Committee on the Use of Third Party Toxicity Research with Human Research Participants's Books

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

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226

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National Academies Press

Published Date

ISBN 10

0309091721

ISBN 13

9780309091725

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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226

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National Academies Press

Published Date

ISBN 10

0309166411

ISBN 13

9780309166416

Reference Manual on Scientific Evidence

Third Edition

By: National Research Council,Federal Judicial Center,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on the Development of the Third Edition of the Reference Manual on Scientific Evidence

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Reference Manual on Scientific Evidence

Third Edition

The Reference Manual on Scientific Evidence, Third Edition, assists judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and by providing examples of cases in which that evidence has been used. First published in 1994 by the Federal Judicial Center, the Reference Manual on Scientific Evidence has been relied upon in the legal and academic communities and is often cited by various courts and others. Judges faced with disputes over the admissibility of scientific and technical evidence refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. The manual is not intended to tell judges what is good science and what is not. Instead, it serves to help judges identify issues on which experts are likely to differ and to guide the inquiry of the court in seeking an informed resolution of the conflict. The core of the manual consists of a series of chapters (reference guides) on various scientific topics, each authored by an expert in that field. The topics have been chosen by an oversight committee because of their complexity and frequency in litigation. Each chapter is intended to provide a general overview of the topic in lay terms, identifying issues that will be useful to judges and others in the legal profession. They are written for a non-technical audience and are not intended as exhaustive presentations of the topic. Rather, the chapters seek to provide judges with the basic information in an area of science, to allow them to have an informed conversation with the experts and attorneys.

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Page Count

1034

Publisher

National Academies Press

Published Date

ISBN 10

0309214211

ISBN 13

9780309214216

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

By: Institute of Medicine,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

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217

Publisher

National Academies Press

Published Date

ISBN 10

0309097266

ISBN 13

9780309097260

Controlled Human Inhalation-Exposure Studies at EPA

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

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Controlled Human Inhalation-Exposure Studies at EPA

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.

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Page Count

159

Publisher

National Academies Press

Published Date

ISBN 10

030945249X

ISBN 13

9780309452496

Book's by Committee on the Use of Third Party Toxicity Research with Human Research Participants

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes

Reference Manual on Scientific Evidence

Reference Manual on Scientific Evidence

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA

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