On-Demand Webinar

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

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Lisa Rooney


Managing Director, Regulatory Consulting

Lauren Hartsmith.png

Lauren Hartsmith


Director, Regulatory Affairs

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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, and investigative sites.

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations. This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

Provider approved by the California Board of Registered Nursing, Provider Number 16549, 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: December 10, 2020
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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