Peta Wainwright

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European Union directive or in the guidelines on good clinical practice, and there is little evidence of it anywhere else in Europe. The idea that there can be “local”, as opposed to “central” ethical issues in research is an interesting one, which raises important issues about the nature of research ethics and ethical review. The aim of this paper is to argue that there are no such things as local issues in research ethics, and suggest that those questions currently addressed as local issues properly belong within the research governance framework

There has been an increase in recent years in the use of empirical methods in healthcare ethics. Appeals to empirical data cannot answer moral questions, but insights into the knowledge, attitudes, experience, preferences and practice of interested parties can play an important part in the development of healthcare ethics. In particular, while we may establish a general ethical principle to provide explanatory and normative guidance for healthcare professionals, the interpretation and application of such general principles to actual practice still requires interpretation and judgement. And many situations in healthcare practice are complex and may involve a variety of principles, each of which may conflict with the others. Simple surveys or interview studies may not be sufficient if we wish to develop a nuanced approach to ethical practice that can be set out in guidelines, codes or directives. We do not resolve moral questions by plebiscite. In this paper, the authors argue for the use of consensus methods to develop shared understanding of ethical practice, and they argue further for the combination of the Delphi method with the use of vignettes to illustrate the kind of situations that may occur in practice. They develop their argument in part by reference to their experience of using this approach in their recent research

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients’ assignment at the point of entry into the open label phase, on the grounds that this may introduce ascertainment bias in the main study.It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons

As family physicians, general practitioners play a key role in safeguarding children. Should they suspect child abuse or neglect they may experience a conflict between responding to the needs and interests of the child and those of an adult patient. English law insists on the paramountcy of the interests of the child, but in family practice many other interests may be at stake. The authors argue that uncritical adoption of the paramountcy principle is too simplistic and can lead, paradoxically, to greater harm. They argue for a more subtle and nuanced view of interests and of conflicts of interest in safeguarding children