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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
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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
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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
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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
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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
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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
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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
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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
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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
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