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Certificates of Confidentiality

U-M Certificate of Confidentiality Policy

HRPP Operations Manual, Part 11, Section III B.6

U-M Requirements

Your HRPP CoC application packet must include:

  1. The "downloaded" version of the CoC application, the IRB approval letter, and the IRB approved consent document(s).
  2. The Letter of Assurances:
  • Use the required template; print on your U-M departmental letterhead and sign.
  • The Letter of Assurances must list the following information for the U-M designated signator: 

Lois Brako, Ph.D.
Assistant Vice President for Research-
Regulatory and Compliance Oversight
University of Michigan
North Campus Research Complex
2800 Plymouth Road
Bldg. 520, Rm. 1190
48109-2800

Effective 10/01/17:  new NIH policy for issuing Certificates of Confidentiality.  Information on this webpage will be updated to reflect the NIH changes once additional guidance is issued.  Contact the applicable U-M IRB if you have questions about the new CoC policy.

Certificate of Confidentiality (CoC) is issued to protect the privacy of research subjects by allowing investigators and institutions to avoid compulsory release of information that could be used to identify subjects with a research project (i.e., any information that could lead directly or indirectly to identification of a research subject).  

CoCs are issued by the:

  • National Institutes of Health (NIH) by institutes under their purview
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA) for studies that obtain an Investigational New Drug (IND) authorization or other FDA authorization

    Certificate of Confidentiality Process

    1.  After receiving IRB approval and prior to submitting your online application to the NIH, compile the following materials for submission to the U-M Human Research Protection Program (HRPP) for review and sign-off:

    • Copy of the online CoC Application (see instructions to print the correct copy on page 4, item 7)
    • Letter of Assurances: (use the UMOR Letter of Assurances-Non-Student Researcher template); the PI must sign the Letter of Assurances before sending to HRPP for review  NOTE:  if the CoC is for student research, contact Mary Ramirez (mramirez@umich.edu) for the correct template
    • A copy of the IRB Approval or Contingent Approval letter: (if contingent approval was issued, obtaining the CoC must be the only remaining contingency to be met)
    • IRB-reviewed and approved informed consent/assent documentation (if contingent approval was issued, the documentation will not display the approval watermark)

    2.  Obtain ​approval from U-M's designated signator:

    Combine the application materials into a single PDF document and email it to the University of Michigan Office of Research (UMOR) at HRPPCoCgroup@umich.edu.  Please include the following information in your email: a) The name of the U-M PI that is submitting the application, b) Whether the application is for a new CoC or to amend or extend/renew an existing CoC,  and c) Whether U-M is a coordinating center or research site.  You will receive a confirmatory email for receipt of your materials.

    Once we confirm that your application packet is complete and the letter of assurances has been signed, you will receive a PDF version of the LOA via email. 

    3.  Upload the signed LOA to your online CoC application and submit to the NIH.

    Each agency may have their own application process and set of submission instructions for  new, amended or extended CoCs.  For additional information, please see:

    • NIH:   Use the online application if applying for a new CoC.  It is also recommended that you discuss the content of the CoC-specific text for your informed consent documents with your NIH agency representative. If amending or extending an existing CoC, first consult with your NIH agency representative to confirm (1) whether you must complete a formal amendment or extension application and (2) obtain the formal application template or a link to the template from them.  Find your NIH representative here: CoC Contacts.  See additional information below. 
    • CDC:  Certificate of Confidentiality Application Instructions (application requirements and submission instructions)  NOTE:  U-M requires that in addition to the PI signature, you must obtain the Deputy Institutional Official's signature.  Contact us for more information.
    • FDA:  Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects (application requirements and submission instructions):  Please consult with the FDA representatives at https://humansubjects.nih.gov/coc/contacts  NOTE:  U-M requires that in addition to the PI signature, you must obtain the Deputy Institutional Official's signature.  Contact us for more information.

    Additional U-M HRPP information for Amendments to, or Extensions of, Existing CoCs:  Amendments to, or extensions of, existing CoCs may require review by the U-M designated signator even if the issuing NIH agency does not require a re-review of your application materials.  If the NIH does not require a formal application to amend or extend your existing CoC, you must complete the HRPP CoC Amendment/Extension Checklist. This information will help inform whether a formal application will be necessary for HRPP review.  Please use the guidance links for more information.

    For Multi-Site or Collaborative Projects where U-M Holds the CoC:  Each site that rolls up under the U-M CoC must obtain a signed letter of assurances from their institution and submit it to the U-M PI.  Upon receipt, the U-M PI should send an electronic copy of the document(s) to Mary Ramirez, mramirez@umich.edu.  U-M researchers will be given additional instructions at the time the Deputy Institutional Official signs off on the CoC application from the HRPP review.

    For Multi-Site or Collaborative Projects where U-M will Roll-up under another Institution's CoC:  U-M must provide a signed letter of assurances to the institution that will hold the CoC.  Please submit a copy of your a) IRB approval letter, b) IRB-approved consent(s)/assent(s), and c) the prepared letter of assurances (using the template found at item 1 above, bullet 2), to HRPPCoCgroup@umich.edu.  If you have a copy of the CoC that has been issued for the institution holding the CoC, please submit that at the same time.

    Questions?

    Contact the following for questions regarding Certificates of Confidentiality:

    For IRB-HSBS studies:

    Mary Ramirez, CIP
    Assistant Director
    Health Sciences and Behavioral Sciences Institutional Review Board
    HRPP/UMOR
    (734) 615-9464
    mramirez@umich.edu 

    For IRBMED studies:

    S. Joseph Austin, J.D., LL.M
    Assistant Director, Regulatory Operations
    Institutional Review Boards
    University of Michigan Medical School
    (734) 763-1236
    sjaustin@med.umich.edu