Becoming partners, retaining autonomy: ethical considerations on the development of precision medicine.

Alessandro Blasimme,Effy Vayena

doi:10.1186/s12910-016-0149-6

Alessandro Blasimme, Effy Vayena

Open Access

https://doi.org/10.1186/s12910-016-0149-6

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Abstract

Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to broaden the focus of discussion beyond individual choice and individuals’ moral interests. The uptake of those concepts in precision medicine is to be welcomed. However, as data and medical information from research participants in precision medicine cohorts will be collected on an individual basis, translating a participatory approach in this emerging area may prove cumbersome. Therefore, drawing on Joseph Raz’s perfectionism, we propose a principle of respect for autonomous agents that, we reckon, can address many of the concerns driving recent scholarship on partnership and public participation, while avoiding some of the limitations these concept have in the context of precision medicine. Our approach offers a normative clarification to how becoming partners in precision is compatible with retaining autonomy.Realigning the value of autonomy with ideals of direct engagement, we show, can provide adequate normative orientation to precision medicine; it can do justice to the idea of moral pluralism by stressing the value of moral self-determination: and, finally, it can reconcile the notion of autonomy with other more communitarian values such as participation and solidarity.

Highlights

Personalized medicine refers to a family of approaches in biomedical research and clinical practice aimed at “steering the patient to the right drug at the right dose at the right time” [1]
Appeals to direct engagement and participation are frequent, but little theoretical work has been devoted to establishing their normative foundations yet
We have traced the emergence of precision medicine as a novel paradigm in biomedical research and clinical practice

Summary

Background

Personalized medicine refers to a family of approaches in biomedical research and clinical practice aimed at “steering the patient to the right drug at the right dose at the right time” [1]. In a 1984 paper, Daniel Callahan recognized that the raise of bioethics had “brought patients into a full partnership with physicians in their medical care” ([4], added emphasis).1 Despite such appearances, the notion of partnership has not enjoyed much consideration in mainstream bioethics until relatively recent times. If the promise of precision medicine will materialize, there will be considerable improvements in understanding disease risk, individual predispositions, as well as the contribution of the environment and lifestyle to disease onset and to the way individuals respond to therapy This is expected to result in a considerably increased capacity to tailor treatment and prevention strategies to the needs and characteristics of individuals – improving treatment outcomes and making health care systems more efficient and more sustainable.. For the establishment of the precision medicine cohort, the PMI explicitly embraces ideals of participation and partnership, as it sets out to capitalize on “Americans’ growing desire to be active partners in modern science” [2]

Discussion

Conclusions