Informed Consent in Developing Countries: Myth or Reality?

Ben Campbell | 2008 | Source: Dartmouth Ethics Institute |

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.

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