Instructions for Obtaining a Certificate of Confidentiality (CoC)

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:
  1. The first step in obtaining a CoC is to determine the agency or institute you will apply to and the contact information for that agency or institute by using the Certificates of Confidentiality Contacts website.

    • If the agency uses an online application process, the Certificates of Confidentiality Kiosk has helpful information on how to get started with the application. NOTE: as of April 2015 all NIH institutes/centers use the online application system.


    • If the agency does NOT use an online application process, you will need to use UW's FDA CoC Template. When applying to an agency that does not use the online application process, it is recommended that you confirm the sufficiency of the UW template with the agency's CoC submission contact person prior to proceeding.

    • 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
      Interim Associate Vice Chancellor for Research Policy and Compliance
      321 Bascom Hall
      500 Lincoln Dr
      Madison, WI 53706

  2. Upon completion of the CoC application, the Office of Research Policy will assist in obtaining a signature from the IO. To initiate this process contact Travis Doran (researchpolicy@research.wisc.edu or 890-4399), and provide electronic copies of the following items:

    • 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 institutional assurances on department letterhead with signature blocks for PI and IO, 
    • copy of 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.

  3. Upon receipt, the materials will be reviewed for accuracy and completeness. You will be contacted if modifications are needed.

  4. Once materials have been reviewed, documents will be forwarded to the IO for signature. The signed assurances document will be returned to you for submission.

  5. If the agency or institute approves your CoC application, submit the approved CoC to the IRB and make any needed modifications to the CoC language in your consent form(s) (ex. change "we have applied for a Certificate of Confidentiality" to "we have obtained a Certificate of Confidentiality"). 

  6. If the agency or institute does not approve your CoC application, notify the IRB of the agency or institute's decision and remove references to a CoC from your consent form(s).

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:Ryan M.Group:VCRGE and Graduate School
Created:2013-12-17 14:35 CSTUpdated:2016-11-21 10:27 CST
Sites:Health Sciences IRBs, VCRGE and Graduate School
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