医疗机构泛知情同意和健康数据共享隐私保护的调查研究

An Investigation of Broad Consent and the Health Data Sharing Privacy Protection in Medical Institutions

随着网络技术的飞速发展,患者健康数据的共享和研究为医学研究和临床指导提供了高效、便捷的通道。为了解患者对数据共享和泛知情同意的意见,本研究组对沿海和内地三甲医院共397例患者进行了健康数据分享、临床剩余血样本科研应用、广泛知情同意的接受度及相关的影响因素的问卷调查,通过数据分析了解到中国患者维护知情权意识较强烈,趋向选择简便快速的知情同意方式;患者视社会获益高于个人获益,具较强的社会奉献精神;中国医疗机构中对于广泛知情同意的应用和总结研究很少,与欧美国家比较,在国家层面上的推广很少。本研究为各伦理委员会在审查此类研究时提供患者角度的参考依据,以了解民众对医疗机构数据共享中的隐私保护和泛知情同意的个人意愿,以利于中国健康数据共享的合理发展和推广。

With the rapid development of network technology, the data sharing and health research provides an efficient and convenient way for medical research and clinical guidance. In order to know patients＇ opinions on informed consent and data sharing, we investigated first-class hospitals in the coastal and inland areas with a total of 397 patients participating the questionnaire on clinical health and data sharing, reusing the remaining clinical blood samples in scientific researches, and the acceptance degree of broad consent investigation and related influencing factors. It was found that patients with strong consciousness of informed consent right tended to choose a simpler way of informed consent based on the analysis. Patients preferred social benefits than personal benefits with a strong spirit of dedication to the community. Medical institutions in China rarely applied broad consents and took relervant summative researhes, compared with the European and American countries＇ promotions at the national level. The research afforded the evidence, from most of patients＇ point of view to ethics committee in the review of such kind of studies to understand the public data sharing in privacy protection and broad consent of the individual opinion, in order to facilitate the rational development and promotion of health data sharing in China ethically.