Populations Requiring Additional Protections Track

2019 AER Conference

A13 - Research With the Vulnerable—The Basics and Beyond

Speaker(s)

• 

  Bruce G. Gordon, MD
  

  Assistant Vice-Chancellor for Regulatory Affairs; Executive Chairman, IRBs; Professor, Pediatrics, University of Nebraska Medical Center
  Professor, University of Nebraska Medical Center
• CR

  Corinne Rogers, MS, CIP
  

  Director, Institutional Review Board, New York State Psychiatric Institute
  

During this session, speakers will discuss an expanded view of vulnerability beyond what is outlined in the regulations, including: diminished capacity, cultural sensitivities, and power differentials (e.g., students as subjects). Attendees should be prepared with a basic understanding of the regulations that cover vulnerable populations. During this session, speakers and attendees will:

Learning Objectives:

• Share examples of different types of vulnerabilities and explore how to consider and deal with them in the context of clinical research
• Discuss the threshold questions an IRB should address before permitting research with these subjects
• Review examples of risks particular to these subjects that may differ from those usually considered
• Show how to incorporate appropriate additional protections into informed consent