Should the Gold Rule? Assessing "Equivalent Protections" for Research Participants across International Borders

There are compelling moral and practical reasons for conducting research across international borders, yet such research can involve particularly difficult ethical issues. Consider the urgent need to develop and evaluate new ways of preventing the transmission of HIV. There is terrible morbidity and mortality associated with the HIV pandemic in certain regions of the world, especially in poverty-stricken parts of sub-Saharan Africa and Southeast Asia. People in wealthier parts of the world arguably have a moral obligation to help, including by engaging in research to find effective ways to lower transmission rates. Yet as those knowledgeable about preventive modalities make clear, new interventions must be tested in the environment where they will be used to ensure that they are culturally acceptable, safe, and effective. Such testing frequently requires collaboration among those working across international borders. While such collaborations can be extraordinarily beneficial and have led to considerable progress, vocal critics have called attention to the ethical challenges that can accompany this research. For instance, there remains considerable debate about the ethical permissibility of research that involved the use of placebo controls in a series of trials assessing the safety and efficacy of methods for decreasing mother-to-child transmission of HIV. More general concerns have arisen about doing research in a host country that would not be acceptable in the sponsoring country (for example, because other treatments or interventions are available in these countries or because they may not be feasible in the host country), about whether the severe constraints of poverty make voluntary participation a realistic option for people within the host countries, and about how the moral beliefs of those in the host country should relate to those of sponsors and investigators. None of these issues have easy answers, yet because how we resolve them is crucial to the design and conduct of vitally needed research, they must be explicitly addressed. A preliminary, overarching question is whether the sponsoring country should impose its own standards and rules or should instead give way to the host country's standards and rules. In the United States, research comes under the jurisdiction of federal regulations for protecting the rights and interests of research participants if the research is federally funded, if its purpose is to seek marketing approval in the United States, or if it is conducted by researchers working in institutions that have agreed always to follow U.S. regulations. Thus, as a condition of funding or collaboration with many U.S. researchers, the U.S. regulations come into play regardless of whether the research itself is taking place in other sovereign nations. It is not unreasonable for the sponsor of research to want to control how funds are spent. Yet the extent to which U.S. rules ought to apply in host countries remains unclear. Perhaps not surprisingly, the imposition of U.S. rules in other nations can seem hegemonic to people who are desperately seeking assistance with devastating social and medical situations. (1) Balancing these competing considerations is tricky but important, since it seems inappropriate either to rely solely on a strict application of U.S. rules or to proceed only according to local standards and rules, regardless of whether they adequately protect the rights and interests of research participants in host countries. In some situations, researchers may be able to find an acceptable balance. In fact, the U.S. federal regulations anticipate this possibility: "When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy.... In these circumstances, if a department or agency head determines that the procedures prescribed by the institution are at least equivalent to those provided by this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. …