As a sponsor of continuing medical education accredited by the Accreditation Council for Continuing Medical Education (ACCME), The Society of Thoracic Surgeons requires that any individual who is in a position to control the content of an educational activity must disclose all financial relationships with any ineligible companies. This is to ensure that that all decisions related to the planning, faculty selection, delivery, and evaluation of accredited education are made without any influence or involvement from the owners and employees of an ineligible company. The ACCME defines ineligible companies as those whose “primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.” The question of whether a disclosed conflict situation could represent undue influence on the educational activity by an ineligible company or whether the disclosed information is sufficient to consider an abstract, presentation, or other educational enduring material to represent potentially biased information must be mitigated prior to an individual’s involvement in STS educational programming.
Required disclosures must include all financial relationships with ineligible companies in the prior 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.
Individuals who are owners or employees of ineligible companies are excluded from controlling content or participating as planners or faculty in STS educational activities. There are three exceptions to this exclusion—employees of ineligible companies can participate as planners or faculty in these specific situations:
1. When the content of the activity is not related to the business lines or products of their employer/company.
2. When the content of the accredited activity is limited to basic science research, such as preclinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
3. 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.
Disclosure is mandatory for any person involved in the planning, management, presentation, and/or evaluation of STS educational activities. Failure to disclose all relationships with ineligible companies disqualifies the individual from being a planning committee member, a teacher, or an author of educational materials, and this individual cannot have any responsibility for the development, management, presentation, or evaluation of STS educational activities. This requirement is intended neither to imply any impropriety of such relationships nor to prejudice any individual planner, presenter or author. It is merely to identify such relationships through full disclosure, and to allow STS to assess and mitigate potential influences on the educational activity prior to the planning and implementation of an educational activity. Speakers are required to disclose that they have nothing to disclose if this is the case.
Additionally, the fact that the presentation, paper, or other educational product describes (a) the use of a device, product, or drug that is not FDA approved or (b) an off-label use of an approved device, product, or drug or (c) a new or evolving topic advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning must also be disclosed. This requirement has been adopted in response to FDA policy and case law involving medical societies, and is not intended to prohibit or inhibit independent presentation or discussion regarding the uses of devices, products, and drugs as described in (a) or (b) above.
All relevant financial information will be disclosed to learners before they engage with or access STS educational content and activities. For live presentations, all disclosures must be stated orally and on a slide at the beginning of the presentation and will be noted in published material related to the activity. Disclosure to learners will include each of the following:
1. The names of the individuals with relevant financial relationships.
2. The names of the ineligible companies with which they have relationships.
3. The nature of the relationships.
4. A statement that all relevant financial relationships have been mitigated.
Disclosure to learners must not include ineligible companies’ corporate or product logos, trade names, or product group messages. If applicable, the absence of relevant financial relationships with ineligible companies will also be disclosed to learners.
In order to ensure that STS educational activities are free of marketing or sales of products and services, faculty must not actively promote or sell products or services that serve their professional or financial interests during accredited education. Slides, handouts, and other materials utilized as part of an educational activity cannot contain any advertising, trade names or a product group message.
Amended by the STS Executive Committee: June 9, 2021