Clinical trials in neonates: ethical issues

Clinical trials in neonatology often raise complex ethical problems. This paper suggests that in tackling these it is useful to identify and separate out those elements of the problem that are genuinely ethical (e.g. can I enter a child into a trial if I am not in personal equipoise?) from those that are empirical (e.g. what is the evidence for a treatment's effectiveness?) and those that are formal (e.g. what do codes or the law permit?) The genuinely ethical elements are examples of philosophical problems and must be tackled in a way appropriate to such problems. In practice this usually means some form of systematic argument. This is often frustrating to clinicians who are more used to the assuredness of empirical research. The paper next examines two ethical problems that arise frequently in neonatal trials. The first is equipoise and the related issue of recruiting parents who are not in equipoise because they strongly desire that their baby get the active treatment. We briefly defend the recruitment of such "desperate volunteers". The second is informed consent. We discuss the nature and value of informed consent and suggest that clinicians can often obtain worthwhile consent even in very difficult trials. The final section of the paper uses the example of clinical trials for brain injury to illustrate the difficulties.