EDITORWe read with some concern the Annotation by Mason et al¹ in which she seems to endorse a major paradigm shift in the informed consent process for neonatal randomised trials. But she does not provide sufficient evidence (as opposed to opinions) that such a shift is really needed. Although reference has been made to an ongoing European study which will "determine the validity of the consent process from the viewpoint of...parents of babies requested to provide proxy consent," Dr Mason has already concluded that "the existing position with regard to informed consent for neonatal research is problematic." She questions the rational basis of the consent process, especially for "those who are poorly educated and emotionally stressed." She also states that voluntariness may be undermined because of the complexity of the medical arguments, feelings of parental powerlessness, and inadequate time for information transfer.

We recently published the first study . . . [Full text of this article]