公民逝世后器官捐献伦理审查的规范化管理探索

Exploration on standardized management of ethical review of organ donation after citizen’s death

目的探讨医院公民逝世后器官捐献伦理委员会的规范化管理模式。方法回顾性分析重庆医科大学附属第一医院人体器官捐献伦理委员会规范化调整前后伦理审查情况,比较人体器官捐献伦理委员会规范化调整前后捐献者的基本资料,分析伦理委员会规范化调整对委员到会率、伦理审查时长的影响。结果伦理委员会结构规范化调整前后性别、年龄、死亡判定等捐献者伦理审查资料的差异均无统计学意义(均为P>0.05);伦理审查死亡原因的差异有统计学意义(P<0.05)。单因素分析结果显示,伦理委员会规范化调整、死亡原因对委员到会率的影响均有统计学意义(均为P<0.05)。多因素分析结果显示,性别、死亡原因、伦理委员会规范化调整是委员到会率的影响因素,规范化调整后委员到会率较调整前提高(P<0.05)。单因素分析结果显示,伦理委员会规范化调整、委员到会率、死亡原因对伦理审查时长的影响均有统计学意义(均为P<0.05);多因素分析结果显示,伦理委员会规范化调整是伦理审查时长的影响因素,规范化调整后伦理审查时长较调整前缩短(P<0.05)。结论合理设置伦理委员会总人数、标准化审核流程,可以提高伦理审核时效,应建立委员考评机制动态调整委员、明确委员和秘书的职责和分工,以进一步提高公民逝世后器官捐献伦理审查规范化管理水平。

Objective To explore the standardized management mode of the Ethics Committee for organ donation after citizen’s death in hospitals.Methods The situations of ethical review before and after the standardized adjustment of the Ethics Committee of human organ donation in the First Affiliated Hospital of Chongqing Medical University were retrospectively analyzed.Baseline data of donors before and after standardized adjustment of the Ethics Committee of human organ donation were compared.The influence of standardized adjustment of the Ethics Committee on the attendance rate of committee members and duration of ethical review were analyzed.Results No significant differences were observed in donors'ethical review data,such as gender,age and death determination,before and after standardized adjustment of Ethics Committee structure(all P>0.05).Significant difference was noted regarding the cause of death in ethical review(P<0.05).Univariate analysis showed that there were significant differences in the impact of Ethics Committee standardization adjustment and cause of death on the attendance rate of committee members(both P<0.05).Multivariate analysis revealed that gender,cause of death and standardized adjustment of the Ethics Committee were the influencing factors of the attendance rate of committee members,and the attendance rate of committee members after standardized adjustment was higher than that before adjustment(P<0.05).Univariate analysis showed that there were statistically significant differences in the effects of Ethics Committee standardized adjustment,attendance rate of committee members and cause of death on the duration of ethical review(all P<0.05).Multivariate analysis indicated that standardized adjustment of the ethics committee was the influencing factor of the duration of ethical review,and the duration of ethics review after standardized adjustment was shorter than that before adjustment(P<0.05).Conclusions Appropriate arrangement of the total number of ethics committee members and standardizing the review process may improve the efficiency of ethical review.Scientific evaluation mechanism for ethical committee members should be established by dynamically adjusting the ethical committee members,clarifying the responsibilities and tasks of members and secretaries,aiming to further improve standardized management level of ethical review for organ donation after citizen’s death.