The situation Stewart and colleagues describe1 is even more ludicrous in relation to health services research, where the study subjects are often healthcare practitioners or organisations and the methods of investigation are interviews or postal questionnaires. Investigators undertaking health services research are subjected to the same regulatory systems as investigators undertaking clinical trials of treatments where there is genuine uncertainty about the risks to patients. We have examples such as a health services researcher required to have occupational health checks to undertake telephone interviews, and another where an ethics committee objected to qualitative case studies in a handful of patients on the grounds that the sample would not be statistically representative of the population. The former illustrates the system's inability to tailor regulatory procedures to the risks posed by the research. The latter illustrates the system's inability to judge the quality (and hence the ethics) of research that does not fit the conventional biomedical model.
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