OHRP Issues Guidance on Human Subjects Protections for Coronavirus Actions

The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issued guidance for institutions and investigators conducting research in response to the COVID-19 pandemic. The guidance covers the following topics: (1) Public Health and Clinical Activities; (2) Excluded Public Health Surveillance Activities; (3) Legally Required Reporting; (4) Research Changes to Eliminate Apparent Immediate Hazards; (5) Proposing and Reviewing Study Changes; and, (6) Whether Suspensions of Research Must be Reported.  The guidance document can be accessed at on OHRP’s website.

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