IRB Policy/Operations Track (SBER)

2019 SBER Conference

C01 - Different Minimal Risk Review Models

Speaker(s)

• 

  Cecilia Brooke Cholka, MA, CIP
  

  IRB Specialist, University of Nevada, Reno
  
• 

  Jeffrey M. Cohen, PhD
  

  Adjunct Assistant Professor, Department of Bioethics, Clarkson University
  

The revised Common Rule provides clear instructions for the conduct of convened meetings, but offers little guidance when it comes to minimal risk review procedures. This session will present two models for minimal risk reviews: a traditional model with designated reviewers and a model of minimal risk review boards. An effective minimal risk research model decreases researcher burden while maximizing protections for research subjects. This didactic session will outline the benefits of each review model while exploring options for streamlining minimal risk review methods. During this session, speakers and attendees will:

Learning Objectives:

• Discuss minimal risk review regulatory requirements
• Explore different minimal risk review models and identify opportunities to streamline minimal risk review
• Consider minimal risk review models for the revised Common Rule (e.g., limited IRB review)