IRB Operations Advanced Track

2019 AER Conference

A23 - Making Limited Review Work Without Reinventing the Wheel

Speaker(s)

• 

  David A. Borasky, Jr., MPH, CIP
  

  Vice President, IRB Compliance, WCG
  
• 

  Teresa Doksum, PhD, MPH
  

  Senior Director of Quality and Research Ethics; IRB Chair; Research Integrity Officer, Abt Associates Inc.
  

Limited review is a new regulatory concept that was incorporated into the revised Common Rule as part of the review process for exempt research under categories §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)). However, the revised Common Rule does not describe how the limited IRB review mechanism should be implemented, and there has been no guidance from OHRP or SACHRP recommendations. In this session, speakers will describe the limited IRB review requirement and describe a process for managing the review without adding significant burdens to IRB programs. During this session, speakers and attendees will:

Learning Objectives:

• Review the regulatory requirements related to limited IRB review
• Describe a process for conducting limited IRB review
• Go over documentation requirements