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U-M Certificate of Confidentiality Policy
- Print the application & letter of assurance on U-M letterhead.
- Include the U-M Federalwide Assurance number: #00004969
- 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
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
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
- NIH: Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects (application requirements); CoC Contacts (submisssion instructions per DHHS agency)
- 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)