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Single IRB Implementation in VAs

Since January 20, 2020, the VA has required that non-exempt human subjects research be approved or transitioned to follow the requirements in the 2018 Common Rule. This includes a requirement that muti-site research be approved by a single IRB if:

Single IRB Required Unless Exception Applies

Please note: The cooperative research provisions (also commonly referred to as the “single IRB” requirement) only applies to those institutions that follow the 2018 Requirement. For example, if VA was conducting an industry-funded clinical trial with 14 universities, 3 VA Facilities, and 2 Department of Defense (DoD) Facilities with no other federal support or funding involved, the VA and DoD Facilities are required to use a single IRB unless an exception applies. 

Determining Whether the §.114 Cooperative Research Provision Applies

Determining Whether the §.114 Cooperative Research Provision Applies

Requesting an Exception from the Single IRB Requirement for Cooperative Non-Exempt Human Subjects Studies

ORD supports use of a single IRB when possible, but ORD also recognizes that mandating use of a single IRB in all cases is not logical or feasible. The §.114 cooperative research provision permits VA to make exceptions for use of a single IRB for VA Facilities when ORD determines and documents that use of a single IRB is not appropriate for the particular study.  

VHA Facilities wishing to request an exception from the single IRB requirement from ORD for an applicable study must go to the following SharePoint page (accessible only within VA network): ORD Single IRB Exception Requests - Home (sharepoint.com)

This page describes who can make a request, how to make a request, how to edit a submitted request, and when to expect ORD’s determination.  If you have reviewed that information and still have a question, please email: IRBRelianceandSIRBExceptions@va.gov.



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