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Ethical Conduct of Clinical Research Involving Children
Appendices
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Ethical Conduct of Clinical Research Involving Children
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
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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.
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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
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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
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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
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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
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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
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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
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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
Representative terms from entire chapter:
research involving
