全过程动物实验伦理审查软件的设计与实现

doi:10.12300/j.issn.1674-5817.2024.086

摘要/Abstract

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。

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

Abstract:

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 urgency with the stringent nature of review processes, and the traceability blind spots in post-approval supervision. Future research will continue to enhance the accuracy and strength of animal welfare ethical reviews and supervision through new technologies and methods.

Key words: Animal ethics and welfare, Ethical review, Informatization, Software design, Full-process monitoring

中图分类号:

TP311

徐骁,吴杰敏,梁翼,等. 全过程动物实验伦理审查软件的设计与实现[J]. 实验动物与比较医学, 2024, 44(6): 682-690. DOI: 10.12300/j.issn.1674-5817.2024.086.

XU Xiao,WU Jiemin,LIANG Yi,et al. Design and Implementation of a Software System for Full-Process Animal Experiment Ethical Review[J]. Laboratory Animal and Comparative Medicine, 2024, 44(6): 682-690. DOI: 10.12300/j.issn.1674-5817.2024.086.

图/表 4

图1 软件整体架构图

Figure 1 Diagram of the overall software architecture

图2 软件业务流程图注：A，课题备案申请流程图；B，动物实验申请流程图。

Figure 2 Flowchart of the software application processNote： A， Flowchart of project registration process； B， Flowchart of animal experiment application process.

图3 软件主要功能界面注：A，项目备案功能界面；B～C，动物实验审查功能界面；D，终结审查功能界面。

Figure 3 Main function interface of the softwareNote： A， Project registration function interface； B-C， Animal experiment review function interface； D， Termination review interface.

图4 2024年1—7月动物实验伦理审查整体情况

Figure 4 Overall status of animal experiment ethical review from January to July 2024

参考文献 22

1	刘晓宇, 贺争鸣. 通过制度建设推进我国实验动物福利伦理审查工作[J]. 实验动物科学, 2021, 38(5):1-3, 36. DOI: 10.3969/j.issn.1006-6179.2021.05.001 .
	LIU X Y, HE Z M. Promotion of the ethical review of laboratory animal welfare through institutional construction[J]. Lab Anim Sci, 2021, 38(5):1-3, 36. DOI: 10.3969/j.issn.1006-6179.2021.05.001 .
2	DAWKINS D S. The science of animal welfare: Understanding what animals want[M]. Oxford University Press, 2021. DOI: 10.1093/oso/9780198848981.001.0001 .
3	OLSSON I A S, NIELSEN B L, CAMERLINK I, et al. An international perspective on ethics approval in animal behaviour and welfare research[J]. Appl Anim Behav Sci, 2022, 253:105658. DOI: 10.1016/j.applanim.2022.105658 .
4	WEBB C E, WOODFORD P, HUCHARD E. Animal ethics and behavioral science: an overdue discussion[J]. BioScience, 2019, 69(10):778-788. DOI: 10.1093/biosci/biz082 .
5	KIANI A K, PHEBY D, HENEHAN G, et al. Ethical considerations regarding animal experimentation[J]. J Prev Med Hyg, 2022, 63(2 ): E255-E266. DOI: 10.15167/2421-4248/jpmh2022.63.2S3.2768 .
6	RUST K, CLEGG I, FERNANDEZ E J. The voice of choice: a scoping review of choice-based animal welfare studies[J]. Appl Anim Behav Sci, 2024, 275:106270. DOI: 10.1016/j.applanim.2024.106270 .
7	BRØNSTAD A, NEWCOMER C E, DECELLE T, et al. Current concepts of harm-benefit analysis of animal experiments - report from the AALAS-FELASA working group on harm-benefit analysis - part 1[J]. Lab Anim, 2016, 50(1 ):1-20. DOI: 10.1177/0023677216642398 .
8	KEUBLER L M, HOPPE N, POTSCHKA H, et al. Where are we heading? Challenges in evidence-based severity assessment[J]. Lab Anim, 2020, 54(1):50-62. DOI: 10.1177/0023677219877216 .
9	刘丽艳, 张宏馨, 边佳悦, 等. 实验动物福利伦理审查发现问题之思考[J]. 中国比较医学杂志, 2023, 33(9):63-68. DOI: 10.3969/j.issn.1671-7856.2023.09.008 .
	LIU L Y, ZHANG H X, BIAN J Y, et al. Reflection of the problems found in the ethical review of experimental animal welfare[J]. Chin J Comp Med, 2023, 33(9):63-68. DOI: 10.3969/j.issn.1671-7856.2023.09.008 .
10	鹿双双, 师晓萌, 刘晓宇, 等. 实验动物福利伦理审查与监管实践及探索[J]. 实验动物与比较医学, 2020, 40(4):339-343. DOI: 10.3969/j.issn.1674-5817.2020.04.011 .
	LU S S, SHI X M, LIU X Y, et al. Practice and exploration on laboratory animal welfare and ethical reviewing and monitoring[J]. Lab Anim Comp Med, 2020, 40(4):339-343. DOI: 10.3969/j.issn.1674-5817.2020.04.011 .
11	刘文华, 张琴, 孙玉花. 医学期刊伦理审查的问题调研与对策探讨[J]. 编辑学报, 2023, 35(4):412-415. DOI: 10.16811/j.cnki.1001-4314.2023.04.012 .
	LIU W H, ZHANG Q, SUN Y H. Problem investigation and countermeasure discussion of ethical review in medical journals[J]. Acta Ed, 2023, 35(4):412-415. DOI: 10.16811/j.cnki.1001-4314.2023.04.012 .
12	刘凤华, 陈立敏, 李启明. 我国生物医学期刊稿件中动物伦理和福利问题的调查与分析[J]. 中国科技期刊研究, 2017, 28(12):1128-1133. DOI: 10.11946/cjstp.201705080353 .
	LIU F H, CHEN L M, LI Q M. A survey of animal ethics and welfare in Chinese biomedical journals[J]. Chin J Sci Tech Period, 2017, 28(12):1128-1133. DOI: 10.11946/cjstp.201705080353 .
13	杜盼盼, 徐嘉. 科技伦理治理中的全过程审查机制构建[J]. 云南大学学报(社会科学版), 2024, 23(1):47-55. DOI: 10.3969/j.issn.1671-7511.2024.01.006 .
	DU P P, XU J. Construction of a whole-process review mechanism in the governance of sci-tech ethics[J]. J Yunnan Univ Soc Sci Ed, 2024, 23(1):47-55. DOI: 10.3969/j.issn.1671-7511.2024.01.006 .
14	Harvard University. E-IACUC[CP/OL]. [2024-11-06]. https:// iacuc.hms.harvard.edu/e-iacuc.
15	Northwestern University. eIACUC [CP/OL]. [2024-11-06]. https: //iacuc.northwestern.edu/.
16	Yale University. MAPS [CP/OL]. [2024-11-06]. https://ires-iacuc. yale.edu/IACUC-Prod.
17	Scionics Computer Innovation GmbH. PyRAT animal facility software[CP/OL]. [2024-11-06].https://www.scionics.com/pyrat.html.
18	TICK^@LAB.TICK^@LAB software for laboratory animal research facilities [CP/OL]. [2024-11-06]. http://www.a-tune.com/products-services-software/ticklab-mouse-colony-management-software/.
19	CARVAJAL C, VALLEJOS C, LEMAITRE D, et al. A REDCap application that links researchers, animal facility staff and members of the IACUC in animal health monitoring[J]. Lab Anim, 2019, 53(5):500-507. DOI: 10.1177/0023677218815723 .
20	徐孝平, 张利棕, 潘永明, 等. 基于浏览器/服务器模式架构的高校动物实验管理系统开发与应用[J]. 实验动物与比较医学, 2019, 39(3):239-243. DOI: 10.3969/j.issn.1674-5817.2019.03.012 .
	XU X P, ZHANG L Z, PAN Y M, et al. Development and application of college animal experiment management system based on browser/server mode architecture[J]. Lab Anim Comp Med, 2019, 39(3):239-243. DOI: 10.3969/j.issn.1674-5817.2019.03.012 .
21	李巍, 陈晓娟, 柯贤福, 等. 高等院校实验动物的信息化管理体系建设及初步运行[J]. 实验动物与比较医学, 2020, 40(2):154-158. DOI: 10.3969/j.issn.1674-5817.2020.02.012 .
	LI W, CHEN X J, KE X F, et al. Summary of the information management system of laboratory animal in colleges and universities[J]. Lab Anim Comp Med, 2020, 40(2):154-158. DOI: 10.3969/j.issn.1674-5817.2020.02.012 .
22	翟亚南, 卢静. 高等医学院校实验动物福利伦理审查工作的实践与探索[J]. 医学教育管理, 2023, 9(S1):119-122. DOI: 10.3969/j.issn.2096-045X.2023.S1.028 .
	ZHAI Y N, LU J. Practice and exploration of ethical review of experimental animal welfare in medical colleges and universities[J]. Med Educ Manag, 2023, 9(S1):119-122. DOI: 10.3969/j.issn.2096-045X.2023.S1.028 .

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