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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 applicaitons of non-NIH funded research using the NIH COC submission system:

When your study needs a CoC and is NOT funded by the NIH, investigators must complete an online application process to obtain that CoC. Your study should be approved (or be determined to be exempt) by the IRB before submitting a CoC request through the NIH. Start by visiting the NIH CoC website and reading the information provided under Steps 1 and 2. Once you are ready to submit the application, click “Request your CoC” and the NIH site will walk you through the application process. Please note, you must complete the CoC request in one session, as you will not be able to save and return at a later time. By submitting the application for verification, it will be automatically routed to the Institutional Official for review and final submission. Please use the below information when completing the CoC application:

Please use the below information when completing the CoC application.

  • Name of Institution:

    • University of Wisconsin - Madison

  • Institution Address:

    • 321 Bascom Hall
      500 Lincoln Dr.
      Madison, WI 53706

  • Name of Institutional Official

    • Nadine Connor, PhD

  • Email Address of Institutional Official

Obtaining signature for Certificates NOT issued through the NIH CoC system

As indicated in Step 1 on the NIH CoC website, some agencies issue their own confidentiality or privacy certificates and must be contacted directly. If an agency requires application materials be signed by the Institutional Official or Institutional Review Board Chair, please email the application materials to for signature routing. Signed assurances are typically returned within 3 business days.

See also: Investigator Manual

Keywords:coc certificate confidentiality sensitive information research records nih dhhs national institutes health human services fda food drug administration disclosure disclose impact   Doc ID:36092
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-12-17 14:35 CSTUpdated:2021-07-02 10:57 CST
Sites:Health Sciences IRBs, VCRGE and Graduate School
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