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The slippery concept of innovation could be applied to all areas of medicine, but surgery has most frequently made use of the term. The rising demand for more ethically sound innovation in surgery from the surgical, the bioethical, and the lay arena appears to be an open invitation for increased and better applicable regulation of clinical surgical research. In general, risk assessment should involve the child and parents as decision makers and, when the innovative procedure is highly experimental, the insight of an institutional review board (IRB) as well. Achieving evidence-based surgery in the pediatric situation is even more complicated than in the adult arena, due to the increased research protections for children. There are several reasons that surgical innovations are continually introduced into practice outside the research realm and without prior formal scrutiny, and reimbursement is one of them.
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