Requirements and countermeasures for continuing review in the Ethical Review Measures for Life Science and Medicine Research involving Humans
10.3760/cma.j.cn113565-20230615-00007
- VernacularTitle:《涉及人的生命科学和医学研究伦理审查办法》对跟踪审查的要求及对策
- Author:
Pei ZHANG
1
;
Wenxi WANG
;
Xiaohui QIU
;
Jun CHEN
;
Jiyin ZHOU
Author Information
1. 宁波市医疗中心李惠利医院伦理委员会办公室，宁波 315000
- Keywords:
Life Science and Medicine Research involving Human;
Ethics Committee;
Continuing Review;
Requirement;
Strategy
- From:
Chinese Journal of Medical Science Research Management
2024;37(3):192-197
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This paper analyzed the current situation of clinical research continuing review in China, and puts forward countermeasures to strengthen continuing review in combination with the requirements of the Measures for the Ethical Review of Life Science and Medical Research Involving Humans, so as to provide a certain reference for standardizing the ethical continuing review of research institutions.Methods:Through literature research, this paper systematically sorted out the current situation of continuing review, and analyzed many problems and related reasons in the process of continuing review of clinical research in China based on the practical experience of ethical review.Results:The requirements for continuing review in the Measures for Ethical Review of Life Science and Medical Research Involving Humans included demphasizing the implementation of continuing review, the entrusted ethics committee should be responsible for continuing review, clarifying the responsibility for continuing review of cooperative research, clarifying the responsibility of participating research institutions for continuing review, and increasing the responsibility of the ethics committee to supervise the submission of continuing review. Countermeasures to strengthen continuing review included the health authorities urging research institutions to strengthen continuing review, research institutions to increase efforts to implement continuing review, establishing a standardized continuing review process, strengthening the ethics training of researchers and other relevant personnel, establishing a multi-channel communication and consultation method between the ethics committee and researchers, strengthening the review capacity of ethics committee members, allocating a corresponding number of ethics committee staff, and using information technology to improve quality and efficiency.Conclusions:Continuing review is indispensable in the whole process of research development, and all parties should take measures to ensure the quality and efficiency of continuing review, standardize continuing review, and promote the healthy development of life science and medical research.
