真实世界研究的知情同意方式选择及数据保护问题探讨

Consideration on choices of informed consent and data protection in Real-World Studies

  • 摘要: 真实世界研究(real-world study,RWS)在医药监管及医疗决策中越来越重要,但由于RWS在真实诊疗环境中实施,且研究设计多样,故传统的知情同意方式在部分RWS研究开展时可能会影响招募进度或带来选择偏倚,从而降低研究结果的普适性。目前有很多学者探讨基于风险大小选择RWS知情同意的方式,但作者认为应依据RWS的实际特点,以研究开始时间为基准选择合适的知情同意方式,如前瞻性研究研究者须得到患者的知情同意,具体采用口头、电子、书面知情同意可依据实际选择,但告知其内容应该一致,且应充分告知;回顾性研究可依据法规规定,伦理委员会审查是否可以豁免知情同意,但建议从现在开始医疗机构应建立并实施泛知情同意管理体系,为未来使用健康数据和生物样本研究合规开展奠定基础。

     

    Abstract: Real-world study (RWS) plays an increasingly important role in medical regulation and medical decision-making. However, due to the implementation of RWS in real diagnosis and treatment environment and diverse study designs, the traditional informed consent method may lead to recruitment difficulties or selection bias in some RWS, thus reducing the universality of the study results. At present, many scholars have discussed the choice of RWS informed consent based on the risk, but the authors believe that it should adapt to the actual characteristics of RWS. In informed consent, appropriate informed consent methods can be selected according to the time of study design. For example, researchers in prospective studies are obliged to obtain the informed consent of patients. Oral, electronic and written informed consent can be selected according to the actual enforceability, but the content should be consistent and fully informed; Based on the content and regulations, the ethics committee of the retrospective study reviews whether informed consent can be exempted. However, it is recommended that medical institutions should establish and implement pan-informed consent from now on, so as to provide evidence for future studies using health data and biological samples.

     

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