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Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×

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

Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 192
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 193
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 194
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 195
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 196
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 197
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 198
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 199
Suggested Citation:"Appendix E: Meeting Agendas." National Research Council. 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press. doi: 10.17226/10927.
×
Page 200
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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:

  • The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can’t be answered with animal studies or nondosing human studies;
  • The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and
  • All recognized ethical standards and procedures for protecting the interests of study participants are observed.

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.

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