Single IRB Implementation in VAs
January 20, 2020 was the compliance date of the cooperative research provisions in 38 CFR§16.114 of the 2018 Requirements. As of January 20, 2020, all VA Non-Exempt Human Subjects Research approved or transitioned to follow the 2018 Requirements of the Common Rule must use a single IRB unless an exception applies to the research activity if more than one institution is engaged in the research and any of the following applies to the multi-site research:
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 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.
- The form must be submitted by the VA Medical Center Director via email to the IRB Reliance and SIRB Exceptions email box at (IRBRelianceandSIRBExceptions@va.gov).
- Any additional individuals the form must be submitted to are included in the directions on the application.
Please note The Institutional Review Board (IRB) Reliance Request Form cannot be used by VA Facilities requesting to start a research program. A dialogue with both ORO and ORD is required before any documentation is sent by a VA Facility wishing to start or re-initiate a research program.
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 also recognizes that use of a single IRB is not always required.
- VHA Facilities wishing to request an exception from the single requirement for an applicable study must
- Submit a request to the IRB Reliance and SIRB Exceptions email box at (IRBRelianceandSIRBExceptions@va.gov) using the spreadsheet: Prospective CHNE Research Exceptions Request. The request must be sent to ORD by the ORD funding service, ACOS/R&D, AO/R&D, VA Human Research Protections Administrator, or the VA Facility’s IRB Administrator.
- The email subject line should reference that it is a request for single IRB exception with the name of the study and the VA Principal Investigator.
Example: Request for sIRB exception: Comparison of X vs. Y, A. Investigator, M.D.
- Requests will be reviewed by ORD with an expected response time no later than 10 business days.