National Academies Press: OpenBook

Ethical Conduct of Clinical Research Involving Children (2004)

Chapter: Appendix E: Committee Biographical Statements

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Suggested Citation:"Appendix E: Committee Biographical Statements." 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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E
Committee Biographical Statements

Richard E. Behrman, J.D., M.D. (Chair), is Executive Chair of the Education Steering Committee of the Federation of Pediatric Organizations. He is also Clinical Professor of Pediatrics at the University of California, San Francisco, and the George Washington University, Washington, D.C. He is a member of the Institute of Medicine (IOM) and has chaired several IOM committees, mostly recently, one that developed recommendations to improve palliative and end-of-life care for children with life-threatening diseases. His areas of special interest include perinatal medicine, intensive and emergency care of children, the provision and organization of children’s health and social services, and related issues of public policy and ethics. Dr. Behrman is editor-in-chief of the Nelson Textbook of Pediatrics. He previously held positions as senior vice president of medical affairs at the Lucile Packard Foundation for Children’s Health, chairman of the boards of the Lucile Packard Foundation for Children’s Health and the Lucile Packard Children’s Hospital and director of the Center for the Future of Children. Prior to holding these positions, he served as vice president of Medical Affairs and dean of the School of Medicine at Case Western Reserve University and earlier served as professor and chairman of the Departments of Pediatrics at Case Western Reserve University and Columbia University.

Arthur L. Beaudet, M.D., is chairman and the Henry & Emma Meyer Professor, Department of Molecular and Human Genetics and professor of pediatrics and molecular and cellular biology, Baylor College of Medicine, Houston. His research interests include the genetic basis underlying cystic

Suggested Citation:"Appendix E: Committee Biographical Statements." 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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fibrosis, metabolic disorders, and several other diseases. Dr. Beaudet was codiscoverer of a gene for Angelman syndrome, a chromosome 15 disorder that causes serious mental retardation and physical disabilities. He is studying the role of genomic imprinting and epigenetics in causing disorders such as autism. He is an editor of The Metabolic and Molecular Bases of Inherited Disease. Dr. Beaudet is a member of the IOM and has served on the National Research Council Panel on Scientific and Medical Aspects of Cloning and the IOM Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.

Russell W. Chesney, M.D., is Le Bonheur Professor and chair of the Department of Pediatrics at Le Bonheur Children’s Hospital, as well as a codirector of the Center for Pediatric Pharmacokinetics and Therapeutics at the University of Tennessee, Memphis. Dr. Chesney is principal investigator for the Pediatric Pharmacology Research Unit, 1 of 13 units in a network of the National Center for Child Health and Development. He previously was a professor of pediatrics at the University of California, Davis. He is editor of the journal Pediatric Nephrology and past president of the American Society of Pediatric Nephrology. Dr. Chesney serves as president of the Association of Medical School Pediatric Department Chairs, president of the American Pediatric Society, and in 2000 was chairman of the board of the American Board of Pediatrics. His ongoing research interests include the regulation of renal amino acid transport; inherited renal tubular disorders; and the physiology, biochemistry, and clinical application of vitamin D metabolites to childhood disorders of bone and mineral metabolism.

Francis Sessions Cole III, M.D., is vice chairman of the Department of Pediatrics, the Park J. White, M.D., Professor of Pediatrics, and professor of cell biology and physiology at the Washington University School of Medicine and director of the Division of Newborn Medicine at St. Louis Children’s Hospital. He is a member of the Society of Pediatric Research, the American Society for Clinical Investigation, and the American Pediatric Society. Dr. Cole served on the IOM Committee on Palliative and End-of-Life Care for Children and Their Families. His research interests focus on the molecular basis of the susceptibility of the newborn infant to infection and, more recently, on the contribution of genetic variation in the surfactant protein B gene to the risk of respiratory distress syndrome in newborn infants.

Deborah L. Dokken, M.P.A., is a family health care advocate and consultant in family-centered care. She is a member of the Institutional Ethics Forum at Children’s National Medical Center in Washington, D.C. She and her husband are the parents of three children born prematurely, one of

Suggested Citation:"Appendix E: Committee Biographical Statements." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

whom survives. Her first child, who died at the age of 5 months, was enrolled in a clinical trial. Ms. Dokken is a coinvestigator with a multisite research project led by the Education Development Center, Boston, that seeks to improve inpatient care for children with life-threatening medical conditions. She was the cofounder of a nonprofit, community-based organization, Partners in Intensive Care, and was a founding member of the Parent Partners Group in the neonatal intensive care unit at the George Washington University Hospital in Washington, D.C.

Celia B. Fisher, Ph.D., is the Marie Ward Doty University Chair, director of the Center for Ethics Education, and professor of psychology at Fordham University, New York City. She has served as chair of the American Psychological Association’s Ethics Code Revisions Task Force, the New York State Board for Licensure in Psychology, and the Society for Research in Child Development Committee for Ethical Conduct in Child Development Research. Dr. Fisher is a member of the Secretary’s Advisory Committee on Human Research Protections (U.S. Department of Health and Human Services) and is also a member of the Data Safety and Monitoring Board at the National Institute of Mental Health (NIMH). Dr. Fisher has written commissioned papers on the ethics of research with mentally impaired and vulnerable populations for the President’s National Bioethics Advisory Commission and for NIMH on the ethical conduct of research involving ethnic minority children and adolescents.

Angela R. Holder, J.D., LL.M., is professor of the practice of medical ethics at the Center for the Study of Medical Ethics and Humanities at the Duke University Medical Center. She was formerly clinical professor of pediatrics (law) at the Yale University School of Medicine. At Duke, among other responsibilities, she oversees the development of educational materials on research ethics for clinical investigators. She served on the IOM Committee on Effects of Medical Liability on Delivery of Maternal and Child Health and the Committee on Palliative and End-of-Life Care for Children. Her research interests include legal and ethical issues related to children and adolescents in the health care system, human subjects research, and confidentiality of medical information. She is the author of Medical Malpractice Law and Legal Issues in Pediatrics and Adolescent Medicine. She is a past president of the American Society of Law and Medicine.

Loretta M. Kopelman, Ph.D., is chair and professor, Department of Medical Humanities, at Brody Medical School, East Carolina University. She serves on eight editorial boards and was president of the Society of Health and Human Values and founding president of the American Society for Bioethics and the Humanities. She edits the research ethics section of the

Suggested Citation:"Appendix E: Committee Biographical Statements." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Encyclopedia of Bioethics. She has edited or coedited six books, including The Rights of Children and Retarded Persons, Ethics and Mental Retardation, and Children and Health Care: Moral and Social Issues. Her research interests include the ethics of research design and the rights and welfare of children, mentally retarded individuals, and research subjects.

Susan Z. Kornetsky, M.P.H., C.I.P., is director of Clinical Research Compliance in the Department of Clinical Investigation at Children’s Hospital Boston. Her responsibilities include directing an institutional review board (IRB) administrative office, assisting investigators in protocol development, and ensuring compliance with all federal and state regulations pertaining to human research. She is a member of the Secretary’s Advisory Committee on Human Research Protections and earlier served on the National Human Protection Advisory Committee and is past president of the Applied Research Ethics National Association. Ms. Kornetsky is a member of the Board of Public Responsibility in Research and Medicine and the Association for the Accreditation of Human Research Programs. She serves as faculty for IRB 101, an educational effort to bring IRB training to individual institutions.

Robert M. Nelson, M.D., Ph.D., is associate professor of anesthesia and pediatrics at the University of Pennsylvania School of Medicine and the Children’s Hospital of Philadelphia. He is also the senior fellow at the Center for Bioethics, University of Pennsylvania. He serves as chair of the Committees for the Protection of Human Research Subjects at the Children’s Hospital of Philadelphia. He is former chair of the Committee on Bioethics of the American Academy of Pediatrics. Dr. Nelson is a member of the Food and Drug Administration Pediatric Advisory Subcommittee, serves as a consultant to the Office of Human Research Protections, and was a member of the Pediatric and Informed Consent Working Groups of the National Human Research Protections Advisory Committee at the U.S. Department of Health and Human Services. His research involves the use of focus groups and individual interviews to explore the views of parents and children about research participation.

David G. Poplack, M.D., is the Elise C. Young Professor of Pediatric Oncology; head, Hematology/Oncology Section, Department of Pediatrics, Baylor College of Medicine; and director, Texas Children’s Cancer Center, Houston. He is principal investigator for the College’s Pediatric Pharmacology Research Unit, 1 of 13 units in a network of the National Center for Child Health and Development. Dr. Poplack is coeditor of the book Principles and Practice of Pediatric Oncology, now in its fourth edition. Before going to Baylor, he was deputy branch chief of the Pediatric Branch of the

Suggested Citation:"Appendix E: Committee Biographical Statements." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

National Cancer Institute and head of the Clinical Pharmacology and Experimental Therapeutics Section. His research has focused on the development of innovative therapies for childhood leukemia and other pediatric cancers.

Bonnie W. Ramsey, M.D., is director of the Cystic Fibrosis Therapeutics Development Network Coordinating Center with the Children’s Hospital Regional Medical Center, which was created to coordinate a network of cystic fibrosis care centers, resource laboratories, and interpretive centers involved in clinical trials. She is also professor of pediatrics at the University of Washington School of Medicine, vice chair for Research, and associate director of the Core Center for Gene Therapy in Cystic Fibrosis and other genetic disorders at the University of Washington School of Medicine. She was a member of the IOM Committee on Assessing the System for Protecting Human Research Participants.

Diane Scott-Jones, Ph.D., is professor of psychology at Boston College, where she serves on the Institutional Review Board and on the Responsible Conduct of Research Committee. Her research interests include family processes, child and adolescent development, and developmental processes in African-Americans and other ethnic groups. She previously was professor of psychology at Temple University and spent 2 years at the National Science Foundation, where she started a grants program in child learning and development. She is a fellow of the American Psychological Association and the American Psychological Society. She is a member of the MacArthur Foundation Research Network on Successful Pathways through Middle Childhood. She is past editor of the Journal of Research on Adolescence and is currently associate editor of the journal Urban Education and editorial board member of the Journal of Social Issues. She served on the American Psychology Association’s Task Force to revise its Ethical Principles for Research with Human Participants and on former President Clinton’s National Bioethics Advisory Commission, which produced six reports on research ethics and bioethics. She is currently chair of the Research Ethics Committee of the Society for Research in Child Development; Advisory Board member of Harvard University’s Murray Research Center, which archives longitudinal data sets; and participant in a new National Institutes of Health-funded project to develop the course Ethical Issues in Behavioral Health Research.

Stephen P. Spielberg, M.D., Ph.D., is vice president of health affairs and professor of pediatrics and of pharmacology and toxicology at Dartmouth College. He also is the dean of Dartmouth Medical School. He is adjunct professor of pediatrics, medicine, and pharmacology at Thomas Jefferson

Suggested Citation:"Appendix E: Committee Biographical Statements." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

University and adjunct professor of pediatrics at the Robert Wood Johnson Medical School. Previously, he served as vice president of pediatric drug development at Johnson and Johnson Pharmaceutical Research and Development, was professor of pediatrics and pharmacology at the University of Toronto and at Johns Hopkins University, and was at Merck Research. He represents the pharmaceutical industry on the Food and Drug Administration Pediatric Advisory Subcommittee and was the rapporteur for the Pediatric International Conference on Harmonisation Initiative to harmonize pediatric drug development regulations among Europe, Japan, and the United States. Dr. Spielberg served on the National Research Council Subcommittee on Reproductive and Developmental Toxicology. His research interests include mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics, and pediatric clinical pharmacology.

Suggested Citation:"Appendix E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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 E: Committee Biographical Statements." 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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