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 - 资源部分使用模型生物和缺乏研究设计的透明度的已发表研究的可重复性差已经成为科学界关注的领域。这些问题可以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效率的研究技术和交付方法。可重复性问题的核心是模型生物本身。遗传背景，基因组完整性和基因工程等位基因的细节的稳定性和身份由于使用相似但独立开发的模型或质量差异，因此在研究之间通常会有所不同模型维护。此外，不同群体使用的研究设计质量的变异性可以显着影响研究结论。高质量维护管道的集中和标准化对于鼠标模型可以帮助解决研究可重复性和透明度的问题，例如敲除鼠标表型项目BCM精确中心的BCM成分的成功医学模型和体细胞基因组编辑的当前BCM-RICE小动物测试中心程序。 BCM/稻米基因组编辑测试中心（GETC）的资源部分将利用我们现有的鼠标建模程序的方法，基础架构和专业知识（1）建立一个确保组织良好的部分操作，高质量的动物资源和及时的管理计划项目进度，（2）表征和维持高质量的鼠标资源以测试输送试剂和基因组编辑工具，（3）保存，进口和分发中心鼠标资源，（4）评估和维护遵守监管指南和生物危害安全协议，（5）实施灾难计划以最小化发生灾难性灾难时，资源的损失和恢复时间。