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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: 

James A. Ashton-Miller, Ph.D.
Associate Vice President -
Research Policy and Compliance
University of Michigan
4080 Fleming Building
503 Thompson Street
Ann Arbor, MI  48109-1340

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

    Note:  Effective April 14, 2015, the NIH changed the application process for CoCs. Applications must now be submitted using the NIH online application system.

    1.  Compile the application materials for submission to UMOR:

    • 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
    • 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.  Include your campus mailing address in the email. You will receive a confirmatory email for receipt of your materials.  Once the letter of assurances has been signed, you will receive a PDF version via email and a hard copy will be sent to your campus mailing address.

    3.  Apply for your CoC at the NIH CoC Kiosk.

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

    Additional U-M HRPP information for Amendments to, or Extensions of, Existing CoCs:  Amendments to, or extensions of, existing CoCs must be reviewed by the U-M designated signator even if the issuing NIH agency does not require a re-review of your application materials.  Please use the guidance links for more information.

    For Multi-Site 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 this 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

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