CORE C: HUMAN SUBJECTS CORE

核心 C：人类受试者核心

• 批准号: 10615009
• 负责人: Karla McGregor
• 金额: $ 47.33万
• 依托单位: FATHER FLANAGAN'S BOYS' HOME
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10615009
• 关键词: Address; Adolescent; Affect; Budgets; Centers of Research Excellence; Cerebral Palsy; Child; Clinical; Clinical assessments; Collaborations; Communication; Communities; Consent; Consultations; Data; Data Collection; Databases; Development; Effectiveness; Enrollment; Ensure; Evaluation; Fee-for-Service Plans; Fees; Foundations; Funding; Goals; Grant; Health Fairs; Individual; Infant; Institutional Review Boards; Laboratories; Laboratory Study; Language Development Disorders; Language Disorders; Measurement; Measures; Minority Groups; Minority Participation; Monitor; Participant; Perception; Periodicals; Phase; Preparation; Procedures; Process; Productivity; Progress Reports; Protocols documentation; Quality Control; Regulation; Reporting; Research; Research Personnel; Resources; Review Committee; Sample Size; School-Age Population; Scientist; Services; Special Population; Standardization; System; Testing; Time; Training; Trust; United States National Institutes of Health; Update; data sharing; design; evidence base; hearing impairment; human subject; innovation; interest; member; minority children; minority communities; programs; quality assurance; recruit; study population

PROJECT SUMMARY/ABSTRACT CORE C: HUMAN SUBJECTS CORE The Human Subjects Core (HSC) is designed to support investigators in clinical measurement, recruitment, and compliance through centralization of services and expertise. Research programs that involve human subjects encounter challenges related to standardized testing, recruitment of special populations, and regulatory compliance. Time, effort, and resources are required to overcome these barriers, and individual investigators and their laboratories rarely have the capacity to address them without consequences to productivity. The HSC addresses these challenges through two integrated programs (1) a Clinical Measurement Program (CMP), and (2) a Recruitment and Quality Assurance Program (RQP). These programs are designed to provide investigators access to clinical experts, recruitment support, data sharing, and staff supports in compliance and quality monitoring. These centralized supports have led to increased efficiency, collaboration, and productivity in the research program during Phase I. In Phase II, we plan to continue these effective programs while also expanding our efforts by recruiting and testing children with developmental language disorders, by updating and integrating our databases, and by implementing plans that will increase the financial self-sufficiency of the HSC over time.

项目摘要/摘要 核心C：人类主体核心 人类受试者核心(HSC)旨在支持研究人员在临床测量、招募、 并通过集中服务和专业知识实现合规性。涉及人类的研究项目 受试者遇到与标准化测试、招募特殊人群以及 监管合规性。克服这些障碍需要时间、精力和资源，每个人 调查人员和他们的实验室很少有能力解决这些问题，而不会产生 生产力。HSC通过两个综合计划应对这些挑战(1)临床 测量计划(CMP)和(2)招聘和质量保证计划(RQP)。这些计划 旨在为研究人员提供联系临床专家、招聘支持、数据共享和工作人员的途径 支持合规性和质量监控。这些集中式支撑提高了效率， 在第一阶段和第二阶段，我们计划继续这些 有效的计划，同时通过招募和测试有发展能力的儿童来扩大我们的努力 语言障碍，通过更新和整合我们的数据库，并通过执行将增加 随着时间的推移，HSC的财务自给自足。