Mitchell Colin, Ploem Corrette, Chico Victoria, Ormondroyd Elizabeth, Hall Alison, Wallace Susan, Fay Michael, Goodwin Deirdre, Bell Jessica, Phillips Simon, Taylor Jenny C, Hennekam Raoul, Kaye Jane
University of Oxford, UK.
University of Amsterdam, the Netherlands.
Med Law Int. 2017 Sep;17(3):158-182. doi: 10.1177/0968533217721966. Epub 2017 Aug 14.
Genome-wide sequencing technologies are beginning to be used in projects that have both clinical diagnostic and research components. The clinical application of this technology, which generates a huge amount of information of varying diagnostic certainty, involves addressing a number of challenges to establish appropriate standards. In this article, we explore the way that UK law may respond to three of these key challenges and could establish new legal duties in relation to feedback of findings that are unrelated to the presenting condition (secondary, additional or incidental findings); duties towards genetic relatives as well as the patient and duties on the part of researchers and professionals who do not have direct contact with patients. When considering these issues, the courts will take account of European and international comparisons, developing guidance and relevant ethical, social and policy factors. The UK courts will also be strongly influenced by precedent set in case law.
全基因组测序技术正开始应用于兼具临床诊断和研究成分的项目中。这项技术的临床应用会产生大量诊断确定性各异的信息,在建立适当标准方面涉及诸多挑战。在本文中,我们探讨英国法律应对其中三个关键挑战的方式,以及可能就与就诊疾病无关的检查结果(次要、额外或偶然发现)反馈确立新的法律义务;对基因亲属以及患者的义务,以及对未直接接触患者的研究人员和专业人员的义务。在考虑这些问题时,法院将参考欧洲和国际上的比较情况、制定的指南以及相关的伦理、社会和政策因素。英国法院也将受到判例法中先例的强烈影响。