Introduction

Clinical research involving human participants can run afoul of various ethical dangers, like therapeutic misconception, violations of clinical equipoise, and undue inducement. Many of these dangers are especially perilous for populations who are already vulnerable or at risk of exploitation for political, economic, or social reasons. In international research, these asymmetric power dynamics are increasingly the subject of calls for regulation and ethical oversight, as high-income nations tend to hold all the de facto leverage and bargaining chips over countries or communities of less means.

Ensuring that host communities are adequately compensated for their participation or otherwise appropriately “bear the fruits” of the research in question has become a core tenet in much of the ethical theory surrounding international research. The difficulty of creating ethical procedures alongside checks and balances for international research consists both in the logistical hurdles of implementation and enforcement, but also in the intractable disagreement over what morality demands in the context of these research agreements. The normative question “what is fair?” must be preceded by the metaethical question “what is fairness?” and neither of these questions have found unanimous consensus.

There is general agreement that, minimally, ethical international research ought to secure safe and equitable conditions under which host communities can genuinely consent to research without needlessly stymying research innovation, growth, or ambition. Defining the terms, though, is half of the challenge (e.g., what counts as sufficiently ‘safe’ ‘equitable’, etc.) and the other half is creating theoretical (and eventually, legislative) infrastructure effective in achieving those desiderata when put into practice.

Assigned Readings

“Health Researchers’ Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What Is Morally Required?” — Maria W. Merritt

  • Thesis: Merritt argues that, in order to to develop robust guidelines for providing ancillary care to research subjects, there needs to be a normative model of the obligation to provide said care. She offers a set of performance criteria to judge the success of normative models and applies these criteria to existing normative accounts. Further inquiry can be directed to support improved performance in existing or new normative models.

“Research at the Auction Block: Problems for the Fair Benefits Approach to International Research” — Alex John London and Kevin J.S. Zollman

  • Thesis: London and Zollman criticize the “fair benefits” approach, which aims to bring about “outcomes that are fair in several concrete respects, ensuring that host communities are not exploited, all without taking a controversial stand on divisive questions of social and distributive justice” (London and Zollman, 2010). A central feature of the “fair benefits” model stipulates that host communities themselves be the final arbiters of what is a fair or unfair accrual of proposed research benefits. This feature is intended to empower host communities to self-determine what benefits available are the most valuable or desirable, and what portion of the trial surplus is appropriate to offset the relative risk(s). As the authors note, however, this seems to generate a perverse incentive whereby researchers “auction” off the benefits to the cheapest bidder (I.e., the bidder willing to receive the least in exchange for participation) in a kind of ‘race to the bottom’. The authors conclude that proponents of a fair benefits model need to (a) specify a consistent set of ideals, (b) justify why these ideals are the relevant set, and (c) demonstrate that the proposed procedure is faithful to those ideals (London and Zollman, 2010). 

Discussion Questions

  1. What do London and Zollman believe to be “ambiguous” about the operationalization of the fair benefits approach and how do they envision the operationalization actually playing out? 
  1. London and Zollman are skeptical that the fair benefits approach is truly “purely procedural.” What is its implicit normative content (hint: Wertheimer) and why do they believe that normative content will not work? 
  1. Are there ways of modifying the fair benefits model to combat the outcomes London and Zollman predict? How might the fair benefits proponent reconcile, on the one hand, the host community’s final discretion to determine fairness, alongside expectations that benefits increase with burdens and/or benefits to others, or that benefits must track the relative contributions? 
  1. Do you agree with London and Zollman that the lack of consensus in the international community about fairness renders external critique generated by the principle of transparency an unreliable check? Is it possible that having research exchanges part of the public record will incur some pressure not to attempt research practices which are self-evidently exploitative?