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Scientific and Ethical Approaches for Observational Exposure Studies
FORTMANN, R. C. Scientific and Ethical Approaches for Observational Exposure Studies. U.S. Environmental Protection Agency, Washington, D.C., EPA/600/R-08/062 (NTIS PB2008-112239), 2008.
To ensure that EPA’s research continues to be based on the most up-to-date science and the highest ethical standards, the Agency has developed this document that contains state-of-the-science approaches for conducting observational human exposure studies. This document is not meant to represent an official Agency “guidance document” but, rather, serves as a resource tool and source of information for NERL and other researchers on which to rely as they develop and conduct observational human exposure studies.
Researchers conduct observational human exposure studies to understand how and the extent to which people come into contact with chemicals and environmental stressors in their everyday lives, through the air they breathe, the food and liquids they consume, and the things they touch. The U.S. Environmental Protection Agency’s (EPA’s) National Exposure Research Laboratory (NERL) has conducted observational human exposure studies for several decades and uses the information and data from these studies to improve the Agency’s understanding of human exposures to chemicals and other stressors and ultimately to support efforts to improve public health. Because these studies involve people as research participants, they are complex and raise numerous scientific and ethical issues that have to be addressed prior to and during their design and implementation.