Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)
Policy on Disclosing Financial Relationships with Ineligible Companies and Managing Relevant Relationships
July 2011 (revised April 2015, February 2018, October 2019, April 2021)
Per the ACCME, “As the stewards of the learning environment for healthcare professionals, the accredited continuing education community plays a critical role in navigating the complex interface between industry and the health professions. Organizations accredited to provide continuing education, known as accredited providers, are responsible for ensuring that healthcare professionals have access to learning and skill development activities that are trustworthy and are based on best practices and high-quality evidence. These activities must serve the needs of patients and not the interests of industry. This independence is the cornerstone of accredited continuing education.”
- It is the responsibility of persons who serve as planners and faculty for accredited education to do so in an honest and open manner, exercising their best skill and judgment, for the benefit of the participants, who, in turn, seek to improve the care given to their patients.
- It is the responsibility of planners and faculty to exercise the utmost good faith in their responsibilities regarding CME accredited activities. Planners and faculty should not use their positions or influence to actively promote their personal interests (financial or professional).
- Any financial relationships with ACCME-defined “ineligible companies” (formerly “commercial interests”) should be disclosed to SAGES. SAGES requires that all individuals involved in the creation of accredited content to complete a disclosure form listing all financial relationships between themselves and ACCME-defined ineligible companies for the previous 24 months. This information is then reviewed and published in the written materials that accompany CME accredited activities. Non-compliance with this policy by individuals will result in adverse actions for those individuals, up to and including dismissal of the individual from educational activities.
- Disclosures will be reviewed by the Conflict of Interest Committee and/or their designees in advance of the SAGES CME activity. The mitigation of relevant financial relationships with ACCME-defined ineligible companies for planners, presenters and faculty is determined by the SAGES Mitigation Process (see attached).
- According to the Accreditation Council for Continuing Medical Education (ACCME), an ineligible company is those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. They are called “ineligible” because they are not eligible to be accredited in the ACCME system. The ACCME states that, ”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 SAGES Conflict of Interest Committee (CIC) and the SAGES Executive Committee have determined that no employees/owners of an ineligible company may be appointed to SAGES Committees or to the SAGES Board. Additionally, no employees/owners of an ineligible company may serve in a position of control of content in SAGES CME accredited activities. This policy is applicable to planners, reviewers, moderators, invited faculty, and abstract presenters. ISAGES may consider an individual exception as long as it meets the one of the ACCME’s three special-use case exceptions.
- SAGES members who are full time employees or owners [see definitions below] of “eligible companies”, as defined by the ACCME, may: (1) serve as planners, presenters or faculty for CME-granting SAGES activities, following the standard SAGES COI Committee policies and procedures; (2) be considered for appointment to selected SAGES Committees, at the discretion of the SAGES Executive Committee, and with the expectation that she/he (as with all Committee members) will recuse themselves from discussions and voting as appropriate; and (3) be considered for service on the SAGES Board, at the discretion of the SAGES Executive Committee and Nominating Committee, and with the expectation that she/he (as with all Board members) will recuse themselves from discussions and voting as appropriate.
- When an unlabeled use of a commercial product, or an investigational use not yet approved by the FDA for that marketing claim, is discussed during a CME accredited educational activity SAGES requires that the faculty disclose that information.
- Presentations in CME accredited activities must give a balanced, evidence-based view of therapeutic options. Use of generic names is preferred. If trade names are used, those of several companies should be used rather than only that of a single supporting company.
- Recommendations for clinical practice in CME-granting activities should be based on the best-available scientific evidence from studies which conform to generally accepted standards of experimental design, data collection, and analysis.
- Faculty, planners, and speakers should not receive payments from ineligible companies to participate in CME accredited educational activities.
SAGES POLICY REGARDING ABSTRACTS
ALL content authors are required to disclose any financial relationship(s) with an ACCME-defined ineligible company (“industry”). Also, no content author may be an owner or employee of an ineligible company.
In accordance with SAGES CME policy, all content authors are required to disclose this year. Also, no content author may be an employee or owner of an ACCME-defined ineligible company. According to the Accreditation Council for Continuing Medical Education (ACCME), “An ineligible company is considered any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.” Click here for full definition and a list of all exceptions. No abstract will be accepted for the CME sessions if any of the content authors are employees or owners of a relevant ineligible company.
Ineligible Companies (formerly “commercial interest”): those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. They are called “ineligible” because they are not eligible to be accredited in the ACCME system.
The ACCME does not consider providers of clinical service directly to patients to be ineligible companies. Additionally, the ACCME considers the following types of organizations to be eligible for accreditation and individuals with financial relationships with these types of entities may control the content of CME: 501-C Non-profit organizations; Government organizations; Non-health care related companies; Liability insurance providers; Health insurance providers; Group medical practices; For-profit hospitals; For profit rehabilitation centers; For-profit nursing homes; Blood banks; Diagnostic laboratories.
Owner/employee: According to the ACCME, “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.”
Equity ownership/stocks in a private company = owner
Unexercised stock options in a private company does NOT = owner
Stock ownership in a public company does NOT = owner
Ownership in a mutual fund or pension does NOT= owner