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Populations Requiring Additional Protections Track
2019 AER Conference
Advanced
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: