Sponsors and investigators conducting federally funded research do not need IRB approval for actions taken in response to the threat of COVID-19 as long as those actions are for public health or clinical treatments purposes rather than research, according to a new guidance from the Office for Human Research Protections (OHRP).

Investigators also are permitted to make changes to approved research plans without prior IRB approval when responding to an immediate threat to patients.

OHRP’s guidance provides recommendations for following the patient protection requirements in the Common Rule (45 CFR 46) when a federally funded research project is impacted by the virus, including releasing identifiable information about research subjects to a public health authority. Investigators must comply with federal, state and local laws that require disclosure of a research subject’s positive COVID-19 test results, the guidance says, adding that the subject should be informed of the disclosure.

OHRP also says the recently issued FDA guidance on conducting trials during the pandemic is consistent with the Common Rule’s patient protection requirements and may be followed by investigators whether or not they are conducting FDA-regulated research.

To read the guidance, click here: https://bit.ly/3e9FVCB.