THE STANDARD OF CARE DEBATE: CONCEPTUAL CLARIFICATIONS

Abstract

In the June issue of the Journal, Wendler et al. discuss the standard of care for research in developing countries and propose a valuable set of criteria.1 However, there are conceptual issues with important implications for this debate that require clarification. Wendler et al. assert that “inequalities in health care have contributed to significant inequalities in health.”1 Lack of access to and poor quality of health care are neither the most important nor the primary reasons for health inequalities. The social determinants of health, including poverty, status of women, and social vulnerability, are more important.2 This premise is critical, as it frames the context within which people live in the developing world. The authors propose focusing on “methods that communities can implement, if proved successful.”1 This concept has been debated within health systems and health research.3 What information is required to determine which intervention can be implemented? What level of evidence should be required from researchers? Wendler et al. do not operationalize this concept, leaving it a theoretical construct—which does not further the debate from previous discussions. The example of the Glaser Foundation is misplaced, since health care allocations are fundamentally different from decisions within health research. The foundation was maximizing benefit per unit of investment—one rational way of resource allocation for health services. The same type of clinical example for research appears in Wendler et al.’s discussion of Niverapine.1 Health research does not (and should not) have a primary aim of provision of health services, and thus cannot be held to principles of health care distribution. Wendler et al. define a ceiling by calling for defense of any standard of care less than the best in the world. A complementary approach is needed to define the floor, by proposing national standards as the minimum for research studies, even if they can defend the use of a standard less than the world’s best. This would prevent the exploitation of the most disadvantaged groups within developing countries (the worst off). Wendler et al.’s article has important implications for ethics committees in the developing world, in terms of their strengthening and their dialogue with those in the developed world.4 For example, what are the competencies required for making such decisions in institutional review boards? In externally funded projects, which committee has precedence—sponsoring country or host country? Finally, there is a need for greater participation of developing-country researchers, ethicists, and health professionals in this debate.