Locate COE
 

BOLD Activation & Approvals

The data collected in BOLD is used for two purposes: 1) to help ensure ongoing compliance with the requirements of the ICE program and 2) for data analysis to develop general knowledge about optimal bariatric surgery practices.

Once provisionally approved, SRC provides ICE participants with a comprehensive BOLD packet of information that explains what is required for:

  • Data Entry and Compliance
    The BOLD packet includes the International BOLD Participation Agreement, which must be signed by each surgeon before they can enter their patient data into BOLD (commonly referred to as “BOLD activation”). As outlined in the provisional qualifications, the signed Agreement should be returned to SRC within 30 days of earning provisional status.
  • Data Analysis
    The BOLD packet contains a standard Patient Information Sheet that must be given to each patient who undergoes bariatric surgery. The sheet explains how their information will be used and gives the patient the opportunity to decline participation in BOLD for research purposes. The BOLD packet also includes the information typically needed to obtain BOLD approval from a hospital’s institutional review board (IRB) or ethics committee.

SRC recognizes that the laws and regulations governing the collection and electronic transmission of patient information vary from country to country. SRC’s initial legal review indicates BOLD already complies with the regulatory guidelines in place in most nations. Some countries, however, may also require that BOLD is approved by specific governing authorities to ensure that the patient information entered into the database is used in a manner consistent with patient privacy and confidentiality laws. The BOLD packet contains the information most government agencies require for approval.

SRC is available to support the efforts of both surgeons and facilities that must gain approval from local, state or national governing bodies for compliance and/or data analysis purposes. SRC also supports national medical societies in this capacity when appropriate.

SRC’s Vice President of Legal Affairs and Director of Research are available to answer specific questions about BOLD activation and approvals. They can be reached by contacting SRC Support at srcsupport@surgicalreview.org (srcsupport null@null surgicalreview NULL.org) or +1.919.792.3770.