Flexible review when an institution has "unchecked the box"

Applies to: Agreement V3.0

My IRB applies flexible review to non-federally funded research (for example, longer approval periods, or expedited review of minimal-risk research outside OHRP's categories) because my institution has not extended its FWA to all research. We have agreed to be the Reviewing IRB for a non-federally funded multisite study. Can we apply that flexibility?

Only if it would not violate any Relying Institution's Assurance. Before applying a flexible approach, the Reviewing IRB must find out whether any Relying Institution has "checked the box" — that is, applies its FWA to all research regardless of funding. If a relying site has, the Reviewing IRB must review that site's participation under the full Common Rule requirements. Ask each site's Point of Contact when the reliance arrangement is set up and record the answer with the study's reliance documentation.

See also - Local Considerations and Other Considerations - The Implementation Checklist