Justice and the Human Development Approach to International Research (Cover Story‪)‬

The intimate relationship between disease and conditions of social and economic deprivation has been at the center of an intense debate about the ethics of international medical research for more than a decade. But while this debate has at times been high-pitched and divisive, behind it lies a broad area of agreement. (1) On the one hand, most commentators accept that medical research can and should play an important role in efforts to address the profound health needs of developing world populations. (2) It is often noted, for example, that 90 percent of the world's research dollars are spent on diseases that affect only 10 percent of the world's population--the so-called 10/90 research gap--and that this imbalance in research priorities contributes to the pervasive lack of access to effective medical care in the developing world. (3) On the other hand, there is also widespread recognition that the sheer extent of health needs in the developing world, combined with poverty and social deprivation, make populations there highly susceptible to abuse and exploitation. (4) While medical research is capable of generating important benefits, it can also impose significant burdens. Too often in the past, the burdens of research participation have been borne in the developing world while the fruits of those endeavors are enjoyed principally in developed nations. (5) Unfortunately, the debate about the ethics of international research has not adequately considered the relationship between research and basic issues of social justice that are raised by these background considerations. For instance, although it is recognized that clinical trials in the developing world must respond to the health needs and priorities of the host country, there has been little discussion of the fundamental relationship between a community's health needs and the broader conditions of social justice that help to shape those needs. And while an intense debate has raged over the standard of care that should be provided to research participants, most of it has centered on the interpretation of the international guidelines for research. (6) Broader issues of social justice are centrally relevant to this topic as well, but they have been addressed only at the margins. In fact, the debate about justice has become synonymous with the question of who gets access to the fruits of successful research. (7) An intense focus on the guidelines for international research has effectively confined this debate to the question of whether, and to what degree, research sponsors must ensure that any interventions shown effective in a clinical trial are made reasonably available to the host population. (8)