Richter Gesine, Trigui Nourane, Caliebe Amke, Krawczak Michael
Institute of Experimental Medicine, Division of Biomedical Ethics, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.
German Center for Lung Research (DZL), Airway Research Center North (ARCN), Borstel, Germany.
Heliyon. 2024 Mar 11;10(6):e27933. doi: 10.1016/j.heliyon.2024.e27933. eCollection 2024 Mar 30.
The design of appropriate consent procedures for the secondary use of personal health data is a key concern of current medical research. In Germany, the concept of 'data donation' has recently come into focus, defined as a legal entitlement to the research use of personal medical data without prior consent, combined with an easy-to-exercise right of the data subjects to opt-out.
Standardized online interviews of 3,013 individuals, representative of the German online population, were conducted in August 2022 to determine their attitude towards data donation for medical research.
A majority of participants supported a consent-free data donation regulation, both for publicly funded (85.1%) and for private medical research (66.4%). Major predictors of a positive attitude towards data donation included (i) sufficient appreciation of the respective kind of research (i.e. public or private), (ii) a reciprocity attitude that patients who benefit from research have a duty to support research, and (iii) sufficient trust in data protection and data control.
People's attitude towards data donation to medical research is generally positive in Germany and depends upon factors that can be curbed by legislation and internal rules of procedure. Worthy of note, designing data donation in the form of an opt-out regulation does not necessarily mean that the paradigm of informedness has to be abandoned. Rather the process of information provision must be shifted towards the creation of basic knowledge in the general population about the risks and benefits of data-intensive medical research ('health data literacy').
为个人健康数据的二次使用设计适当的同意程序是当前医学研究的一个关键问题。在德国，“数据捐赠”的概念最近成为焦点，它被定义为无需事先同意即可对个人医疗数据进行研究使用的合法权利，同时数据主体拥有易于行使的退出权。
2022年8月，对3013名代表德国在线人群的个体进行了标准化在线访谈，以确定他们对医学研究数据捐赠的态度。
大多数参与者支持无同意的数据捐赠规定，无论是对于公共资助的研究（85.1%）还是私人医学研究（66.4%）。对数据捐赠持积极态度的主要预测因素包括：（i）对相应类型研究（即公共或私人）有足够的重视，（ii）有一种互惠态度，即从研究中受益的患者有义务支持研究，以及（iii）对数据保护和数据控制有足够的信任。
在德国，人们对医学研究数据捐赠的态度总体上是积极的，并且取决于可以通过立法和内部程序规则加以控制的因素。值得注意的是，以退出规定的形式设计数据捐赠并不一定意味着必须放弃知情范式。相反，信息提供过程必须转向在普通人群中创建关于数据密集型医学研究的风险和益处的基础知识（“健康数据素养”）。
