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

Commission Wraps Up Miami Meeting

For the past year the Presidential Commission for the Study of Bioethical Issues has been conducting a careful and transparent review of the ethical considerations of conducting clinical trials of medical countermeasures (MCM) with children.

The examination raises many challenging and complex issues.  MCM research could carry some risk in order to protect children from high consequence events that have an unknown or unknowable likelihood of occurring.  This is the Commission’s fourth meeting on the topic.  A sampling of comments from the meeting in Miami (January 14-15):

Amy Gutmann, Ph.D., Commission Chair:  “We must keep in mind that we do not have a research protocol before us.  We are not equipped to sit as an IRB or a national review panel under Section 407 and it is outside the purview of our Charter to do so.  The question we must address is whether the U.S. Government could ethically support a pediatric AVA study under any circumstance.  We will not render a final decision as to whether a particular study should move forward.  Nor are we working to justify any particular protocol or outcome.”

Amy Gutmann, Ph.D., Commission Chair:  “[In post-event research] there are still ethical guidelines, but they have a different implication when children stand to directly benefit from research. And then you impose no more than necessary risk.  Risk has to be proportionate to the benefit and you still want the informed consent of parents and if possible of children, but there is a direct benefit to the child and that makes all the difference and we absolutely will make sure we articulate that in the report.”

Dan Sulmasy, M.D., Ph.D., Commission Member:  “What I think we need to be clear about, is that by doing age de-escalation protocols, we turn what would be by definition because of the uncertainty more than minimal risk research into minimal risk.  We have got to be very clear about that.”

Christine Grady, Ph.D, R.N., Commission Member:  “We are more resistant in this case to research than we were in the genome project… I think that the reason we are is because it’s MCM research. I don’t think anybody around this table is saying that research with children in general is not a good thing if it finds ways to treat children who are ill, or prevents illness in children.  The issue here of course… is that these are conditions that may never happen, that we hope never will happen, and so we’re sort of balancing a different kind of need than we would be if it was studying a treatment for a disease that kids have.”

Lonnie Ali, Commission Member:  “We always talk about military personnel feeling coerced, perhaps because their superior office is asking; but children too can have that feeling.  ‘I want to please my mother, the doctor;’ so they assent. I feel having somebody in there who is independent [to review the informed consent process] so the child’s not feeling coerced is extremely important.”

Col. Nelson Michael, M.D., Ph.D., Commission Member:  “There is no body of clinical data on the safety and immunogenicity of AVA in children. What is the optimal AVA regimen for children in terms of dose, schedule, route of administration in terms of the critical research results of safety and immunogenicity? What are the correlates of risk of infection and mechanistic correlates of protection for AVA in animal models and, by extension, in vaccinated adults? These are critical questions to ask.”

“Col. Nelson Michael, M.D., Ph.D., Commission Member:  “Given our Commission’s concern about endorsing greater than minimal risk pre-event research with no current benefit to pediatric research volunteers, it seems logical to me to explore the questions above first in young adults in the 18-20 range. Especially in terms of expanded safety data, the assessment of levels of risk could be made in young adults with increased statistical confidence. This, in turn, would influence possible experimental protocol design of a series of age de-escalating safety and immunogenicity studies, starting with 16-17 year old adolescents, that could possibly be done in a pre-event, non-imminent framework if risks could be assessed to be at minimal level or with a minor increment over minimal risk in an imminent threat framework.”

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