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

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