Certificate of Confidentiality
Application Help
The National Institutes of Health (NIH) and other Department of Health and Human Service (DHHS) agencies, including the Food and Drug Administration (FDA), issue Certificates of Confidentiality (CoCs). A CoC allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Whether or not a CoC is necessary depends on the sensitivity of the research data and the potential impact it may have on participants should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation).
Instructions for COC Applications of NON-NIH Funded Research
When your study needs a CoC and is NOT funded by the NIH, investigators must complete an online application process to obtain that CoC. Start by visiting the NIH CoC website and clicking on the appropriate selection from the "Select Your Funder" dropdown. From there, the NIH site will walk you through the application process.
Application Information
Please use the below information when completing the CoC application.
Creighton University Federalwide Assurance number is:
- Biomedical Board #IRB00000155
- Social-Behavioral Board #IRB00007137
Creighton University's Institutional Official (IO) is:
- Juliane K. Strauss-Soukup. B.S, Ph.D.
Creighton University
2500 California Plaza, Omaha, NE 68178
Obtaining Institutional Official (IO) Signature for Certificate of Confidentiality (COC) Assurance Document
As part of the online CoC application process, the NIH requires a signed assurance document be uploaded along with the application. That assurance document can be created using the template language on the NIH website. This document should be created on departmental letterhead and include signature blocks for the Principal Investigator and the IO.
To obtain IO signature for the assurance document, please send a request to IRB@Creighton.edu containing electronic copies of the following items:
- the assurance document for IO signature,
- current notice of IRB approval (not required for FDA CoC applications),
- all currently approved consent forms or scripts (not required for FDA CoC applications),
- copy of the CoC application
- and if applicable the DEA Certificate of Registration (not required for FDA CoC applications).
- For FDA CoC applications, include a copy the application itself signed by the PI.
Signed assurances are typically returned within 3 business days.
