The American Society of Breast Surgeons
Continuing Medical Education (CME) Activity Disclosure Policy
Recognizing that professional education is a lifelong endeavor, the purpose of the American Society of Breast Surgeons (ASBrS) continuing medical education (CME) activities are to continually improve the quality of care for breast disease by keeping practicing surgeons current in knowledge and skills, including evolving technologies, by developing and delivering relevant educational programming in a variety of formats to our target audience.
The Society is charged with ensuring its CME activities are balanced, independent, objective, and scientifically rigorous, through, but not limited to, by identifying and mitigating relevant financial relationships or non-financial/strategic business relationships or partnerships (relationships) between individuals in control of educational content and ineligible companies. By identifying and mitigating relevant relationships, we work together to create a protected space to learn, teach, and engage in scientific discourse free from influence from individuals that may have an incentive to insert commercial bias into a CME activity.
Policy
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As a CME provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), the ASBrS requires individuals in a position to control the educational content of a CME activity (including but not limited to, course/program chairs, moderators, faculty, authors, content reviewers, editors, planning committees, and ASBrS staff) to disclose all financial and non-financial/strategic business relationships or partnerships (relationships) with ACCME-defined ineligible company, within the 24 months prior to their involvement with the CME activity.
Individuals must review and adhere to the ASBrS CME Activity Policy and Disclosure Process as well as complete the applicable ASBrS Disclosure Form at the time they are invited to participate in a CME activity. Participation will not be confirmed without the completion of the disclosure form and will be contingent upon mitigation, if necessary.
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Owners or employees of ineligible companies are excluded from controlling content or participating as planners or faculty in a CME activity. The owners and employees of ineligible companies are considered to have unresolvable financial relationships and must be excluded from participating as planners or faculty and must not be allowed to influence or control any aspect of the planning, delivery, or evaluation of accredited continuing education.
There are three exceptions to this exclusion—employees of ineligible companies can participate as planners or faculty in these specific situations:
- When the content of the activity is not related to the business lines or products of their employer/company.
- When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
- When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.
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To assist all CME planners and contributors in identifying relevant relationships, ASBrS staff provides a sample list of typical relevant relationships and possible methods for mitigation –as well as examples of non-compliant actions. However, this list is not an exhaustive list of all scenarios. Participants are required to disclose all possible competing interests, both financial and non-financial, that could interfere with, or could reasonably be perceived as interfering with, their ability to provide objective and valuable contributions to the ASBrS CME activity.
All identified relevant relationships are mitigated prior to the education activity being delivered to learners per ACCME Standards. The inability to mitigate an identified relevant relationship results in the participant's withdrawal from participation in the CME activity.
A list of disclosures from all CME planners and contributors, as well as all potential and actual mitigation methods (including any instances of non-compliance), are documented and maintained by ASBrS staff. This list is made available to all CME activity planners.
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The non-compliance process is initiated when an individual's (in a position to control educational content of the CME activity) undisclosed relationship(s) with an ineligible company is identified or reported during or after the CME activity. The Board of Directors, CME Committee, Ethics Committee, and applicable committee chair(s) will discuss the act of noncompliance and agree upon a resolution.
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In accordance with ACCME standards, the following is disclosed to learners before the start of a CME activity:
- Individuals with relevant financial or non-financial/strategic business relationships or partnerships with ACCME-defined ineligible companies
- Individuals with no relevant relationship(s) with ACCME-defined ineligible companies
- How the relevant relationships were mitigated
- The receipt of ineligible companies financial and non-financial support of CME activities
Oversight
The CME Committee and Ethics Committees ensure that there is no commercial bias or influence in ASBrS CME activities. They work together to ensure proper conflict management. Members of these committees serve as additional oversight, participating and observing ASBrS CME activities to look for any evidence of bias and ensure compliance with the ASBrS policies.
Reporting Conflicts
Participants of any ASBrS CME activity may report any improprieties on the applicable evaluation form and to the CME and Ethics Committee at cme@breastsurgeons.org.
Please contact the CME Committee at cme@breastsurgeons.org if you have any questions.
Glossary of Terms
Ineligible Company
ACCME defines ineligible companies as those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such companies/organizations include:
- Advertising, marketing, or communication firms whose clients are ineligible companies
- Bio-medical startups that have begun a governmental regulatory approval process
- Compounding pharmacies that manufacture proprietary compounds
- Device manufacturers or distributors
- Diagnostic labs that sell proprietary products
- Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
- Manufacturers of health-related wearable products
- Pharmaceutical companies or distributors
- Pharmacy benefit managers
- Reagent manufacturers or sellers
Financial or Non-financial/Strategic Business Relationships or Partnerships
For individuals in a position to control the educational content of a CME activity, the ASBrS focuses on all financial and non-financial/strategic business relationships or partnerships with any ineligible company they had over the past 24 months.
Examples of financial relationships include employee, researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patent beneficiary, executive role, and ownership interest. Individual stocks and stock options should be disclosed; diversified mutual funds do not need to be disclosed. Research funding from ineligible companies should be disclosed by the principal or named investigator even if that individual's institution receives the research grant and manages the funds. ASBrS has not set a minimal dollar amount for financial relationships to be considered significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.
ASBrS recognizes that some non-financial strategic business relationships or partnerships with ACCME-defined ineligible companies have the potential to cloud objectivity and foster institutional loyalty. Therefore, participants are required to disclose all sources of secondary competing interests that may impact their impartiality.
For example, if a presenter serves on an ineligible company's advisory board or is involved in its lobbying group, the content of the presenter's CME activity could be impacted even if no honoraria was received. Furthermore, an individual may benefit from am ineligible company by receiving non-financial incentives, including equipment, disposable supplies, paid trainings, paid vacations, etc. These types of potential non-financial conflicts must be listed on the ASBrS Disclosure Form so that a designated meeting or CME official can determine which, if any, necessitate a mitigation plan.
Relevant Financial or Non-financial/Strategic Business Relationships or Partnerships
Financial relationships of any dollar amount and non-financial/strategic business relationships or partnerships, which occurred in the past 24 months, are relevant if the educational content an individual can control is related to the business lines or products of the ineligible company.
Owners and Employees of Ineligible Companies
Owners and employees are individuals who have a legal duty to act in the company's best interests.
- Owners are defined as individuals who have an ownership interest in a company, except for stockholders of publicly traded companies, or holders of shares through a pension or mutual fund.
- Employees are defined as individuals hired to work for another person or business (the employer) for compensation and who are subject to the employer's direction as to the details of how to perform the job.
The owners and employees of ineligible companies are considered to have unresolvable financial relationships and must be excluded from participating as planners or faculty and must not be allowed to influence or control any aspect of the planning, delivery, or evaluation of accredited continuing education, except in the limited circumstances outlined in Standard 3.2.
The American Society of Breast Surgeons is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.