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Consensus protocols, used in common by different research laboratories, have been proposed as a means of making clinical research data across different laboratories directly comparable for purposes of determining the no-effects level of inhalation exposure to air pollutants in man. Such consensus protocols appear attractive to some, and they may be helpful for a limited number of studies, for example, if investigators from several laboratories wished to collaborate on a common research problem requiring a broad-based approach or to provide a means of concentrating differing skills or techniques available at several laboratories to attack a specific question. However, there is a larger body of research that would potentially be inhibited by the imposition of consensus protocols. Mechanistic studies, designed to address questions of how pollutants act, would probably be difficult to design effectively under consensus guidelines since they may require specialized exposure, exercise, or study conditions. Indeed, studies into the mechanism of pollutant action are likely to be of the greatest use to end-users (in this case, program officers and regulators), since studies of this nature provide health effects data and information on the significance of the response to an inhaled pollutant. Hypothesis testing should not be driven by design considerations. On the contrary, experimental and statistical design should be appropriate for and determined by the hypothesis being tested.
experimental protocols, air pollution, statistical design, inhalation toxicology, experimental design, consensus protocols
Chief, Clinical Research Branch, Health Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC