Fiore Robin N, Goodman Kenneth W
University of Miami Miller School of Medicine, Institute for Bioethics and Health Policy, Miami, Florida, USA.
Curr Opin Oncol. 2016 Jan;28(1):83-7. doi: 10.1097/CCO.0000000000000247.
In early 2015 the National Institutes of Health launched a new, national Precision Medicine Initiative with the primary goal of rapidly improving the prevention, diagnosis, and treatment of cancers. The first-stage emphasis on oncology presents unique opportunities for clinical oncology to influence how the ethical challenges of precision medicine are to be articulated and addressed. Thus, a review of recent developments in connection with the Initiative, in particular on core ethics issues in clinical genomics, is a useful starting point.
Unique ethical issues arise in precision medicine because of the enormous amounts of data generated by clinical whole-genome or whole-exome sequencing and the extent of current uncertainties with respect to data interpretations and disease associations. Among the most ethically challenging issues for clinicians are complicated informed consent processes, returning results - particularly secondary and incidental findings-and privacy and confidentiality.
The first tests of precision medicine ethics in practice will be in clinical oncology, providing a rare opportunity to shape the agenda and integrate practical ethics considerations. These efforts can benefit from pre-existing research ethics analyses and recommendations from clinical and translational genetics research.
2015年初，美国国立卫生研究院发起了一项新的全国精准医学计划，其主要目标是迅速改善癌症的预防、诊断和治疗。该计划第一阶段对肿瘤学的重视为临床肿瘤学带来了独特机遇，使其能够影响如何阐明和应对精准医学的伦理挑战。因此，回顾与该计划相关的近期进展，特别是临床基因组学中的核心伦理问题，是一个有益的起点。
由于临床全基因组或全外显子组测序产生的大量数据以及目前在数据解读和疾病关联方面的不确定性程度，精准医学中出现了独特的伦理问题。对临床医生来说，最具伦理挑战性的问题包括复杂的知情同意过程、返回结果——尤其是次要和偶然发现——以及隐私和保密。
精准医学伦理在实践中的首次检验将出现在临床肿瘤学中，这为制定议程和整合实际伦理考量提供了难得的机会。这些努力可以受益于先前的研究伦理分析以及临床和转化遗传学研究的建议。
