医疗卫生机构与高校或科研院所合作项目的伦理审查和互认探讨

Discussion on Ethis Review and Mutual Recognition of Cooperative Projects between Medical and Health Institutions,Universities and Research Institutes

越来越多的生命科学研究项目和医学研究项目需要多个学科和领域的参与,可能涉及受试者的招募、干预、样本和数据的采集、转移、处理、分析等多个环节,不同的环节由不同的合作单位负责,常见的是医院与高校或科研院所的合作项目。不同单位承担的研究任务中或多或少都包含有“涉及人”的研究,如何在确保受试者权益的基础上提高伦理审查效率,一直是困扰研究者和机构伦理委员会的一个问题。从法律法规对机构伦理委员会职能的界定以及受试者保护两方面分析了医疗卫生机构与高校、科研院所合作项目开展伦理审查的模式,并提出了存在的问题及可能的解决方式,以期为该类项目的伦理审查提供参考。

An increasing number of life sciences and medical research require cooperation of multiple disciplines and fields,which may involve the recruitment of subjects,intervention,sample and data collection,transfer,processing,analysis and other links.Different links are handled by different cooperative units,most commonly by hospitals and universities or research institutes.The research tasks undertaken by different units all include varying degree“involving human”research.How to improve ethical review efficiency on the basis of ensuring the right and interest of subjects,which has always been a problem that perplexed researchers and institutional ethics committees.This paper analyzed the ethical review mode of medical and health institutions,universities and research institutes from two aspects,which including the functions of institutional review board and subject protection,and put forward the existing problems and possible solutions to provide reference for the ethical review of relevant projects.