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Medical ethics

Bioethics commission meets at UM to consider testing anthrax vaccine on children

 

A 13-person commission is taking a year to analyze the ethical issues of whether children can participate in research to determine safe dosage levels of an anthrax vaccine.

 

The commission on bioethics, on the back from left to right are Dr. Nelson Michael, Yolanda Ali, Dr. Stephen Hauser, Dr. Alexander Garza, John Arras, Dr. Daniel Sulmasy, Christine Grady, Dr. Barbara Atkinson. On the front are Raju Kucherlapati, Nita A. Farahany, Amy Gutmann, James Wagner and Anita Allen.
The commission on bioethics, on the back from left to right are Dr. Nelson Michael, Yolanda Ali, Dr. Stephen Hauser, Dr. Alexander Garza, John Arras, Dr. Daniel Sulmasy, Christine Grady, Dr. Barbara Atkinson. On the front are Raju Kucherlapati, Nita A. Farahany, Amy Gutmann, James Wagner and Anita Allen.
Presidential Commission for the Study of Bioethical Issues

aedgerton@MiamiHerald.com

Lee said the last factor that makes this research different is the hope that the results will never be used.

“This is an extremely unusual question, and we haven’t been able to find the perfect analogy,” Lee said. “It really is without precedent.”

In public meetings held in Washington D.C., Chicago and Miami, the commission has consulted scientists, representatives from the Food and Drug Administration, pediatricians, vaccine researchers and other academics. Monday, the commission heard the testimony of two philosophy professors who specialize in bioethics.

Tom Beauchamp, a professor of philosophy at Georgetown University, spoke to the commission via video chat. Beauchamp was one of the authors of the Belmont Report, the 1978 paper that established the first ethical guidelines for conducting research on humans.

He questioned the commission on informed consent, both for minors who by legal definition can’t give consent and also for their parents. He recommended the consent process be observed by an independent person who is knowledgeable about the research but does not have a personal interest in the research going forward.

Dennis Thompson, professor of public policy at the Harvard University Kennedy School of Government, raised questions about minimal risk, pointing out that “risks of government-sponsored experiments are not of the status ethically as the risks to which parents expose their children in daily life.”

While commending the commission for the ethical heavy lifting they’d already done, Thompson also pointed out that ethical questions are unlike case law, which is based on legal precedents.

“This is not a judicial proceeding or process – too much respect for precedent, especially when the history of cases is so short and probably too permissive,” Thompson said. “That can lead to underestimating risks or getting distorted, I think, a misleading set of standards and examples for what should be permitted.”

The commission’s job was not to definitively answer these questions, but rather to provide ethical guidance for the government’s decision on future research. They left Miami Tuesday with consensus on some of the stickier issues like the definition of “minimal risk” and the “de-escalation” of research that would begin with adolescents.

The commission will fashion its year-long deliberation into a report destined for the desks of the U.S. president and his secretary of health, who will then decide if this research should be pursued.

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