The Unintended Implications of Blurring the Line Between Research and Clinical Care in a Genomic Age

Abstract

While the development of next-generation sequencing technology has had a paradigm-changing impact on biomedical research, there is likely to be a gap between discovery of therapeutic benefits in research and actual adoption of the new technology into clinical practice. This gap can create pressure on the research enterprise to provide individualized care more typical of the clinic setting because it is uniquely accessible in research. This blurring of the line between research and clinical care is understandable, and perhaps even inevitable. But even if the gap is only transitory, such a blurring can have lasting implications, both by expanding obligations imposed on researchers, but also by challenging long-held ethical views. We explore this idea, focusing on how the dissolving distinction between research and clinical care has influenced the vigorous debate around how researchers should manage genetic findings (sometimes separated into primary and incidental or secondary findings) resulting from research.

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

“…Although they are generally distinct, the line between research and clinical care is often blurry, particularly in the context of genomics. 13 Institutional review boards (IRBs), perhaps with expert consultation, are in the best position to determine whether and how to disclose secondary findings in a given research setting.…”

Participant Engagement in Translational Genomics Research: Respect for Persons—and Then Some

“…These themes are not novel to our work, obviously. Both have received extensive attention in the normative literature on research ethics, 12 and there has even been some empirical work examining these phenomena 13 . Of importance here, however, are the contours of these themes that have emerged in translational research that pursues engagement in an informal way, that is, without the adoption of a formal model of engagement.…”

The Duty to Look for Incidental Findings in Imaging Research

“…This formulation of the duty of easy rescue is admittedly broader than others that have been discussed in relation to incidental findings. 34 It is not limited to imminent risks of extreme harm; instead, it applies to the broader category of harms that are large relative to the cost of preventing them (and where the cost of preventing this harm is reasonably bearable). Although this makes our version of the duty broader than some other formulations, we think it nonetheless captures a plausible-and uncontroversial-moral view.…”