Stoeklé Henri-Corto, Deleuze Jean-François, Vogt Guillaume, Hervé Christian
Laboratoire d'éthique médicale et médecine légale, EA4569, Université Paris Descartes, Centre universitaire des Saints Pères, 45, rue des Saints-Pères, 75006 Paris, France - Cancer research for personalized medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) Inserm, Paris, France.
Centre national de génotypage, Institut de génomique, CEA, 2, rue Gaston Crémieux, 91057 Évry, France - LaBex GenMed, Fondation Jean Dausset, Paris, France.
Med Sci (Paris). 2017 Feb;33(2):188-192. doi: 10.1051/medsci/20173302015. Epub 2017 Feb 27.
"Personalized medicine" or "data medicine" should make it possible to use mass data to tailor patient treatment. These data are collected from analyses of biological samples, combined with clinical data. At a time when all sorts of information are instantly available via the Internet, the protection of genetic data, in particular, raises new issues with regard to the nature, means, status and usage of these data. Solutions to these problems are required, together with a clear, unambiguous legal, moral and ethical stance, to facilitate the spatial and temporal development of personalized medicine. At the forefront of these issues is the model of informed consent, which consent that has not been modified, despite many advances in technology. Medicine is now much more dynamic, and the possibilities for the real-time exchange and sharing of information, genetic data, or even biological samples, between patients, clinicians, researchers and industrial partners, must now be considered. We describe herein the particular advantages of a so-called "dynamic" and "enriched" consent, given via electronic means, in the context of the development of personalized medicine.
“个性化医疗”或“数据医疗”应能利用海量数据为患者量身定制治疗方案。这些数据是通过对生物样本的分析收集而来，并与临床数据相结合。在各类信息可通过互联网即时获取的时代，尤其是遗传数据的保护，在这些数据的性质、获取方式、地位和使用方面引发了新问题。需要针对这些问题找到解决方案，并确立明确、不含糊的法律、道德和伦理立场，以促进个性化医疗在空间和时间上的发展。这些问题的核心是知情同意模式，尽管技术有了诸多进步，但这种同意并未改变。医学如今更具活力，现在必须考虑患者、临床医生、研究人员和产业合作伙伴之间实时交换和共享信息、遗传数据甚至生物样本的可能性。我们在此描述在个性化医疗发展背景下，通过电子方式给予的所谓“动态”和“强化”同意的特殊优势。
