泛化知情同意的临床操作及思考

The Clinical Practice and Thinking of the Broad Informed Consent

健康医疗大数据和人工智能技术的飞速发展让我们迎来了信息共享和数据再次利用的高峰,在不同行政国家/地区的样本库伦理的法律和法规各不相同,对于数据信息的隐私保护的要求也各有不同,对研究人员、伦理委员会也提出了新要求。与此同时,基于临床诊疗产生的生物样本及信息数据的再次利用/被用于未来研究时,如何在法律、法规许可的范围内,既能保障信息的充分告知,又能保障临床在操作泛化知情时充分的信息保护、充分的自主自愿,同样是大家都很关注的问题。为此,邀请临床研究、医学伦理、医院管理等多方面学者一起探讨,以期能为泛化知情同意的实施开展提供思路。并且提供了几个典型的泛知情同意的案例,从研究者、伦理委员、受试者角度分析其存在的问题,和可能的对未来的影响,与读者一起找到解决办法。

The rapid development of health care big data and artificial intelligence technology has ushered in the peak of information sharing and data reuse.The ethics laws and regulations of sample banks in different administrative countries/regions are different.The requirements of the privacy protection of data information are also different.New requirements have been put on researchers and ethics committees.At the same time,based on the reuse of biological samples and information data generated in clinical diagnosis and treatment/used for future research,how to ensure the full disclosure of information within the scope permitted by laws and regulations,and it can guarantee the full protection of information and the full willingness of the patients when they are informed of the operation of generalization,which is also a problem of great concern to all of us.To this end,scholars in clinical research,medical ethics,hospital management and other aspects are invited to discuss together,in order to provide ideas for the implementation of generalized and informed implementation.It also provided several typical cases of pan-informed consent,analyzed the existing problems from the perspective of researchers,ethics committee members and subjects,and may affect the future to work with readers to find solutions.