Key IRB Considerations
As the specialty of bariatric surgery continues to evolve, new procedures and techniques related to existing procedures are often identified and introduced into practice. Surgeons must therefore consider what defines a new procedure as investigational and at what point a new procedure or version of a procedure needs to undergo regulatory oversight through an institutional review board.
At this time, the American Society for Metabolic and Bariatric Surgery (ASMBS) supports the following procedures:1
- Laparoscopic Roux-en-Y gastric bypass
- Duodenal switch
- Sleeve gastrectomy
- Adjustable gastric banding
- Bariatric reoperative procedures
- Open procedures as deemed appropriate by the surgeon
The recommendation from the ASMBS specifically related to single-anastomosis DS procedures, dated May 2016, reads:2
Single-anastomosis duodenal switch procedures are considered investigational at present. The procedure should be performed under a study protocol with third-party oversight (local or regional ethics committee, institutional review board, data monitoring and safety board, clinicaltrials.gov, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.
From a liability and risk management standpoint, it is advised to obtain IRB approval and collect data on patient outcomes to support future acceptance of new surgical techniques. Performing these procedures outside of investigational oversight opens a door for liability exposure and gives a plaintiff’s attorney leverage in the event of an adverse outcome.
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“The issue of ‘should an IRB be used?’ has been a discussion point for many years for the bariatric surgeon. Our society has grappled with this topic and, I think, has come up with a logical process to evaluate new or unique procedures. Over the many years of its existence, the ASMBS has worked hard to educate, develop guidelines, and advance strategies that help protect bariatric surgeons while allowing the advancement of bariatric and metabolic surgery. We, as surgeons, should embrace that process and use the IRB to protect our patients as well as the surgeons.” —Alan Wittgrove, MD