FWAs Part 2: Managing a Federalwide Assurance and IRB Registration

As discussed in our Part 1 webinar Institutional Responsibilities Under a Federalwide Assurance (FWA), when institutions engage in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance stating they will abide by Common Rule requirements; this written assurance is referred to as a Federalwide Assurance (FWA). The FWA is currently the only assurance accepted and approved by the Office for Human Research Protections (OHRP).

Additionally, all IRBs must register with OHRP if they oversee research the Department of Health and Human Services (DHHS) conducts or supports, or if they oversee clinical investigations subject to Food & Drug Administration (FDA) regulations.

Join Advarra’s regulatory experts Lisa Rooney, Managing Director, Institutional Research Center of Excellence , and Lauren Hartsmith, Director of Regulatory Affairs, in another discussion of institutional responsibilities, digging deeper into the FWA topic and adding IRB responsibilities to the mix. They’ll answer questions such as how to obtain an FWA, when to update one, when an institution has to register an IRB, how an IRB registration fits in with the FWA process, and what to do if an IRB no longer reviews research.

Note: It will be helpful for attendees to view the Part 1 webinar before attending this Part 2 presentation.

Learning Objectives:

• Summarize what an FWA is, how it has changed, and when an institution is required to have one
• Outline additional expectations (described in the “Terms of the Assurance”) for FWA-holding institutions
• Summarize the IRB registration process including when an IRB has to be registered, by whom, and how the IRB registration process differs from the FWA process
• Explain when an institution might deactivate an FWA or IRB
• Discuss where the regulated community can receive technical support for submitting assurances and registering IRBs

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