Background: Innovative surgery is not clearly defined, nor is it formally regulated by governing bodies as is the development of drugs and medical devices. This unclear status and the subsequent questionable applicability of existing federal guidelines for human subject research pose an ethical concern. To clarify its position, we solicited US surgeons' definitions of, opinions toward, and attitudes about innovative surgery. Surgeons were also invited to self-report knowledge about current federal regulations guiding human subject research and rules for informed consent for and IRB review of clinical research.
Study design: A group of US surgeons received a 46-item questionnaire addressing the definition of innovative surgery versus those for research and practice, regulations for human subject research, need for specific informed consent, and IRB review of surgical innovations.
Results: A total of 665 responses were used in the content analysis. Respondents expressed a fairly prudent stance when judging hypothetical innovative scenarios. Hallmarks for experimentation and clinical research as modes of innovation were defined more clearly for the surgical situation.
Conclusions: Defining criteria exist that prompt added scrutiny and previous review of surgical innovations. Some forms of innovation clearly fall under the current regulations for human subject research; others might not fully meet the definition but could still require some additional oversight.