Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical IssuesThe 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 studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making. |
Contents
1 | |
21 | |
2 The Regulatory Framework for Protecting Humans in Research | 46 |
3 Scientific Justification for and Conduct of Intentional Human Dosing Studies | 66 |
4 A RiskBenefit Framework for Assessing Intentional Human Dosing Studies | 84 |
5 Ethical Considerations in the Review of Intentional Human Dosing Studies | 110 |
6 Procedures for EPA Review of Intentional Human Dosing Studies | 132 |
7 EPAs Use of Data from Intentional Human Dosing Studies in Risk Assessment | 144 |
APPENDIXES | 159 |
Appendix B Pharmacokinetics and Metabolism of Pesticides | 168 |
Appendix C Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Pa... | 173 |
Appendix D Biographical Sketches of the Members of the Science Technology and Law Panel | 185 |
Appendix E Meeting Agendas | 192 |
Appendix F Combined Registrants List for All Meetings | 201 |
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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and ... No preview available - 2004 |