瑞士的普遍同意概念与苏黎世大学附属医院的实施情况，一项横断面研究。
The concept of General Consent in Switzerland and the implementation at the University Hospital Zurich, a cross-sectional study.
机构信息
Clinical Trials Center Zürich, University Hospital Zurich, Zurich, Switzerland.
University Zurich, Department of Biomedicine, Zurich, Switzerland.
出版信息
Swiss Med Wkly. 2022 Apr 14;152:w30159. doi: 10.4414/smw.2022.w30159. eCollection 2022 Mar 28.
BACKGROUND
General Consent (GC) allows the further use of health-related data/samples for multiple, unspecified research projects and/or for the collection in databases and biobanks in Switzerland. The application of General Consent in the context of human research is regulated within the scope of the Human Research Act. At the University Hospital Zurich patients are informed about General Consent to which they can agree (GC = yes) or disagree (GC = no) to the use of their routinely collected data/samples in research. In this paper, we investigated the association of demographic and medical factors on a patient's General Consent choice.
METHODS
In this cross-sectional study, we investigated the association of age, gender, number of visits and number of diagnoses on General Consent choice. The study population was stratified by General Consent status group (GC choice: Yes, No, Not issued) and examined by means of descriptive statistics, comparative statistics and a multinomial and logistic regression model. A p-value of 0.001 was determined as significant.
RESULTS
The female gender was found to associate with decreased odds in positive General Consent choice (<0.001) whereas age (<0.001) and number of diagnoses (<0.001) were associated with increased odds in positive General Consent choice (reference "GC = no" group). The number of visits (<0.001) as well as the number of diagnoses associated (<0.001) with increased General Consent collection (increase in positive as well as negative General Consent status).
CONCLUSION
General Consent is an innovative concept that simultaneously informs patients about human research in accordance with Swiss regulations and promotes research with routinely collected data and biological samples in an era with large information repositories. Our results show that medical and demographic factors may influence a patient's choice. Therefore, approaching these populations and taking additional care to adequately inform and ensure ethical conformity and behaviour is essential. Flexible communication channels may help us reach this goal.
背景
一般同意（GC）允许将与健康相关的数据/样本进一步用于多个未指定的研究项目和/或用于瑞士的数据库和生物库收集。一般同意在人类研究中的应用在《人类研究法》的范围内进行监管。在苏黎世大学医院，患者会被告知一般同意的相关信息，他们可以选择同意（GC=是）或不同意（GC=否）将其常规收集的数据/样本用于研究。在本文中，我们研究了人口统计学和医学因素对患者一般同意选择的影响。
方法
在这项横断面研究中，我们研究了年龄、性别、就诊次数和诊断次数对一般同意选择的影响。研究人群按一般同意状况分组（GC 选择：是、否、未发放），通过描述性统计、比较性统计以及多项和逻辑回归模型进行检查。p 值为 0.001 被确定为显著。
结果
女性性别与积极的一般同意选择的几率降低有关（<0.001），而年龄（<0.001）和诊断次数（<0.001）与积极的一般同意选择的几率增加有关（参考“GC=否”组）。就诊次数（<0.001）以及诊断次数的增加（<0.001）与一般同意收集的增加有关（积极和消极的一般同意状态均增加）。
结论
一般同意是一个创新的概念，它同时根据瑞士法规告知患者有关人类研究的信息，并在信息库庞大的时代促进了对常规收集的数据和生物样本的研究。我们的研究结果表明，医学和人口统计学因素可能会影响患者的选择。因此，接近这些人群并额外注意充分告知和确保符合伦理规范和行为至关重要。灵活的沟通渠道可能有助于我们实现这一目标。
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