My institution previously "unchecked the box" on our Federalwide Assurance (FWA) and my IRB wants to apply a flexible approach to the review of non-federally-funded Research, such as extending the review period or reviewing the minimal risk research under an expedited category not currently identified by OHRP. My institution 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?
The Reviewing IRB must determine whether any Relying Institutions have “checked the box” on their FWAs (until such time as HHS may discontinue that option on the FWA) before applying a "flexible" approach to the review of the study, even if allowed by the Reviewing IRB's policy. If the flexible approach does not violate any of the Relying Institutions’ FWAs, then it can be applied.