Conducting research involving human subjects during COVID? Read here for information on requesting an exception to the use of a single IRB.
NIH released a Guide Notice to inform the extramural research community how NIH is implementing the Office for Human Research Protections (OHRP)’s determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
The Notice provides instructions for Applicants, Offerors, and Recipients subject to the 2018 Cooperative research requirements at 45 CFR 46.114, with cooperative research that is ongoing or initially reviewed during the COVID-19 public health emergency, who would like to seek an exception to use of a single IRB. The request for an exception needs to include a justification as to why the study meets the exception criteria defined by OHRP. Note that NIH anticipates the use of this exception will be rare.
For further information, see the Notice NOT-OD-21-006, Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.