IRB Operations Advanced Track

2019 AER Conference

Advanced

A22 - From Non-Exempt to Exempt and Back Again—Navigating Exemption 2iii

Speaker(s)

• 

  Petrice B. Longenecker, PhD, CIP
  

  Human Protections Administrator, Uniformed Services University of the Health Sciences
  
• 

  Laura R. Brosch, RN, PhD
  

  Assistant Vice President for Research Initiatives and Compliance, Uniformed Services University of the Health Sciences
  Uniformed Services University of the Health Sciences

This session will help attendees navigate the changes to exemption category 2, which allows data collection to include sensitive data or data that could put subjects at risk. Speakers will focus on how to determine when a study qualifies for exemption 2 with a limited IRB review, when it should be reviewed by the IRB, and whether IRB review triggers a greater than minimal risk determination. Before attending this session, attendees should have experience with social behavioral studies that employ data collection methods using surveys, interviews, questionnaires and focus groups, an understanding of the exemption categories, particularly determining historically which studies can be considered exemption 2 versus requiring IRB review (under the pre-2018 Common Rule), and be familiar with applying the minimal risk definition and making determinations of what types of studies are greater than minimal risk. During this session, speakers and attendees will:

Learning Objectives:

• Review the changes to exemption category 2
• Describe when to use a limited IRB review versus the full 7 at 111
• Determine whether surveys, interviews, and questionnaires can be considered "greater than minimal risk"