摘要
Abstract
The ethical review exemption system was introduced to meet the needs of modernized ethical governance,implement hierarchical management for ethical review projects involving human subjects,and explore an ethical management model that reduces procedural supervision for specific types of research involving no greater than minimal risk.Through a comparative study,this paper seeks to elaborate on the differences between China and the United States(US)in the ethical review exemption system from multiple aspects,such as ethical regulations,risk definition,preconditions,applicable scenarios,and operational procedures.The aim is to provide references for ethical review committees to better implement the ethical review exemption system,enhance policy research,and ensure the fairness and objectivity of ethical review.Through the comparative study of the ethics review exemption system in China and the US,the following recommendations are proposed for institutions implementing the ethical review exemption system for reference.First,the system should clearly define the meaning of ethical review exemption to prevent researchers or even committee members from misunderstanding it as falling outside the scope of ethical review,thereby exposing research participants'rights and interests to unnecessary risks.Second,the system should specifically explain the preconditions,including the requirements for research types and research risks.Among them,risks should be considered from multiple dimensions such as physiology,psychology,society,and economy.Clear explanations should be provided for involving commercial interests and sensitive personal information.Finally,the system should establish basic principles and judgment criteria for applicable scenarios,including specifying exactly what the public data refers to and legal requirements that need to be met,providing a concept of anonymization to distinguish it from deidentified information data,and clarifying the relevant regulations and ethical principles to be followed,as well as the clear requirements for informed consent.关键词
免除伦理审查/风险/知情同意/比较研究Key words
ethical review exemption/risk/informed consent/comparative study分类
医药卫生
