266 CHAPTER 4
CLINICAL TRIALS I N DEVELOPING COUNTRIES
RESEARCH IN DEVELOPING COUNTRIES: TAKING BENEFIT SERIOUSLY Leonard If. Glant:. George J. Antlas, Micl~ael A. Grodin, and Wendy K. Mariner
The authors confront the issue of whether it can be acceptaide for researchers in wealthy countries to enroll citizens of developing countries in clinical trials. Citing guidelines published I>y the Council for International Organizations of Medical Sci- ences, the authors argue that t o justify such trials, the risks or burdens imposed o n trial participants must be offset by the prospect of actual benefit to the inhabitants of the developing country. Thus, if the trial yields beneficial knowledge, benefits l l l ~ ~ s t i~ctually reach individuals in the country in which the trial took place; other- wise, the subjects will have been exploited. A practical implication of this approach is that “an essential prerequisite to designing ethical research in underdeveloped countries is identifying the source and amount of funding for providing the fn~ i t s of the research to the people of the developing countryn-a moral requirement that was not satisfied in recent African AZT studies. The authors then consider and reply to a wide range of objections to the ethical standard they propose.
An April 1998 New York Times Magazine article de- scribed Ronald Munger’s efforts to obtain blood samples from a group of extremely impoverished people in the Philippine Island of Cebu.’ Munger sought the blood to study whether there was a ge- netic 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 coopera- tion 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 consen
t 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 appar- ently 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 fami- lies could win simple toys and other small items.
Reprinted with pertnission of Leonard H. Glaritz al~d lhe publisher from Hrt.$rirlgs CEII~PI. Repor!, vol. 28 (November-December 1998). pp. 3842. Copyright 0 1998 by The Hasr~ngs Center.
Munger told the health officer that if his hy- potheses were correct, the research would benefit the population of Cebu: if the research shows that in- creased 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 re- porter 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 il- lustrates almost all the issues presented by research in developing countries. First is the threshold ques- tion 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 partici- pation 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 popu-