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机构动物护理和使用委员会事后批准监测计划:拟议的综合分类方案。

Institutional Animal Care and Use Committee Postapproval Monitoring Programs: A Proposed Comprehensive Classification Scheme.

机构信息

University of Texas Southwestern Medical Center, Dallas, Texas;, Email:

Mississippi State University, Starkville, Mississippi.

出版信息

J Am Assoc Lab Anim Sci. 2020 Mar 1;59(2):127-131. doi: 10.30802/AALAS-JAALAS-19-000096. Epub 2020 Feb 14.

DOI:10.30802/AALAS-JAALAS-19-000096
PMID:32059755
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7073392/
Abstract

Introduced over 20 y ago, IACUCs undertaking postapproval monitoring (PAM) of animal research procedures as a means to ensure researcher compliance is now widely used as an oversight tool in laboratory animal research. Through a literature review evaluating the history of PAM in the United States, discussions of controversy surrounding PAM activities, and reflections on how PAM activities are described within the IACUC community, we present an up-to-date and comprehensive classification system for PAM program methodologies that could serve to standardize how such activities are characterized in IACUC policies, communicated to research staff, used in training programs, implemented for the desired impact by individuals involved in animal research oversight, and referenced by regulatory agencies.

摘要

引入 20 多年前,IACUC 委员会承担动物研究程序的批准后监测(PAM),作为确保研究人员合规的一种手段,现在已广泛用作实验室动物研究的监督工具。通过对美国 PAM 历史的文献回顾,对 PAM 活动争议的讨论,以及对 IACUC 社区内如何描述 PAM 活动的反思,我们提出了一个最新和全面的 PAM 计划方法分类系统,该系统可以用来标准化 IACUC 政策中此类活动的特征,传达给研究人员,用于培训计划,由参与动物研究监督的个人实施以产生预期影响,并由监管机构参考。

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本文引用的文献

1
Postapproval Monitoring Practices at Biomedical Research Facilities.生物医学研究机构的批准后监测实践
J Am Assoc Lab Anim Sci. 2019 Jul 1;58(4):469-474. doi: 10.30802/AALAS-JAALAS-18-000132. Epub 2019 May 15.
2
Assessing the satisfaction and burden within an academic animal care and use program.评估学术动物护理与使用计划中的满意度和负担。
FASEB J. 2017 Sep;31(9):3913-3921. doi: 10.1096/fj.201700072RR. Epub 2017 May 17.
3
The Interplay of Ethics, Animal Welfare, and IACUC Oversight on the Reproducibility of Animal Studies.伦理、动物福利与机构动物护理和使用委员会监督对动物研究可重复性的相互作用
Comp Med. 2017 Mar 1;67(2):101-105.
4
The role of the IACUC in ensuring research reproducibility.IACUC 在确保研究可重复性方面的作用。
Lab Anim (NY). 2017 Mar 22;46(4):129-135. doi: 10.1038/laban.1213.
5
A retrospective review of postapproval monitoring at a large academic institution.对一家大型学术机构批准后监测情况的回顾性研究。
Lab Anim (NY). 2015 Oct;44(10):395-401. doi: 10.1038/laban.856.
6
Avoiding an overzealous approach: a perspective on regulatory burden.避免过度激进的做法:关于监管负担的一种观点。
ILAR J. 2008;49(4):426-34. doi: 10.1093/ilar.49.4.426.
7
Program oversight enhancements (POE): the big PAM.项目监督强化措施(POE):大型绩效评估与管理(PAM)
ILAR J. 2008;49(4):419-25. doi: 10.1093/ilar.49.4.419.
8
A sample postapproval monitoring program in academia.学术界一个样本性的批准后监测项目。
ILAR J. 2008;49(4):402-18. doi: 10.1093/ilar.49.4.402.
9
Postapproval monitoring and the role of the compliance office.批准后监测与合规办公室的作用。
ILAR J. 2008;49(4):393-401. doi: 10.1093/ilar.49.4.393.
10
Postapproval monitoring and the IACUC.批准后监测与机构动物护理和使用委员会
ILAR J. 2008;49(4):388-92. doi: 10.1093/ilar.49.4.388.