In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.
Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant social value of the kind necessary to fulfill the social value requirement. The article goes on to illustrate how this framework can provide a clearer account of the responsiveness requirement, an ethical dictum that is oft-repeated but whose content and value as a guideline in international research remains contested. Although I introduce this conception of social value in the context of the responsiveness requirement, the account offered can, and is intended to, stand alone as a tool for the assessment of the social value of research. As such it can be usefully applied to discussions about the value of comparative effectiveness trials, the assessment of the continued proliferation of me-too drugs and the research done to develop them, the demand for public access to study-generated data, and persistent deficits in the publication of negative results.
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