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 using the NIH COC submission system:
When your study needs a CoC and is NOT funded by the NIH, investigators must complete an online application process to obtain that CoC. A CoC can be requested through the NIH submission system prior to or after IRB approval and will be processed by the Office of Research Compliance, once it is determined that a CoC is appropriate for the study. Start by visiting the NIH CoC website and reading the information provided under Steps 1 and 2. Once you are ready to submit the application, click “Request your CoC” and the NIH site will walk you through the application process. Please note, you must complete the CoC request in one session, as you will not be able to save and return at a later time. By submitting the application for verification, it will be automatically routed to the Office of Research Compliance and the Institutional Official for review and final submission.
Please use the below information when completing the CoC application.
Obtaining signature for Certificates NOT issued through the NIH CoC system
As indicated on the NIH CoC website, some agencies issue their own confidentiality or privacy certificates and must be contacted directly. If an agency requires application materials be signed by the Institutional Official or Institutional Review Board Chair, please email the application materials to email@example.com for signature routing. Signed assurances are typically returned within 3 business days.
See also: Investigator Manual