多中心临床研究认可牵头机构伦理审查结论实施的专家共识

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-1087-07

DOI：10.12026/j.issn.1001-8565.2025.08.18

Expert consensus on the implementation of recognizing leading institutions’ethical review conclusions in multi-centerclinicalresearch

HebeiMedical Ethics Association，Beijing Medical Ethics Asociation，Tianjin Medical Ethics Association

Abstract： How to improve thequality and eficiency of ethical review in multi-center clinical research is a practical problem jointly faced by current clinical research-related parties such as the ethical review commitee and the sponsors.The Expert Consensus on the Implementation of Recognizing Leading Institutions’Ethical Review Conclusions in Multi-Center Clinical Research is based on relevantdocuments such as the Opinions on Deepening the Reform ofthe Review and Approual System to Encourage the Innovation of Drugs and Medical Devices，the Measures for the Ethical Review ofLife Sciences and Medical Research Involuing Humans，and the Guidelines for the Construction of Ethical Reuview Commitees for Clinical Research Inooluing Humans （2023 version）.It advocates the recognition of the ethical review conclusions of the leading institutions.The ethical reviewcommittee of the leading institutions conducts an ethical reviewof the clinical research project in the form of a meeting review.The ethical review commitees of participating institutions can use a simplified procedure to confirm the review conclusions and to review the feasibilityof the research within their institutions. In this process，it is necessrytoclarify the responsibilities of all parties，standardize the ethicalreview process， and optimize related procedures.Based on effectively safeguarding the legitimate rights and interests of research participants，it is essential to avoid duplicate reviews，enhance the eficiency of ethical review，and promote the healthy development of life sciences and medical research.

Keywords： multi-center clinical research； ethical review；expert consensus；leading institution; participating institution

0 引言

近年来，多中心临床研究呈现出快速发展的趋势，但面临着伦理审查的诸多挑战。（剩余9926字）