Administration and Sample Acquisition

管理和样品采集

• 批准号: 10549500
• 负责人: Todd Michael Brusko
• 金额: $ 24.79万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10549500
• 关键词: Address; Administrator; Age; Ambulatory Care Facilities; Autoimmune; Autoimmunity; Belief; Beta Cell; Biological; Biological Markers; Biology; Blood; Blood specimen; COVID-19 pandemic; Clinical; Collaborations; Collection; Communication; Communication Programs; Communities; Consent; Data; Data Protection; Data Set; Databases; Diabetes Mellitus; Direct Costs; Disease; Education; Elements; Equilibrium; Evaluation; FAIR principles; Feedback; Florida; Generations; Genetic; Genotype; Goals; Grant; Group Meetings; Human; Human Resources; Immune; Immunity; Individual; Infrastructure; Insulin-Dependent Diabetes Mellitus; Interruption; Laboratories; Leadership; Light; Metabolic; Metadata; Methods; Mission; Modification; National Institute of Allergy and Infectious Disease; Pancreas; Participant; Pathogenicity; Pathology; Patient Recruitments; Patients; Phenotype; Population Heterogeneity; Principal Investigator; Process; Program Reviews; Progress Reports; Publications; Recording of previous events; Research; Research Institute; Research Personnel; Resource Allocation; Role; Safety; Sampling; Schedule; Secure; Series; Site Visit; Study Subject; Tissues; Trust; United States National Institutes of Health; Universities; Virginia; Visit; Work; Workplace; data management; data reuse; design; disorder risk; disparity reduction; experience; human subject; immune function; improved; meetings; operation; peripheral blood; polygenic risk score; prevent; programs; public database; recruit; sample collection; sex; social media; success; symposium; synergism; trafficking; training project; web site; webinar; working group; Address; Administrator; Age; Ambulatory Care Facilities; Autoimmune; Autoimmunity; Belief; Beta Cell; Biological; Biological Markers; Biology; Blood; Blood specimen; COVID-19 pandemic; Clinical; Collaborations; Collection; Communication; Communication Programs; Communities; Consent; Data; Data Protection; Data Set; Databases; Diabetes Mellitus; Direct Costs; Disease; Education; Elements; Equilibrium; Evaluation; FAIR principles; Feedback; Florida; Generations; Genetic; Genotype; Goals; Grant; Group Meetings; Human; Human Resources; Immune; Immunity; Individual; Infrastructure; Insulin-Dependent Diabetes Mellitus; Interruption; Laboratories; Leadership; Light; Metabolic; Metadata; Methods; Mission; Modification; National Institute of Allergy and Infectious Disease; Pancreas; Participant; Pathogenicity; Pathology; Patient Recruitments; Patients; Phenotype; Population Heterogeneity; Principal Investigator; Process; Program Reviews; Progress Reports; Publications; Recording of previous events; Research; Research Institute; Research Personnel; Resource Allocation; Role; Safety; Sampling; Schedule; Secure; Series; Site Visit; Study Subject; Tissues; Trust; United States National Institutes of Health; Universities; Virginia; Visit; Work; Workplace; data management; data reuse; design; disorder risk; disparity reduction; experience; human subject; immune function; improved; meetings; operation; peripheral blood; polygenic risk score; prevent; programs; public database; recruit; sample collection; sex; social media; success; symposium; synergism; trafficking; training project; web site; webinar; working group

Based on our near 25 years of experience with this P01, we believe the notion of “success” for the program is dependent on the existence of an effective Administrative Core as a central element of fiscal/regulatory coordination, human subject recruitment, and scientific guidance/external evaluation. With this belief, the five goals of Core A are as follows: 1) Manage the budgetary and fiscal aspects of this program. The proposed program involves direct cost disbursements to investigators of Projects 1, 2 & 3 as well as Cores A & B; hence, careful oversight represents an absolute administrative requirement. 2) Coordinate ongoing feedback with regard to the goals and activities of the P01, and facilitate communication among investigators within the program. This aim takes a pragmatic form through implementation of a variety of functions ranging from organizing regularly scheduled meetings to training of Project investigators by the program's Cores. Core A also provides mechanisms for program optimization through meetings of the Internal Program Executive Committee as well as through input provided by the External Advisory Board —for the purposes of maximizing progress and synergy within the program. 3) Organize the collection of human materials through consenting of participants and blood sample collection, assuring compliance with appropriate regulatory bodies and edicts. Our P01 places substantial emphasis on diversity in both the research team and the subjects we study. Our partnerships with units external to UF enable discretion in recruitment of participants with balance for age, sex and diversity in terms of genetic ancestry composition. Through collection of these metadata, data generated by the three Projects and Core B will be robust, generalizable and reflective of population heterogeneity, contributing toward mitigation of disparities. 4) Provide database support for storage of regulatory documents as well as data/metadata in order to facilitate investigator access to appropriate sample sets. We propose upgrades to our existing “Diabase” in order to improve the investigator interface for sample selection (e.g., based on subject genotype at specific loci, polygenic risk score, age, disease status, sex) as well as FAIR Principles-compliant data management and stewardship. 5) Compile appropriate datasets and facilitate communication of program results. Core A will communicate with NIH staff, provide assistance with publications, and presentation of program results.The Internal Program Executive Committee has reviewed changing priorities and advances in the field of type 1 diabetes (T1D) and with this renewal application, organized itself to address the growing needs for: a) identifying processes at the intersection of pancreas biology and anti-β-cell immunity; b) understanding genotype/phenotype interactions that impact immune responsiveness and trafficking; c) developing improved biomarkers (immune, metabolic, genetic) reflective of key pathogenic processes; and d) discovering methods that impart immune modification capable of interrupting T1D progression. We expect that Core A's commitment to facilitating synergy and collaboration across the P01 will continue to prove beneficial for achieving these goals.

根据我们在此P01的近25年的经验，我们认为该计划的“成功”概念是 取决于存在有效的行政核心作为财政/监管的核心要素 协调，人类受试者招聘和科学指导/外部评估。有了这个信念，五个 核心A的目标如下：1）管理该计划的预算和财政方面。提议 计划涉及向项目1、2和3的调查人员以及核心A＆B的直接支付。因此， 仔细的监督代表了绝对的行政要求。 2）协调正在进行的反馈 达到P01的目标和活动，并促进了计划中的调查人员之间的沟通。这 AIM通过实施各种功能从定期组织 预定的会议由该计划的核心对项目调查人员进行培训。核心A还提供 还通过内部计划执行委员会会议进行计划优化的机制 通过外部顾问委员会提供的意见，以最大程度地提高进度和协同作用 在程序中。 3）通过同意参与者和血液来组织人类材料的收集 样本收集，确保符合适当的监管机构和EDCT。我们的P01地方 研究团队和我们研究的主题的多样性都非常重视。我们与我们的合作伙伴关系 UF外部的单位可以酌情招募具有年龄，性别和多样性平衡的参与者 遗传祖先组成的术语。通过收集这些元数据，三个生成的数据 项目和核心B将是强大的，可推广的和反映人口异质性的，有助于 缓解分布。 4）提供数据库支持，以存储监管文件以及 数据/元数据是为了促进研究者访问适当的样品集。我们建议升级到我们的 现有的“植物症”以改善研究者的界面进行样本选择（例如，基于主题 特定基因座的基因型，多基因风险评分，年龄，疾病状况，性别）以及符合公平原则 数据管理和管理。 5）编译适当的数据集并促进程序的通信 结果。核心A将与NIH员工进行交流，提供出版物的帮助，并向 计划结果。内部计划执行委员会已审查了不断变化的优先事项和进步 1型糖尿病（T1D）的领域以及此更新应用程序，以满足不断增长的需求 对于：a）在胰腺生物学和抗β细胞免疫的交集处识别过程； b）理解 影响免疫反应性和贩运的基因型/表型相互作用； c）发展有所改善 生物标志物（免疫，代谢，遗传）反映了关键的致病过程； d）发现方法 这种免疫修饰能够中断T1D进展。我们期望核心A的承诺 为了促进P01的协同作用和协作，将继续证明有益于实现这些目标。