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Published March 2019

MBSAQIP-Accredited centers must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures that are not endorsed by the ASMBS. The IRB approval must be for performing the procedures, and not solely for data collection of outcomes from these procedures. In the event that an IRB determines a study protocol unnecessary for a primary procedure that is not endorsed by the ASMBS, a letter of exemption from the IRB is required to demonstrate compliance with MBSAQIP standards. Procedures and devices used for re-operative purposes do not require IRB approval or IRB exemption. However, the ASMBS recommends conforming to the endorsed procedure list when selecting procedures and devices for re-operative purposes whenever possible:

ASMBS Endorsed Procedures and Devices for Metabolic and Bariatric Treatment

ASMBS Endorsed Procedures and FDA approved
Devices which do not require IRB
Primary Case
Adjustable Gastric Banding – is FDA approved No IRB
Sleeve Gastrectomy No IRB
Roux-en-Y Gastric Bypass No IRB
BPD/Duodenal Switch No IRB
AspireAssistĀ® is FDA approved No IRB
Intragastric balloons – are FDA approved and endorsed by ASMBS No IRB
Vagal nerve blocking therapy
(vBlocĀ®) is FDA approved
Vertical Banded Gastroplasty No IRB
Bariatric Re-operative Procedures N/A
Open procedures as deemed appropriate No IRB

Non-Endorsed Procedures and Devices Primary Case
Single Anastomosis Duodenal Switch Procedures
Exemption Required
Single Anastomosis Gastric Bypass
(Mini-Loop Gastric Bypass)
Exemption Required
Endoluminal/Endoscopic Sleeve Gastroplasty IRB or IRB
Exemption Required
Gastric plication IRB or IRB
Exemption Required

Pathway for Endorsement for New Devices and Procedures

With the advent of new obesity devices and procedures entering our field, ASMBS developed an official pathway for the approval and sanction of new procedures and devices. Any ASMBS member can submit an application for a new procedure or removal of an approved procedure by following the below link.

Originally posted October 18, 2016
Updated March 27, 2019

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