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

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”的概念是 取决于有效的行政核心的存在，如财政/监管的中心要素 与该信念的协调，人类招聘和科学指导/外部评估。 核心的目标如下：1）管理该计划的预算和财政方面 计划涉及向项目1、2和3的调查人员以及核心A＆B的直接成本支出； 仔细的监督代表了绝对的行政要求。 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。 AIM通过实施各种策略以定期组织来采取务实的形式 核心也提供了核心。 还通过内部计划执行委员会会议进行编程机制 如外部顾问委员会提供的输入 - 为了最大化进度和协同作用 在计划中。 样本收集，分配适当的监管机构和法令 研究团队和我们研究的主题的多样性都非常重视 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 这些元数据的遗传术语术语。 项目和核心B将是强大的，可推广的，并且反映了人口异性表，从而有助于 减轻差异4）为存储监管文件提供数据库支持 数据/元数据为了促进研究者访问适当的样品集。 现有的“植物酶”，以改善研究者的界面以进行样品选择（例如 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。 结果A将与NIH员工交流，提供出版物的帮助 计划结果。内部计划执行委员会已审查了优先事项和进步 1型糖尿病（T1D）的领域和续订应用程序，有组织的Iseelf增加了不断增长的需求 对于：a）识别palcress生物学和抗β细胞免疫的相交的过程； b）理解 影响免疫反应性和运输的基因型/表型相互作用得到了改善 生物标志物（免疫，代谢，遗传）反映了关键的致病过程； 这种免疫修饰能够中断T1D的进展。 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。