NIH funding will or has ended but your study has completed all enrollment and data collection, there is no need to extend the Certificate. Sensitive, identifiable research information maintained by investigators during any time a Certificate is in effect, is protected permanently.
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