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E-raamat: Controlled Human Inhalation-Exposure Studies at EPA

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  • Formaat: 158 pages
  • Ilmumisaeg: 10-Apr-2017
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309452502
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Controlled Human Inhalation-Exposure Studies at EPASuurem pilt
  • Formaat: 158 pages
  • Ilmumisaeg: 10-Apr-2017
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309452502
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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.

Table of Contents



Front Matter Summary 1 Introduction 2 Foundational Aspects of Human-Subjects Research 3 Value of Controlled Human Inhalation Exposure Studies 4 Assessment of Controlled Human Inhalation Exposure Studies at EPA and Associated Adverse Events 5 The Continued Conduct of Controlled Human Inhalation Exposure Studies by EPA 6 Characterizing Risks to Subjects in Controlled Human Inhalation Exposure Studies 7 Communication about Informed Consent in Controlled Human Inhalation Exposure Studies References 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
Summary 1(10)
1 Introduction
11(6)
A Prior National Research Council Report on Controlled Human Exposure Studies
11(1)
CHIE Studies at EPA
12(2)
EPA's Office of Inspector General Report
14(1)
Committee's Statement of Task
15(1)
Terms for Referring to Individuals Exposed in CHIE Studies
15(1)
Organization of the Report
16(1)
2 Foundational Aspects Of Human-Subjects Research
17(16)
Introduction
17(1)
Air Pollution Health Effects Science for Managing Air Quality
18(2)
Human-Subjects Research
20(5)
Risk-Benefit Framework
25(8)
3 Value Of Controlled Human Inhalation Exposure Studies
33(19)
Introduction
33(1)
A Framework for Evaluating CHIE Studies
34(2)
Sensitive Groups
36(1)
CHIE Studies in the Context of Toxicologic and Epidemiologic Studies, and the Larger Research Agenda
37(1)
Use of Biomarkers in CHIE Studies
37(1)
Comparing CHIE Study Exposures with Ambient Pollutant Exposures
38(2)
Considerations of CHIE Study Value for EPA Decision Making
40(1)
CHIE Ozone Studies
40(4)
CHIE PM Studies
44(7)
Conclusions
51(1)
4 Assessment Of Controlled Human Inhalation Exposure Studies At Epa And Associated Adverse Events
52(16)
Introduction
52(1)
The Eight Studies Identified by EPA for Consideration by the Committee
53(8)
Evaluation of Evidence for Adverse Events Resulting from Participation in a CHIE Study
61(2)
Adverse Event Reporting
63(3)
Relationship of Short-Term CHIE Study Exposure to Chronic Disease Risks
66(1)
Conclusions
67(1)
5 The Continued Conduct Of Controlled Human Inhalation Exposure Studies By Epa
68(9)
Scientific Contributions of Past CHIE Studies
68(1)
Past Benefits to Society
69(2)
Study Participant Safety
71(3)
Potential Future Societal Benefits
74(1)
Additional External Scientific Input
75(1)
Conclusion and Recommendation
76(1)
6 Characterizing Risks To Subjects In Controlled Human Inhalation Exposure Studies
77(10)
Audiences for Risk Characterization Associated with CHIE Studies
77(1)
Exclusion Criteria for Screening Study Subjects
78(1)
Factors That Might Trigger an Adverse Outcome
78(1)
What Adverse Outcomes Might Be Expected and When? Reasonably Foreseeable Risks
79(1)
Characterization of Risks Associated with CHIE Pollutant Exposures
79(1)
Use of the Exposure Comparator Approach for Characterizing Risk
80(5)
Recommendations
85(2)
7 Communication About Informed Consent In Controlled Human Inhalation Exposure Studies
87(19)
Introduction to Informed Consent and the Common Rule
87(3)
Researcher Communication and Participant Understanding of Informed Consent
90(3)
Recommendations
93(2)
References
95(11)
Appendixes
A Biographical Information On The Committee On Assessing Toxicologic Risks To Human Subjects Used In Controlled Exposure Studies Of Environmental Pollutants
106(4)
B Public Information-Gathering Sessions
110(2)
C Assessment Of Eight Controlled Human Exposure Studies
112
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