Ask The Bioethicist: Guinea Kids

Gary Taxali


Question: Is it ethical to test drugs on children?

Answer: It is not only ethical; it would be irresponsible not to test drugs on children.

Testing drugs on children is the best way we have to assure that the drugs they take are safe and effective. Research on adults is no substitute — because children are not simply small adults. A child’s developing body and an adult’s mature one respond differently to treatments. In fact, in the absence of pediatric clinical trials, pediatric practice itself becomes de facto research. Pediatricians treat the children with untested drugs and observe the consequences.

If this isn’t reason enough, here’s another: Clinical research on children might be the only way to develop treatments for the many diseases that afflict children but not adults. These include terminal illnesses such as Tay-Sachs disease — conditions that typically prevent children from ever reaching adulthood.

But as your question recognizes, carrying out research on children in an ethical fashion poses challenges. Children, especially younger children or infants, cannot give informed consent to participate in a study. And while adults can always decide to sacrifice themselves to help others, we generally do not allow people (even parents) to sacrifice others for a greater good. Not surprisingly, Congress and the U.S. Food and Drug Administration have developed legal guidelines defining when research on children is permissible.

According to these guidelines, research is normally justified in three circumstances. First, it’s permitted if the research exposes a child only to minimal risk. The reasoning goes that if the risk is truly minimal, the sacrifice associated with the study will also be minimal. But opinions differ over the definition of minimal risk. Some limit it to the level of risks a child faces in everyday life — so that collecting urine samples, drawing blood and other minimally invasive procedures would be justified, but nothing more extreme. Others argue that our understanding of risk changes if the child is critically ill. For a very sick child, the risks of everyday life include great suffering and death. Hence, much greater risk could potentially be justified for these children.

Second, if the research might be risky but also might benefit a child participating in the trial, we would generally allow parents to weigh the risks and benefits and decide whether to enroll their child in the study.

Finally, if a trial exposes a child to a relatively small amount of risk (though more than minimal risk), but could lead to important knowledge about a condition that afflicts the child, it is possible to ethically carry out the research.

This means that researchers normally cannot conduct research that exposes a child to a significant degree of risk unless the study offers a real prospect of benefit to the child. In practice, this means that researchers pioneering radically new treatments such as gene therapy — where the mechanisms are unproven and there is virtually no likelihood of benefit during the early phase of research — cannot ethically test the treatments in children. They must first prove the basic strategy works in adults.


David Magnus, PhD, directs the Stanford Center for Biomedical Ethics. Send your questions to or Ask the Bioethicist, Stanford Center for Biomedical Ethics, 701 Welch Road, Suite 1105, Palo Alto, CA 94304

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