ABSTRACT

The recommendations are the result of reflection on, and discussion of, our empirical findings. The discussions took place mainly at three colloquia at which Euricon partners were present. Analysis of parental and clinician interviews has revealed that informed consent, as understood in the preamble, was obtained unproblematically in approximately one third of parents asked for their consent. If the role of parental informed consent is to protect the neonatal research subject, then its presence to an attenuated degree would seem to imply that research subjects have reduced protection in such cases. Euricon analyses revealed that in none of the participating countries do researchers receive training explicitly in the process of seeking informed consent. Euricon analysis found considerable diversity in the attitudes of committees both within countries and across Europe. The majority seemed to be opposed to such a recommendation, but some felt there were points in its favour.