Modernizing biomedical regulation: foresight and values in the promotion of responsible research and innovation
نویسنده
چکیده
INTRODUCTION A new, more responsive and personalized era in healthcare has long been anticipated.1 And while one might dismiss as hyperbole some of the claims that have been made in relation ‘personalized’, ‘stratified’, or ‘precision’ medicine, it is undeniable that some of the associated technologies and practices (such as stem cell research, genome sequencing, and sample/data banking) do indeed promise to improve healthcare interventions, both preventive and curative.2 This promise has given rise to widespread excitement, and to initiatives like US President Obama’s Precision Medicine Initiative. Underwritten byUS$215million, it is meant to pioneer amodel of patient-powered research that will result in new clinical knowledge and tools.3 However, as Nicol et al. acknowledge (pp. 4–5) in their wide-ranging and informative article,4 so-called precision medicine could also generate as much burden as boon.
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