ABSTRACT

As attention is now being given to the development of Research Ethics Committees (RECs) both at European and national levels, the account presented and analysed must be seen as a snapshot of a changing picture. Questionnaires were sent to RECs in each of 11 countries represented in Euricon. The RECs were asked number of questions about the procedures by which they require informed consent for randomised clinical trials on neonates to be obtained. Almost all committees permit written consent. Some require it, and do not permit oral consent. There are practical reasons for preferring written consent. The requirement for written authorisation emphasises the parent's responsibility for what is being permitted for the baby, and from the doctor's point of view it can serve as concrete evidence that consent has been sought. Although the committees were largely uniform in stipulating who should seek consent from parents, none of the committees surveyed stipulated any training required for those carrying out the task.