Christine Bezouska, University of Pittsburgh
While IRB review of human subject research is well-established in academic medicine, oversight of technical innovation, especially in surgery, is not. The goal of protecting the interests of human patients and subjects is accepted; the best means to that goal is very much in dispute. Some authors assert that all innovation is essentially research, and should be treated as such. Others recognize a difference between innovation and research, but see a need to better understand the developmental processes involved in innovation. This paper considers the nature of clinical innovation in surgery, where technical innovation is particularly important. I examine two historical examples of surgical innovation, and propose that such innovations typically evolve through three distinct stages. These stages differ in the degree to which the surgeon is motivated by his or her care-giving duties, versus the desire to acquire new information. The ethical justification for innovation and the potential need for third-party oversight at each stage are derived from the fundamental trust relationship between physician and patient. Possible systems for regulating the dissemination of new technologies and techniques, including approaches currently being tried in other countries, are briefly considered.