Oversight for First-in-Human Surgical Procedures

Abstract

Surgical innovation spans a spectrum from minor modifications of existing procedures to the development of new procedures. Surgeons routinely innovate at the lower end of this spectrum to adapt standardized procedures to the unique needs of individual patients. These innovations can be made at the surgeon's discretion without external oversight because they form part of clinical practice. In contrast, new procedures present challenges for oversight because they occur at the boundary between clinical practice and research. Partial heart transplantation is a new procedure designed to provide growing heart valve substitutes for children. Partial heart transplants differ from heart transplants because only the part of the heart containing the necessary valve is transplanted. The rationale for partial heart transplantation is that the valves contained in pediatric heart transplants grow. After partial heart transplant growth had been experimentally confirmed in a piglet model, the stage was set for first-in-human implementation. This Ethics Rounds article discusses potential mechanisms of oversight for first-in-human surgical procedures. Although all 3 commentators agree that relying solely on individual surgeon discretion is inadequate to protect patients, they differ on the most appropriate form of oversight. The perspectives presented advocate for oversight by local surgical departments, institutional review boards, and specially convened surgical innovation boards.