On-Demand Webinar

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

Presented By

Lisa Rooney.png

Lisa Rooney

JD

Managing Director, Institutional Research Center of Excellence, Advarra Consulting
Advarra

Lauren Hartsmith.png

Lauren Hartsmith

JD, CIP

Director, Regulatory Affairs
Advarra

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Who should watch?

This content applies to HRPP/IRB directors; principal investigators; sponsors and sponsor-investigators; regulatory affairs representatives; research operations personnel; and others involved in human subjects research from sponsors, CROs, government organizations, non-profits and foundations, and investigative sites.

CE Credits

Provider approved by the California Board of Registered Nursing, Provider Number 17600, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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