ABSTRACT
This chapter examines the workings of Research Ethics Committees (RECs) in 11 European countries, and their effectiveness as ethical regulators. It focuses on the treatment by RECs, in the sample countries, of an important and difficult ethical issue, the obtaining of informed consent for neonatal randomised controlled trials. In the absence of an audit process it is obviously hard for RECs to determine to what extent it is possible for parents to gain adequate understanding to decide in an informed way whether or not to enter their child into a trial. Similarly it is difficult for committees to assess whether parents may sometimes suffer from problems of coercion, or whether their competence to decide is ever adversely affected by their emotional condition. RECs clearly consider the informed consent of parents is generally an important requirement if a trial procedure is to be ethically defensible. They give a good deal of time to scrutiny of the parent information sheet.
