医学科学数据共享与使用的伦理要求和管理规范(十二)通用伦理准则要点建议及其注释

Ethical Requirements and Management Standards for the Sharing and Re-use of Scientific Data in Healthcare and Medicine(Ⅻ)Suggestions and Their Explanations for Important Issues of General Ethical Guideline

作为医学伦理学热点讨论的新主题,医学科学数据的共享应用已逐渐成为医学伦理管理体系的重要内容。虽然与涉及人的健康相关研究遵循相同的伦理基本原则,医学科学数据共享应用实践中这些原则的适用和侧重有所不同,亟须建立专门指导该实践的通用伦理准则。针对实践中需要阐明的重要问题,提出通用伦理准则的一些建议,为行业或国家相关标准提供思路和基础。建议是基于伦理基本原则,综合考虑数据共享应用的趋势和实践需求,特别参考由国际医学科学组织理事会与世界卫生组织在2016年合作修订的《涉及人的健康相关研究国际伦理准则》框架。

As a new topic of discussion for medical ethics,the sharing and application of scientific data in healthcare and medicine has gradually become an important content of ethical management system.Although following the same ethical basic principles to those of human health-related research,there have some special requirements for the principles when application during the sharing and re-use practice of scientific data in healthcare and medicine.Thus,it is urgent to establish a general ethical guideline specially to guide the practice.Here in this paper,the author preliminarily puts forward some suggestions of such potential general ethical guidelines on the important issues that need to be clarified during the practice of data sharing and application in healthcare and medicine,so as to provide some ideas and basis for further draft of relevant industry or national guidelines.The suggestions provided was based on the basic ethical principles,especially under the framework of the International Ethics Guidelines for Health-related Research revised in 2016 by the council for international organizations of medical sciences(CIOMS)and world health organization(WHO).