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
10.3760/cma.j.cn113565-20220505-00075
- VernacularTitle:横向科研项目伦理审查要点探析
- Author:
Lingling XU
1
;
Beibei XU
;
Wei SUN
;
Shuping XIAO
;
Caizhen BAI
Author Information
1. 首都医科大学附属北京天坛医院，北京 100070
- Keywords:
Horizontal scientific research project;
Investigator-initiated trial;
Ethics review
- From:
Chinese Journal of Medical Science Research Management
2023;36(1):24-27
- CountryChina
- Language:Chinese
-
Abstract:
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.
