The NIEHS Clinical Research Program Team has put together an operational plan delineating research options for the NIEHS, presented this plan to the Institute and Program Directors, and received approval for operations. The new NIEHS Clinical Research Unit (CRU) was inaugurated in July 2009. Initial staff has been hired and has implemented a set of standard operating procedures for CRU function. The CRU was audited by high-level NIH Clinical Center Representatives and their suggestions have been incorporated into the CRU operations. The CRP Team has completed a standard operational procedure draft for scientific and utilization review processes in the evaluation of clinical research proposals. This is meant to ensure highest quality research while maintaining fiscal prudence. Furthermore, the CRP Team has been in close contact with members of the Clinical Research Center in Bethesda, MD, in an effort to streamline NIEHS clinical operations with the pre-existing framework of NIH Clinical Research. Finally, a clinical research software has been purchased and is now being tailored to the needs of NIEHS investigators. With this operational background in place, several studies have been proposed by CRU staff in collaboration with NIEHS investigators, involving the fields of cancer, asthma, metabolic disease and cardiovascular disease. Patients have been already recruited for some of these studies. Furthermore, collaboration avenues with local universities as well as other governmental agencies are currently being pursued. 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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