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BOLD Study Oversight

The data collected in BOLD is used for two purposes: 1) to help ensure compliance with COE program requirements and 2) for data analysis to develop general knowledge about optimal bariatric surgery practices. Each purpose necessitates a different level of institutional review board (IRB) oversight.

COE Program Compliance

All data collected in BOLD is used to ensure ongoing compliance with COE program requirements. In addition, national summary reports containing BOLD aggregate data are provided to participants so they can assess their own patterns of care and outcomes relative to national norms. These activities are implemented solely for the purpose of assessing the quality of care and do not require review by an IRB, according to 45 CFR Part 164.501, 506.

General Knowledge: The BOLD Study

BOLD data is also analyzed to advance general knowledge about optimal bariatric surgery practices, which is referred to as the “BOLD study.” This is considered human subject research and requires IRB review. The Copernicus Group Independent Review Board (CGIRB) (http://www NULL.cgirb NULL.com/) provides IRB oversight of the BOLD study.

  • IRB Oversight: CGIRB determined that SRC’s research staff is the only group engaged in the analysis of BOLD data for general knowledge purposes. Therefore, SRC is the only entity required to have IRB oversight. More specifically, participating facilities are not required to have IRB approval and/or oversight because their surgeons do not conduct research using BOLD. While not required by SRC, a facility may elect to have its local IRB review its participation in BOLD. This optional oversight is sometimes needed because the facility has a policy requiring its IRB to review all studies conducted at the institution (even if only to determine that the facility is not engaged in research).
  • Waiver of Informed Consent: No patient-identifying information (e.g., names, medical record or social security number) is contained in BOLD study research data, and SRC has safeguards in place to ensure the confidentiality of the protected health information described in the study protocol. CGIRB concluded that the BOLD study poses minimal risk to patients and granted approval for SRC to engage in research with a waiver of informed consent. Therefore, surgeons and facilities do not need to ask their patients to sign an informed consent document to participate in BOLD – instead, a Patient Information Sheet must be provided to each patient prior to their surgery.

Support

Participants may access information and documents related to the BOLD study and IRBs oversight under the Getting Started tab of their account portfolio. SRC Support (srcsupport null@null surgicalreview NULL.org) is also a valuable resource for questions regarding BOLD.