| Description |
1 online resource (1 PDF file (xv, 141 pages)) : illustrations |
| Physical Medium |
polychrome |
| Description |
text file |
| Note |
"A report of the National Academies of Sciences, Engineering, Medicine." |
| Bibliography |
Includes bibliographical references. |
| Summary |
The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility. |
| Funding |
This activity was supported by Contract No. EP-C-14-005 from the U.S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| Contents |
Introduction -- Foundational aspects of human-subjects research -- Value of controlled human inhalation exposure studies -- Assessment of controlled human inhalation exposure studies at EPA and associated adverse events -- The continued conduct of controlled human inhalation exposure studies by EPA -- Characterizing risks to subjects in controlled human inhalation exposure studies -- Communication about informed consent in controlled humanm inhalation exposure studies -- Reference -- Appendix A: Biographical information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Expposure Studies of Environmental Pollutants -- Appendix B: Public information-Gathering sessions -- Appendix C: Assessment of eight controlled human exposure studies. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
United States. Environmental Protection Agency.
|
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United States. Environmental Protection Agency. |
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Pulmonary toxicology.
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Pulmonary toxicology. |
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Pollutants -- Health aspects.
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Pollutants -- Health aspects. |
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Pollutants. |
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Risk assessment.
|
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United States. |
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Risk assessment. |
|
risk assessment. |
| Genre/Form |
Technical reports.
|
|
Technical reports.
|
| Added Author |
National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants, issuing body.
|
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National Academies of Sciences, Engineering, and Medicine (U.S.), issuing body.
|
| Other Form: |
Print version: Controlled Human Inhalation-Exposure Studies at EPA. Washington, D.C. : National Academies Press, [2017] 9780309452496 |
| ISBN |
0309452503 |
|
9780309452502 (electronic book) |
|
9780309452496 |
|
030945249X |
| Standard No. |
10.17226/24618 |
|
