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OHRP issues guidance on COVID-19

On April 8, 2020, the Office for Human Research Protections (OHRP) issued guidance on the regulatory requirements of 45 CFR 46 and actions taken during COVID-19 for the research community. Specifically, the guidance addresses public health and clinical activities, research changes to eliminate apparent immediate hazards, proposing and reviewing study changes, and whether suspensions of research must be reported. CITI Program’s Hot Topics module, part of the Human Subjects Research training, has been updated to reflect this guidance.

OHRP Guidance on COVID-19