NIH Implementation of Automatic Certificates of Confidentiality

With the advent and increasing popularity of large-scale data sets and genomic information in NIH-funded research, it is now more important than ever that sensitive information about patients is protected. Previously NIH and other Department of Health and Human Services agencies issued Certificates of Confidentiality upon request that allowed researchers to refuse to disclose names or identifying characteristics of research subjects in response to legal demands; however, effective October 1, 2017 (NOT-OD-17-109), CoCs will be provided automatically for NIH-supported research. Researchers and institutions will also no longer receive a physical certificate. This new policy applies to grants, cooperative agreements, contracts, and intramural research projects funded wholly or in part by NIH. This new feature arose as part of the 21st Century Cures Act. The passage of the 21st Century Cures Act radically changed how both sponsors and researchers approached healthcare, medicine, and research. This particular legislation touched on a variety of issues related to clinical research, transparency, and privacy, including

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