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There is an urgent need to develop and implement more effective interventions against the major diseases afflicting populations in developing countries. It is important that the performances of such potential interventions are evaluated before they are deployed on a widespread basis, so that the most effective can be selected for use in disease control programmes. Randomised controlled trials are generally agreed to provide the most rigorous scientific evidence of the efficacy of an intervention. However, ethical issues generally arise in the design or implementation of such trials, and some have led to considerable controversy.
In recent years, several organisations have published guidance related to ethical conduct in clinical trials, and there has been some convergence on key issues (see Key ethical guidance applicable to research in developing countries, see page 76). The document that has had the strongest influence and authority is the World Medical Association’s (WMA) Declaration of Helsinki. The Declaration was first elaborated in 1964, and since then eight major revisions have been made. The latest review, completed in 2008, was one of the most comprehensive revisions. This article highlights changes in key areas that are of particular relevance for those involved in the conduct of research in developing countries, particularly in the context of randomised controlled trials (1). |
