横向科研项目伦理审查要点探析——基于某三甲医院横向科研项目伦理审查管理体系  

Analysis on key points of ethics review of horizontal scientific research projects:Based on the ethics review management system of horizontal scientific research projects in a tertiary hospital

作　　者：徐灵灵 徐贝贝[1] 孙伟 肖淑萍[1] 白彩珍[1] Xu Lingling;Xu Beibei;Sun Wei;Xiao Shuping;Bai Caizhen(Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院,北京100070

出　　处：《中华医学科研管理杂志》2023年第1期24-27,共4页Chinese Journal of Medical Science Research Management

基　　金：北京医学伦理学会科研课题(BMEA2021103);院科研基金(管理专项)课题(TYGL202208)。

摘　　要：目的本文旨在通过梳理某三甲医院横向科研项目的伦理审查现状以及伦理审查过程中常见的问题,相关原因分析与相应的解决方案,以进一步促进横向科研项目伦理审查的规范化进行,提高横向科研项目伦理审查质量。方法通过介绍某三甲医院横向科研项目的伦理审查现状,分析横向科研项目与纵向科研项目伦理审查要点的不同,从而梳理出横向科研项目伦理审查过程中常见的问题与可能的原因,进而探索出相应的解决方案。结果基于横向科研项目的特点,与纵向科研项目相比,伦理审查时需重点关注其科学与社会价值、潜在的利益冲突问题、受试者权益保护以及过程管理与质量管理。目前尚存在项目数量较多,研究价值较高的项目却不是很多、项目过程管理不到位、伦理审查意见未能有效执行等问题。结论医院将进一步完善横向科研项目立项审批管理制度,多专家、多角度、全方位进行立项审批,设置伦理专员,加强横向科研项目的过程管理,强化伦理宣传教育,提高研究者的伦理意识,从而充分保护受试者权益,促进临床研究高质量发展。Objective This paper aims to promote the standardization of ethics review of horizontal scientific research projects and improve the ethics review quality by analyzing the current ethics review practice in a certain tertiary hospital,identifying common problems during the review process,illustrating relevant causes and proposing corresponding solutions.Methods Through introducing the current situation of ethics review of horizontal scientific research projects in a tertiary level hospital,the differences between the main points of ethics review of horizontal scientific research projects and government-funded scientific research projects were analyzed,so as to sort out the common problems and possible causes in the process of ethics review of horizontal scientific research projects,and then explore the possible corresponding solutions.Results Based on the characteristics of horizontal research projects,ethics review should focus on their scientific and social values,potential conflicts of interest,protection of subjects′rights and interests,and whole-process management and quality assurance.At present,there are still many problems,such as a large number of projects,but not many projects with high research value,inadequate project process management,and ineffective implementation of ethics review opinions.Conclusions The hospital should further improve the management system of horizontal scientific research project approval,bring in more comprehensive review regarding to both scientific and ethics review,engage more experts at the outset of project funding decision-making,set up ethics specialists,strengthen the process management of horizontal scientific research projects,strengthen ethical publicity and education,and improve the ethical awareness of researchers to fully protect the rights and interests of subjects and promote the high-quality development of clinical research.

关 键 词：横向科研项目 研究者发起的临床研究 伦理审查 

分 类 号：R-052[医药卫生]