Background: A growing literature has raised—skeptically—the question of whether cutting-edge scientific research can identify and address broader ethical and policy considerations in real time. In genomics, the question is: Can ELSI contribute to genomics in real time, or will it be relegated to its historical role of after-the-fact outsider critique? We address this question against the background of a genomic screening project where we participated as embedded, real-time ELSI researchers and observers, from its initial design through its conclusion.Methods: As part (...) of the ELSI study design, the project included an ongoing reflexive ethnography in which the authors studied the process of its design and implementation. The authors were true participant observers, serving as members of various task-oriented groups while recording meetings and other events for ongoing qualitative analysis. We also conducted and analyzed interviews of multiple participants at the conclusion of the project.Results: Our real-time ELSI initiative had a mixed record of successes and challenges. If we define success as ELSI researchers having had an opportunity to participate fully in the project and to make the ELSI perspective heard, then our assessment is largely positive. If, however, we define successes as instances where real-time ELSI contributions changed the direction of the genomic or public health aspects of the GeneScreen project or, after careful deliberation, confirmed the appropriateness of the status quo, then we can identify only a few examples. While we had a seat at the table, we were, for the most part, tolerated guests.Conclusions: We conclude that there are significant barriers to real-time ELSI influence. The difficulty does not reside in any intended exclusion of an ELSI perspective, but in factors endemic to genomic research, including knowledge disparities, epistemological biases, and the pressures of time and money. (shrink)

ELSI efforts long have been troubled by critiques that they privilege scientific frameworks and grant scientists the power to set ethical agendas. As the first director of the Human Genome Project’...

I take up the call for a more nuanced engagement with race in bioethics by using Creary’s analytic of bounded justice and argue that it helps illuminate processes of racialization, or racial formation, specifically Blackness, as a dialectical processes of both invisibility and hyper-visibility. This dialectical view of race provides a lens through which the ethical, legal, and social implications (ELSI) of genetics and genomics field can reflect on fraught issues such as inclusion in genomic and biomedical research. Countering or (...) interrupting racialization in precision medicine can involve asking how marginalized groups are made invisible or hyper-visible in various aspects of the research process. Incorporating these kinds of questions into biomedical research inclusion efforts could lead to potentially powerful engagements with marginalized groups and could provide the opportunity for stakeholders to engage with the ways that racialization can happen in real-time and might undermine good intentions. (shrink)

Adaptive pragmatic clinical trials offer an innovative approach that integrates clinical care and research. Yet, blurring the boundaries between research and clinical care raises questions about how clinicians and investigators balance their patient care and research roles and what types of knowledge and risk assessment are most valued. This paper presents findings from an ethnographic ELSI (Ethical, Legal, Social Implications) study of an innovative clinical trial of risk-based breast cancer screening that utilizes genomics to stratify risk and recommend a breast (...) cancer screening schedule commensurate with the assessed risk. We argue that the trial demonstrates a fundamental tension between the promissory ideals of personalized medicine, and the reality of implementing risk-stratified care on a population scale. We examine the development of a Screening Assignment Review Board in response to this tension which allows clinician-investigators to negotiate, but never fully resolve, the inherent contradiction of “precision population screening.”. (shrink)