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 relationships with commercial interests (including known relationships of his or her immediate family, department, and partners). The ACCME defines a commercial interest as “any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests.” The question of whether a disclosed conflict situation could represent undue influence on the educational activity by a commercial interest or whether the disclosed information is sufficient to consider an abstract, presentation, or other educational enduring material to represent potentially biased information must be resolved prior to an individual’s involvement in STS educational programming.
Required disclosures include (1) a financial interest of any amount (e.g., through ownership of stock, stock options, or bonds) (2) the receipt of any amount of cash, goods or services within the current 12-month period (e.g., through research grants, employment, consulting fees, royalties, travel, or gifts) or (3) a nonremunerative position of influence (e.g., as officer, director, trustee or public spokesperson). EXCLUDED from this disclosure requirement are blind trusts or other passive investments such as mutual funds. In the case of a financial or other relationship disclosure, the company, product/service, and specific nature of the relationship must be noted. 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 commercial interests 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 resolve potential influences on the educational activity prior to the planning and implementation of an educational activity. If no relationships with commercial interests exist, the individual must indicate this on the disclosure form.
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 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.
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. Slides, handouts, and other materials utilized as part of an educational activity cannot contain any advertising, trade names or a product group message. Speakers are required to disclose that they have nothing to disclose if this is the case.
Amended by the STS Executive Committee: April 11, 2012