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:
In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies – both at the beginning and upon completion of the experiments – if they are carried out with the intent of affecting the agency's policy-making.
Table of Contents
|Executive Summary and Recommendations||1-20|
|1 Introduction and Background||21-45|
|2 The Regulatory Framework for Protecting Humans in Research||46-65|
|3 Scientific Justification for and Conduct of Intentional Human Dosing Studies||66-83|
|4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies||84-109|
|5 Ethical Considerations in the Review of Intentional Human Dosing Studies||110-131|
|6 Procedures for EPA Review of Intentional Human Dosing Studies||132-143|
|7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment||144-158|
|Appendix A: Values and Limitations of Animal Toxicity Data||159-167|
|Appendix B: Pharmacokinetics and Metabolism of Pesticides||168-172|
|Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants||173-184|
|Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel||185-191|
|Appendix E: Meeting Agendas||192-200|
|Appendix F: Combined Registrants List for All Meetings||201-208|
The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:
For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.
For information on how to request permission to translate our work and for any other rights related query please click here.
For questions about using the Copyright.com service, please contact:
Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
Loading stats for Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues...