The Clinical Research Program at the NIEHS conducts or oversees clinical research studies within the Division of Intramural Research. The objectives of these studies are to: 1) investigate the interaction between genetic susceptibility and environmental factors as related to complex traits and diseases in human populations; and 2) intervene in disease development or progression by reducing genetic and environmental risk factors using therapeutic, surgical or radiation techniques, or by altering environmental exposures, diet and lifestyles. This contract will provide all types of support to principal investigators (PIs) in the OCR and DIR needed to conduct both observational clinical research studies and interventional clinical trials. Although clinical research has been ongoing within the DIR, it has been severely limited by the number of personnel in the CRP, the lack of support personnel required to carry out the various tasks, and lack of already established mechanisms for patient care and conducting clinical trials. Furthermore, conducting clinical research studies by DIR staff in various localities, especially for smaller studies, can be costly, difficult, or simply not feasible. Private sector efforts now exist with access to national networks of personnel with experience in many phases of such work, and could more effectively provide such support. Especially for small projects, a single team of support personnel under a central management concept would be more efficient, provide more continuity, and be more subject to quality control than periodically finding and training support personnel at the site of each project. Such a support services contract for conducting clinical research will facilitate achieving NIEHS goals which are to identify and understand genetic susceptibility and environmental influences in human disease, and develop prevention and intervention strategies for reducing these same human diseases.
