GENETIC SUSCEPTIBILITY AND ENVIRONMENTAL FACTORS

NIEHS的临床研究计划在内科研究部内进行或监督临床研究。这些研究的目的是：1)调查人类群体中与复杂特征和疾病有关的遗传易感性和环境因素之间的相互作用；2)通过使用治疗、外科或放射技术减少遗传和环境风险因素，或通过改变环境暴露、饮食和生活方式，干预疾病的发展或进展。该合同将为OCR和DIR的首席研究员(PI)提供进行观察性临床研究和干预性临床试验所需的所有类型的支持。尽管临床研究一直在DIR内进行，但由于CRP人员数量有限，缺乏执行各种任务所需的支助人员，以及缺乏已经建立的患者护理和进行临床试验的机制，临床研究受到严重限制。此外，由各地的DIR工作人员进行临床研究，特别是对于较小规模的研究，可能是昂贵、困难或根本不可行的。私营部门现在作出了努力，可以利用在这类工作的许多阶段都有经验的国家人员网络，并可以更有效地提供这种支助。特别是对于小型项目，与定期在每个项目现场寻找和培训支助人员相比，在中央管理概念下设立一个单一的支助人员小组将更有效率，提供更多的连续性，并更受质量控制的约束。这样一份进行临床研究的支持服务合同将有助于实现NIEHS的目标，即识别和了解人类疾病的遗传易感性和环境影响，并制定预防和干预战略，以减少这些相同的人类疾病。

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.