Ethics Blog 4

Ethical Issue: FDA Experiment for children

A few years ago, a heavily debate topic was whether or not the FDA should have allowed healthy children to be drugged for scientific research. In this particular study, healthy children between the ages of nine and eighteen would receive a single ten milligram dose of dextroamphetamine, a drug commonly used in Adderall. The goal of this study was to compare those children with ADHD to those without, and also, to gain information about how their brains function differently. Families were given a cash incentive of $570 to have their healthy child participate. When reviewed by the FDA subcommittee, the vote on approval was split.

Although this study had been done nearly twenty years ago, it was performed without regard to current ethical codes or legislation. Many FDA board members thought the experiment’s intentions in expanding knowledge of the drug was a great idea, but it ultimately failed to ethically acknowledge the participating children’s rights. Thus, the study was never approved.

I became interested in this case because it involved children – a different age population than what we normally discuss in class. If this study had been approved, it would have possibly violated the children’s right of autonomy if they participated against their will. Also, I wondered how it would have been right to conduct the study, knowing that most children between ages nine and eighteen would have been unable to fully comprehend the extent of this experience, especially the younger ones. By not understanding the study, they possibly could have been totally unaware that the drug taken could cause temporary insomnia, poor appetite, or hallucinations.

Although parents or researchers could explain the experiment to the child, information, such as possible side effects, could have been withheld, creating an issue of trustworthiness between the child and parent or child and researcher. Since a cash incentive was offered, I feel as if the study was trying to appeal to the parents, who researchers knew would possibly force their child to participate in order to reap the monetary benefit. Also, it goes down to the question if it is fair to drug a healthy child, just to see what will happen and how they compare to a child with a condition, such as ADHD. In this case, I think the answerto the question is no. I understand that researchers want to expand their knowledge in this area of science, but there has to be a safer, more ethical, way of doing so. I am glad the board did not approve this study, for children have ethical rights as well, even if they are not of age. Researchers would never submit an unwilling adult to participate in a study only because his/her spouse wanted it. In my opinion, this experiment would have taken advantage of the participants, healthy children, with their lack of knowledge about the details of the experiment and the possible side effects of the drugs, totally to benefit of the research company.