While the revised Common Rule permits organizations to transition their entire research portfolio to the revised Rule, many organizations have found this type of transition impractical and burdensome to researchers. Organizations that do not make a complete transition are now required to implement strategies for operating their IRBs in a world where two sets of regulatory criteria apply. Moreover, for organizations that must also comply with FDA regulations, a third set of regulatory criterion may apply. Challenges include appropriate identification and application of the correct regulatory framework to existing and new studies, ensuring IRB members and staff are aware of and appropriately apply the applicable criteria, and effectively communicating applicable requirements to study teams. This session will explore these challenges, identify potential compliance risks and offer solutions developed by two IRBs to address this hybrid world. Attendees should have an understanding of the requirements of the revised Common Rule and of the requirements for IRB record keeping including meeting minutes before attending this session.
Identify the challenges faced by IRBs operating under varied regulatory frameworks
Understand how these challenges can create potential compliance risks for IRBs in performing and documenting their key responsibilities
Consider examples of potential operational solutions and how to adapt them for their own HRPP