Genomic research has the potential to improve global health by elucidating basic mechanisms of disease, susceptibility, and resistance, thereby guiding the development of preventive interventions [1]. Recently developed methods for exploring how human genetic variation affects resistance are likely to provide strategic clues about vaccine development for researchers working on malaria, HIV, tuberculosis, and other diseases of the developing world [2].

A key scientific challenge facing the genomic epidemiology of common diseases is the vast number of genetic and environmental factors potentially involved. Taken together with the fact that certain genetic effects may be more apparent in some populations than others, this means that genomic epidemiology studies must often include large numbers of participants across multiple populations. Such studies pose not only scientific but also ethical challenges, including how to achieve valid consent for the collection of large numbers of samples and phenotypic information across a variety of diverse, often resource-poor settings.

While there are many statements setting out ethical principles for biomedical research in developing countries [3–5], there are few validated methods by which to apply those principles to large-scale genomic studies. While the concept of “valid consent” as codified in the Declaration of Helsinki has long been established as a cornerstone of ethical research, the interpretation of this concept in practice is not straightforward [6–8] and is further complicated by the fact that what guidance there is on consent tends to be biased towards clinical trials and does not address novel issues raised in genomic studies [8].

Drawing on experience gained from a long-term programme of basic and applied research on malaria in Mali, including smaller-scale genetic studies [9,10], and from current efforts to bring together malaria research groups across multiple centres on four continents, we discuss the practical challenges of defining and obtaining valid consent for genomic epidemiological research in developing countries.

Citation: Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, et al. (2007) Valid consent for genomic epidemiology in developing countries. PLoS Med 4(4): e95.