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Beyond informed consent

In this review article, Zulfiqar Bhutta focuses on recent developments in informed consent and highlights issues relevant to developing countries. This paper provides a very brief history of consent to medical research, before summarising the provisions on consent provisions in recent reports and guidance. Current areas of concern are identified and briefly discussed, including: procedures for obtaining and documenting consent; community versus individual consent; consent on complex issues; ethical review and feedback, consent from vulnerable populations and the lack of research on consent processes in developing countries. The review concludes by making a number of recommendations for improving consent processes. These involve focusing on improving participant understanding, using innovative materials and processes to explain research, finding alternative and more user-friendly means of documenting consent and involving senior staff and communication experts in the consent process.