March 1, 2023
NOT-OD-23-095 - Expiration of the COVID-19 Public Health Emergency
NOT-OD-21-006 - Exceptions to Use of a Single IRB During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
NOT-OD-20-058 - Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
NOT-OD-18-004 - Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
NOT-OD-18-003 - Guidance on Exceptions to the NIH Single IRB Policy
NOT-OD-17-076 - Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institution Review Board for Multi-Site Research
NOT-OD-16-109 - Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
NOT-OD-16-094 - Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Office of The Director, National Institutes of Health (OD)
The purpose of this Notice is to remind the extramural research community that once the federal Public Health Emergency for COVID-19 expires, NIH will no longer be able to grant single IRB (sIRB) 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.”
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. As indicated by OHRP in their Important Updates about the COVID-19 Single Institutional Review Board (IRB) Exception, 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.
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.
Resources
- NIH sIRB Policy for Multi-site Research (Policy implementation website)
- 2018 Revised Common Rule
- OHRP Guidance, The Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114)
- Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap
- Important Updates about the COVID-19 Single Institutional Review Board (IRB) Exception
NIH Office of Extramural Research
Email: SingleIRBPolicy@mail.nih.gov
and Human Services (HHS)
