Centre for Health Law and Emerging Technologies, NDPH, University of Oxford, Ewert House, Ewert Place, Summertown, Oxford, OX2 7DD, UK.
Melbourne Law School, University of Melbourne, 185 Pelham Street, Carlton, Victoria, 3053, Australia.
Hum Genomics. 2018 Mar 7;12(1):13. doi: 10.1186/s40246-018-0143-9.
Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and medicine by allowing the maximum returns from the investment in research, as well as reducing waste and promoting transparency. As this approach gains momentum, these data-sharing practices have implications for many kinds of research as they become standard practice across the world.
The governance frameworks that have been developed to support biomedical research are not well equipped to deal with the complexities of international data sharing. This system is nationally based and is dependent upon expert committees for oversight and compliance, which has often led to piece-meal decision-making. This system tends to perpetuate inequalities by obscuring the contributions and the important role of different data providers along the data stream, whether they be low- or middle-income country researchers, patients, research participants, groups, or communities. As research and data-sharing activities are largely publicly funded, there is a strong moral argument for including the people who provide the data in decision-making and to develop governance systems for their continued participation.
We recommend that governance of science becomes more transparent, representative, and responsive to the voices of many constituencies by conducting public consultations about data-sharing addressing issues of access and use; including all data providers in decision-making about the use and sharing of data along the whole of the data stream; and using digital technologies to encourage accessibility, transparency, and accountability. We anticipate that this approach could enhance the legitimacy of the research process, generate insights that may otherwise be overlooked or ignored, and help to bring valuable perspectives into the decision-making around international data sharing.
政府、资助机构、机构和出版商已经制定了许多策略来鼓励研究人员促进数据集的获取。这种方法背后的基本原理是，这将带来许多好处，并通过允许从研究投资中获得最大回报，以及减少浪费和促进透明度，从而推动医疗保健和医学的发展。随着这种方法的发展，这些数据共享实践对许多类型的研究都有影响，因为它们在全球范围内成为标准做法。
支持生物医学研究的治理框架还没有为处理国际数据共享的复杂性做好准备。该系统基于国家，依赖专家委员会进行监督和合规，这往往导致决策零碎。这种系统往往通过掩盖数据流中不同数据提供者的贡献和重要作用，使不平等现象长期存在，无论他们是来自低收入或中等收入国家的研究人员、患者、研究参与者、群体还是社区。由于研究和数据共享活动主要由公共资金资助，因此有一个强烈的道德论据，即包括提供数据的人参与决策，并为他们的持续参与制定治理系统。
我们建议通过就数据共享的访问和使用问题进行公开咨询，使科学治理更加透明、具有代表性，并对多方利益相关者的声音做出回应；让所有数据提供者参与到关于整个数据流中数据的使用和共享的决策中；并利用数字技术提高可及性、透明度和问责制。我们预计，这种方法可以增强研究过程的合法性，产生可能被忽视或忽略的见解，并有助于在国际数据共享决策中纳入有价值的观点。
