Surgical innovation represents a spectrum of activities ranging from minor “tinkering” to formal investigation of fundamentally different treatment alternatives. While most would acknowledge that the surgeon must exercise a degree of improvisation and individual judgment within the course of many—if not all—operations, the absence of clear guidelines distinguishing idiosyncratic variations from those requiring regulation and oversight creates a range of ethical, legal, and even societal challenges. These challenges are particularly evident in rapidly evolving fields such as minimally-invasive surgery, where therapies are technology-dependent and may be driven by patient perception of reduced postoperative pain, scarring, and time of convalescence. Enthusiasm for innovation must be balanced by concern for patient safety. Scrutiny by the media and various external agencies may erode confidence that caregivers always develop new therapies responsibly and without bias. Because many forms of surgical innovation carry substantial commercial implications, the need for heightened awareness and disclosure of potential conflicts of interest has been emphasized.[1]
In 2004, the Association of American Medical Colleges called upon the surgical community to provide guidance and leadership with respect to issues of disclosure, informed consent, and regulatory oversight of surgical innovation. A recent position statement by the Society of University Surgeons[2] addresses many of these concerns, including recommendations for the types of surgical innovation that might require formal review ( Table 1 ). The consensus panel encouraged the creation of local Surgical Innovation Committees in order to monitor early outcomes, the impact of learning curve, and the need for formal protocol development for evaluation by the Institutional Review Board (IRB) as well as participation in a national registry of surgical innovation such as that maintained by the American College of Surgeons (http://web.facs.org/innovations/innovationsdefault.htm).
In contrast to the unbridled enthusiasm and somewhat unregulated introduction of laparoscopic and other minimally-invasive therapies seen during the 1990s, a more measured approach has been endorsed by leaders of the emerging field of natural orifice transluminal endoscopic surgery (NOTES). NOTES evolved from experimental work[3] demonstrating the feasibility of intraperitoneal surgical intervention with access through transgastric, transrectal, or transvaginal routes without the need for abdominal wall incision. In the wake of anecdotal, possibly premature, reports of application in humans, a working group consisting of leading interventional gastroenterologists (representing the American Society of Gastrointestinal Endoscopists) and minimally invasive surgery (representing the Society of American Gastrointestinal and Endoscopic Surgeons) was established to ensure the safe introduction and systematic evaluation of NOTES.[4] This group has emphasized the need for multidisciplinary collaboration, firmly grounded in laboratory research, with frequent sharing of data, IRB oversight for all human applications, and participation in a national registry.
