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Human Studies Divison
Background & History
Human Studies Division Navigation
From its inception, EPA has recognized the importance of understanding the relationship between air pollution and human health. Through study of the effects of controlled exposures on healthy and diseased human subjects, clinical research has contributed substantially to advancing that understanding. In the late 1970's, EPA entered into a Memorandum of Understanding with the University of North Carolina (UNC) at Chapel Hill to address the emerging concern over the effects of air pollution on the human respiratory system by developing a controlled experimental research program and exposure facility on the medical school campus. This led to the initiation of cooperative research agreements in the 1980's, first with the UNC School of Medicine and later with the UNC School of Public Health.
The physical setting and collaborative relationships were designed to facilitate clinical research involving children as well as adults, and patients as well as healthy volunteers. It also was recognized that EPA's in-house expertise in human toxicology would benefit from being collocated with a strong academic medical center. Similar research using animals was conducted in Research Triangle Park (RTP). These two research units, the Clinical Research Branch (CRB) in Chapel Hill and the Pulmonary Toxicology Branch in RTP, formed the Inhalation Toxicology Division. Also in RTP was the Biometry Division, which included classical epidemiology studying the effects of environmental pollutants on human health, and biostatistics.
In 1988, the Office of Health Research and the Health Effects Research Laboratory reorganized to consolidate clinical and field studies of human populations. A second purpose of the reorganization was to relocate and integrate research conducted in Cincinnati on drinking water pollutants into the RTP human health program. The resulting new division was renamed the Human Studies Division (HSD) and included the CRB which continued to focus on the human respiratory system, and the Epidemiology Branch which studied effects of air pollution, drinking water contamination, and exposure to toxics and pesticides using population studies.
In the late 1980's, Congress approved construction of a new EPA research facility on the UNC medical school campus. Ground was broken in 1991 and construction completed in 1994. The move to the new building, the Human Studies Facility (HSF), in 1995 allowed EPA to consolidate all of NHEERL's human health effects research program into one building and to add researchers who focus on the development and validation of biomarkers for human field studies. The reorganized HSD created a staff to provide administrative support to the investigators, quality assurance of the research, medical staff to support clinical studies, computer and graphics support, and to coordinate visiting scientist programs.
The move into the HSF in 1995 also provided an opportunity for the UNC Center for Environmental Medicine and Lung Biology (CEMLB), later renamed the Center for Environmental Medicine, Asthma, and Lung Biology 
(CEMALB), to consolidate its investigator core within the building and enhance opportunities to collaborate with HSD. The School of Public Health researchers, located only 3 blocks away, also have convenient access to the Facility, its resources and EPA collaborators. This access is particularly important for pre and post doctoral trainees in environmental health related fields. In addition to Federal trainees, referred to as "R" authority post-doctoral trainees, other trainees are using the facility under cooperative research and training agreements with the UNC Schools of Public Health and Medicine, and with the UNC Curriculum in Toxicology . UNC trainees are recruited and selected by UNC with cooperation from an EPA researcher who agrees to be a mentor.