Responsible Innovation in Children's Surgical Care.

Advances in medical care may occur when a change in practice incorporates a new treatment or methodology. In surgery, this may involve the translation of a completely novel concept into a new procedure or device or the adaptation of existing treatment approaches or technology to a new clinical application. Regardless of the specifics, innovation should have, as its primary goal, the enhancement of care leading to improved outcomes from the patient's perspective. This policy statement examines innovation as it pertains to surgical care, focusing on some of the definitions that help differentiate applied innovation or innovative therapy from research. The ethical challenges and the potential for conflict of interest for surgeons or institutions seeking to offer innovative surgical therapy are examined. The importance of engaging patients and families as "innovation partners" to ensure complete transparency of expectations from the patient's and provider's perspectives is also examined, with specific emphasis on cultural competence and mutually respectful approaches. A framework for identifying, evaluating, and safely implementing innovative surgical therapy in children is provided.