On October 8, 2020, Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (DHHS), issued an exception determination as permitted by 45 CFR 46.114(b)(2)(ii) stating that certain categories of cooperative research supported or conducted by DHHS and subject to the 2018 Common Rule are not required to comply with the single IRB (sIRB) review requirements in 45 CFR 46.114(b)(1).

Since the peak of the Omicron surge at the end of January 2022, daily COVID-19 reported cases are down 92%, COVID-19 deaths have declined by over 80%, and new COVID-19 hospitalizations are down nearly 80%. Based on these current COVID-19 trends, DHHS 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. Once the federal PHE for COVID-19 expires, NIH will no longer grant sIRB exceptions for multi-site research that is subject to the revised Common Rule cooperative research provision.

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. Research for which the DHHS has already approved the use of the exception will continue to be excepted from the single IRB requirement, since the exception applies for the duration of the research.