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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

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 192
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 192
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 192
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 192
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 192
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 192
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 192
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 192
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