Innovation versus Experimentation: An Application of Ethical Frameworks to the Acceptance of Fluorescence-Guided...

Innovation is essential to the advancement of the field of pediatric surgery. The natural skepticism toward new technologies in pediatrics leads to frequent confusion of surgical innovation and research. Using fluorescence-guided surgery as an archetype for this ethical discussion, we apply existing conceptual frameworks of surgical innovation to understand the distinction between innovation and experimentation, acknowledging the spectrum and "grey zone" in between. In this review, we discuss the role of Institutional Review Boards in evaluating surgical practice innovations, and the aspects of certain surgical innovations that are distinct from experimentation, including a thorough understanding of the risk profile, preexisting use in humans, and adaptation from related fields. Examining fluorescence-guided surgery through these existing frameworks as well as the concept of equipoise, we conclude that new applications of indocyanine green do not constitute human subjects research. Most importantly, this example gives practitioners a lens through which they may appraise potential surgical innovations to allow for a sensible and efficient improvement of the field of pediatric surgery. LEVEL OF EVIDENCE: V.