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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

  1. Print the application & letter of assurance on U-M letterhead. 
  2. Include the U-M Federalwide Assurance number:  #00004969
  3. List U-M's Deputy Institutional Official name and title as the as designated signator:

James Ashton-Miller, Ph.D
Associate Vice President for Research

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.  Compile the application materials:

    • CoC Application, completed per agency-specific instructions (see links below)
    • Letter of assurance (listed in the agency's application)
    • IRB Approval notice, indicating that there are no contingencies except the requirement to obtain a CoC
    • IRB-approved informed consent documentation

    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.  Once the letter of assurance has been signed, you will receive a PDF version via email and a hard copy will be sent to your campus mailing address. 

    If applying for a CoC online (NIH), only submit the letter of assurance, IRB approval notice, and informed consent documentation to UMOR.

    3.  Submit the application materials with the signed letter of assurance to the applicable federal agency.

    Each agency has their own application process and set of submission instructions

    Questions?

    Contact the following for questions regarding Certificates of Confidentiality:

    HRPPCoCgroup@umich.edu

    Mary Ramirez
    Assistant Director IRB-HSBS
    (734)-615-9464
    mramirez@umich.edu