My institution has "unchecked the box" on our Federalwide Assurance (FWA) and has agreed to serve as a Reviewing IRB for a non-federally funded, multi-site study. Can my IRB apply a flexible approach to the review of the research, such as extending the review period or reviewing the minimal risk research under an expedited category not currently identified by OHRP?
Unless all Relying Institutions have also "unchecked the box", the Reviewing IRB could not use a "flexible" approach to the review of the study, even if allowed by the Reviewing IRB's policy, because the Relying Institutions that have "checked the box" on their FWAs would be out of compliance with the terms of their FWAs. The Reviewing IRB should disclose any intention to apply a flexible approach to the IRB review to potential Relying Institutions as part of the reliant review process. If all Relying Institutions can comply with the flexible approach, then it can be applied.