Ask Advarra Live: The Real-World Impact of COVID-19 on Research

image iconDuration: 1 hour

The unprecedented COVID-19 pandemic has quickly changed how we live and work. This extraordinary situation has resulted in a significant impact on IRB-approved protocols and research yet to go through the IRB process. In addition, IRB review of COVID-19 research itself has raised unique and challenging issues with the application of various regulatory criteria in the Revised Common Rule and the FDA Regulations.

Find out about specific issues the research community has encountered during the current pandemic from experts in human subject protection and institutional research administration—and gain practical guidance you can use immediately.

The webinar includes dedicated time to discuss real-world questions submitted by the research community. Presenters will also review recently released regulatory guidance, identify IRB issues and concerns in reviewing COVID-19 research, and describe how to manage pandemic-related changes to ongoing research, including enrollment holds and suspensions.

Learning Objectives

Following this free webinar, attendees will be able to:
  • Identify unique IRB considerations during the COVID-19 pandemic.
  • Apply current best practices to new and ongoing research during the COVID-19 pandemic.
  • Describe current regulatory guidance relating to the impact of COVID-19 on IRB review of research.

Presented By

Michele Russell-Einhorn

JD
Chief Compliance Officer and Institutional Official
Advarra

Megan Kasimatis Singleton

JD, MBE, CIP
Assistant Dean, Human Research Protection; Director, HRPP
Johns Hopkins University School of Medicine

Judith Carrithers

JD, MPA
Director of Regulatory Affairs
Advarra




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