Troubling the Uncertain Boundary between Research and Clinical Care: What Role Should ELSI Research Play?

• In Event: Situated Ethics and Normativities in Knowledge Making and Communities of Practice - I

Abstract

Traditional research ethics relies on a strict division between research and clinical care; many aspects of translational genomics have challenged this separation. Some researchers have asked whether the dichotomy between research and clinical care should be abandoned, but perhaps the more pressing question is how bioethicists should intervene as this boundary dissolves. In this paper based on our ethnographic ELSI study, we describe a complex pragmatic clinical trial that utilizes genomics to investigate “risk-stratified” approaches to breast cancer screening. Promoting the notion of a “learning healthcare system,” investigators seek to seamlessly integrate cutting edge knowledge from the bench to the bedside. Yet, clinicians tasked with implementing research results, which may conflict with standard of care, find this challenging in practice. In clinical care, compared to research, the primary duty of the provider is to the patient, not necessarily the common good or health system. When clinical care and research are blurred, to whom is the clinician-researcher most responsible? Additionally, most known genomic links to breast cancer have been constructed with data from a largely white European population, yet in this study, clinical recommendations are made to women of color based on these non-representative genomic datasets. This raises several critical questions: is there sufficient data to offer clinical recommendations to women of color based on genomics? Do scientists have an obligation to include a diverse population of women? What role should social scientists and bioethicists play in ensuring that the legacy of racism in genomics is not reproduced in the clinic?

Authors

• Jennifer James, University of California, San Francisco

• Galen Joseph, University of California, San Francisco