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INFORMATION SHEET Certificate of Confidentiality

Purpose and Applicability

A federal Certificate of Confidentiality (CoC) protects sensitive identifiable information collected as part of a study and can be used to refuse to disclose study information.

This information sheet lists key facts and responsibilities for researchers who have a CoC for their study. More details can be found in the GUIDANCE Certificate of Confidentiality [1].

Researcher responsibilities

Disclosure and sharing of information/biospecimens

Responding to requests for access to CoC-protected information/biospecimens

Mandatory reporting requirements

CoC protections

Extending an expiration date or amending a CoC

CoCs and research consent

Automatic CoC

Some federal agencies automatically issue CoCs as a term of the grant or contact [4]. If your study has an automatic CoC, note the following:

Applied for CoC

Some federal agencies have a process by which a researcher can apply for a CoC [5], even without active funding from the agency. The process differs depending on the agency. Most commonly, CoCs may be obtained by applying to the NIH. The information below is specific to NIH CoCs obtained through the application process:

Version History

Open the accordion below for version changes to this guidance.

Version History

Version Number Posted Date Implementation Date Change Notes
2.1 11.30.2022 11.30.2022 Add that CoC protections apply to data placed in repositories
2.0 10.27.2022 10.27.2022 Revise and transfer content from ACKNOWLEDGEMENT CoC to new webpage; change taxonomy to INFO SHEET; reorganize information
1.6 11.08.2019 11.08.2019 Revised language throughout for multi-site and collaborative research; added advisory language regarding CoC consent statement at funding expiration
1.5 08.28.2019 08.28.2019 Inserted the missing flow chart; corrected info about expiration and modification for auto-CoCs to align with NIH website
1.4 11.30.2018 11.30.2018 Add CDC to list of funders with auto-CoCs
Previous versions For older versions: HSD staff see the SharePoint Document Library; Others – contact hsdinfo@uw.edu.

Keywords: CoC and privacy certificate