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开展体内研究:存在哪些问题?

Contracting in vivo research: what are the issues?

作者信息

Underwood Wendy J

机构信息

Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

J Am Assoc Lab Anim Sci. 2007 Jul;46(4):16-9.

Abstract

As a result of increasing internal and external pressures, research institutions are using contract research organizations for the conduct of in vivo research. Many issues arise when contracting animal research, including concern regarding animal health and welfare. Each sponsor institution should develop a program for outsourced in vivo research that evaluates and ensures appropriate care and use of research animals. Each sponsoring institution should consider establishing a policy and procedure for how outsourced in vivo studies will be approved, conducted, and monitored. An approved list of contract facilities can be established on the basis of accepted standards for animal care and use. Written contracts should include confidentiality agreements, the delineation of animal ownership, and the expectation to comply with all applicable regulations and guidelines for research animal care and use. Finally, a process for communication of adverse study or animal welfare events should be established. Thorough evaluation of contract organizations will help ensure appropriate research animal care and use.

摘要

由于内部和外部压力不断增加,研究机构正在利用合同研究组织开展体内研究。在签订动物研究合同时会出现许多问题,包括对动物健康和福利的关注。每个赞助机构都应制定一个外包体内研究的计划,以评估并确保对研究动物进行适当的照料和使用。每个赞助机构都应考虑制定一项政策和程序,规定外包体内研究将如何获得批准、开展和监督。可以根据公认的动物照料和使用标准建立一份合同设施的批准名单。书面合同应包括保密协议、动物所有权的界定,以及遵守所有适用的研究动物照料和使用法规及指南的期望。最后,应建立一个报告不良研究或动物福利事件的流程。对合同组织进行全面评估将有助于确保对研究动物进行适当的照料和使用。

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