Identifying Surgical Innovation in Practice

Case Scenarios

The following cases provide examples of practices that can be considered clinical research or routine variation in clinical practice. You should read each case and decide which of the descriptions is most accurate. Once you have reviewed all of the cases, you will find a link to another page that lists the best choices for each scenario along with an explanation. You can also see what other surgeons thought when they were asked the comparable questions as part of a survey on innovative surgery.

CASE 1: During a standard operation you depart from the standard procedure by introducing small novelty modifications you believe will improve the patient's outcome. How would you classify this change?

A) Routine variation in clinical practice
B) Clinical research

CASE 2: At a department meeting, several attending surgeons discuss their idea for an experimental procedure and wonder whether it will show some advantage. They decide they will perform this procedure on a group of patients selected from neighborhood clinics. How would you categorize what they are attempting?

A) Routine variation in clinical practice
B) Clinical research

CASE 3: A local colleague is famous for his creativity in the OR. Attempting to improve his technique and outcomes, he seeks to find new ways of modifying standard procedures every time he operates. In your mind, which of the following best describes his work?

A) Routine variation in clinical practice
B) Clinical research

CASE SCENARIO EXPLANATIONS

 

The current ambiguities in conventions and definitions concerning surgical resesarch and innovation signify that some situations will not distinctly fit into one category. Some cases of surgical innovation fall outside the purview of IRB authority, though they may benefit from some form of expert review. The following list from our recent book: "Ethical Guidelines for Innovative Surgery"; is a useful guide to what circumstances can necessitate expert consultations.

 Criteria That Warrant Expert Consultation:

 

  • If the procedure is planned*, and:
  • The surgeon seeks to test a hunch, theory or hypothesis about the procedure; or:
  • The procedure is experimental (significantly different from existing standard of care) or:
  • Outcomes of the procedure are largely unpredictable (true risks and benefits are unknown and/or have not been adequately described in the surgical literature) or:
  • Potential risks of the procedure are significant (more than of available alternative or than of the more conventional approaches) or:
  • Specific/additional patient consent appears appropriate, then the described expert consultation process is required plus additional informed consent of the patient specific to the experimental nature of the procedure.

Next - Case 1 Explanation
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