Effective October 1, 2017, NIH will automatically issue Certificates of Confidentiality to all research funded by NIH that is collecting or using identifiable sensitive information. Additional information can be found on the NIH Certificates of Confidentiality Kiosk at https://humansubjects.nih.gov/coc/NIH-funded. In part, the new policy reads:
"For the purposes of this Policy, consistent with subsection 301(d) of the Public Health Service Act (42 U.S.C 241), the term "identifiable, sensitive information" means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur:
An individual is identified; or
For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual."
Consent documents should be updated with wording related to the Certificate of Confidentiality. Please refer to the NIH Certificates of Confidentiality Kiosk for sample language.
Existing studies will be reviewed at the time of renewal or modification to determine if the Certificate of Confidentiality is in place and if language needs to be added.
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