Important Updates about the COVID-19 Single Institutional Review Board (IRB) Exception

Based on current COVID-19 trends, 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 Office for Human Research Protections (OHRP) is sending this announcement in anticipation of the PHE expiration.

On October 8, 2020, OHRP, on behalf of HHS, 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 HHS and subject to the 2018 Requirements are not required to comply with the single IRB mandate in 45 CFR 46.114(b)(1). The full text of the exception can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html

Use of this exception is permitted for research that is ongoing or initially reviewed by the IRB during the COVID-19 public health emergency declared by the Secretary of HHS when reliance on a single IRB would not be practical and when the HHS division supporting or conducting the research approves the use of the exception. OHRP granted this exception due to the unprecedented burden and disruption to the research enterprise caused by the COVID-19 public health emergency, which also necessitated urgent research responses.

Institutions and IRBs should be cognizant of the impact that conclusion of the COVID-19 public health emergency will have on the ability to use this exception. Specifically, as of the date of the conclusion of the public health emergency, the exception will expire and cannot be applied to additional studies. Research for which the HHS division supporting or conducting the research study 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.

Please direct questions to OHRP@hhs.gov or to the HHS division supporting or conducting a particular research activity.

An HHS fact sheet on the COVID-19 PHE transition roadmap can be found here: https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html