Ethical aspects of precision medicine: an introduction to the ethics and concept of clinical innovation

HOLZER, FELICITAS; MASTROLEO, IGNACIO

Precision Medicine: Tools and Quantitative Approaches

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Lugar: Brooklin, Nueva York; Año: 2018; p. 1 - 19

[Indización: El presente capítulo se encuentra indizado en SCOPUS como se da cuenta en el archivo adjunto]This chapter analyses and develops the concept as well as the ethics of clinical innovation in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. We will characterize clinical innovation as ´new and insufficiently validated practice´ because it resembles medical practice in terms of the aim to directly benefit individual patients. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features. We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research.