DBT Labs, Boston, Massachusetts, USA.
Department of Critical Care, Guy's and St Thomas' Hospitals NHS Trust, London, UK
BMJ Health Care Inform. 2023 Jun;30(1). doi: 10.1136/bmjhci-2023-100771.
In January, the National Institutes of Health (NIH) implemented a Data Management and Sharing Policy aiming to leverage data collected during NIH-funded research. The COVID-19 pandemic illustrated that this practice is equally vital for augmenting patient research. In addition, data sharing acts as a necessary safeguard against the introduction of analytical biases. While the pandemic provided an opportunity to curtail critical research issues such as reproducibility and validity through data sharing, this did not materialise in practice and became an example of 'Open Data in Appearance Only' (ODIAO). Here, we define ODIAO as the intent of data sharing without the occurrence of actual data sharing (eg, material or digital data transfers). Propose a framework that states the main risks associated with data sharing, systematically present risk mitigation strategies and provide examples through a healthcare lens. This framework was informed by critical aspects of both the Open Data Institute and the NIH's 2023 Data Management and Sharing Policy plan guidelines. Through our examination of legal, technical, reputational and commercial categories, we find barriers to data sharing ranging from misinterpretation of General Data Privacy Rule to lack of technical personnel able to execute large data transfers. From this, we deduce that at numerous touchpoints, data sharing is presently too disincentivised to become the norm. In order to move towards Open Data, we propose the creation of mechanisms for incentivisation, beginning with recentring data sharing on patient benefits, additional clauses in grant requirements and committees to encourage adherence to data reporting practices.
1 月,美国国立卫生研究院 (NIH) 实施了一项数据管理和共享政策,旨在利用 NIH 资助研究中收集的数据。COVID-19 大流行表明,这种做法对于增强患者研究同样至关重要。此外,数据共享是防止引入分析偏差的必要保障。虽然大流行提供了一个机会,可以通过数据共享来解决关键研究问题,例如可重复性和有效性,但实际上并没有实现,这成为了“表面上的数据共享”(ODIAO)的一个例子。在这里,我们将 ODIAO 定义为有数据共享的意图,但实际上没有发生数据共享(例如,材料或数字数据传输)。提出了一个框架,该框架说明了与数据共享相关的主要风险,系统地提出了风险缓解策略,并通过医疗保健视角提供了示例。该框架借鉴了开放数据研究所和 NIH 2023 年数据管理和共享政策计划指南的关键方面。通过对法律、技术、声誉和商业类别的审查,我们发现数据共享存在障碍,包括对一般数据隐私规则的误解以及缺乏能够执行大数据传输的技术人员。由此推断,在许多接触点,数据共享目前的激励措施不足,无法成为常态。为了迈向开放数据,我们提议创建激励机制,首先将数据共享的重点放在患者利益上,在资助要求中增加附加条款,并设立委员会以鼓励遵守数据报告实践。