Research in Developing Countries: Taking "Benefit" Seriously

By Glantz, Leonard H.; Annas, George J. et al. | The Hastings Center Report, November 1998 | Go to article overview

Research in Developing Countries: Taking "Benefit" Seriously

Glantz, Leonard H., Annas, George J., Grodin, Michael A., Mariner, Wendy K., The Hastings Center Report

An April 1998 New York Times Magazine article described Ronald Munger's efforts to obtain blood samples from a group of extremely impoverished people in the Philippine island of Cebu.[1] Munger sought the blood to study whether there was a genetic cause for this group's unusually high incidence of cleft lip and palate. One of many obstacles to the research project was the need to obtain the cooperation of the local health officer. It was not clear to Munger, or the reader, whether the health officer had a bona fide interest in protecting the populace or was looking for a bribe. The health officer asked Munger a few perfunctory questions about informed consent and the study's ethical review in the United States, which Munger answered. Munger also explained the benefits that mothers and children would derive from participating in the research. The mothers would learn their blood types (which they apparently desired) and whether they were anemic. If they were anemic, they would be given iron pills. Lunch would be served, and raffles arranged so that families could win simple toys and other small items.

Munger told the health officer that if his hypotheses were correct, the research would benefit the population of Cebu: if the research shows that increased folate and vitamin B6 reduces the risk of cleft lip and palate, families could reduce the risk of facial deformities in their future offspring. The reporter noted that the health officer "laughs aloud at the suggestion that much of what is being discovered in American laboratories will make it back to Cebu any time soon." Reflecting on his experience with another simple intervention, iodized salt, the health officer said that when salt was iodized, the price rose threefold "so those who need it couldn't afford it and those who didn't need it are the only ones who could afford it."

The simple blood collecting mission to Cebu illustrates almost all the issues presented by research in developing countries. First is the threshold question of the goal of the research and its importance to the population represented by the research subjects. Next is the quality of informed consent, including whether the potential subjects thought that participation in the research was related to free surgical care that was offered in the same facility (although it clearly was not) and whether one could adequately explain genetic hypotheses to an uneducated populace. Finally, there is the question whether the population from which subjects were drawn could benefit from the research. This research intervention is very low risk--the collection of 10 drops of blood from affected people and their family members. The risk of job or insurance discrimination that genetic research poses in this country did not exist for the Cebu population; ironically, they were protected from the risk of economic discrimination by the profound poverty in which they lived.

Even this simple study raises the most fundamental question: "Why is it acceptable for researchers in developed countries to use citizens of developing countries as research subjects?" A cautionary approach to permitting research with human subjects in underdeveloped countries has been recommended because of the risk of their inadvertent or deliberate exploitation by researchers from developed countries. This cautionary approach generally is invoked when researchers propose to use what are considered "vulnerable populations," such as prisoners and children, as research subjects.[2] Vulnerable populations are those that are less able to protect themselves, either because they are not capable of making their own decisions or because they are particularly susceptible to mistreatment.[3] For example, children may be incapable of giving informed consent or of standing up to adult authority, while prisoners are especially vulnerable to being coerced into becoming subjects. Citizens of developing countries are often in vulnerable situations because of their lack of political power, lack of education, unfamiliarity with medical interventions, extreme poverty, or dire need for health care and nutrition. …

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