中国医学伦理委员会委员的伦理认知分析

 基于2020年中国医学科学院发起的一项对全国11164名医学科研人员的随机抽样调查数据，分析其中960位各伦理委员会委员的伦理认知情况、认知途径及相关影响因素。研究显示：（1）伦理委员中拥有博士学位、正高职称、海外经历的比例均超过7成，对医学文件了解3项及以上的占90.8%，不同单位类型的伦理委员对医学伦理文件的了解有统计学差异（χ²=39.60，P<0.01）；（2）对科研伦理规范了解的占95.2%，对科研伦理四大基本原则比较熟悉的占98.4%，男性和女性之间（χ²=5.75，P=0.05）、不同单位类型（χ²=12.87，P<0.05）之间差异有统计学意义；对涉及人的生物医学研究伦理审查了解的占90.0%，是否有海外经历（χ²=3.93，P<0.05）和不同单位类型（χ²=32.38，P<0.01）之间差异有统计学意义；（3）伦理委员均有伦理知识获得途径，其对科研伦理规范了解程度的影响因素有年龄（OR=1.88，P<0.01）和海外经历（OR=1.80，P=0.06），对伦理审查了解程度的影响因素有年龄（OR=1.47，P<0.01）和单位类型（OR=0.69，P=0.03）；（4）伦理委员的伦理认知情况普遍好于一般医学科研人员，医疗机构更加重视伦理委员会的建设，单位组织的专门培训、科研项目组织的培训和自学是伦理委员获取伦理知识的主要途径，针对影响其伦理认知情况的影响因素进行适当干预，可以有效提高伦理委员的认知程度，全面提升伦理审查质量。

Analysis of ethical cognition state of members of Medical Ethic Committee in China

This paper explores the ethical cognition state of members of the ethic committee in China. Based on the data of a random sampling survey of 11164 medical researchers nationwide initiated by the Chinese Academy of Medical Sciences in 2020, with 960 of them served as members of ethics committees, their cognition state, cognitive ways and related influencing factors of ethical knowledge are analyzed. More than 70% of the ethics committee members have a doctor's degree, a senior professional title and overseas experience, and 90.8% of them have read three or more related medical documents. Significant differences are found in the understanding of the medical ethics documents among the ethics committee members from different units (χ²=39.60, P<0.01). 95.2% of them understand the scientific research ethics. 98.4% of them are familiar with the four basic principles of the scientific research ethics, significant differences are found between male and female members (χ²=5.75, P =0.05), and different units (χ²=12.87, P<0.05). 90.0% of them understand the ethical review of the biomedical research, significant differences are also found between those with and without overseas experience (χ²=3.93, P<0.05), and different units (χ²=32.38， P<0.01). All ethics committee members have some appropriate ethical knowledge acquisition method. The influencing factors of the ethics committee members' understanding of the scientific research ethics include the age (OR=1.88, P<0.01) and the overseas experience (OR=1.80, P=0.06), and the influencing factors of their understanding of the ethical review include the age (OR=1.47, P<0.01) and the unit type (OR=0.69, P=0.03). It is concluded that the ethics committee members' ethical cognition is generally better than that of medical researchers, the medical institutions should pay more attention to the construction of the ethics committee. Special training organized by the unit, by the scientific research projects and the self-study programs are the main ways for the ethics members to obtain ethical knowledge. To properly intervene the influencing factors affecting their cognition of ethical knowledge can effectively improve the degree of cognition and comprehensively improve the quality of the ethical review.