Muller Sam H A, van Thiel Ghislaine J M W, Vrana Marilena, Mostert Menno, van Delden Johannes J M
Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
European Heart Network, Brussels, Belgium.
JMIR Hum Factors. 2022 Sep 7;9(3):e36797. doi: 10.2196/36797.
Patients and publics are generally positive about data-intensive health research. However, conditions need to be fulfilled for their support. Ensuring confidentiality, security, and privacy of patients' health data is pivotal. Patients and publics have concerns about secondary use of data by commercial parties and the risk of data misuse, reasons for which they favor personal control of their data. Yet, the potential of public benefit highlights the potential of building trust to attenuate these perceptions of harm and risk. Nevertheless, empirical evidence on how conditions for support of data-intensive health research can be operationalized to that end remains scant.
This study aims to inform efforts to design governance frameworks for data-intensive health research, by gaining insight into the preferences of patients and publics for governance policies and measures.
We distributed a digital questionnaire among a purposive sample of patients and publics. Data were analyzed using descriptive statistics and nonparametric inferential statistics to compare group differences and explore associations between policy preferences.
Study participants (N=987) strongly favored sharing their health data for scientific health research. Personal decision-making about which research projects health data are shared with (346/980, 35.3%), which researchers/organizations can have access (380/978, 38.9%), and the provision of information (458/981, 46.7%) were found highly important. Health data-sharing policies strengthening direct personal control, like being able to decide under which conditions health data are shared (538/969, 55.5%), were found highly important. Policies strengthening collective governance, like reliability checks (805/967, 83.2%) and security safeguards (787/976, 80.6%), were also found highly important. Further analysis revealed that participants willing to share health data, to a lesser extent, demanded policies strengthening direct personal control than participants who were reluctant to share health data. This was the case for the option to have health data deleted at any time (P<.001) and the ability to decide the conditions under which health data can be shared (P<.001). Overall, policies and measures enforcing conditions for support at the collective level of governance, like having an independent committee to evaluate requests for access to health data (P=.02), were most strongly favored. This also applied to participants who explicitly stressed that it was important to be able to decide the conditions under which health data can be shared, for instance, whether sanctions on data misuse are in place (P=.03).
This study revealed that both a positive attitude toward health data sharing and demand for personal decision-making abilities were associated with policies and measures strengthening control at the collective level of governance. We recommend pursuing the development of this type of governance policy. More importantly, further study is required to understand how governance policies and measures can contribute to the trustworthiness of data-intensive health research.
患者和公众总体上对数据密集型健康研究持积极态度。然而，要获得他们的支持需要满足一定条件。确保患者健康数据的保密性、安全性和隐私性至关重要。患者和公众担心商业机构二次使用数据以及数据被滥用的风险，因此他们倾向于对自己的数据进行个人控制。然而，公共利益的潜力凸显了建立信任以减轻这些危害和风险认知的可能性。尽管如此，关于如何将支持数据密集型健康研究的条件付诸实践的实证证据仍然很少。
本研究旨在通过深入了解患者和公众对治理政策及措施的偏好，为设计数据密集型健康研究的治理框架提供参考。
我们在有目的选取的患者和公众样本中发放了一份数字问卷。使用描述性统计和非参数推断统计对数据进行分析，以比较组间差异并探索政策偏好之间的关联。
研究参与者（N = 987）强烈支持为科学健康研究分享他们的健康数据。对于决定与哪些研究项目分享健康数据（346/980，35.3%）、哪些研究人员/组织可以访问（380/978，38.9%）以及提供信息（458/981，46.7%）的个人决策权，被认为非常重要。加强直接个人控制的健康数据共享政策，如能够决定在何种条件下分享健康数据（538/969，55.5%），也被认为非常重要。加强集体治理的政策，如可靠性检查（805/967，83.2%）和安全保障措施（787/976，80.6%），同样被认为非常重要。进一步分析表明，愿意分享健康数据的参与者在较小程度上要求加强直接个人控制的政策，这一比例低于不愿意分享健康数据的参与者。在任何时候删除健康数据的选项（P <.001）以及决定健康数据可共享条件的能力（P <.001）方面都是如此。总体而言，在集体治理层面执行支持条件的政策和措施最受青睐，比如设立独立委员会来评估获取健康数据的请求（P = 0.02）。这也适用于那些明确强调能够决定健康数据可共享条件很重要的参与者，例如是否存在对数据滥用的制裁措施（P = 0.03）。
本研究表明，对健康数据共享的积极态度和对个人决策能力的需求都与在集体治理层面加强控制的政策和措施相关。我们建议推进这类治理政策的制定。更重要的是，需要进一步研究以了解治理政策和措施如何能够提高数据密集型健康研究的可信度。
