Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project.
Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project.
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DOI：
10.1136/medethics-2017-104588
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发表时间：
2018-06
影响因子：
4.1
通讯作者：
Farsides B
中科院分区：
文献类型：
--
作者：
Dheensa S;Samuel G;Lucassen AM;Farsides B
临床实践和研究受不同的规则和法规的约束，并且有不同的方法，例如同意和提供结果。然而，基因组学是研究和临床实践相互依赖的一个例子。100000基因组计划（100 kGP）是一个混合型项目，只有当一个人同意参与正在进行的研究，包括工业和商业公司的研究，他或她才能获得临床研究。在本文中，它借鉴了20个专业的利益相关者参与100 kGP的采访，我们调查了这个项目的混合性质所提出的道德问题。虽然一些受访者认为100 kGP的混合性质是其先锋，但受访者确定了围绕混合实践的几个紧张关系：如何决定谁应该能够参与;如何确定提供结果是否可能不适当地影响参与广泛但通常尚未未知的研究，以及如何确保患者/家属不会对获得结果产生错误的期望。随着100 kGP以国家基因组医学服务的形式进入常规医疗保健，这些领域需要进一步辩论。为了解决所确定的紧张局势，我们探讨了Faden等人的适当性。当研究和临床护理完全整合时，美国的伦理义务框架。我们还认为，围绕100 kGP应允许的研究类型，在患者/家属和专业人员之间进行持续透明和值得信赖的沟通，将有助于理解并确保期望保持现实。我们的论文旨在鼓励对这些问题进行重点讨论，并为卫生服务中的研究和临床护理提供新的“社会契约”。
Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service.
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影响因子：
2.7
作者：
Samuel, Gabrielle Natalie;Dheensa, Sandi;Lucassen, Anneke
通讯作者：
Lucassen, Anneke
影响因子：
--
作者：
De Vries RG;Tomlinson T;Kim HM;Krenz CD;Ryan KA;Lehpamer N;Kim SY
通讯作者：
Kim SY
研究的社会许可证：为什么Care.Data遇到了麻烦。
影响因子：
4.1
作者：
Carter P;Laurie GT;Dixon-Woods M
通讯作者：
Dixon-Woods M
影响因子：
2.1
作者：
Cargill, Stephanie Solomon
通讯作者：
Cargill, Stephanie Solomon
影响因子：
4.1
作者：
Hallowell, N.;Cooke, S.;Snowdon, C.
通讯作者：
Snowdon, C.