Appendices



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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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Ethical Conduct of Clinical Research Involving Children 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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Ethical Conduct of Clinical Research Involving Children 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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Ethical Conduct of Clinical Research Involving Children 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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Ethical Conduct of Clinical Research Involving Children   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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Ethical Conduct of Clinical Research Involving Children 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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Ethical Conduct of Clinical Research Involving Children   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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Ethical Conduct of Clinical Research Involving Children 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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Ethical Conduct of Clinical Research Involving Children   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