Advanced Track (SBER)

2019 SBER Conference

Advanced

B01 - From Flexible to More Flexibility—What's Left to Review?

Speaker(s)

• 

  Rebecca D. Armstrong, DVM, PhD
  

  Director of Research Subject Protection, University of California, Berkeley
  
• 

  Cecilia Brooke Cholka, MA, CIP
  

  IRB Specialist, University of Nevada, Reno
  

At institutions that already implemented extensive flexibility for non-federal minimal risk research, the 2018 regulatory revisions had limited impact in many ways. However, with limited IRB review, navigating whether projects previously triaged to greater than minimal risk could be reviewed at the exempt level pose new challenges for the IRB. Attendees should be familiar with federal requirements and flexibility afforded to institutions who conduct some research that is not formally regulated by the common rule or FDA regulations before attending this session. During this session, speakers and attendees will:

Learning Objectives:

• Explore the range of flexibility for minimal risk research pre- and post- the 2018 regulatory changes
• Learn to differentiate the nuances of proposed projects relative to their institutional policies for triage and review
• Assess the risks to subjects and develop recommendations to minimize risk to subjects while reducing burden on IRBs and principal investigators