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:

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 isiting 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.

  • UW-Madison's Federalwide Assurance number is:

    • FWA00005399

  • UW-Madison's Institutional Official (IO) is:

    • Nadine Connor, PhD
      Associate Vice Chancellor for Research Policy and Compliance
      321 Bascom Hall
      500 Lincoln Dr.
      Madison, WI 53706

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 Invsetigator 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:

  • the assurance document for IO signature,
  • current notice of IRB approval (not required for FDA CoC applications),
  • all currently approved consent forms or scripts (not required for FDA CoC applications),
  • copy of the CoC application (see this document for help with creating readable PDF of application),
  • and if applicable the DEA Certificate of Registration (not required for FDA CoC applications).
  • For FDA CoC applications, include a copy the application itself signed by the PI.

Signed assurances are typically returned within 3 business days.

See Also:

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 15:35 CDTUpdated:2018-03-09 16:41 CDT
Sites:Health Sciences IRBs, VCRGE and Graduate School
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