ETHICS OF DOUBLE BLIND STUDIES IN CHILDREN
Rev. Luz D. Diaz, MA. EdS, Regalo de Vido Program Administrator,
Santa Monica UCLA, specializing in medical ethics
Doing basic research on children poses an extremely emotional problem. It is a great consternation to the mothers to know that one child who will receive air, the other child will receive hyperbaric oxygen. This is especially true when there is a known risk factor at the time of the delivery such as cord strangulation, stroke and some type of severe hypoxic ischemic episode that may be benefited by immediate hyperbaric oxygenation. The question here is not only ethics but also moral. It is imperative that all children be given the very finest available care at any time. In the older child, the design on the crossover study, again is upsetting to the mother but not nearly as emergent as the acute episode. Under these circumstances one group of children will receive air and the other group will receive oxygen. For those receiving the air, they would then, in the next series would be with 100-percent and these children would be used as their own control. Unfortunately, the scientific community today insists upon double blind crossover documentation. It is the purpose of this talk to explain to the parents the possible fact between science, emotion, and research. The certain conditions allocated by Medicare and other agencies, such as the Undersea Hyperbaric Medical Society, are known as covered conditions by insurance and acceptable having had adequate clinical data presented to substantiate them scientifically. In view of the compelling evidence that is forthcoming, additional investigative standards must be formulated and a new category in investigative uses by has been expounded by the UHMS. It is the consensus of the group speaking here today, that the use of hyperbaric oxygenation in Cerebral Palsy and the Brain Injured Child should be academically evaluated to identify the subset of patients in which this therapy is specific. Devising a specific protocol creating a database for standardization will hopefully produce adequate data for insurance and other funding agencies so that when this work is scientifically validated, no child will go without treatment because of financial reasons.