The blog of the Presidential Commission for the Study of Bioethical Issues

Risk and Minimal Risk: How Low Can You Go?

David Wendler, Ph.D.

David Wendler leads the Vulnerable Populations Unit in the National Institutes of Health Clinical Center’s Bioethics Department. In a conversation ranging from child soldiers to high school car washes, he led the Presidential Commission for the Study of Bioethical Issues through an exploration of minimal risk and societal benefit that will help inform the Commission’s deliberations on medical counter-measures for children.

Wendler has literally written the book on the ethics of pediatric research (published by Oxford University Press) and has published numerous academic papers on the subject.

“When is it acceptable to have children in an activity with risk that is designed to benefit others?” Wendler asked the Commission.

Wendler then expanded on the definition of minimal risk, providing data on risk levels. The risk of death in everyday activities is 3 per million; disability, 40 per million; broken bones, 300 per million. Moving above these levels to test an anthrax vaccine for children, he noted, depends on how you define the benefit.

Commission Member Daniel P. Sulmasy, M.D., Ph.D., Franciscan Friar, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago, asked Wendler to look at children as a category of vulnerable population. “Does it matter in the moral analysis when the benefits of the research help this category?”

“But what is their group?” Wendler asked in response. “You can define children in so many ways, by age, ethnicity, height and weight. Essentially, you shouldn’t be doing this on people who don’t understand what you are doing unless you have to.”

Dr. Amy Gutmann, Commission Chair and President of the University of Pennsylvania, asked about a pair of public research polls discussing situations in which children take physical risks above the norms.

“We accept the idea of children taking on risk for the benefit of their siblings,” she pointed out. “And we dislike the idea of child soldiers, where children take risks for the benefit of their country.”

Where, she pondered, does the testing of medical counter-measures for children fit in?

Wendler responded by examining the risk in car washes. “There are lots of schools,” he said, “Where they take 10 to 17 year-old kids and they’re standing by the highway with a big sign and they’re collecting money for hurricane victims. These risks are downplayed.”

Wendler then posed a separate question to the Commission. “You’ve got someone in serious trouble, you’ve got someone drowning, you’ve broken your leg and can’t go, would you send your 14 year-old in?”

The answer always depends, he pointed out. “The chances that the project will succeed are tremendously important.”

“There are very few moments in life when children can make a difference that adults cannot. This might be another situation,” he concluded, “Adults can’t be the final test subject of a vaccine for children.”

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

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