LAUSR

One of the foundational aims of bioethics is to advocate for the rights and interests of patients (Jonsen 2010). In their normative work, bioethicists assess ethical arguments and develop recommendations that support patients’ goals. Similarly, in empirical studies, bioethicists seek to clarify the broader social impact of healthcare, including how the delivery of healthcare services aligns with the interests of patients and enables them to achieve their health-related goals. From either of these professional orientations, the work of bioethics often supports clinical practices that protect patient rights and interests. At other times, this work may support normative positions that challenge the acceptability of medical interventions that fail to align with patients’ goals. To the extent that bioethicists working in both normative and empirical areas have shared a common goal of advocating on behalf of patients’ rights and interests, their work has been remarkably complementary (Kon 2009). In recent years, however, the goals of empirical bioethics research have broadened, and while the aim of protecting patients’ interests is still very central in the universe of empirical bioethics, opportunities for empirical research have grown exponentially—in number, scale, and diversity (Borry, Schotsmans, and Dierickx 2005). This growth includes a number of bioethics research projects that are “embedded” in large clinical trials and clinical implementation studies (McEwen et al. 2014). While broadening of the aims of empirical bioethics research may be healthy for the field, it can lead to instances in which empirical findings may seem to be at odds with moral intuitions that support patient interests. To illustrate this possibility, consider a study we published in early 2019. To assess the quality of patient decision making around genomic screening, we surveyed research participants who received a multi-gene screen for disease risks and who were not required to have genetic counseling prior to receiving genetic testing (which some would consider to be a best practice in relation to genomic screening) (Pacyna et al. 2019). We found that patients had little difficulty making an informed decision to receive genetic testing despite not talking with a genetic counselor in advance of their decision. Because our findings challenged a longstanding normative position in genetic testing (i.e., the requirement of pretest genetic counseling), our empirical results may be viewed as in tension with well-established norms and moral intuitions regarding the value of pretest counseling as a tool for promoting patient autonomy and informed choice. Our experience highlights an issue that has been largely unexplored in empirical bioethics research— namely, how to assess the value of bioethics research that seems to be inconsistent with long-held moral positions. In examining this question, we must ask to what extent this kind of research rolls back the progress made possible by years of normative scholarship or fosters cynicism about the contributions of normative analyses to science and medicine. Indeed, some may worry that empirical bioethics research like our study provides fuel for those who wish to dismiss the protective intuitions of the bioethics community as baseless or out of touch with clinical realities. These are difficult issues requiring broader reflection on the potential for empirical bioethics research to conflict with interventions supported by normative analysis. To encourage such reflection, we will situate empirical bioethics within the broader field of biomedical research and draw parallels with other forms of health outcomes research that evaluate clinical practices. Drawing analogies with deimplementation science and the concept of overdiagnosis developed by Gilbert Welch, we will argue that empirical bioethics