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Program in Clinical Research, Clinical Support Services and Clinical Training

临床研究、临床支持服务和临床培训项目

基本信息

批准号：
8554185
负责人：
Frederick Miller
金额：
$ 464.7万
依托单位：
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8554185
关键词：
Address Area Asthma Back Cardiovascular Diseases Cells Centrifugation Cerium Client satisfaction Clinical Clinical Protocols Clinical Research Clinical Services Clinical Trials Database Collaborations Core Facility DNA DNA Damage Development Disease Education Educational workshop Electronic Health Record Electronics Endocrine Engineering Enrollment Ensure Environmental Exposure Ethics Follow-Up Studies Generations Genetic Polymorphism Goals Guidelines Health Human Human Rights Human Subject Research Immune Individual Inflammation Inflammatory Institutes Institution Institutional Review Boards Investigation Lung Lung diseases Malignant Neoplasms Metabolic Diseases Mission Monitor National Institute of Environmental Health Sciences North Carolina Participant Patient Recruitments Patients Phenotype Population Procedures Process Protocols documentation Registries Regulation Research Research Design Research Personnel Research Project Grants Respiratory System Respiratory tract structure Rights Sampling Scientist Series Services Social Welfare Specimen Structure Susceptibility Gene System Testing Training Training Programs Translational Research United States National Institutes of Health Universities Work clinical research site cohort design drug testing injury and repair multi walled carbon nanotube nanomaterials nanoparticle operation programs protocol development quality assurance receptor symposium translational study web site

项目摘要

The NIEHS Clinical Research Program Team has continued to expand its scope of support for clinical and translational studies. The NIEHS Clinical Research Unit (CRU) has recorded over 3000 patient encounters with over 95% patient satisfaction. Additional staff has been hired to support CRU function. The NIEHs CRU is integrated into the Bethesda CC via the CRIS electronic health record system and the Clinical Trials Database. Several studies are currently underway at the CRU, involving the fields of cancer, asthma, metabolic disease and cardiovascular disease. Many studies take advantage of the Environmental Polymorphisms Registry (EPR), a NIEHS-operated cohort encompasing over 18,000 North Carolina residents, who have donated DNA and have agreed to be called back to phenotypic studies. EPR-related follow up studies address issues of inflammation, DNA injury repair, endocrine receptor polymorphisms, endothelial function and lung disease. Furthermore, collaboration avenues with local universities as well as other governmental agencies are currently underway. Finally, the NIEHS CRU is leading a NanoHealth initiative, investigating the effect of engineered nanomaterials on human health, with special emphasis on susceptible populations, such as subjects with pre-existing disease. We are currently investigating the toxic and pro-inflammatory effects of cerium diioxide nanoparticles and multi-walled carbon nanotubes on circulating and resident lung immune cells, as well as eithelia along the respiratory tract. The NIEHS Program in Clinical Research has established a comprehensive Human Research Protection Program within the FY2008 thru the development of the Office of Human Research Compliance (OHRC). This office will be responsible for managing and coordinating the pre-IRB clinical and scientific review of NIEHS clinical studies, supporting the day to day administrative operations of the IRB, Developing and maintaining electronic management systems and websites that support activities of the OHRC, Performing quality assurance/quality improvement audits of clinical sites, stregthening and enhancing the human research protection education and training program, working with scientific / clinical PIs and their staff to develop human research protocols, developing and implementing standard operationanl procedures,to ensure that NIEHS complies with DHHS, FDA, NIH guidlines and regulations.

NIEHS临床研究计划团队继续扩大对临床和转化性研究的支持范围。NIEHS临床研究单位(CRU)记录了超过3000例患者就诊，患者满意度超过95%。已经聘请了额外的工作人员来支持CRU的职能。NIEHS CRU通过CRIS电子健康记录系统和临床试验数据库被整合到贝塞斯达CC。CRU目前正在进行几项研究，涉及癌症、哮喘、代谢性疾病和心血管疾病等领域。许多研究利用了环境多态注册中心(EPR)，这是一个由NIEHS运营的队列，涵盖了超过1.8万名北卡罗来纳州居民，他们捐赠了DNA，并同意被召回进行表型研究。EPR相关的后续研究涉及炎症、DNA损伤修复、内分泌受体多态、内皮功能和肺部疾病等问题。此外，目前正在与当地大学和其他政府机构建立合作渠道。最后，NIEHS CRU正在领导一项纳米健康倡议，调查工程纳米材料对人类健康的影响，特别强调易感人群，如既有疾病的受试者。我们目前正在研究二氧化铈纳米颗粒和多壁碳纳米管对循环和驻留的肺免疫细胞以及呼吸道的免疫细胞的毒性和促炎作用。NIEHS临床研究计划通过人类研究合规办公室(OHRC)的发展，在2008财年建立了一个全面的人类研究保护计划。该办公室将负责管理和协调NIEHS临床研究的IRB前临床和科学审查，支持IRB的日常行政操作，开发和维护支持OHRC活动的电子管理系统和网站，执行临床站点的质量保证/质量改进审计，加强和改进人类研究保护教育和培训计划，与科学/临床PI及其工作人员合作制定人类研究方案，制定和实施标准操作程序，以确保NIEHS遵守DHHS、FDA、NIH指南和法规。