Intentional human dosing studies for EPA regulatory purposes scientific and ethical issues

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...

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Bibliographic Details
Main Authors 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
Format eBook Book
LanguageEnglish
Published Washington, D.C National Academies Press 2004
Edition1
Subjects
Government policy
Human experimentation in medicine
MEDICAL
Medical ethics
Medicine
Moral and ethical aspects
United States
United States
Online AccessGet full text
ISBN9780309530989
9780309091725
0309530989
0309091721
0309385660
9780309385664
DOI10.17226/10927

Cover

Table of 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