IRB Operations Advanced Track

2019 AER Conference

Advanced

B09 - Taking the Plunge—Transitioning Studies to the Revised Common Rule

Speaker(s)

• 

  Lauren Hartsmith, JD
  

  Policy Analyst, OHRP
  
• 

  John Heldens, CIP, CCRP
  

  IRB Director, University of Colorado Denver, Anschutz Medical Campus
  
• 

  Nathalia Henry, MS, CHRC, CIP
  

  Executive Director, IRB Office, Northwestern University
  

Many organizations working to adapt to the revised Common Rule are facing the decision of whether or not to transition existing research to the new requirements and, more importantly, how to operationalize this change. With the help of representatives from OHRP, this session will review the transition provisions outlined in the revised Common Rule, and discuss varied approaches to practical implementation of this transition. Speakers will review which studies to transition, the best timing for transition, what documentation is needed to reflect the change, and how the change and its implications should be communicated to researchers. Lessons learned to date from organizations that have begun to transition studies will be shared and tools to help manage the change will be reviewed. Before attending this session, attendees should have basic knowledge of the regulatory requirements related to informed consent and be familiar with the new key information requirement of the Revised Common Rule. During this session, speakers and attendees will:

Learning Objectives:

• Review the transition provisions for the revised Common Rule
• Discuss different approaches for transitioning research and managing the change, and share lessons learned from making the change
• Explore tools to assist with the transition process