全过程动物实验伦理审查软件的设计与实现  

Design and Implementation of a Software System for Full-Process Animal Experiment Ethical Review

作　　者：徐骁 吴杰敏 梁翼 叶明霞[1] 周顺长[1] XU Xiao;WU Jiemin;LIANG Yi;YE Mingxia;ZHOU Shunchang(Laboratory Animal Center,Huazhong University of Science and Technology,Wuhan 430030,China;Xiamen Baoyi Intelligent Technology Co.,Ltd.,Xiamen 361000,China)

机构地区：[1]华中科技大学实验动物中心,武汉430030 [2]厦门抱壹智能科技有限公司,厦门361000

出　　处：《实验动物与比较医学》2024年第6期682-690,共9页Laboratory Animal and Comparative Medicine

摘　　要：探讨并优化高等院校实验动物机构在承担动物实验项目数量多,实验类型复杂的情况下,如何通过信息化手段提高动物伦理审查效率并确保监督质量。基于华中科技大学实验动物中心伦理审查的工作现状,本文设计并开发了一套全过程伦理审查软件系统,结合信息化手段以改进高等院校动物福利伦理的审查与监督机制。该系统运用“事前审批、事中监管、事后回顾”的全过程监管理念,聚焦强化实验动物研究及使用计划审核与批准后监督环节。事前审批阶段,系统优化了实验动物研究及使用计划审核中的指定成员审核流程,确保所有动物实验项目都符合伦理标准和法律法规要求;事中监管阶段,由执行兽医进行兽医验证和咨询,采取“线下巡查、线上记录”的方式开展监督;事后回顾阶段,要求研究者提供回顾性资料,对实验过程进行回顾性评估。本文详细描述了本系统设计时考虑的功能需求、非功能需求及安全需求,以及软件整体架构、业务流程设计、业务细节设计,并展示了本系统上线以来的运行成效。同时,对该系统的适用性和实用性进行了讨论,分析了存在的不足和面临的挑战,如实验紧迫性与审查严谨性的难以平衡,批准后监管存在的溯源盲区等。后续研究将结合新技术、新方法,继续提升动物福利伦理审查与监督的准确性和力度。Institutions of higher education undertake a significant number of animal experiment projects with diverse types.To standardize animal experiments and ensure animal welfare,ethical review has become a core task for the Institutional Animal Care and Use Committee(IACUC)in these higher education institutions.A key issue worth exploring is how to improve the efficiency of animal ethical reviews while maintaining systematic quality of supervision.Based on the current status of ethical reviews at the Laboratory Animal Center of Huazhong University of Science and Technology,this paper designs and implements a full-process ethical review software system.This system seeks to offer solutions for the ethical review and supervision of animal welfare in institutions of higher education through information technology.The system employs a full-process supervision philosophy of"pre-approval,in-process supervision,post-review,"focusing on strengthening the review and approval of animal research protocols,as well as post-approval monitoring.At the pre-approval stage,the system optimizes the process for designated members involved in the project review,ensuring that all projects comply with ethical standards and legal regulations.At the in-process stage,veterinary verification and consultation are carried out by executive veterinarians,using a method of"offline inspections and online records"for supervision.At the post-review stage,researchers are required to provide retrospective data to evaluate the experimental process.Additionally,this paper provides an in-depth exploration of the software,detailing its functional and non-functional requirements,as well as its security considerations.It also delves into the comprehensive software architecture,process design,and operational details.Furthermore,it illustrates the system's operational efficacy and impact since its launch.This paper discusses the software's applicability and practicality,analyzing existing limitations and challenges,such as the difficulty of balancing experiment u

关 键 词：动物伦理福利 伦理审查 信息化 软件设计 全过程监管 

分 类 号：TP311[自动化与计算机技术—计算机软件与理论] R-052[自动化与计算机技术—计算机科学与技术]