Single IRB Issues Related to Planned Emergency Research
February 17, 2021 2:00-3:30pm ET
This SMART Talk will explore the impact of using a single IRB to review emergency research, an investigation to determine the safety and effectiveness of FDA-regulated products in emergency settings and with an exception from the informed consent requirements. Emergency research, also referred to as exception from informed consent (EFIC) research, presents unique challenges for a single IRB arrangement, especially in terms of distribution of responsibilities between the Reviewing IRB and Relying Institutions. For example, how can the community consultation and disclosure requirements be addressed? Is it the Reviewing IRB’s responsibility to draft the plan or should that be the responsibility of Relying Institutions? Join this session to learn about approaches to single IRB for emergency research from colleagues who have navigated these waters before, including perspectives from academic institutions and an independent IRB.
Lizbeth Adams, Advarra IRB
Jeannie Barone, University of Pittsburgh
Ann Johnson, University of Utah