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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: This Policy applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH, whether supported through grants, cooperative agreements, contracts, other transaction awards, or conducted by the NIH Intramural Research Program, that collects or uses identifiable, sensitive information. If the research is not federally funded, the Secretary may issue a Certificate to an investigator or institution engaged in such research, upon application. The authority also specifies the prohibitions on disclosure of the names of research participants or any information, documents, or biospecimens that contain identifiable, sensitive information collected or used in research by an investigator or institution with a Certificate. Specifically, the amended authority requires the Secretary to issue to investigators or institutions engaged in biomedical, behavioral, clinical, or other research in which identifiable, sensitive information is collected (“Covered Information”), a Certificate to protect the privacy of individuals who are subjects of such research, if the research is funded wholly or in part by the Federal Government. Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act. These Certificates protect the privacy of subjects by limiting the disclosure of identifiable, sensitive information. 114-255, which states that the Secretary, HHS shall issue Certificates of Confidentiality to persons engaged in biomedical, behavioral, clinical or other research, in which identifiable, sensitive information is collected.

The update of this Policy comes as a result of the need to implement Section 2012 of the 21st Century Cures Act, P.L. The purpose of this guide notice is to inform the research community that NIH is updating its policy for issuing Certificates of Confidentiality (Certificates) for NIH-funded and conducted research.

Notice of Changes to NIH Policy for Issuing Certificates of ConfidentialityĮffective Date: OctoRelated Announcements

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