医学科研项目的伦理审查实践和思考

摘要

Objective To enhance the recognition of the ethical principles and provide reference for the ethical review in medical research involving human subjects.Methods By summarizing the ethical review of the projects involving human subjects in past three years,analyzing common issues identified,and proposing the corresponding solutions.Results Conducting ethical review for research involving human subject according to ethical principles,is helpful for the protection of human subject,and also for the internationalization of medical research in China.Conclusions For the development of medical research in long term,the ethical review is necessary.All investigators need to improve their understandings and execute the ethical principles well in their research practice.%目的 提高对涉及人的医学科学研究活动中的科学性、尊重受试者及公正性等重要伦理要素的重视,为医学科研项目的伦理审查提供借鉴.方法 以医学伦理审查原则为指导,对近三年来涉及人的医学科研项目的伦理审查进行了回顾,解析研究项目中常见的不规范问题,并提出解决路径.结果 在医学伦理原则下审查涉及人的医学科学研究,有利于保护受试者和科学研究走向国际化.结论 从涉及人的医学科研长远发展来看,医学伦理审查是必经之路,需要所有研究者在实践中不断完善和进步.