Resource Section

资源部分

• 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
• 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

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 采用模式生物的已发表研究的重现性差，研究设计缺乏透明度 已经成为科学界关注的领域。这些问题可以深刻地影响解释 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。可重复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、基因组完整性和基因工程等位基因的特异性 由于使用相似但独立开发的模型或质量差异， 模型维护。此外，不同群体所使用的研究设计质量的差异可能会导致 对研究结论产生重大影响。高质量维修管道的集中化和标准化 可以帮助解决研究再现性和透明度的问题，例如 基因敲除小鼠表型分型项目的成功， 医学模型，以及目前BCM-水稻小动物试验中心的体细胞基因组编辑 程序.水稻基因组编辑测试中心（GETC）的资源部门将利用 方法，基础设施和我们现有的鼠标建模程序的专业知识，以（1）建立一个 管理计划，确保组织良好的部门运作，高质量的动物资源，并及时 项目进展，（2）表征和维护用于交付试剂测试的高质量小鼠资源 和基因组编辑工具，（3）保存，进口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，以最大限度地减少 在发生灾难性灾难时资源的损失和恢复时间。