Saturday, July 19, 2008

Defining 'responsiveness' in global health research

The concept of the '90/10 gap' has become part of popular consciousness, i.e. the idea that only ten per cent of worldwide expenditure on health research and development is devoted to the problems that primarily affect the poorest 90 per cent of the world's population. This concept -- which even has its own wikipedia entry by now -- was based on old (1990) figures, and the expenditures on diseases affecting the poor have significantly risen in the meantime. There have also been epidemiological transitions among low-income countries, as they have begun to suffer rising rates of cancer, diabetes and heart disease and stroke. Nevertheless, though hard numbers are difficult to find, there is a sense that there is still a lot of biomedical research going on in low-income countries whose impact on health may be greater in developed countries than the host countries themselves. And, of course, the moral intuition that this way of conducting research is unjust.

This moral intuition, in turn, gave rise to the idea that health research should be 'responsive' to the needs of communities in which the research was conducted. The idea of responsiveness has found expression in different international ethics documents, including later versions of the Helsinki Declaration, CIOMS' International Ethical Guidelines for Biomedical Research Involving Human Subjects, and UNAIDS documents. Inevitably, the multiple formulations of 'responsiveness' in all these documents, as well as its variant uses among ethicists, has rendered the concept ambiguous. When is a research project responsive, and when not? Since all research projects typically include some benefits for individual participants or communities, aren't all of them 'responsive' in a sense? So where is the problem? If the concept of responsiveness stays indeterminate, it has no teeth to criticize actual research projects and hence to help counteract the '90/10 gap' . At worst, it just ends up being another stock phrase in global research ethics circles, bounced around at conferences, and ignored (or paid lip service to) by those with power in international research.

In the July 5th issue of the Lancet, Alex John London and Jonathan Kimmelman attempt to give a definition of responsiveness that aims to do some work for global justice. According to London and Kimmelman, " . . . [research] protocols should be defined as responsive to the health needs of the host community only if they are part of a program of inquiry that will expand the capacity of health-related social structures in the host community to meet urgent health needs." Some research -- the authors cite gene transfer studies in Brazil -- going on in low-income countries does not pass the criterion of responsiveness, and at least by this measure, are unethical. There will be inevitably discussions about whether such-and-such study passes or does not meet the responsiveness definition. But the proposed definition will at least do away with arguments that an international research project is 'responsive' because (for example) a laboratory has been set up or a couple of field workers have been hired to faciliate a project that has, in fact, little to do with urgent health needs of the local population.

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