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:
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
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.
Requesting Change in IRB Arrangements
- ORD policy requires that the VA Medical Center Director request approval from the Chief Research and Development Officer (CRADO) approval when the VA facility wants to establish a new HRPP, change its IRB(s) of Record, or wants its internal IRB to serve as an IRB of Record for a non-VA entity if allowed by ORD policy.
- VA Facilities wishing to change IRB arrangements for a single or multiple studies must submit the ORD application form: Institutional Review Board (IRB) Reliance Request Form.