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Recent Exception to Single IRB Review Mandate Provides Research Institutions Flexibility During COVID-19 Pandemic

This Bulletin is brought to you by AHLA’s Academic Medical Centers and Teaching Hospitals Practice Group.
  • November 25, 2020
  • Jacob Simpson , Breazeale Sachse & Wilson LLP

In an effort to provide institutions flexibility in seeking Institutional Review Board (IRB) review and to prioritize the health and safety of research subjects and investigators in the current Coronavirus Disease (COVID-19) Public Health Emergency, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) recently issued an exception determination to the single IRB review requirement for certain categories of cooperative research. This article explains the exception determination and the potential benefit it provides teaching hospitals and academic medical centers in determining the most appropriate IRB review structure in circumstances where reliance on a single IRB is not practical.

Background of Single IRB Mandate and Exception Determinations

The single IRB review requirement is one of several changes that emerged from the revised Common Rule (the 2018 Requirements[1]). Under the single IRB review mandate, all institutions located in the United States that are engaged in cooperative research[2] conducted or supported by a federal department or agency must rely upon approval of a single IRB for that portion of the research conducted in the United States.[3] The 2018 Requirements also allow the federal agencies conducting or supporting cooperative research to make an exception when the use of a single IRB is not appropriate.[4] The federal agency issuing an exception determination must document the determination for why single IRB review is not appropriate in a given context.[5]

OHRP Exception Determination

On October 8, 2020, OHRP issued such an exception determination from the single IRB mandate for certain categories of cooperative research that allows institutions to determine the most appropriate IRB review structure during the COVID-19 pandemic.[6] The OHRP exception determination applies for cooperative research:

  1. that is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of Health and Human Services at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx;
  2. where reliance on a single IRB would not be practical; and
  3. for which the HHS division supporting or conducting the research approves of the use of this exception.[7]

In making this exception determination, OHRP recognized that the COVID-19 pandemic “has created unprecedented burdens and disruption to the research enterprise, while at the same time requiring urgent research responses that necessitate flexible approaches to oversight in order to provide vital information and to allow other research to continue where possible.”[8] This exception determination allows institutions to avoid the requirement of single IRB review where such a review is not practical. OHRP provided examples where single IRB review may not be practical including, such as:

  • Clinical trials where timely administration of a study drug for the COVID-19 virus is required, but the institution lacks a reliance agreement with the single IRB of record and is unable to timely negotiate a reliance agreement.
  • Clinical trials where the research sites cannot be identified in advance and patients cannot be moved to an institution having a reliance agreement with the single IRB of record without risking increased exposure to others.
  • Clinical trials where operations at the current IRB of record or lead site may be disrupted due to the COVID-19 pandemic and selecting a new site as IRB of record would significantly delay the study while new reliance agreements were negotiated.[9]

While OHRP issued this exception determination to provide institutions flexibility when determining the appropriate IRB review structure during the COVID-19 pandemic, it also made clear that the exception determination should not be viewed as discouraging or preventing the use of single IRB review. Rather, OHRP expects institutions to continue the use of single IRB review where possible.

NIH Implementation

Shortly after OHRP issued the determination exception from the use of single IRB, the National Institutes of Health (NIH) followed suit. On October 23, 2020, NIH issued NOT-OD-21-006 (Notice), which implements the OHRP exception determination for NIH-funded research and provides guidance to those institutions seeking an exception to the use of a single IRB.[10] The Notice states that NIH will not require use of a single IRB for NIH-funded research meeting the criteria in the OHRP exception determination, as long as the use of the exception is approved by NIH.

The Notice provides guidance on how to seek an exception to use of a single IRB both pre-award and post-award, including the requirement to submit an exception request to NIH with justification as to why the study meets the exception criteria defined by OHRP. Institutions seeking an exception request should carefully review the Notice and follow the instructions provided.

Conclusion

The COVID-19 public health emergency has created new challenges for teaching hospitals and academic medical centers, but the demand for life-saving research to address the pandemic continues to rise. To ease the burden on the research enterprise, OHRP has determined that use of a single IRB is not appropriate for cooperative research meeting the criteria set forth above. The exception determination gives research institutions the latitude to consider the health and welfare of research subjects and investigators and other factors that may make use of a single IRB impractical. By issuing the determination of exception to the single IRB review mandate, OHRP has provided research institutions an avenue to avoid the use of a single IRB and the flexibility to determine the most appropriate IRB review structure for those institutions to continue providing critical research.

 

[1] 45 C.F.R. § 46.

[2] In accordance with 45 C.F.R. § 46.116(a), cooperative research projects are those projects covered by this policy that involve more than one institution.

[3] 45 C.F.R. § 46.114(b).

[4] 45 C.F.R. § 46.114(b)(2)(ii).

[5] Id.

[6] U.S. Department of Health & Human Servs., Office for Human Research Protections, October 8, 2020: 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, https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html.

[7] Id.

[8] Id.

[9] Id.

[10] Nat’l Institutes of Health, NOT-OD-21-006, Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-006.html.