The guidance responds to questions OHRP received from the research community regarding how the Department of Health and Human Services (HHS) human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. OHRP offers guidance on the following topics: (i) Public Health and Clinical Activities; (ii) Excluded Public Health Surveillance Activities; (iii) Legally Required Reporting; (iv) Research Changes to Eliminate Apparent Immediate Hazards; (v) Proposing and Reviewing Study Changes; and, (vi) Whether Suspensions of Research Must be Reported.
