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

Bibliographic Details
Corporate Authors:	National Research Council (U.S.). Policy and Global Affairs (-), National Research Council (U.S.). Committee on the Use of Third Party Toxicity Research with Human Research Participants
Format:	eBook
Language:	Inglés
Published:	Washington, D.C. : National Academies Press c2004.
Edition:	1st ed
Subjects:	United States. > Environmental Protection Agency. Human experimentation in medicine > Moral and ethical aspects. Human experimentation in medicine > Government policy > United States. Medical ethics. Medicine > Research > Moral and ethical aspects.
See on Biblioteca Universitat Ramon Llull:	https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009618553406719

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.

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