Certificate of Confidentiality (CoC) Application Help

The National Institutes of Health (NIH) and other Department of Health and Human Service (DHHS) agencies, including the Food and Drug Administration (FDA), issue Certificates of Confidentiality (CoCs). 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. Whether or not a CoC is necessary depends on the sensitivity of the research data and the potential impact it may have on participants should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation).

Instructions for CoC applications of non-NIH funded research:

When your study needs a CoC and is NOT funded by the NIH, investigators must complete an online application process to obtain that CoC. Start by visiting the NIH CoC website and clicking on the appropriate selection from the "Select Your Funder" dropdown. From there, the NIH site will walk you through the application process.

Application Information

Please use the below information when completing the CoC application.

Obtaining Institutional Official (IO) Signature for Certificate of Confidentiality (CoC) Assurance Document

As part of the online CoC application process, the NIH requires a signed assurance document be uploaded along with the application. That assurance document can be created using the template language on the NIH website found here. This document should be created on departmental letterhead and include signature blocks for the Principal Investigator and the IO.

To obtain IO signature for the assurance document, please send a request to compliance@research.wisc.edu containing electronic copies of the following items:

Signed assurances are typically returned within 3 business days.

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