Undue Fear of Inducements in Research in Developing Countries

Abstract

Prematurely born children who have underdeveloped lungs may suffer a potentially fatal condition called respiratory distress syndrome. A U.S. company developed a drug, called Surfaxin, to treat such poorly functioning lungs. A placebo-controlled study was planned in four Latin American countries (Mexico, Ecuador, Bolivia, and Peru). At the time, in 2001, four treatments were already on the market, although not available to the research populations used in the study. This case is usually discussed as part of the standard of care debate or offered as an example of exploitation. However, what concerns us in this case is rather the choice given to the parents of a prematurely born child under these circumstances: “You can give consent for your child's participation in this study. Half of the babies enrolled will receive sham air and are as likely to die as if they had not enrolled. The other half will receive an active treatment and are more likely to survive.” The parents can vastly increase their baby's chances of survival by participating in the study. Can the consent be voluntary? Do the parents have any meaningful choice?