Populations Requiring Additional Protections Track

2019 AER Conference

Advanced

E13 - Under the Influence—Capacity and Consent

Speaker(s)

• 

  Amy Ben-Arieh, JD MPH
  

  Director of Research Compliance, The Fenway Institute at Fenway Health
  
• 

  Lara N. Sloboda, PhD
  

  Associate Director of Research, Dana Farber Cancer Insititute
  

This session will focus on the challenges presented by the informed consent process when research participants competence or capacity to provide consent may be in question due to use of intoxicant substances. The session will provide an overview of recent literature on the topic, an introduction to relevant regulatory and ethical guidelines, and a few brief case discussions. Before attending this session, attendees should have one year or more IRB administration experience or research experience, and have a solid foundation of knowledge of the HHS and FDA regulations and applications thereof. During this session, speakers and attendees will:

Learning Objectives:

• Explore how to define the threshold for intoxication under which truly effective consent can be obtained, and explore strategies for assessing comprehension and learn when HHS and FDA regulations might allow for waiving consent in certain circumstances
• Become familiar with legal and clinical precedents for determining research participants' capacity to consent when under the influence
• Review the recent literature on this topic, and how the issue is addressed by relevant professional groups
• Apply best practice and regulatory framework to cases adapted from actual studies