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The Ethics of Clinical Trials: A Child's View

Published online by Cambridge University Press:  01 January 2021

Jennifer Rosato
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Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.

The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration (FDA) that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults.

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Journal of Law, Medicine & Ethics , Volume 28 , Issue 4 , Winter 2000 , pp. 362 - 378
Copyright
Copyright © American Society of Law, Medicine and Ethics 2000

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References

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This protection is a variation of 45 C.F.R. § 46.406, but it eliminates references to the subject's disorder or condition since a reference to the subject is unnecessary.Google Scholar
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