With the FDA’s September NPRM publication, the research community will likely soon have additional sIRB reliance requirements to navigate for multisite research. sIRB mandates are nothing new; OHRP and NIH have had them for years, and industry sponsors have long encouraged sites to rely on a single IRB. sIRB mandates are not always easy to comply with. Policies may need revising, additional trainings may be necessary, new working relationships may need navigating, and agreements need to be executed—it can be a lot. But, some institutions seem to be handling sIRB requirements just fine. What is their secret? Find out in this session, as longtime IRB professionals share the sIRB techniques and approaches that have proven successful for many organizations. This session will take place in Zoom meeting. The use of attendee video is encouraged for participation and interaction with your peers.
Learning Objectives:
Identify ways existing policies can be modified to accommodate sIRB requirements
Describe how certain policies can hinder sIRB efficiencies and approaches to removing such obstacles
Recognize roles team members can play in ensuring sIRB compliance
