United States: OHRP Issues Guidance for Research Impacted by COVID-19

April 16, 2020
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On April 8, 2020, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) issued guidance on how HHS human subjects protection regulations (45 CFR part 46) apply to institutional and investigator actions responding to COVID-19. The guidance covers:

  • Public Health and Clinical Activities
  • Excluded Public Health Surveillance Activities
  • Legally Required Reporting
  • Research Changes to Eliminate Apparent Immediate Hazards
  • Proposing and Reviewing Study Changes
  • Whether Suspensions of Research Must be Reported
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