Key Dates

Related Announcements

NOT-OD-23-097 - NIH Can No Longer Grant Common Rule Exceptions to the Use of a Single IRB for Multi-site Research After the COVID-19 Public Health Emergency Expiration Date of May 11, 2023

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-16-094 - Final NIH Policy on the Use of a Single Institutional 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

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Notice is to provide information to the extramural research community regarding NIH implementation of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)’s 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.

Applicability

Applicants, offerors, and recipients proposing or conducting NIH-funded research studies subject to the 2018 requirements for the Federal Policy for the Protection of Human Subjects (also known as the "Common Rule") and its cooperative research provision (45 CFR 46.114(b)) and that are ongoing or initially reviewed by the Institutional Review Board (IRB) during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of the Department of Health and Human Services at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx, may request an exception to the use of a single IRB.

NIH Implementation of OHRP’s 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

On October 8, 2020, as specifically permitted by 45 CFR 46.114(b)(2)(ii), the Office for Human Research Protections (OHRP) issued in the Federal Register its 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 (OHRP COVID-19 Exception Determination). The determination states that, for certain studies that are conducted or supported by HHS and subject to the 2018 Requirements, and for purposes of 45 CFR 46.114(b)(2)(ii), an exception to the requirement to use a single IRB is appropriate for the following category:

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.

For as long as the OHRP's determination is in place, NIH will not require use of a single IRB for NIH-funded research that qualifies for an exception as outlined in the OHRP COVID-19 Exception Determination and for which the use of the exception is approved by NIH. Approved exceptions apply for the duration of the NIH-conducted or supported research. NIH will grant an exception to the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research for these studies.

Requesting an Exception to Use of a Single IRB

NIH will consider exception requests for studies subject to the 2018 requirements. To request an exception to use of a single IRB, eligible applicants, offerors, or recipients for NIH-conducted or supported cooperative research must submit an exception request to NIH, including justification as to why the study meets the exception criteria defined by OHRP. Applicants, offerors, and recipients must include the name of the site(s) for which an IRB other than the single IRB of record is proposed to review the study for the site(s).

Pre-Award Exception Requests

Applicants who wish to seek an exception must provide the exception request and accompanying justification in the Other Attachments section of the Research & Related Other Project Information form in the grant application. Applicants should name the PDF document SIRBexceptionrequest.pdf. and follow instructions in the NIH Application Guide.

Offerors shall follow the instructions that are contained in the Request for Proposal (RFP) for submitting an exception request.

Note that the proposed budget in the application or contract proposal must reflect all necessary single IRB costs without an approved exception. Applicants and offerors should not assume that an exception will be granted when considering what single IRB costs to include in the budget.

Post-Award Exception Request

Grant and cooperative agreement recipients seeking an exception to use of single IRB post-award should submit a prior approval request in writing, to the NIH Grants Management Official (GMO), no later than 30 days before the proposed change, and signed by the Authorized Organization Representative (AOR) as described in NIH GPS 8.1.3. NIH contract recipients should submit the single IRB exception request and justification to the Contracting Officer (CO).

Notice of Approval or Disapproval of Request

NIH applicants, offerors, and recipients will be notified of the final decision by their NIH Program Officer/Program Director (PO/PD) or CO prior to award. Applicants and offerors should not assume an exception is granted unless notified of approval. For both grant applications and contracts, the award budget may need to be adjusted if an exception is approved.

Note: This exception does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements.

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

Inquiries

Please direct all inquiries to:

NIH Office of Extramural Research
Email:SingleIRBPolicy@mail.nih.gov