The Fair Benefits Approach Revisited

In this issue, Alex London and Kevin Zollman provide an analysis of an influential approach to the ethics of international research, known as the “fair benefits” approach. According to them, the fair benefits approach suffers from a fatal flaw: it is either too vague to be useful, or worse, is internally inconsistent.

The fair benefits approach was developed based on a presentation I gave at a workshop organized in Malawi in March 2001 by the National Institutes of Health Clinical Center’s Department of Bioethics. In this presentation, I made what I still think is a valid point, which was accepted by the diverse group of participants and formed the basis of the subsequent publications: One should not require guaranteed availability of a product as a necessary condition for approval of research proposals. Research can address important health needs and priorities of host countries in other ways than by product development. This can be plausibly argued in the Thai Havrix case, for example. If that trial was the most prudent use of in-country resources to develop infrastructure to address important health needs and priorities for the Thai population, then it was justified even though the product of that trial itself was not particularly useful for the Thai population.

Two additional claims that can be attributed to those who advocate the fair benefits approach are, however, rightly criticized by London and Zollman. These are, first, that only the distribution of burdens and benefits among those involved in a research proposal is relevant when judging its fairness, and second, that benefits should be distributed according to the relative contributions and risks borne by those involved. Those who contribute more and bear more risks should receive more of the benefits resulting from the interaction. In addition to ignoring background conditions of injustice, these claims fail to take into account why we do research in the first place.

Surely it is appropriate to consider whether a proposal under consideration is a reasonable use of scarce resources in terms of its expected impact on the disease burden, inside the country or outside. The distribution of benefits among those involved in the individual transaction cannot be the only relevant consideration any more than reasonable availability of the product can be. The fair benefits approach tells us to distribute burdens and benefits according to the relative contributions of the parties to the individual transaction. It recommends the wrong action whenever there are alternatives open to us that represent a better use of scarce research funds than that criterion.

Contrary to what some critics of the approach have advocated, however, prudent use of scarce research resources is not simply to study conditions with a high disease burden in the host country, and therefore to prefer research on HIV or malaria over research on Burkitt’s lymphoma. When prioritizing research, one should not only consider the disease burden in isolation, but also the potential for the research to have an important effect on the disease burden. At least sometimes, this entails that we should choose research where the result—either the product or the knowledge—may not affect the disease burden directly. There may be other aspects of the research that are useful, or, because of the current state of knowledge, there may not be any alternatives that can be expected to have a higher impact on the disease burden. Requiring that research always address diseases common in poor countries may not be the most efficient way to be responsive to important and priority health needs, but one still needs to argue that a particular research proposal is the best way to address such needs.

Alex London and Kevin Zollman’s essay makes it clear that there is something fundamentally wrong with the fair benefits approach. When the normal safeguards to protect human subjects have been satisfied, any additional distribution of burdens and benefits to the individuals involved in a particular research project should be irrelevant when judging its appropriateness. Judging research is not analogous to determining the fair price for a plumber to fix my leaking faucet. The goal of research is to develop knowledge that is most useful...