1 BEN CAMPBELL INFORMED CONSENT IN DEVELOPING COUNTRIES: MYTH OR REALITY? In the last decade, biomedical research conducted by researchers from developed countries in developing countries has been a topic of significant controversy. One serious concern is that research participants in the developing world are unable to give valid informed consent and thus are highly susceptible to exploitation. Some critics voice concerns about understanding—perhaps no matter how extensively researchers explain the details and essence of a particular study, uneducated participants will never be able to grasp what is being presented to them. Others claim that it is virtually impossible for participants in such settings to freely and voluntarily join a clinical trial. These worries about voluntariness appeal to the argument that most subjects have no other option but to enter research studies and are therefore not able to make fully autonomous, uncoerced decisions. Together, these critics believe that valid informed consent is not obtained nearly enough in clinical research in the developing world. Undoubtedly, conditions of poverty and poor education make it more difficult to uphold this ethical requirement of clinical research, as the critics suggest. However, I argue that there is no reason to believe that valid informed consent is impossible to obtain in such settings. Beyond this, I offer some considerations for how we might improve the quality of informed consent, in both developing and developed settings. Here, I emphasize the need to employ a more serious interdisciplinary approach to research ethics. Only by considering multiple perspectives—using empirical and qualitative work in philosophy and anthropology—can we improve the quality of informed consent and minimize the possibility of exploitation in the increasingly globalized efforts of biomedical research. WHAT IS INFORMED CONSENT? Informed consent represents the need to respect people‟s autonomy. Although it is never entirely sufficient for ethical clinical research, informed consent is widely2 recognized as a requirement for ethical research on human subjects. Three requirements are necessary in order to obtain valid informed consent from either the participant or his or her surrogate. First, participants must be accurately informed of the purpose, methods, risks, benefits, and alternatives of research. Second, they must understand this information and how it is related to their personal clinical situation. Third, individuals must make a voluntary and uncoerced decision whether to participate (Emanuel et al. 2000, 2706). Each of these elements is necessary to ensure that individuals freely and rationally determine that the research is consonant with their interests. For the purpose of this paper, I will assume that the first requirement is generally upheld. Certainly it is always possible for researchers to disclose to participants the relevant information involved in a study. The real concern is with the latter two requirements, namely participant understanding and voluntariness. Let‟s look first at the possibility of obtaining participant understanding in clinical research in developing countries. OBTAINING ADEQUATE UNDERSTANDING Is the validity of informed consent severely jeopardized in research conducted in areas with poor education or little familiarity with biomedical research? Many critics who believe this to be true site anecdotes like the following from a 1997 New York Times article: They gave me a bunch of pills to take, and told me how to take them. Some were for malaria, some were for fevers, and some were supposed to be for the virus. I knew that there were different kinds, but I figured that if one of them didn‟t work against AIDS, then one of the other ones would (French). This account, taken from a participant in one of the controversial AZT trials in Cote d‟Ivoire, raises serious concerns about participant understanding, the second requirement of valid informed consent mentioned above. This example cannot be generalized to all trial participants in the developing world. However, the case is understandably disconcerting for those who prioritize participant understanding in biomedical research.3 Undoubtedly, there are many barriers to ensuring participant understanding in research. Language and cross-cultural differences are among the more daunting hurdles. Some languages lack certain words and many cultures cannot readily conceptualize important biomedical and scientific ideas (LaFraniere 2000). For example, it is oftentimes very challenging for researchers to explain to participants the concepts of a placebo and randomization (Hawkins, Emanuel 2008, 24). Some argue that poor and uneducated participants cannot fathom these ideas regardless of a researcher‟s efforts to explain them. However, it is not evident that research participants in the developing world even have these characteristics. For example, a recent survey conducted in Thailand found that as many as 72 percent of participants in an HIV trial had completed high school (Pace el al. 2003). Not only are assumptions about participant characteristics unwarranted; there is also no substantial evidence that understanding differs between participants in the developing world and those in developed countries. When it comes to the concept of randomization, for example, empirical data show that there is no significant difference in understanding between the settings (Campbell et al., in press). Rather than assuming the inability of some people to grasp western biomedical concepts, researchers need to realize that understanding suffers in both developed and developing settings and that the real focus should be on adapting the universal paradigms of research to local cultural norms, ideas, and literacy levels. This is echoed by Emanuel et al., who say that the ethical requirements of biomedical research “must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted” (2000, 2708). The demanding nature of this task, particularly with informed consent protocols, was revealed by a 2007 study in Tibet. Results from this two-year study show that the presentation of informed consent protocols will be more effective if it is more flexible and focuses on the intent rather than the specific information of the informed consent