Title Intentional human dosing studies for EPA regulatory purposes : scientific and ethical issues / Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs Division, National Research Council of the National Academies

Published Washington, D.C. : National Academies Press, ©2004

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Description 1 online resource (xviii, 208 pages) Series Online access: National Academy of Sciences National Academies Press Online access: NCBI NCBI Bookshelf Contents ""FrontMatter""; ""Acknowledgments""; ""Preface""; ""Contents""; ""List of Tables and Boxes""; ""Acronyms""; ""Executive Summary and Recommendations""; ""1 Introduction and Background""; ""2 The Regulatory Framework for Protecting Humans in Research""; ""3 Scientific Justification for and Conduct of Intentional Human Dosing Studies""; ""4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies""; ""5 Ethical Considerations in the Review of Intentional Human Dosing Studies""; ""6 Procedures for EPA Review of Intentional Human Dosing Studies"" ""7 EPA�s Use of Data from Intentional Human Dosing Studies in Risk Assessment""""APPENDIXES""; ""Appendix A Values and Limitations of Animal Toxicity Data""; ""Appendix B Pharmacokinetics and Metabolism of Pesticides""; ""Appendix C Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants""; ""Appendix D Biographical Sketches of the Members of the Science, Technology, and Law Panel""; ""Appendix E Meeting Agendas""; ""Appendix F Combined Registrants List for All Meetings"" Bibliography Includes bibliographical references Notes Print version record Subject United States. Environmental Protection Agency. SUBJECT United States Environmental Protection Agency United States. Environmental Protection Agency fast Federal Policy (Common Rule) for the Protection of Human Subjects 1991 Subject Human experimentation in medicine -- Moral and ethical aspects Human experimentation in medicine -- Government policy -- United States Medical ethics. Medicine -- Research -- Moral and ethical aspects Institutional review boards (Medicine) Federal government. Risk assessment. Human Experimentation -- ethics Environmental Exposure Nontherapeutic Human Experimentation -- ethics Pesticides -- toxicity Toxicity Tests -- ethics United States Environmental Protection Agency Ethics Committees, Research Federal Government Government Regulation Nontherapeutic Human Experimentation -- legislation & jurisprudence Research Design Risk Assessment Ethics, Medical federal government. risk assessment. BUSINESS & ECONOMICS -- Business Ethics. Risk assessment Institutional review boards (Medicine) Federal government Human experimentation in medicine -- Government policy Human experimentation in medicine -- Moral and ethical aspects Medical ethics Medicine -- Research -- Moral and ethical aspects SUBJECT United States Subject United States Form Electronic book Author National Research Council (U.S.) ISBN 9780309530989 0309530989

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