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Ethical considerations in the design and conduct of a cluster-randomised mycotoxin mitigation trial in Tanzania

Aflatoxins are fungal metabolites that commonly contaminate staple food crops in tropical regions. Acute aflatoxin consumption in very high concentration causes aflatoxicosis and acute liver failure, while chronic, moderate levels of intake cause hepatocellular carcinoma. The effects of frequent moderate- to high-level exposure during infancy, however, is less clearly understood. Half a billion people in low- and middle-income countries continue to be exposed to aflatoxins through dietary consumption, in part because of lack of enforcement of regulatory limits and few feasible long-term mitigation options in these settings. Several epidemiologic studies have shown an association between aflatoxin exposure in infants and young children and growth failure, but strong experimental evidence is lacking. The Mycotoxin Mitigation Trial conducted in Tanzania was a cluster-randomised trial to assess the effect of a reduced aflatoxin diet on linear growth. Prior to the design and implementation of this trial, a group of multi-disciplinary and multi-national scientists reviewed literature in biomedical, public health, environmental health ethics. In this paper we outline the most salient ethical questions and dilemmas in the potential conduct of such a study and describe the ethical precedents and principles that informed our decision-making processes and ultimate study protocol.