Clinical research is a morally complex activity. When properly conducted, it represents a powerful tool for generating information and knowledge that often cannot be obtained by other means. When properly oriented, this knowledge represents the key to advancing the standard of care and creating the policies, practices and interventions that can be used to improve the health of large populations of people.

For almost two decades now, clinical research has become an increasingly global enterprise. With the “outsourcing” or “off-shoring” of research, new ethical complexities have arisen that are not easily accommodated within frameworks that are primarily oriented to protecting research participants in a domestic context. In part this is because profound conditions of social, economic and political deprivation and inequality play a fundamental, and sometimes unique, role in cross-national research. Because of such deprivation and inequality, for instance, what is an unreasonable risk for someone in a high-income country (HIC) may represent a valuable opportunity for someone in a low- or middle-income country (LMIC). Similarly, information that has the potential to generate significant social benefits in HICs may be of little relevance to host communities that struggle with poverty and underdeveloped medical, public health and scientific infrastructures.

Although there is widespread agreement that international research should not take unfair advantage of the disease and deprivation in LMICs, there is significant disagreement about what conditions need to be met in order to ensure that research is fair and consistent with fundamental principles of justice (Angell, 1997; Lurie & Wolfe, 1997; Crouch & Arras, 1998; Glantz et al., 1998).