Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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Appendix A: Study Origins and Activities
Appendix A: Study Origins and Activities
Pages 309-319
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Appendices
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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 311
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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.
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study: Housing interventions involving children Jane Ross, Ph.D., Acting Director IOM/NRC Board on Children Youth and Families
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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.
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* 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
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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.
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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
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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.
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* 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.
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