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05/25/2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement

by David Wendler, PhD

The distribution of resources around the globe is characterized by staggering inequalities and inequities, with the result that individuals in lower income countries have greater disease burden and shorter lives than individuals in high-income countries. Commentators on research ethics are well aware of this concern and have searched for ways to design and conduct clinical trials to help to address it. Much of this work focuses on how to protect individuals and communities in lower income countries from exploitation. In particular, what requirements are needed to prevent clinical investigators and funders from wrongly using participants and communities in lower income countries to develop new interventions for the benefit of high-income countries?

To date, two primary requirements have been endorsed. The first, the “responsiveness” requirement, stipulates that clinical trials conducted in lower-income countries should be responsive to the health needs of those countries. The second, the “reasonable availability” requirement, stipulates that any interventions found to be effective as the result of clinical trials conducted in lower income countries should be made reasonably available to them. More recently, commentators have described a range of other approaches to help to address the potential for exploitation. These include proposals that investigators address the conditions of oppression in host communities, provide host communities with fair benefits, or offer all the added benefits of conducting a clinical trial in lower income countries to those countries.

The article by Denburg and colleagues describes still another way in which lower income countries might benefit from their hosting clinical trials. The authors argue that clinical trials may “function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials.” The basic idea here is that involving local clinicians in clinical trials may lead to improved clinical care. It may lead to local clinicians learning better techniques, developing increased expertise, and becoming more familiar with, and more likely to make treatment decisions based on, the available data.

As the authors are careful to note, there are essentially no data to suggest that the conduct of clinical trials has this effect. In addition, as several of the commentaries point out, conducting clinical trials in lower income countries can have negative infrastructure effects. It can exacerbate inequalities across patients, across regions, and across countries. It can divert local resources from clinical care to research. Granting the potential for infrastructure harms, and the lack of evidence for infrastructure benefits, new thinking about the risks and potential benefits of clinical trials conducted in lower income countries is welcome and the theoretical plausibility of the authors’ proposal provides reason enough to consider its potential implications.

Denburg and colleagues focus on trials that “answer pressing, context-sensitive clinical questions in a pragmatic way, as these are most likely to enhance locally relevant infrastructure.” This makes sense as a way to maximize the potential benefits to lower income countries. And the (theoretical) possibility that this approach may lead to significant benefits for lower income countries suggests that there are at least two ways to understand the responsiveness requirement. Typically, the responsiveness requirement is characterized as requiring that the data to be collected from a trial must be responsive to the community’s health needs. On this characterization, whether a vaccine trial satisfies the responsiveness requirement depends on the extent to which preventing the disease in question is important for the host community.

In contrast, if the potential for infrastructure benefits traces to local clinicians performing community relevant procedures in a high-standards environment, these benefits may be independent of the data being collected in the trial. To see this, imagine that the infrastructure benefits that (might) result from a particular trial trace to local surgeons learning improved techniques for making incisions and suturing, and monitoring patients postsurgery. In this case, realization of the infrastructure benefits is independent of why the surgeons opened up the participants in the first place, whether they are evaluating an intervention that is relevant to the health needs of the host community or not. The potential for infrastructure benefits thus reveals that there are at least two ways in which a clinical trial might be responsive to the health needs of the host community. It might be responsive in the traditional sense that the data being collected is relevant to the health needs of the host community. Or, it might be responsive because the procedures performed and the skills learned in the process of carrying out the trial are relevant to the health needs of the host community. Given the latter possibility, those who endorse the traditional responsiveness requirement will have to explain why responsiveness in terms of infrastructure benefits cannot address the potential for exploitation.

One way to defend the responsiveness requirement is to argue that it helps to address the potential for outcome exploitation: the potential that the host community does not realize a sufficient level of benefits. However, on theoretical grounds, there does not seem to be any reason to think that infrastructure benefits might not be enough to provide the host community with sufficient benefits, at least with respect to some trials. If that is right, it suggests that defense of the traditional understanding of the responsiveness requirement may have to appeal instead to the potential for process exploitation. Specifically, proponents will need to show that in order to avoid wrongfully taking advantage of the conditions in lower income countries, clinical trials must collect data that are relevant to their health needs. The challenge for this defense is to explain why the potential (assuming it exists) that a lower income country might realize important infrastructure benefits as the result of local clinicians’ involvement is not sufficient to justify conducting the trial in that country. Why, in other words, is it necessary for the hosts to benefit from the data to be collected in order to avoid wrongly taking advantage of their circumstances? By considering a new way in which clinical trials might benefit host communities, the present article poses an important challenge for what has long been regarded as a necessary requirement for ethical research in lower income countries.

 

Disclaimer: The opinions expressed are the author’s own. They do not represent the position or policy of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services. Funding: This research was supported by the Intramural Research Program of the NIH Clinical Center. Acknowledgment: Thanks to Joseph Millum for helpful comments on a previous version of the editorial.

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