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PAPERBACK list:$49.00 Web:$44.10 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Ethical Conduct of Clinical Research Involving Children Toxicity Testing for Assessment of Environmental Agents: Interim Report Other Related Titles Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues (2004) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 192   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix E Meeting Agendas Meeting 1 December 16-17, 2002 8:20 Welcome and Introductions   Jim Childress and Mike Taylor Committee Cochairs 8:30 Charge to the Committee   Stephen L. Johnson Assistant Administrator Office of Prevention, Pesticides and Toxic Substances U.S. Environmental Protection Agency 9:30-1:15 Closed Session 1:15 Policies, Protocols, Guidelines Governing Research with Human Participants   Nancy E. Kass The Phoebe R. Berman Professor of Bioethics and Public Health Professor, The Bioethics Institute Director, Program in Law, Ethics and Health Johns Hopkins University Bloomberg School of Public Health Page 192 Front Matter (R1-R18) 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)

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OCR for page 192
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues Appendix E Meeting Agendas Meeting 1 December 16-17, 2002 8:20 Welcome and Introductions   Jim Childress and Mike Taylor Committee Cochairs 8:30 Charge to the Committee   Stephen L. Johnson Assistant Administrator Office of Prevention, Pesticides and Toxic Substances U.S. Environmental Protection Agency 9:30-1:15 Closed Session 1:15 Policies, Protocols, Guidelines Governing Research with Human Participants   Nancy E. Kass The Phoebe R. Berman Professor of Bioethics and Public Health Professor, The Bioethics Institute Director, Program in Law, Ethics and Health Johns Hopkins University Bloomberg School of Public Health

OCR for page 193
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues 2:15 Joint SAB/SAP Report: Comments on the Use of Data from the Testing of Human Subjects   Christopher J. Portier Director Environmental Toxicology Program National Institute of Environmental Health Sciences 3:45 Break 4:00 Closed Session 5:30 Adjourn Tuesday, December 17, 2002 8:30 Overview of FIFRA/FQPA   Stanley H. Abramson Partner Arent, Fox, Kintner, Plotkin & Kahn, PLLC   Erik D. Olson Senior Attorney Natural Resources Defense Council 10:30 Human Subjects Research in Environmental Policy   Penny Fenner-Crisp Executive Director ILSI Risk Science Institute 11:15 Break 11:30 Using Human Data in the Assessment and Management of Risk   Michael D. Dourson Director Toxicology Excellence for Risk Assessment 12:15 Lunch

OCR for page 194
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues 1:00 Pesticides in the Diets of Infants and Children   Philip J. Landrigan Ethel H. Wise Professor of Community Medicine Chairman, Department of Community and Preventive Medicine Director, Center for Children’s Health and the Environment Mt. Sinai School of Medicine 1:40 Small Clinical Trials: Issues and Challenges   Suzanne T. Ildstad Director, Institute for Cellular Therapeutics Professor of Surgery, Jewish Hospital Distinguished Professor of Transplantation University of Louisville 2:20 Preserving Public Trust: Accreditation and Human Research Participant Programs and Responsible Research: A Systems Approach to Protecting Research Participants   Daniel Federman Senior Dean for Alumni Relations and Clinical Teaching Carol W. Walter Distinguished Professor of Medicine and Medical Education Harvard Medical School 3:00 Break 3:15 Joint SAB/SAP Report: Minority Statement   Herbert L. Needleman Professor of Pediatrics Member, Research Group on Lead University of Pittsburgh Medical School 4:00-5:45 Closed Session

OCR for page 195
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues PUBLIC FORUM JANUARY 8, 2003 8:30 Welcome and Purpose of Forum   Jim Childress and Mike Taylor Committee Cochairs 8:45 Public Input Session Moderator Mike Taylor Cochair Speakers 8:50 Gail Charnley HealthRisk Strategies   Jacqueline Patterson Toxicology Excellence for Risk Assessment 9:10 Richard Wiles Vice President for Research Environmental Working Group 9:30 William Kelly Western Representative The Center for Regulatory Effectiveness 9:50 Jennifer Sass Senior Scientist Natural Resources Defense Council 10:10 Break 10:20 Ray McAllister Vice President, Science and Regulatory Affairs CropLife Association 10:40 Lynn Goldman Chairman of the Board Children’s Environmental Health Network Professor, Environmental Health Sciences Johns Hopkins Bloomberg School of Public Health

OCR for page 196
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues 11:00 Shelley Davis Co-Executive Director Farm Worker Justice Fund 11:20 Alan Herbert Lockwood Physicians for Social Responsibility Professor of Neurology, Nuclear Medicine, and Communicative Disorders and Sciences State University of New York, Buffalo, School of Medicine and Biomedical Sciences 11:40 Vera Hassner Sharav President Alliance for Human Research Protection 12:00 Lunch 12:50 Five Minute Remarks from Registered Attendees Requesting An Opportunity to Speak Before the Committee Moderator Jim Childress Cochair   Speakers Judith A. MacGregor Toxicology Consulting Service   Steven H. Lamm Consultants in Epidemiology and Occupational Health, Inc. 1:50 Break 2:00 Examination of the Use of Human Toxicity Studies by Industry Moderator Jim Childress Cochair   The Role of Human Volunteer Studies in a Tiered Approach to Safety Assessment Monty Eberhart Director, Product Safety Management Bayer CropScience

OCR for page 197
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues 2:30 Design and Conduct of Human Volunteer Studies: Ethics and Methodologies   Angus Cameron BCG Europe (representing Inveresk Research International) 3:00 Size and Statistical Power in Human Safety Studies   Bob Sielken Sielken and Associates Consulting, Inc. 3:15 Case Studies   Aldicarb Neil Carmichael Global Director of Toxicology Bayer CropScience   Malathion Chris F. Wilkinson Principle C. Wilkinson, LLC   Dichlorvos Ian Chart Vice President, Director of Regulatory Affairs AMVAC Chemical Corporation   Perchlorate Steven H. Lamm Consultants in Epidemiology and Occupational Health, Inc.   Summary Remarks Abraham J. Tobia Regulatory Toxicologist—NFTA Toxicology Group Bayer CropScience 4:30 Questions/Comments 5:00 Adjourn

OCR for page 198
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues MEETING 2 JANUARY 9, 2003 8:30 Welcome   Jim Childress and Mike Taylor Committee Cochairs 8:35 An Overview of Risk Assessment at EPA   William H. Farland Acting Deputy Assistant Administrator for Science Office of Research and Development U.S. Environmental Protection Agency 9:30 Application of the Common Rule to EPA Conducted and Sponsored Research   Peter W. Preuss Director National Center for Environmental Research Office of Research and Development U.S. Environmental Protection Agency 10:30 Break 10:45 FQPA—Applying the Safety Factors   Susan Mackris Senior Toxicologist Office of Pesticide Programs U.S. Environmental Protection Agency 11:45 Risk Assessment—Pesticide Case Study—Phosmet   Christina B. Swartz Senior Scientist Office of Pesticide Programs U.S. Environmental Protection Agency 12:45 Lunch 1:30 Research with Human Research Participants—The FDA Experience   Robert Temple Director Office of Medical Policy Center for Drug Evaluation and Research 2:30-3:30 Closed Session

OCR for page 199
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues MEETING 3 MARCH 19, 2003 8:00 Consideration, Use, and Value of Human Subjects Research to EPA Program Offices   Rita S. Schoeny Senior Science Advisor Office of Water U.S. Environmental Protection Agency   Deirdre L. Murphy Emissions Standards Divison Risk & Exposure Assessment Group Office of Air Quality Planning & Standards U.S. Environmental Protection Agency   Karen M. Martin Group Leader, Health and Ecosystems Effects Group Office of Air Quality Planning & Standards U.S. Environmental Protection Agency 10:00 Value of Human Toxicity Studies   Ernest E. McConnell President ToxPath 10:45 Break 11:00 Pesticides and Children: Research Challenges/Exposure Issues/ Effects of Neural Development   John L. Adgate Assistant Professor School of Public Health University of Minnesota   W. Stephen Brimijoin Professor and Chair Department of Molecular Pharmacology and Mayo Clinic Experimental Therapeutics 12:15 Lunch

OCR for page 200
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues 1:30 Ethical Issues Associated with Intentional Dosing of Human Research   Jeffrey Kahn Director and Professor Center for Bioethics University of Minnesota   Arthur Caplan The Emanuel and Robert Hart Professor of Bioethics Chair, Deparment of Medical Ethics Director, Center for Bioethics University of Pennsylvania 3:00 Adjourn

Representative terms from entire chapter:

human subjects