Research Ethics & Policy Series (REPS): Returning Results to Participants in Pragmatic Trials - Catherine Auriemma, MD, MSHP

Returning Results to Participants in Pragmatic Trials

Catherine Auriemma, MD, MSHP

Assistant Professor of Medicine
division of Pulmonary, Allergy, and Critical Care
Core Faculty at the PAIR Center
University of Pennsylvania

Funders and regulators are increasingly requiring investigators to return study results to research participants. Return of research results is thought to improve trust and engender future participation in research. However, evidence for the benefits of returning results is primarily in study designs that include individual informed consent. Pragmatic clinical trials, a key approach to conducing comparative effectiveness research in real-world clinical-care settings, are often conducted with waivers of individual informed consent. As a result, individuals are generally unaware of their research participation. We will discuss what is known (and not known) about the optimal approach to returning research results in such contexts.

Registration required; Lunch provided.
Streaming available via Zoom.