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Human subjects protection: an event monitoring committee for research studies of girls from breast cancer families.

Authors
  • Harris, Diana1
  • Patrick-Miller, Linda2
  • Schwartz, Lisa3
  • Lantos, John4
  • Daugherty, Chris2
  • Daly, Mary5
  • Andrulis, Irene L6
  • Buys, Saundra S7
  • Chung, Wendy K8
  • Frost, Caren J9
  • John, Esther M10
  • Keegan, Theresa H M11
  • Knight, Julia A12
  • Terry, Mary Beth13
  • Bradbury, Angela R14
  • 1 Division of Hematology/Oncology, Department of Medicine, The University of Pennsylvania, Philadelphia, Pennsylvania.
  • 2 Division of Hematology/Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.
  • 3 Division of Oncology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
  • 4 Department of Pediatrics/Children's Mercy Hospital Bioethics Center, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.
  • 5 Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
  • 6 Department of Medicine/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada. , (Canada)
  • 7 Division of Oncology, Department of Internal Medicine/Huntsman Cancer Institute, The University of Utah School of Medicine, Salt Lake City, Utah.
  • 8 Department of Pediatrics/Institute of Human Nutrition, Columbia University Medical Center, New York, New York.
  • 9 College of Social Work/Family and Preventative Medicine, The University of Utah, Salt Lake City, Utah.
  • 10 Cancer Prevention Institute of California, Fremont, California; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
  • 11 Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California.
  • 12 Dalla Lana School of Public Health/Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, The University of Toronto, Toronto, Ontario, Canada. , (Canada)
  • 13 Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.
  • 14 Division of Hematology/Oncology, Department of Medicine, The University of Pennsylvania, Philadelphia, Pennsylvania; Department of Medical Ethics and Health Policy, The University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: [email protected]
Type
Published Article
Journal
The Journal of adolescent health : official publication of the Society for Adolescent Medicine
Publication Date
September 2014
Volume
55
Issue
3
Pages
352–357
Identifiers
DOI: 10.1016/j.jadohealth.2014.03.007
PMID: 24845866
Source
Medline
Keywords
License
Unknown

Abstract

An EMC provides an alternative oversight approach where additional independent assessment and oversight of study-related risks are desired, particularly in the setting of vulnerable populations, children and adolescents, or where risks nontraditional to the medical field (i.e., social, emotional, or cultural) are possible.

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