New Report Examines Controlled Human Inhalation Exposure Studies at EPA

Published April 5, 2017

A new report published by the National Academies Press (NAP) focuses on EPA’s controlled human inhalation exposure (CHIE) studies, which are also referred to as human clinical studies or human challenge studies. These studies involve individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings. According to the report, CHIE studies allow measurements to be made of “biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses.” The results of this research are used to help inform policy decisions and establish or revise standards intended to protect public health and improve air quality.

The report provides guidance on the conduct of CHIE studies, assesses the utility of these studies to inform and reduce uncertainties in setting air-pollution standards, assesses whether the continuation of CHIE studies is warranted, and evaluates the potential health risks to test subjects who have participated in recent studies at EPA’s clinical research facility.

A free PDF download of Controlled Human Inhalation-Exposure Studies at EPA is available on NAP’s website.