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Controlled human Inhalation-exposure studies at EPA / Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants, Board on Environmental Studies and Toxicology, Division on Earth and Life Studies ; a report of the National Academies of Sciences, Engineering, Medicine.
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
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Format
Book
Language
English
Published/Created
Washington, DC : the National Academies Press, [2017]
©2017
Description
xv, 141 pages : illustrations (some color) ; 28 cm
Availability
Available Online
National Academies Press
Copies in the Library
Location
Call Number
Status
Location Service
Notes
ReCAP - Remote Storage
RC720 .N38 2017g
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Details
Subject(s)
United States Environmental Protection Agency
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Pulmonary toxicology
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Pollutants
—
Health aspects
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Summary note
"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"--Publisher's description.
Bibliographic references
Includes bibliographical references (pages 95-105).
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 human inhalation exposure studies
Reference
Appendix A: Biographical information on the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants
Appendix B: Public information-Gathering sessions
Appendix C: Assessment of eight controlled human exposure studies.
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Other title(s)
Controlled human Inhalation-exposure studies at Environmental Protection Agency
ISBN
9780309452496 ((paperback))
030945249X ((paperback))
OCLC
985120577
RCP
C - S
Statement on language in description
Princeton University Library aims to describe library materials in a manner that is respectful to the individuals and communities who create, use, and are represented in the collections we manage.
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Controlled human Inhalation-exposure studies at EPA / National Academies of Sciences, Engineering, and Medicine (U.S.).
id
99125429624106421