ABSTRACT

The aim of the Euricon study was to examine the validity of obtaining informed consent for neonatal research across Europe, and suggest practical improvements if necessary. This chapter focuses on the experience of parents asked for consent and of clinicians seeking it. Between January 1997 and September 1998, semi-structured interviews were performed with the parents of 200 infants and with 107 neonatologists in nine European countries. The sample of countries was designed to be geographically representative. Euricon clinician partners were asked to categorise the research protocols for which the parent interviewees’ consent had been sought as being non-urgent or urgent and whether they contained no/minimal risk or discomfort or risk or discomfort greater than no/minimal. The findings suggest that the quality of consent given by parents to neonatal research is often problematic; in over two-thirds of cases there was some impairment in at least one of the criteria for valid consent.