Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this Policy is now deemed to have been issued a Certificate of Confidentiality (CoC) and the policy’s disclosure requirements apply. Certificates issued in this manner (by policy) will not be issued as a separate document.
Under this policy, CoCs will become a term and condition of NIH grant awards rather than issued through a separate application process.
Institutions and investigators are responsible for determining whether the NIH research they conduct is subject to the policy and therefore automatically under a CoC. (See questions below to determine if a COC will apply below.)
Questions for Determining Applicability of NIH CoC Policy
If the research was begun or ongoing on or after December 13, 2016 and funded by NIH, respond to these questions to determine if NIH Policy for Issuing Certificates of Confidentiality applies:
- Is the activity biomedical, behavioral, clinical, or other research?
- Does the research involve human subjects as defined by 45 CFR Part 46?
- Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
- If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
- Does the research involve the generation of individual level, human genomic data?
See an explanation of the policy’s disclosure requirements in Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC) (NOT-OD-17-109).