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Consent in genomic research in malaria (MalariaGEN)

Susi Bull

While there is explicit recognition in much of the international and national guidance that consent processes must be appropriately tailored to the research population, the guidance does not address how this should be done in practice. In addition, much of the guidance is at a relatively general level, and does not provide specific advice about how to address specific issues arising when seeking consent. As a result empirical research is beginning to be conducted to examine how consent processes are actually conducted in developing countries, how well they work, and examples of best practice. The proposed research outlined here builds on such studies and examines how best to tailor consent processes to the type of research being conducted and the context in which it is taking place. The qualitative methods used have the flexibility to be adapted to address ethical issues identified in advance by individual sites as of particular concern, and also to identify issues that sites may not have previously considered. Detailed site by site reports on research findings will not only assist the three selected sites to evaluate their own roadblocks when conducting consent processes, and but will also identify means of best practice in addressing these. The findings from specific sites can additionally inform best practice across the network as a whole. Conducting such research will not only demonstrate MalariaGEN’s commitment to best practice when asking prospective participants for consent but is also likely to form a valuable component of the small but growing body of empirical research in this field.