Research ethics and complex studies

The operation of research ethics committees in England now follows standard procedures. However, the new ethical review process favours research where research questions and protocols can be clearly specified in advance of the study. While this may not be problematic for those conducting clinical trials, it can prove more difficult for qualitative researchers seeking to study complex and changing environments, such as the health service. Here, the changing nature of the services being investigated and the emphasis placed on involving users and carers in the research process, makes it hard to predict methods in advance of the study. This paper argues for greater flexibility within the ethical review process better to respond to the needs not only of this type of research, but also to other research and development activities, such as audit and practice development. It highlights the need for trust, ongoing dialogue, approval of frameworks and codes of practice.