National leaders in medicine, law, public health and disease control gathered Nov. 5, 6, at the University of Chicago Divinity School to participate in a two-day meeting of the Presidential Commission for the Study of Bioethical Issues to examine the numerous and complex issues surrounding medical research involving children.
Specifically, what threat conditions would be sufficient or necessary to enroll children in clinical trials of vaccines ahead of any crisis, how would those trials be structured, and what type of study could be done after a terror attack to gather research on the aftereffects.
“How does the duty to protect children from the harms of bioterrorism or epidemics, etc., get balanced against the duty to protect them from potential exploitation or the harms of research,” said Daniel Sulmasy, MD, PhD, Kilbride-Clinton Professor of Medicine and Ethics in the Department of Medicine and the Divinity School, and one of 13 commissioners.
The commission heard from a number of presenters Nov. 5, including Suzet McKinney, Dr. PH, MPH, deputy commissioner in Chicago’s Public Health Preparedness and Emergency Response department and an adjunct professor at the University of Illinois at Chicago.
Based on the challenges from the 2008 meningococcal mass vaccination campaign and the 2009 H1N1 outbreak in Chicago, she urged the committee to include significant community consultation as a key element in effectively protecting children from threat.
McKinney noted certain groups within society have a distrust of government involvement in public health in general, and a more acute sense of distrust when dealing with vaccines.
They need to be included in advance of a crisis to better understand what concerns would need to be allayed to ensure proper acceptance of any medical countermeasures.
Commission members picked up on that suggestion in their discussions on the second day, emphasizing that the community, however that would be defined, needs to be involved from the very beginning.
“An essential component of an ethical framework is to educate the public,” said Commissioner Nita A. Farahany, JD, PhD, professor of law and a research professor of genome sciences and policy at Duke University.
Further, some commissioners agreed that it’s not enough to educate people and have them participate in any trial protocols, but they have to actually agree to be vaccinated.
“People have to be willing to take advantage of the research, and if that doesn’t happen, in some sense we’ve failed,” added Commissioner Anita L. Allen, JD, PhD, the Henry R. Silverman Professor of Law and Professor of Philosophy at the University of Pennsylvania where she is a Senior Fellow in the Bioethics Department, School of Medicine, and was formerly a Deputy Dean for Academic Affairs of the Law School.
The committee is expected for finalize its conclusions and recommendations at its next meeting in January, and issue its report to the president and Sebelius in early 2013.