Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure
Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure
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DOI：
10.1186/s40246-018-0154-6
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发表时间：
2018-04-26
期刊：
影响因子：
4.5
通讯作者：
Burton, Paul R.
中科院分区：
文献类型：
--
作者：
Murtagh, Madeleine J.;Blell, Mwenza T.;Burton, Paul R.
背景：关于个体的基因组和生物社会研究数据正在迅速增加，为数据整合和使用带来了潜在的新机会。这些应用的规模、速度和新颖性引发了许多紧迫的社会技术、伦理和法律问题，包括数据存储、管理和访问的最佳方法。尽管开放科学运动提倡不受限制地获取研究数据，但英国的许多纵向队列研究运行的是管理数据访问的系统，在这个系统中，访问受研究数据集管理者和希望使用它们的研究人员之间的法律和伦理协议的约束。除其他事项外，这些协议旨在尊重在同意过程中表达的提供数据和样本的研究参与者的合理期望。可以说，数据和样本使用的负责任的数据管理和治理是纵向研究中同意过程的基础，也是那些为基因组和生物社会研究提供数据的人眼中值得信赖的重要来源。方法：本文提出了一个民族志案例研究，探讨了数据访问（METADAC）中管理伦理社会、技术和行政问题的治理基础设施的基本原则，该基础设施通过一个名为METADAC访问委员会的委员会进行操作。METADAC管理来自英国五项纵向研究的表型、基因型和“遗漏”数据和样本的获取。以METADAC为例，我们认为三个关键的结构特征是实践负责任的数据共享的基础：独立性和透明度；跨学科性;以及以参与者为中心的决策。我们注意到，国际研究界正在积极努力优化研究数据的使用，将这些数据与保健和社会保健服务及其他行政数据服务产生的日常数据整合/联系起来，以改进这些数据的分析、解释和利用。这些新的复杂数据组合的治理将需要来自多个领域和学科的一系列专业知识，包括研究参与者的专业知识。人为中介的决策机构将是确保就这些数据的使用作出可实现、合理和负责任的决定的核心；本文中描述的METADAC模型提供了如何实现这一目标的示例。
Background: Genomic and biosocial research data about individuals is rapidly proliferating, bringing the potential for novel opportunities for data integration and use. The scale, pace and novelty of these applications raise a number of urgent sociotechnical, ethical and legal questions, including optimal methods of data storage, management and access. Although the open science movement advocates unfettered access to research data, many of the UK's longitudinal cohort studies operate systems of managed data access, in which access is governed by legal and ethical agreements between stewards of research datasets and researchers wishing to make use of them. Amongst other things, these agreements aim to respect the reasonable expectations of the research participants who provided data and samples, as expressed in the consent process. Arguably, responsible data management and governance of data and sample use are foundational to the consent process in longitudinal studies and are an important source of trustworthiness in the eyes of those who contribute data to genomic and biosocial research.Methods: This paper presents an ethnographic case study exploring the foundational principles of a governance infrastructure for Managing Ethico-social, Technical and Administrative issues in Data ACcess (METADAC), which are operationalised through a committee known as the METADAC Access Committee. METADAC governs access to phenotype, genotype and 'omit' data and samples from five UK longitudinal studies.Findings: Using the example of METADAC, we argue that three key structural features are foundational for practising responsible data sharing: independence and transparency; interdisciplinarity; and participant-centric decision-making. We observe that the international research community is proactively working towards optimising the use of research data, integrating/linking these data with routine data generated by health and social care services and other administrative data services to improve the analysis, interpretation and utility of these data. The governance of these new complex data assemblages will require a range of expertise from across a number of domains and disciplines, including that of study participants. Human-mediated decision-making bodies will be central to ensuring achievable, reasoned and responsible decisions about the use of these data; the METADAC model described in this paper provides an example of how this could be realised.