Mchale Jean V
Centre for Health Law,Science and Policy,Birmingham Law School,University of Birmingham,Birmingham,UK.
Health Econ Policy Law. 2017 Oct;12(4):435-452. doi: 10.1017/S174413311700010X. Epub 2017 Apr 27.
The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.
最高法院在“蒙哥马利诉拉纳克郡案”（[2015] UKSC11）中的判决被誉为一个里程碑，这尤其是因为法院首次将知情同意原则正式纳入英国关于医疗治疗的法律中。本文探讨了“蒙哥马利案”的判决。它审视了该判决未来对于健康研究及创新治疗中的同意程序可能产生的影响，以及它是否可能成为一个分水岭时刻，从而导致在同意问题上对话和期望的改变。首先，本文通过国际、欧洲理事会和欧盟的文书来探讨临床研究中“知情同意”的概念。其次，它思考英国法律目前在临床研究背景下是如何管理向研究参与者提供信息的。它质疑这种方法在未来是否可持续。第三，它讨论了英国最高法院在“蒙哥马利诉拉纳克郡案”中的判决，并询问该最高法院判决在健康研究背景下可能产生什么影响。它询问“蒙哥马利案”是否可能导致健康研究及创新治疗中同意问题的新方法。
