基层医疗机构“横向合作课题”伦理备案审查体会与问题  

Experience and Problems of Ethical Record Review of Horizontal Cooperation Project in Primary Medical Institutions

作　　者：张东海[1] 邵悦 刚君[1] 王英 赵留庄[1] ZHANG Donghai;SHAO Yue;GANG Jun;WANG Ying;ZHAO Liuzhuang(Ethics Committee,Daxing Hospital,Capital Medical University,Beijing 102600,China)

机构地区：[1]首都医科大学大兴医院伦理委员会,北京102600

出　　处：《中国医学伦理学》2021年第5期555-559,565,共6页Chinese Medical Ethics

基　　金：2019首都医科大学大兴教学医院科技项目(4201853256)。

摘　　要：“横向合作课题”是具备一定条件的基层医疗机构经常遇到的问题。医院对此类课题原则上仅进行“形式性审查”(需资料完整),而不再进行“实质性审查”(即不再进行科学性审查与伦理学审查);对伦理审查处理方式基本原则为备案制;但可以不批准备案申请,风险较高项目必要时提交会议审查。医院的合作项目主持者为伦理审查备案申请人,并要求达到研究资质;组长单位承担伦理责任,并提供组长单位伦理委员会审查的所有文件,同时需要提供利益保护声明。伦理备案基本要求管好自身(本院)、坚持原则(伦理委员会批准研究项目的7条基本标准)、坚守底线、专人负责、跟踪审查。伦理备案要求提交的各种文件内容需要相符(签字方、文件目录与内容)、已经按照标准严格进行了风险评估(受试者的风险、试验风险等级)、知识产权归属合理,要注意基金项目是否合规。Horizontal cooperation project is a common problem encountered by primary medical institutions with certain conditions. In principle, hospitals only carry out “formal review” (complete data is required), but no “substantive review” (i.e. no scientific review and ethical review), and the basic principle of handling the ethical review is filing system, but the application for record-keeping may not be approved, and the high risk projects can be submitted to the meeting for review as necessary. The host of cooperative project of the hospitals must be the applicant for ethics review and filing, and it is required to stick to the research qualification. The group leader unit undertakes the ethical responsibilities and provides all documents reviewed by the ethical committee, as well as a statement of interest protection. The basic requirements of ethic filing are to manage themselves (their hospital), adhere to the principles (the 7 basic standards of research projects approved by ethics committee), stick to the lowest requirements, assign special personnel to take charge and follow up the review. Ethical filing requires that the contents of various documents (signer, document directory and contents) submitted should be consistent, the risk assessment (subject's risk and test risk level) has been carried out in strict accordance with the standards, the ownership of intellectual property rights is reasonable, and attention shall be paid to whether the fund project is in compliance.

关 键 词：基层医疗机构 横向合作课题 伦理备案 伦理审查 

分 类 号：R-052[医药卫生]