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Ethical Conduct of Clinical Research Involving Children (2004)

Chapter: Appendix A: Study Origins and Activities

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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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Appendices

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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A
Study Origins and Activities

The Best Pharmaceuticals for Children Act of 2002 (P.L. 107-109) called for the Institute of Medicine (IOM) to conduct a study of research involving children. The report was to review federal regulations, reports, and research and to make recommendations about desirable practices in ethical research involving children. IOM appointed a committee of 14 experts to oversee the study. Its task was to develop a report that specifically examined

  • the appropriateness of the federal regulations for children of different ages and maturity levels;

  • the interpretation of regulatory criteria for approving research involving children, including the concept of “minimal risk”;

  • the processes for securing parent’s and children’s agreement to a child’s participation in research;

  • the expectations and comprehension of children and parents about

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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what it means to participate in research and how research differs from medical treatment;;

  • the appropriateness of payment to a child, parent, guardian, or legally authorized representative for the child’s participation in research;

  • the compliance with and enforcement of federal regulations; and

  • the roles and responsibilities of institutional review boards (IRBs) in reviewing research involving children.

The committee met five times between January 2003 and November 2003. It commissioned a background paper, included as Appendix B of this report, to review state laws relating to children’s agreement to medical care and research participation. The committee conducted four public meetings, including a 1-day meeting to hear the views of family support and advocacy organizations and health care groups (with written statements invited from additional organizations). The committee also met for a half day with parents and adolescents who had personal experiences with studies involving children. The agendas and participants for the public meetings are included in this appendix.

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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INSTITUTE OF MEDICINE

COMMITTEE ON CLINICAL RESEARCH INVOLVING CHILDREN

Room 101, The Keck Center, National Academy of Sciences

500 Fifth Street NW, Washington, DC

January 9, 2003

1:00

Welcome and Introductions

1:10

Overview of OHRP research ethics compliance activities and data resources

Michael Carome, M.D., Associate Director for Regulatory Affairs

Director, Division of Compliance Oversight,

Office for Human Research Protections

U.S. Department of Health and Human Services

 

FDA’s oversight of clinical research

David Lepay, M.D., Ph.D., Senior Advisor for Clinical Science

Office of the Commissioner

Food and Drug Administration

2:40

Break

3:00

Survey of IRB chairs on issues related to children

David Wendler, Ph.D., Head, Unit on Vulnerable Populations

Department of Clinical Bioethics

National Institutes of Health

3:45

Work of National Human Research Protections Advisory Committee

Alan Fleischman, M.D., Senior Vice President

New York Academy of Medicine

4:15

National Institute of Child Health and Human Development perspectives and activities

Duane Alexander, M.D., Director

National Institute of Child Health and Human Development

4:45

Proposed IOM/National Research Council (NRC) study: Housing interventions involving children

Jane Ross, Ph.D., Acting Director

IOM/NRC Board on Children Youth and Families

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

5:00

Opportunity for Public Comment

5:15

Adjourn

***

INSTITUTE OF MEDICINE

COMMITTEE ON CLINICAL RESEARCH INVOLVING CHILDREN

Huntington Room, Arnold and Mabel Beckman Center,

National Academy of Sciences

100 Academy Drive, Irvine, California

March 15, 2003

8:30

Welcome and Introductions

Richard E. Behrman, M.D., J.D., IOM Committee Chair

Executive Chair, Federation of Pediatric Organizations,

Education Steering Committee

8:40

Panel 1: Minimal Risk and the NRHPAC Working Group Report

Robert Nelson, M.D., IOM Committee Member

Associate Professor of Anesthesia & Pediatrics, University of Pennsylvania

Chair, Committees for the Protection of Human Subjects

The Children’s Hospital of Philadelphia

 

Thomas G. Keens, M.D., Professor of Medicine

University of Southern California School of Medicine

Chair, Children’s Hospital Los Angeles Institutional Review Board

9:45

Panel 2: Pediatric Research and 45 CFR 46.407

Ernest Prentice, Ph.D., Vice Chancellor for Academic Affairs and Regulatory Compliance

University of Nebraska Medical School

Chair, Secretary’s Advisory Committee on Human Research Protections,

U.S. Department of Health and Human Services

 

Stewart A. Laidlaw, Ph.D., Director, Office of Compliance and Regulatory Affairs

Harbor-UCLA Research and Education Institute

Adjunct Associate Professor of Medicine

University of California, Los Angeles

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

Susan Partridge, B.S.N., M.B.A., Assistant Professor of Pediatrics

Division of Pediatric Infectious Diseases, Department of Pediatrics

Harbor-UCLA Medical Center

Member, Harbor-UCLA Internal Review Board

 

Leslie K. Ball, M.D., Medical Officer [by telephone]

Office for Human Research Protections

U.S. Department of Health and Human Services

11:00

Break

11:20

Panel 3: Selected Issues in Longitudinal Research

John Landsverk, Ph.D., Director

Child and Adolescent Services Research Center

San Diego

 

Benjamin Wilfond, M.D.

Cochair, Ethics Working Group, National Children’s Study

Department of Clinical Bioethics

National Human Genome Research Institute

National Institutes of Health

12:45

Comments

Adjourn

***

INSTITUTE OF MEDICINE

COMMITTEE ON CLINICAL RESEARCH INVOLVING CHILDREN

Lecture Room, National Academy of Sciences

2101 Constitution Avenue NW/2100 C Street NW, Washington, DC

July 9, 2003

8:45

Welcome and Introductions

Richard E. Behrman, M.D., J.D., Chair, IOM Committee on Clinical Research Involving Children

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

8:55

Panel 1

 

American Academy of Pediatrics (AAP)

David J. Schonfeld, M.D.

Member, AAP Committee on Pediatric Research

Yale University School of Medicine

 

Society for Pediatric Research

Christine A. Gleason, M.D.

University of Washington, Seattle

 

Association of Medical School Pediatric Department Chairs

George J. Dover, M.D.

Johns Hopkins University School of Medicine

9:35

Panel 2

 

Children’s Oncology Group (COG)

Gregory H. Reaman, M.D.

Chair, COG

The George Washington University and Children’s National Medical Center

 

The Pediatric AIDS Clinical Trials Group (PACTG)

Stephen A. Spector, M.D.

PACTG Group Chair, Executive Committee

University of California, San Diego, School of Medicine

 

Allergy & Asthma Network, Mothers of Asthmatics

Nancy Sander

President and Founder

Martha White, M.D.

Founding Board Member

10:15

Break

10:50

Panel 3

 

Children’s Clinical Research Institute, The Children’s Hospital of Philadelphia

Mark S. Schreiner, M.D.

Senior Medical Director

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

American Society of Transplantation

William E. Harmon, M.D.

Immediate Past President, American Society of Transplantation

Director of the Division of Nephrology, Children’s Hospital Boston

Chair, North American Pediatric Renal Transplant Cooperative Study

11:20

Panel 4

 

Public Citizen, Health Research Group

Peter Lurie, M.D., M.P.H.

Deputy Director

 

Citizens for Responsible Care and Research

Paul Gelsinger

Vice President

Adil E. Shamoo, Ph.D.

Founder

Editor-in-Chief, Accountability in Research

11:50

Break

1:00

Panel 5

 

Genetic Alliance

Mary Ann Wilson

Consumer Staff Representative

 

Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD)

Phyllis Anne Teeter Ellison, Ed.D.

Immediate Past Chair, CHADD Professional Advisory Board

Chair, CHADD Editorial Advisory Board

University of Wisconsin, Milwaukee

 

Cystic Fibrosis Foundation

Suzanne R. Pattee, J.D.

Vice President of Public Policy & Patient Affairs

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

1:40

Panel 6

 

Applied Research Ethics National Association/PRIMR

Leonard H. Glantz, J.D.

Board Chair, PRIMR

Boston University School of Public Health

 

Association for the Accreditation of Human Research Protection

Programs, Inc.

Marjorie A. Speers, Ph.D.

Executive Director

 

Partnership for Human Research Protection

Jessica Briefer French

Assistant Vice President

2:20

Break

2:40

Issues in Research in Pediatric Psychology and Psychiatry

Anthony Spirito, Ph.D.

Brown University Medical School

Philip C. Kendall, Ph.D., ABPP

Temple University

Laurence L. Greenhill, M.D.

New York State Psychiatric Institute

3:50

Research on Children’s Comprehension of Research Participation

Eric D. Kodish, M.D.

Rainbow Babies and Children’s Hospital

Myra Bluebond-Langner, Ph.D.

Rutgers University, Camden, New Jersey

5:00

Public Comment

Adjourn

The following organization submitted written statements.

 

NIH Neonatal Network

Pediatric Pharmacology Research Unit Network

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

Society for Adolescent Medicine

Society for Developmental and Behavioral Pediatrics

Society for Research in Child Development

The Children’s Cause

Alliance for Human Research Protection

Association of American Medical Colleges

Juvenile Diabetes Research Foundation

(National Association of Children’s Hospitals and Related

Institutions endorsed the statement of the American Academy of Pediatrics)

***

INSTITUTE OF MEDICINE

Committee on Clinical Research Involving Children

Lecture Room, National Academy of Sciences

2101 Constitution Avenue NW/2100 C Street NW, Washington, DC

10:00 a.m. - 12:15 p.m., July 11, 2003

Parents

Joan Lippincott

Maureen and Joseph Lilly

Lise Yasui

Andrell Vaughn

Research Participants

Carolyn Brokowski

Sarah Lippincott

Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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Suggested Citation:"Appendix A: Study Origins and Activities." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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