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Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule. The Federalwide Assurance (FWA) is currently the only assurance accepted and approved by the Office for Human Research Protections (OHRP). During the Common Rule revision process, several regulatory requirements related to the assurance process were removed. Additional nonregulatory changes were announced but have not been implemented.
What is an FWA, and what is required of FWA-holding institutions? How has the assurance process changed in light of the revised Common Rule, and will there be any additional changes? What does it mean to be “engaged” in research? Join Advarra’s regulatory experts Lisa Rooney, Managing Director of Regulatory Consulting, and Lauren Hartsmith, Director of Regulatory Affairs, in discussing institutional responsibilities under an FWA.
Learning Objectives:
- Outline an overview of the FWA, and how it has changed (or not) considering the revised Common Rule
- Define what it means to be “engaged” in research under the Common Rule and how that intersects with FDA regulated research
- Explain institutional responsibilities under an FWA
- Describe the role of the Institutional Official
Presented By
Lisa Rooney
JD
Managing Director, Regulatory Consulting
Advarra
Lauren Hartsmith
JD, CIP
Director, Regulatory Affairs
Advarra
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DATE: December 10, 2020
Time: 1 pm ET | 10 am PT
Duration: 1 hour