HHS Releases Draft Guidance on Activities Deemed Not to be Research

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When finalized, the draft guidance will represent the Office for Human Research Protections’ (OHRPs) current thinking on determining whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements (45 CFR 46, Subpart A). It is intended for institutions, Institutional Review Boards (IRBs), investigators, institutional officials, and other human research protection staff.

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Essentials of Public Health Research provides an overview of the structure and function of public health systems, differentiates research and practice, and reviews consent and ethical issues for public health researchers.

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