Managing expectations, rights, and duties in large-scale genomics initiatives: a European comparison.
Managing expectations, rights, and duties in large-scale genomics initiatives: a European comparison.
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DOI：
10.1038/s41431-022-01247-y
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发表时间：
2023-03
期刊：
影响因子：
--
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中科院分区：
文献类型：
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本文报告了英国-法国基因组学和伦理网络 (UK-FR GENE) 于 2021 年组织的国际研讨会的调查结果。研讨会特别关注基因组数据的收集、存储和共享如何对已经实施或即将实施大规模国家基因组计划的国家的信任、保密和隐私等既定原则和价值观构成挑战。这些挑战影响患者/公民与医学/科学之间的关系，以及各方相互之间的权利和义务。我们比较分析的地理范围包括英国（英国基因组学）、法国（法国医学基因组计划）和德国（德国人类基因组-表型档案）正在进行的举措。我们讨论了每个国家大规模健康数据收集和管理所带来的现有和未来挑战。我们的结论是，改善个体化患者医疗保健以及为任何从事健康数据收集、存储和处理的特定国家的科学研究繁荣做出贡献的前景是不可否认的。然而，我们还试图证明生物医学数据需要仔细管理，以及透明和负责任的治理结构，并与患者/参与者和公民清楚地沟通。此外，当第三方作为利益相关者参与时，与数据访问和使用相关的透明同意协议成为中心舞台，患者利益必须明显超过商业利益。最后，任何跨境数据传输都需要谨慎管理，以解决区域、国家和超国家法规和建议之间的不一致问题。
This article reports on the findings of an international workshop organised by the UK-France Genomics and Ethics Network (UK-FR GENE) in 2021. They focus specifically on how collection, storage and sharing of genomic data may pose challenges to established principles and values such as trust, confidentiality, and privacy in countries that have implemented, or are about to implement, large-scale national genomic initiatives. These challenges impact the relationships between patients/citizens and medicine/science, and on each party’s rights and duties towards each other. Our geographic scope of comparative analysis includes initiatives underway in England (Genomics England), France (Plan France Médecine Génomique) and Germany (German Human Genome-Phenome Archive). We discuss existing as well as future challenges raised by large-scale health data collection and management in each country. We conclude that the prospects of improving individualised patient healthcare as well as contributing to the scientific and research prosperity of any given nation engaged in health data collection, storage and processing are undeniable. However, we also attempt to demonstrate that biomedical data requires careful management, and transparent and accountable governance structures that are clearly communicated to patients/participants and citizens. Furthermore, when third parties partake as stakeholders, transparent consent protocols relative to data access and use come centre stage, and patient benefits must clearly outweigh commercial interests. Finally, any cross-border data transfer needs to be carefully managed to address incoherencies between regional, national, and supranational regulations and recommendations.
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DOI：
10.1038/s41431-020-00782-w
发表时间：
2021-04
期刊：
European journal of human genetics : EJHG
影响因子：
--
作者：
Haas MA;Teare H;Prictor M;Ceregra G;Vidgen ME;Bunker D;Kaye J;Boughtwood T
通讯作者：
Boughtwood T
影响因子：
12.3
作者：
Milne R;Morley KI;Almarri MA;Anwer S;Atutornu J;Baranova EE;Bevan P;Cerezo M;Cong Y;Costa A;Critchley C;Fernow J;Goodhand P;Hasan Q;Hibino A;Houeland G;Howard HC;Hussain SZ;Malmgren CI;Izhevskaya VL;Jędrzejak A;Jinhong C;Kimura M;Kleiderman E;Leach B;Liu K;Mascalzoni D;Mendes Á;Minari J;Nicol D;Niemiec E;Patch C;Pollard J;Prainsack B;Rivière M;Robarts L;Roberts J;Romano V;Sheerah HA;Smith J;Soulier A;Steed C;Stefànsdóttir V;Tandre C;Thorogood A;Voigt TH;Wang N;West AV;Yoshizawa G;Middleton A
通讯作者：
Middleton A
影响因子：
4.1
作者：
Dheensa S;Samuel G;Lucassen AM;Farsides B
通讯作者：
Farsides B
DOI：
10.1038/s41431-020-00798-2
发表时间：
2021-05
期刊：
European journal of human genetics : EJHG
影响因子：
--
作者：
Gaille M;Horn R;UK-FR GENE (Genetics and Ethics Network) Consortia
通讯作者：
UK-FR GENE (Genetics and Ethics Network) Consortia
影响因子：
1.9
作者：
Dheensa, Sandi;Lucassen, Anneke;Fenwick, Angela
通讯作者：
Fenwick, Angela