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2022 PRIM&R Annual Conference

Emerging Challenges and Breaking Issues

A02 - Ethical Considerations in Studies Involving Usual Care Arms

Monday, December 12, 2022

11:45 AM – 12:45 PM ET

Location: Livestreamed

Speaker(s)

ND

Neal W. Dickert, MD, PhD (he/him/his)

Emory University School of Medicine, Division of Cardiology
Emory University School of Medicine
Todd W. Rice, MD

Vanderbilt University Medical Center
Vanderbilt University School of Medicine
Nashville, Tennessee
Robert Silbergleit, MD

University of Michigan
University of Michigan Medical School
Ann Arbor, Michigan

Resource Person(s)

IP

Ivor A. Pritchard, PhD

OHRP
Rockville, Maryland

There have been a number of recent high-profile cases where studies have been criticized for not including usual care arms. This raises deep questions related to ethical dimensions of study design and intersects with important issues, including vulnerability.

Learning Objectives:

Consider the pros and cons of including "non-protocolized" populations in trials
Discuss the challenges of defining "usual care" and the implications of adopting different definitions
Identify implications for IRBs in evaluating risks, given that standard care is not as "standardized" as one might think