Flexibility and Innovation in IRB Processes Track

2019 AER Conference

Advanced

B23 - Flexible Strategies to Manage Unregulated Research in the Era of the Revised Common Rule

Speaker(s)

• 

  Jeffrey A. Cooper, MD, MMM
  

  Vice President Process and Strategic Improvement, WIRB-Copernicus Group
  

In the era of the revised Common Rule, research may be subject to FDA regulations, the pre-revised Common Rule, the revised Common Rule, or be unregulated. This session will describe the opportunities for flexible review of unregulated research in ways that are consistent with the revised Common Rule and other regulations. Before attending this session, attendees should have experience in managing or overseeing IRBs or HRPPs, and in writing and maintaining standard operating procedures. During this session, speakers and attendees will:

Learning Objectives:

• Review the ethical requirements for the oversight of unregulated research
• Go over strategies for flexibly handling unregulated research in a manner that is consistent with current regulatory requirements
• Discuss how to apply flexibility in the review of unregulated research in a manner consistent with local institutional requirements