Research and Human Subjects
Arch Pediatr Adolesc Med. 2002;156:641-642.
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RECENTLY, WE have received a number of manuscripts at the ARCHIVES that
were troubling because of the lack of institutional review board (IRB) examination
and approval. These have included studies by physicians in private practice,
physicians employed by state health departments, and pediatricians in academic
medicine. The rationale in each case was that since patients were not being
contacted, IRB review was unnecessary. We strongly disagree.
The medical research community is under markedly increased scrutiny
by the public for the ethics of the research that we conduct. The death of
18-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania
raised the issues not only of informed consent but also of financial conflicts
of interest by the investigators conducting the trial.1-2
The death of a volunteer in a study of asthma temporarily shut down all federal
funding for medical research at Johns Hopkins Hospital, the top recipient
. . . [Full Text of this Article]
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
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Hodge
J Law Med Ethics 2005;33:125-141.
Instructions for Authors
Arch Pediatr Adolesc Med 2005;159:197-197.
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MANUSCRIPT CRITERIA AND INFORMATION
Arch Pediatr Adolesc Med 2004;158:709-709.
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Arch Pediatr Adolesc Med 2004;158:92-92.
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Arch Pediatr Adolesc Med 2003;157:832-832.
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