Academic

Wolf on Incidental Findings in Neuroscience Research, Bioethics, and Health Law

By Lawrence Solum

Susan M. Wolf (University of Minnesota Law School) has posted Incidental Findings in Neuroscience Research: A Fundamental Challenge to the Structure of Bioethics and Health Law (OXFORD HANDBOOK OF NEUROETHICS, Judy Illes, Barbara Sahakian, eds., Oxford University Press, 2011) on SSRN. Here is the abstract:

Incidental findings are an unavoidable by-product of conducting research in human beings. Depending on the research method being used and the population being studied, researchers may encounter incidental findings in the majority of the participants in their research. Even in studies in which incidental findings are less common, they may include urgent and even life-threatening findings. The empirical research documenting the incidence and potential gravity of incidental findings forces researchers to face difficult questions. The most fundamental of these is whether researchers have any duty to identify, evaluate, and disclose these findings to the research participant. What makes these questions so difficult is that at root they ask whether researchers have some kind of duty to trigger or provide clinical care. Merely asking this question is a profound challenge to the structure of bioethics and health law. Both fields approach the world of research and the world of medical care very differently. The problem of incidental findings challenges this traditional dichotomy. The problem forces attention to the question of whether the two-world vision that has been fundamental to the architecture of health law and bioethics is wrong.

This chapter traces the emergence of the incidental findings problem and analyzes the fundamental challenge posed to the structure of health law and bioethics. It then suggests how to reconstitute the conception of researcher duties that both domains embrace. The chapter rejects the old dichotomy between research and treatment that would absolve the researcher of any duties to evaluate and offer to disclose findings of potential clinical significance. While arguing for a new vision of researcher duties that would impose some clinical responsibilities, the chapter rejects erasure of the distinction between research and care. Clinical care must focus on the well-being of the individual patient; the fundamentally different enterprise of research strives to create generalizable knowledge. Yet the traditional dichotomy went too far when it absolved researchers of duties of clinical care and information sharing. The author suggests how bioethics and health law can now reconstitute the traditional vision of researcher duties to bring the researcher back into relationship with the research participant.

Preparation of this chapter was supported in part by National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI) grant #2-R01-HG003178 (Susan M. Wolf, Principal Investigator). The chapter also benefited from the author?s participation in the Project on Law & Neuroscience funded by the MacArthur Foundation (Michael Gazzaniga, Principal Investigator).

Full post as published by Legal Theory Blog on January 07, 2011 (boomark / email).