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Children in Medical ResearchAccess versus Protection$
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Lainie Friedman Ross

Print publication date: 2006

Print ISBN-13: 9780199273287

Published to Oxford Scholarship Online: May 2006

DOI: 10.1093/0199273286.001.0001

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Clinical Asthma Trials

Clinical Asthma Trials

Chapter:
(p.220) 13 Clinical Asthma Trials
Source:
Children in Medical Research
Author(s):

Lainie Friedman Ross (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/0199273286.003.0014

This chapter examines four ethical issues raised by clinical asthma research involving children subjects: (1) to what extent are clinical asthma trials designed as placebo-controlled trials as opposed to active-drug controlled trials?; (2) do placebo-controlled trials in a condition like asthma place the research subjects at increased risk of harm?; (3) are the new guidelines promoting increased access of children to research changing the enrollment pattern of children in research?; and (4) are the new guidelines achieving their goal of garnering useful information about medication safety, efficacy, and dosing for children as a class? It is argued that children are a vulnerable population in clinical research and need additional protection. This means that the former recommendations of the National Commission to perform research first on animals, second on adults, and only then on children should be maintained. It also means that when children are involved, highest scientific and ethical standards must be maintained.

Keywords:   asthma, pediatric research, medical research, placebo, medical ethics

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