伦理审查在卫生管理研究中的重要性与更新要点——基于《涉及人的生命科学和医学研究伦理审查办法》  

The importance and updated key point of ethical review in health management research:based on the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans

作　　者：王曦 邱五七[1] 田荣 李艳玲[1] 许航 李晓萌 孙红燕 WANG Xi;QIU Wuqi;TIAN Rong;LI Yanling;XU Hang;LI Xiaomeng;Sun Hongyan(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China)

机构地区：[1]中国医学科学院医学信息研究所,北京100020

出　　处：《中国医学伦理学》2024年第4期415-419,共5页Chinese Medical Ethics

基　　金：中央高校基本科研业务费项目“基于卫生管理研究的科研伦理审查需求与应对策略研究”(3332022094)。

摘　　要：《涉及人的生命科学和医学研究伦理审查办法》的发布对于卫生管理研究领域的伦理审查提出了新的要求。基于新规背景,结合卫生管理学科特性,探究了卫生管理研究的伦理审查需求和必要性。在《办法》中,针对卫生管理研究的伦理治理进行了更新,提出了免除伦理审查概念和强调研究参与者权益保护,以及个人信息保护的重要性。还针对卫生管理研究的伦理审查框架进行了探索,包括制定免除伦理审查操作规范、细化规范伦理审查工作制度与流程,以及明确信息数据的来源证明。这些探索旨在为卫生管理研究提供伦理保障,促进其健康发展,并确保研究参与者的权益得到充分尊重和保护。通过研究,希望能够进一步提高卫生管理研究的伦理水平,推动学科的发展和社会的进步。The release of the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans has brought new requirements to the field of ethical review in health management research.Based on the background of new regulations and combining the characteristics of the health management discipline,this paper explored the needs and necessity of ethical review in health management research.In the Measures,the ethical governance of health management research was updated,the concept of exemption from the ethical review was put forward,as well as the importance of protecting the rights and interests of research participants and the protection of personal information were emphasized.This paper also explored the ethical review framework for health management research,including the formulation of operational standards for exemption from ethical review,the refinement of standardized ethical review work systems and processes,and the clarification of information data source verification.These explorations aimed to provide an ethical guarantee for health management research,promote its healthy development,and ensure that the rights and interests of research participants are fully respected and protected.Through research,it is hoped that the ethical level of health management research can be further improved,promoting the development of the discipline and social progress.

关 键 词：卫生管理 伦理审查 研究参与者权益 个人信息保护 免除伦理审查 

分 类 号：R-052[医药卫生]