- The accredited provider partner(s) make all decisions regarding the disposition and disbursement of the commercial support funds and in-kind support received for CME activities. SCS 3.1
- LynxCME shall not be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including activity content and format, from a commercial interest as conditions of contributing funds or services. SCS 3.2
- All commercial support associated with a CME activity must be given with the full knowledge and approval of LynxCME. No additional funds or in-kind support will be provided to the planning committee members, teachers, or authors beyond those defined in the budget. SCS 3.3
- All educational grant amounts will be based on an itemized and estimated budget prepared in advance and shared with the commercial supporter. [Industry Best Practice]
- The total dollar amount will be reflected in the Letter of Agreement. [Industry Best Practice]
- All commercial support expenditures must be documented and, upon request, provided to the commercial supporter. SCS 3.13
- If expenses are exceeded, the accredited provider(s) and LynxCME will send a budget addendum and request for additional funds to the commercial supporter. Any additional funds will be documented in an addendum to the Letter of Agreement. [Industry Best Practice]
- LynxCME may NOT seek suggestions from the commercial interest regarding faculty members, content, and other aspects of the CME activity. The commercial interest cannot make the acceptance of advice or services concerning teachers, authors, or participants or other education matters, including content, a condition of support. SCS 3.2
- The Letter of Agreement shall define the terms, purposes, and conditions of the grant and shall be signed by the commercial interest and the accredited provider partner(s) may be signed by LynxCME. The originating source of the funds shall be considered the commercial interest for purposes of signing the agreement and acknowledgment. SCS 3.4, 3.5, 3.6
- Definition of CME: “CME consists of educational activities that serve to maintain, develop, or increase the knowledge, skills, professional competence and relationships a physician uses to provide services for patients, the public, or the profession. The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.”
- LynxCME attests that all recommendations involving clinical medicine in a CME activity will be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
- LynxCME attests that all scientific research referred to, reported or used in a CME activity in support or justification of a patient care recommendation will conform to the generally accepted standards of experimental design, data collection and analysis.
- LynxCME attests that all recommendations, treatment, or manners of practicing medicine discussed in a CME activity will be within the definition of CME and will not be known (a) to have risks or dangers that outweigh the benefits or (b) to be ineffective in the treatment of patients.
- A relevant financial relationship is defined as a financial relationship in any amount occurring in the past 12 months that creates a conflict of interest. SCS 2.2
- Completed disclosure forms must be received in ample time to be reviewed and discussed by the appropriate monitoring group, i.e. the Accredited Provider’s CME Advisory Committee. Planners, teachers, and authors shall receive clear and unambiguous instructions that failure to return the form in a timely manner may result in disqualification from participation in the CME activity. Reminders (calls, e-mails, faxes) shall be sent at reasonable periods prior to the deadline. [Industry Best Practice]
- Faculty members failing or refusing to provide disclosure information in ample time to be reviewed by the monitoring group shall be automatically disqualified as a planning committee member, teacher or author. [Industry Best Practice]
- The following information regarding relevant financial relationship(s) of all individuals in a position to control CME content will be disclosed to learners: a) The name of the individual b) The name of the commercial interest(s) with which the relationship exists; c) The nature of the relationship the individual has with each commercial interest. SCS 6.1
- For an individual with no relevant financial relationship(s), the learners will be informed that no relevant financial relationship(s) exist. SCS 6.2
- Individuals who fail or refuse to disclose their relevant financial relationship(s) will be prohibited from participation in the planning, presentation, or evaluation of a CME activity. SCS 2.2
- The source of all support from commercial interests will be disclosed to learners. When commercial support is “in-kind”, the nature of the support must be disclosed to learners. SCS 6.3
- “Disclosure” must never include the use of a trade name or a product-group message. SCS 6.4
- If a faculty member does not provide disclosure information prior to the deadline for printed activity materials, that information must be disclosed verbally at the live activity prior to the faculty member’s presentation. An accredited provider staff member or designated agent must also witness the communication of the information and must complete the Verification of Verbal Disclosure Form. SCS 6.5
- All disclosure information will be provided to learners prior to the beginning of the educational activity. SCS 6.5
- All planning committee members, teachers, presenters, editors, and authors (SCS 2.1) must complete a Full Disclosure Form indicating any relevant financial relationship(s).
- The information from the Full Disclosure Forms will be presented in writing in activity materials. [Industry Best Practice]
- The source and nature of all support from commercial interests will be disclosed to learners in writing in all promotional and activity materials prior to the beginning of the activity.
- In order to maintain the independence of the CME provider, the following decisions regarding CME activities must be made free of control of any commercial interest (SCS 1.1):
- Identification of CME needs
- Determination of educational objectives
- Selection and presentation of content
- Selection of all persons and organizations that will be in a position to control the content of the CME
- Selection of education methods
- Evaluation of the activity
- Independence of the CME provider must be stipulated in the Commercial Support Letter of Agreement.
- The accredited provider and commercial interest(s) must sign the Commercial Support Letter of Agreement. All parties of the agreement, including the joint sponsor, must comply with the ACCME Standards for Commercial Support.
- An accredited provider must make all decisions regarding the disposition and disbursement of commercial support. SCS 3.1
- Providers [accredited or non-accredited] may not seek suggestions from the commercial interest regarding faculty members, content, and other aspects of the CME activity. SCS 3.2
- A commercial interest cannot take the role of the non-accredited partner in a joint sponsorship relationship. SCS 1.2