On February 10, 2023, the Office for Human Research Protections (“OHRP”) announced that the COVID-19 single institutional review board (“IRB”) exception determination will expire on May 11, 2023, consistent with the expiration of the COVID-19 Public Health Emergency (“PHE”). With the expiration of the COVID-19 single IRB exception determination (the “COVID-19 Exception Determination”), research institutions and IRBs engaging in cooperative research studies should examine their current policies and procedures for situations where they must rely on a single IRB for such research.
Background
The single IRB requirement was part of a major revision to the Federal Policy for the Protection of Human Subjects (more widely known as the “Common Rule”), which was published in a final rule on January 19, 2017. These revisions became effective on July 19, 2018 (the “2018 Requirements”). The 2018 Requirements stipulate that institutions located within the United States that are engaged in cooperative research conducted (or supported) by a federal department or agency that has adopted the Common Rule must rely on the approval of a single IRB for the portion of the research that is conducted within the United States. Per, 45 C.F.R. § 46.114(b), cooperative research projects are defined as those projects that are subject to the Common Rule and involve more than one institution. The single IRB may either be identified by the federal department or agency supporting or conducting the research, or the lead institution may propose it for the research study—in which case, the proposed IRB is subject to acceptance by the federal department or agency supporting the research. The 2018 Requirements also permit a federal department or agency conducting or supporting the cooperative research to except the research from the single IRB requirement by both determining and documenting that using a single IRB is not appropriate for the particular context.
The initial compliance date for the single IRB requirement was January 20, 2020. However, due to the COVID-19 PHE, OHRP issued the COVID-19 Exception Determination (as permitted under 45 CFR § 46.114(b)(2)(ii)) on October 8, 2020, to the single IRB requirement. The COVID-19 Exception Determination applies in instances where the following factors are met:
- The cooperative research is ongoing or initially reviewed by the IRB during the COVID-19 PHE, as declared by the Secretary of Health and Human Services (“HHS”);
- Where reliance on a single IRB would not be practical (e.g., where establishing new IRB reliance agreements would result in a lost opportunity to administer a COVID-19 intervention or collect critical COVID-19 samples and data); and
- The HHS division supporting or conducting the research approves the use of this exception.
While the COVID-19 Exception Determination was issued to address the burdens and disruption to research caused by the COVID-19 PHE, it was not limited to only those studies focused on COVID-19 treatments or interventions. Instead, the COVID-19 Exception Determination could be applied to any cooperative research projects that may have been impacted by the COVID-19 pandemic and that required flexibility for the research to continue, provided that the HHS division supporting or conducting the research approved the use of the exception. In addition, although the COVID-19 Exception Determination may not be applied to research studies beginning on or after May 12, 2023, OHRP clarified in its most recent announcement, on February 10, 2023, that research that has already been approved under the COVID-19 Exception Determination may continue to be excepted from the single IRB requirement for the duration of the research.
Practical Takeaways
The expiration of the COVID-19 Exception Determination means that research institutions and IRBs must resume complying with the 2018 Requirements for single IRB review of multi-site studies. This compliance obligation will likely increase the administrative burden on IRBs and research institutions, as they must coordinate and manage single IRB reviews for multi-site studies. The end of the COVID-19 Exception Determination may also result in longer review times for cooperative research projects that focus on COVID-19, as these projects will also need to follow the single IRB review process.
Accordingly, research institutions and IRBs should begin planning now for the end of the COVID-19 Exception Determination by ensuring they have the necessary policies, procedures and resources to effectively manage the single IRB review process for cooperative research in accordance with the 2018 Requirements. This may involve training IRB staff and researchers on the Common Rule’s 2018 Requirements for a single IRB review and potentially hiring additional staff to manage the increased workload.
For more information on these requirements and possible impacts to institutions as a result of the end of the COVID-19 exception determination for single IRB review, please contact:
• Liza Brooks at (248) 457-7842 or lbrooks@hallrender.com;
• Julie Mitchell at (317) 429-3643 or jmitchell@hallrender.com; or
• Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot give legal advice outside of an attorney-client relationship.
