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Delivery Room Research: When Does Poor Quality Evidence Become an Ethical Issue?

Year: 2015

Type: article

Abstract: The November 2014 Ethics Rounds questioned: “When is waiver of consent appropriate in a neonatal clinical trial?” As neonatal clinical trialists, we believe that a waiver of prospective informed consent is often required and ethically appropriate to conduct scientifically rigorous delivery room clinical trials. As Drs Wootton, Arnold, and Tyson acknowledged, many emergency therapies have never been rigorously studied. Neonatal resuscitation medicine is especially bereft of high-level evidence. Only 23 of 157 (15%) publications cited in the 2010 ILCOR statement on neonatal resuscitation were randomized trials or meta-analyses of trials … E-mail: foglia{at}email.chop.edu

Source: PEDIATRICS

DOI: 10.1542/peds.2015-0546a

Authors: Elizabeth E. Foglia, Louise S. Owen, Haresh Kirpalani

Institution: Children's Hospital of Philadelphia

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funder: Eunice Kennedy Shriver National Institute of Child Health and Human Development