IRB Operations Advanced Track

2019 AER Conference

Advanced

C23 - Exempt Human Subjects Research Case Studies— Implementing Changes to the Exemption Categories Under the Revised Common Rule

Speaker(s)

• 

  Christine DeLussey, MS, CIP
  

  IRB Operations Supervisor, Children's Hospital of Philadelphia
  
• 

  Julie M. Eiserman, MA, CCRP
  

  Senior Regulatory Analyst, National Institutes of Health
  
• 

  Caitlin Alcorn, MPA, CIP
  

  Senior Research Compliance Administrator, University of Oregon
  

The revised Common Rule includes many changes to the categories of exemption including the introduction of new categories. The main implication of these changes is that some human subjects research that previously required expedited IRB review may now be considered exempt. The research oversight community is awaiting detailed guidance about how to interpret and apply these regulatory changes. This session will evaluate determinations of exemption under the revised Common Rule at different institutions. Using real case examples, this session will delineate how organizational requirements, along with the special considerations of exempt reviewers, may factor into exempt determinations. Before attending this session, attendees should be familiar with the revised Common Rule exempt categories. During this session, speakers and attendees will:

Learning Objectives:

• Identify important changes to the exemption categories under the revised Common Rule, including requirements for limited IRB review
• Review examples of studies that qualify for exemption under the revised Common Rule and features that allow or prohibit exemption within certain categories.
• Discuss areas of confusion and identify resources to navigate questions in absence of federally issued guidance
• Explore operational considerations for the changes to exemption and become familiar with review strategies that address limited IRB review
• Understand how different organizations are approaching the review of applications that may qualify for exemption under the revised Common Rule and share resources that can aid in navigating the revised exempt criteria
• Note: This is a double session and will end at 12:45 PM.