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Understanding the New Common Rule and Its Impact to Industry
Session Chair(s)
James Riddle
Senior Vice President, Global Review Operations
Advarra, United States
On the final days of the outgoing administration, the Office of Human Subject Protections posted sweeping changes to federal regulations regarding human subjects research. The first substantive changes to human subjects research regulation in nearly 30 years! While the changes are focused at federal funding agencies, the implications for industry are enormous. New consenting requirements, new IRB requirements, requirements to post final consent forms to clinical trials.gov and a host of other changes will impact research operations, protocol design, and clinical trial implementation across the industry.
This late breaking session will explore all changes and give practical tips to sponsors on how to address the change.
Learning Objective : Discuss the basics of the new requirements; Explain the history and rationale for the changes; Identify how to activate programs and systems to prepare for the new requirements.
Speaker(s)
Perspective From the Office of Human Subject Protection
Laura Odwazny
Department of Health and Human Services, United States
Senior Attorney, Office of Human Subject Protection, Office of General Counsel
Common Rule Changes: Impact on Industry
James Riddle
Advarra, United States
Senior Vice President, Global Review Operations
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