摘要：To avoid exploitaiton of host communities, many commentators argue that subjects must receive the best methods available worldwide. Others worry that this requirement may block important research intended to improve health care, especially in developing countries. To resolve this dilemma, we propose a framework for the conditions under which it is acceptable to provide subjects with less than the best methods. Specifically, institutional review boards should assume a default of requiring the “worldwide best” methods, meaning the best methods available anywhere in the world, in all cases. However, institutional review boards should be willing to grant exceptions to this default for research studies that satisfy the following 4 conditions: (1) scientific necessity, (2) relevance for the host community, (3) sufficient host community benefit, and (4) subject and host community nonmaleficence. THE DISTRIBUTION OF HEALTH care around the world is marked by dramatic inequalities. Individuals in developed countries typically have access to safe water, new vaccines, and effective medications; individuals in developing countries often have access to little or no health care at all. These inequalities in health care have contributed to significant inequalities in health, with individuals who happen to live in the developing world experiencing far greater disease burdens and far shorter lives than individuals in the developed world. These inequalities have also led to a debate over what clinical investigators can do to improve health care in developing countries and thereby reduce health disparities between rich and poor. 1– 6 To protect host communities from exploitation, most commentators argue that efforts to improve health care in the developing world should never involve research that uses less than the “worldwide best” 7 methods, meaning the best methods available anywhere in the world. 8– 15 Most notably, paragraph 29 of the Declaration of Helsinki states: “The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.” 7 Similarly, Shapiro and Meslin, chairman and executive director of the US National Bioethics Advisory Commission write: “In our view, an experimental intervention should normally be compared with an established, effective treatment . . . whether or not that treatment is available in the host [developing] country.” 16(p140) A ban on research using less than the worldwide best methods would definitively address the potential for such research to exploit host communities. Yet, such a ban may also block important research designed to improve health care for the world’s poor. Is it possible to address the potential for exploitation while allowing research that has the potential to benefit the host communities? The debate over what standard of care should be required for individuals participating in research trials typically focuses on research conducted in developing countries by investigators from developed countries. This focus makes sense. Most clinical research is conducted by investigators from developed countries, and most communities lacking access to good health care are located in developing countries. Nonetheless, researchers from developing countries may also exploit host communities. And communities in developed countries sometimes lack access to the best methods available worldwide, increasing the potential that they may be exploited. A complete analysis, then, should address the potential for exploitation independent of the nationality of the investigators, or the geographic location of the study.
