The FDA's Office for Human Research Protections has issued new guidance intended to address questions regarding how the Department of Health and Human Services human subjects protection regulations apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. Among the guidance were assurances that actions taken for public health or clinical purposes, not for research, don't require institutional review board (IRB) approval before being implemented and that "investigators may implement changes to approved research prior to IRB review and approval, if the changes are necessary to eliminate apparent immediate hazards to the subject." An example of the latter would be "cancelling or postponing non-essential study visits or conducting phone visits instead of in-person visits to reduce COVID-19 transmission risks," the office said.

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