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 5000 patient encounters with over 95% patient satisfaction. Additional staff have been hired to support CRU functions. The NIEH's CRU is integrated into the Bethesda CC via the CRIS electronic health record system and the Clinical Trials Database, and collaborated with the NIEHS Environmental Autoimmunity Group in Bethesda. Studies are currently underway at the CRU, involving the fields of asthma, cancer, cardiovascular disease, immunology, inflammation, metabolic disease, and pharmacokinetics. Many studies take advantage of the Environmental Polymorphisms Registry (EPR), a NIEHS-operated cohort encompassing over 15,000 North Carolina residents, who have donated DNA and have agreed to be called back for 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 Nano-Health 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 dioxide nanoparticles and multi-walled carbon nanotubes on circulating and resident lung immune cells, as well as epithelia along the respiratory tract. The NIEHS Program in Clinical Research has established a comprehensive Human Research Protection Program thru the development of the Office of Human Research Compliance (OHRC). This office is 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, strengthening 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 operational procedures, to ensure that NIEHS complies with DHHS, FDA, NIH guidelines and regulations.
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