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Resource Section

资源部分

基本信息

批准号：
10773479
负责人：
Denise Grant Lanza
金额：
$ 23.33万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-12-01 至 2028-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10773479
关键词：
Accreditation Address Adherence Affect Alleles Animal Experiments Animal Testing Animals Archives Area Biohazardous Substance Biological Breeding Communication Communities Cryopreservation Data Analyses Disaster Planning Disasters Disease Disease model Educational Materials Emergency Situation Ensure Environment Essential worker Event Familiarity Genetic Drift Genetic Engineering Genetic Identity Genotype Goals Guidelines Health Heart IACUC Inbred Strains Mice Infrastructure Institution Knockout Mice Leadership Maintenance Medicine Methods Modeling Monitor Mus Natural Disasters Phenotype Policies Procedures Protocols documentation Publishing Reagent Recovery Reporter Reproducibility Research Research Design Resources Rice Safety Sample Size Site Standardization Statistical Methods Techniques Technology Testing Time Training Activity United States National Institutes of Health Work animal resource cohort comparative genome editing genome integrity informatics tool institutional biosafety committee instrumentation model organism mouse model operation organizational structure precision medicine preclinical study preservation programs quality assurance repository responsible research conduct safety assessment somatic cell gene editing success tool

项目摘要

3. ABSTRACT – RESOURCES SECTION Poor reproducibility of published research employing model organisms and lack of transparency of study designs have become areas of concern for the scientific community. These issues can profoundly affect the interpretation of preclinical studies, including those assessing the safety and efficacy of somatic cell genome editing technologies and delivery approaches. At the heart of reproducibility issues are the model organism themselves. Stability and identity of the genetic background, genome integrity, and specifics of genetically engineered alleles often vary between studies due to use of similar but independently developed models or differences in the quality of model maintenance. Moreover, variabilities in the quality of study designs used by different groups can significantly impact study conclusions. Centralization and standardization of high-quality maintenance pipelines for mouse models can help to addresses issues with study reproducibility and transparency, as exemplified by the successes of the BCM component of the Knockout Mouse Phenotyping Project, BCM Center for Precision Medicine Models, and the current BCM-Rice Small Animal Testing Center of the Somatic Cell Genome Editing program. The Resource Section of the BCM/Rice Genome Editing Testing Center (GETC) will leverage the approaches, infrastructures, and expertise of our existing mouse modeling programs to (1) establish a management plan that ensures well-organized Section operations, high-quality animal resources, and timely project progression, (2) characterize and maintain high-quality mouse resources for testing of delivery reagents and genome editing tools, (3) preserve, import, and distribute Center mouse resources, (4) evaluate and maintain adherence to regulatory guidelines and biohazard safety protocols, and (5) implement a disaster plan to minimize loss and recovery time of resources in the event of a catastrophic disaster.

3. 摘要——资源部分使用模式生物的已发表研究的重复性差且研究设计缺乏透明度已成为科学界关注的领域。这些问题都会深刻影响解释临床前研究，包括评估体细胞基因组编辑的安全性和有效性的研究技术和交付方法。再现性问题的核心是模式生物本身。遗传背景的稳定性和同一性、基因组完整性以及基因工程等位基因的特性由于使用相似但独立开发的模型或质量差异，研究之间经常存在差异的模型维护。此外，不同群体使用的研究设计质量存在差异显着影响研究结论。高品质维修管道集中化、标准化小鼠模型可以帮助解决研究重现性和透明度问题，例如 BCM 精密中心敲除小鼠表型项目的 BCM 部分取得的成功医学模型，以及目前的BCM-Rice小动物体细胞基因组编辑检测中心程序。 BCM/水稻基因组编辑测试中心 (GETC) 的资源部分将利用我们现有的小鼠建模程序的方法、基础设施和专业知识，以（1）建立一个管理计划，确保部门运作井然有序、动物资源优质、及时项目进展，(2) 表征和维护用于测试递送试剂的高质量小鼠资源和基因组编辑工具，(3) 保存、导入和分发中心小鼠资源，(4) 评估和维护遵守监管指南和生物危害安全协议，以及 (5) 实施灾难计划，以尽量减少发生灾难性灾难时资源的损失和恢复时间。