克服健康研究中数据链接的伦理和法律障碍：利益相关者的观点。
Overcoming ethical and legal obstacles to data linkage in health research: stakeholder perspectives.
机构信息
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
出版信息
Int J Popul Data Sci. 2023 Sep 25;8(1):2151. doi: 10.23889/ijpds.v8i1.2151. eCollection 2023.
INTRODUCTION
Data linkage for health research purposes enables the answering of countless new research questions, is said to be cost effective and less intrusive than other means of data collection. Nevertheless, health researchers are currently dealing with a complicated, fragmented, and inconsistent regulatory landscape with regard to the processing of data, and progress in health research is hindered.
AIM
We designed a qualitative study to assess what different stakeholders perceive as ethical and legal obstacles to data linkage for health research purposes, and how these obstacles could be overcome.
METHODS
Two focus groups and eighteen semi-structured in-depth interviews were held to collect opinions and insights of various stakeholders. An inductive thematic analysis approach was used to identify overarching themes.
RESULTS
This study showed that the ambiguity regarding the 'correct' interpretation of the law, the fragmentation of policies governing the processing of personal health data, and the demandingness of legal requirements are experienced as causes for the impediment of data linkage for research purposes by the participating stakeholders. To remove or reduce these obstacles authoritative interpretations of the laws and regulations governing data linkage should be issued. The participants furthermore encouraged the harmonisation of data linkage policies, as well as promoting trust and transparency and the enhancement of technical and organisational measures. Lastly, there is a demand for legislative and regulatory modifications amongst the participants.
CONCLUSIONS
To overcome the obstacles in data linkage for scientific research purposes, perhaps we should shift the focus from adapting the current laws and regulations governing data linkage, or even designing completely new laws, towards creating a more thorough understanding of the law and making better use of the flexibilities within the existing legislation. Important steps in achieving this shift could be clarification of the legal provisions governing data linkage by issuing authoritative interpretations, as well as the strengthening of ethical-legal oversight bodies.
简介
出于健康研究的目的进行数据链接可以回答无数新的研究问题，据说这种方法比其他数据收集方式更具成本效益且侵犯性更小。然而，健康研究人员目前正在处理一个复杂、分散和不一致的监管环境，涉及数据处理，健康研究的进展受到阻碍。
目的
我们设计了一项定性研究，以评估不同利益相关者认为数据链接用于健康研究的伦理和法律障碍是什么，以及如何克服这些障碍。
方法
通过两个焦点小组和 18 次半结构化深度访谈收集了不同利益相关者的意见和见解。采用归纳主题分析方法确定了总体主题。
结果
这项研究表明，对法律“正确”解释的模糊性、管理个人健康数据处理的政策的分散性以及法律要求的苛刻性，被参与的利益相关者视为阻碍研究目的数据链接的原因。为了消除或减少这些障碍，应该发布有关数据链接的法律和法规的权威解释。参与者还鼓励协调数据链接政策，以及促进信任和透明度，并加强技术和组织措施。最后，参与者呼吁进行立法和监管修改。
结论
为了克服科学研究数据链接中的障碍，我们或许应该将重点从调整现有的数据链接法规，甚至设计全新的法律，转移到更深入地理解法律并更好地利用现有法规中的灵活性。实现这一转变的重要步骤可能是通过发布权威解释澄清有关数据链接的法律规定，以及加强伦理法律监督机构。
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