Surgical Innovation
What is surgical innovation and how is it (sometimes) different from research?
Although a frequently used term, surgical innovation is not clearly defined nor is it regulated by governing bodies, as is the development of new drugs and devices. There is no "surgical FDA" that would guide surgeons in the ethical introduction of new surgical procedures, techniques and therapies.
Uncertainties and disagreement subsist among surgeons as to what is an acceptable variation on an existing technique versus when the introduction of an innovation amounts to human experimentation, warranting formal overview such as by IRB submission.
It appears that most authors on this subject can agree on one approach to this problem: that surgical innovation has a broad and vague definition. Arguably, it covers a spectrum of activities, ranging from minor modifications in clinical care and surgical technique to complex and sometimes risky experimental surgery with or without controlled clinical trials comparing two operative techniques.
With regard to this spectrum, we believe that routine and minor intra-operative innovation should be viewed as treatment for the benefit of the individual patient, and continue to rely on professional surgical ethics; on the other hand, prospective trials comparing techniques (even in the absence of a formal protocol) clearly amount to research and should comply with ethical and regulatory standards for human subjects' research.
Between the two ends of the spectrum, where the innovation is neither clearly a research activity nor a routine variation on clinical practice, however, current practice guidelines remain too vague or inadequate for the protection of patients, surgeons, and the public interest.
This web course is also intended to help surgeons and surgical residents learn to distinguish and recognize the various forms of surgical innovation and subsequently apply the necessary ethical guiding principles and regulations.