The Secretary of the U.S. Department of Health and Human Services (HHS) is planning for the Federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023.
The extramural community is reminded that as of that date NIH will no longer be able to grant single IRB exceptions for multi-site research that is subject to the revised Common Rule cooperative research provision under the Office for Human Research Protections (OHRP) 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.”
As indicated by OHRP in their Important Updates about the COVID-19 Single Institutional Review Board (IRB) Exceptions, as of the date of the conclusion of the public health emergency, the COVID-19 Single IRB exception will expire and cannot be applied to additional studies. All exceptions that have been granted by NIH prior to May 11, 2023, will be effective for the duration of the research or the time they were granted, as indicated in the determination letters. For more information, please see NOT-OD-23-097.
To ensure that sIRB exception requests for research that is subject to the revised Common rule cooperative research provision can be reviewed and a determination made prior to May 11, 2023, NIH suggests submitting any new exception requests no later than March 31, 2023 per the process outlined in NOT-OD-21-006.