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U-M Certificate of Confidentiality Policy
- Print the application, IRB approval letter, IRB approved consent documents.
- Use the appropriate Letter of Assurances template and print on your U-M departmental letterhead.
- Include the U-M Federalwide Assurance number: #00004969
- List U-M's Deputy Institutional Official as the 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
A 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 new 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
- Letter of Assurances: (use the UMOR Letter of Assurances-Non-Student Researcher 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. Include your campus mailing address in the email. You will receive a confirmatory email for receipt of your materials. 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.
3. Apply for your CoC:
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: Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects (NOTE: Use the NIH online application when seeking a new CoC. Use the instructions for Extramural Projects when amending or extending/renewing an existing CoC. See guidance links below); CoC Contacts (Consult with your NIH representative for additional information or assistance)
- CDC: Certificate of Confidentiality Application Instructions (application requirements and submission instructions)
- FDA: Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects (application requirements and submission instructions)
For Amendments to, or Extensions of, Existing CoCs: If you currently hold a CoC and need to amend or extend it, please contact your agency representative for specific application instructions. Amendments to, or extensions of, existing CoCs must also be reviewed by the U-M designated signator prior to submission to the issuing agency.
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, email@example.com.
Contact the following for questions regarding Certificates of Confidentiality:
For IRB-HSBS studies:
Mary Ramirez, CIP
Health Sciences and Behavioral Sciences Institutional Review Board
For IRBMED studies:
S Joe Austin, J.D., LL.M
Assistant Director, Regulatory Operations
Institutional Review Boards
University of Michigan Medical School