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.

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