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Pediatric PET Imaging pp 59–71Cite as

Issues in the Institutional Review Board Review of PET Scan Protocols

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Abstract

The lack of reliable information on the use of medications for children has been addressed in the United States through two legislative initiatives: the Best Pharmaceuticals for Children Act (BPCA) of 2002 (1) and the Pediatric Research Equity Act (PREA) of 2003 (2). These two initiatives have stimulated pediatric pharmaceutical research, resulting in valuable information to guide the appropriate use of many medications (3). In addition, the National Institutes of Health now requires (as of 1998) that children be included in research unless there are scientific and ethical reasons not to include them (4). The resulting increase in pediatric research has led to concerns that the regulations governing pediatric research provide insufficient protection. This chapter refers to only the Food and Drug Administration (FDA) regulations governing research with children (21 CFR 50 and 56), as the use of radiopharmaceuticals in PET scanning is regulated by the FDA. Comparable regulations are found in 45 CFR 46, subparts A and D.

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Author information

Authors and Affiliations

  1. Departments of Anesthesiology, Pediatrics and Critical Care Medicine, University of Pennsylvania, Children’s Hospital of Philadelphia, Philadelphia, PA, 19104, USA

    Robert M. Nelson

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  1. Robert M. Nelson
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Editor information

Editors and Affiliations

  1. Department of Radiology, Division Head of Nuclear Medicine, Research Institute The Hospital for Sick Children University of Toronto, Toronto, M5G 1X8, Canada

    Martin Charron MD, FRCP(C) (Professor, Head of Research for Diagnostic Imaging Senior Associate Scientist) (Professor, Head of Research for Diagnostic Imaging Senior Associate Scientist)

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© 2006 Springer Science+Business Media, Inc.

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Nelson, R.M. (2006). Issues in the Institutional Review Board Review of PET Scan Protocols. In: Charron, M. (eds) Pediatric PET Imaging. Springer, New York, NY. https://doi.org/10.1007/0-387-34641-4_6

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  • DOI: https://doi.org/10.1007/0-387-34641-4_6

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-0-387-28836-9

  • Online ISBN: 978-0-387-34641-0

  • eBook Packages: MedicineMedicine (R0)

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