The movement of clinical research overseas reflects an array of economic, social, and political forces related to such factors as the cost of doing research and the rigors of regulations governing the conduct of research (and the ease of on-site inspection of research sites). It also reflects the higher prevalence of many serious medical problems in less developed countries and, thus, the larger pool of potential research participants. This is not a trivial attraction, given that most children in developed countries are healthy, which means that recruiting sufficient numbers of children for clinical studies is often difficult.

As noted earlier in this chapter, international research can raise problems of justice, particularly when sponsors of research in resource-poor countries largely ignore the needs of those of countries; for example, when knowledge derived from research in those countries will mainly benefit wealthier countries. This may occur when diseases that are rare in wealthy nations but common in poorer countries are neglected or when the prices or costs of new preventive or therapeutic measures are beyond the resources of poorer countries.

A major impetus for the CIOMS guidelines has been concerns about ethics in international biomedical research and the challenges of applying universal ethical principles “in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care” (CIOMS, 2002, online, unpaged). The Declaration of Helsinki, last revised in 2000 and 2002, also reflects concerns about justice in research involving resource-poor countries (WMA, 2002).

The next chapter considers many of the challenges in undertaking research involving infants, children, and adolescents. It also outlines the necessity and rationale for this research.

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