When is waiver of consent appropriate in a neonatal clinical trial?

It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. How...

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Veröffentlicht in:	Pediatrics (Evanston) 2014-11, Vol.134 (5), p.1006-1012
Hauptverfasser:	Schreiner, Mark S, Feltman, Dalia, Wiswell, Thomas, Wootton, Susan, Arnold, Cody, Tyson, Jon, Lantos, John D
Format:	Artikel
Sprache:	eng
Schlagworte:	Care and treatment Clinical trials Consent Diseases Emergency Medical Services - ethics Emergency Medical Services - methods Ethical aspects Ethics Rounds Evidence-based medicine Humans Infant, Newborn Infants (Newborn) Informed Consent - ethics Neonatal diseases Parental Consent - ethics Parents & parenting Pediatrics Protocol Randomized Controlled Trials as Topic - ethics Randomized Controlled Trials as Topic - methods Review boards Risk factors
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Zusammenfassung:	It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
ISSN:	0031-4005 1098-4275
DOI:	10.1542/peds.2014-0207