Sponsored Presentation from Advarra: FDA sIRB Mandate – Deja Vu All Over Again?
Tuesday, November 19, 2024
7:30 AM – 8:15 AM PT
Location: Flex Hall BC
Sponsored By
We’re expecting FDA will finalize its single IRB requirement by the first half of 2025. And it’s looking like this sIRB mandate will be different…
Even if you’re already set up to comply with NIH and Common Rule sIRB requirements, now is the time to assess your program to ensure you’re prepared for FDA’s final rule.
In this session, we’ll discuss how FDA’s proposed rule poses different challenges than existing sIRB mandates. We’ll also provide academic and independent IRB perspectives on the FDA mandate, and how we as a community can work together to support more efficient sIRB review that appreciates local context and policies.
Learning Objectives:
Describe key ways FDA’s proposed sIRB rule differs from other existing sIRB polices/mandates
Explain how institutions can begin assessing policies now in advance of the final rule
Discuss how institutional responsibilities overlap (and don’t) with FDA single IRB responsibilities
