Intentional Human Dosing Studies for EPA Regulatory Purposes - Technology Committee on the Use of Third Party Toxicity Research with Human Research Participants Science  and Law Program,  Policy and Global Affairs,  National Research Council,  National Academy of Sciences

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues
Buch | Softcover
226 Seiten
2004
National Academies Press (Verlag)
978-0-309-09172-5 (ISBN)
68,55 inkl. MwSt
The EPA commissioned the National Academies to provide advice on whether and, under what circumstances EPA should accept and consider intentional human dosing studies to gather evidence relating to the risks of a chemical. This report recommends that such studies be conducted and used for regulatory purposes only if the strict conditions are met.
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 cana (TM)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 studies a " both at the beginning and upon completion of the experiments a " if they are carried out with the intent of affecting the agency's policy-making.

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

1 Front Matter; 2 Executive Summary and Recommendations; 3 1 Introduction and Background; 4 2 The Regulatory Framework for Protecting Humans in Research; 5 3 Scientific Justification for and Conduct of Intentional Human Dosing Studies; 6 4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies; 7 5 Ethical Considerations in the Review of Intentional Human Dosing Studies; 8 6 Procedures for EPA Review of Intentional Human Dosing Studies; 9 7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment; 10 Appendix A: Values and Limitations of Animal Toxicity Data; 11 Appendix B: Pharmacokinetics and Metabolism of Pesticides; 12 Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants; 13 Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel; 14 Appendix E: Meeting Agendas; 15 Appendix F: Combined Registrants List for All Meetings

Erscheint lt. Verlag 4.7.2004
Verlagsort Washington
Sprache englisch
Maße 152 x 229 mm
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Medizinethik
Studium Querschnittsbereiche Geschichte / Ethik der Medizin
ISBN-10 0-309-09172-1 / 0309091721
ISBN-13 978-0-309-09172-5 / 9780309091725
Zustand Neuware
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