Policy on Compliance with ACCME Standards
In accordance with the Standards for Commercial Support (SCS-1), AAGL develops its CME activities independent of any commercial interest. Specifically, a commercial interest and commercial supporter of the activity can have no involvement in the following:
- Identification of practice gaps and needs that become the foundation for the activity
- Preparation of or input into the learning objectives
- Selection and presentation of content
- Recommendation of persons to serve as faculty for the activity or any other persons that will be in the position to control the content of CME
- Influence over the selection of the educational design for the activity
- Selection of vendors or methods for the evaluation of the activity
Requests for “technical review” of the content of the CME activity by the commercial supporters will not be accepted.
Management of Funds
1. Written Letters of Agreement
- AAGL requires that a written letter of agreement be signed by both the provider and the commercial supporter. This document specifies terms and condition in compliance with the SCS. Specifically, no language will be permitted in the LOA relating to any requirements for the supporter’s involvement in content, faculty selection, and methods as described above. The LOA may be either AAGL’s document or one produced by the supporter, in which case the language is vetted for adherence to all required areas of the SCS.
- An LOA will be completed for both in-kind funds and educational grants.
2. Control of Funds
- AAGL controls all aspects of the management of funds from a commercial supporter. AAGL does not currently joint sponsor activities, so there is no other entities involved in the procurement or execution of Letters of Agreement.
3. Additional Funds Provided to Those in Position to Control Content
- AAGL ensures that supporters of a CME activity are not providing additional funds to those in a position to control content relative to the specific CME activity. This requirement is included both in the LOA as well as in faculty letters.
4. Provision of Funds to Learners
- AAGL does not provide funds to offset the costs of attending CME activities for its learners. Such honoraria and expense support is provided only to faculty associated with the activity.
5. Social Events
- Social events that take place at a CME activity, regardless of whether those events are provided with funds from a commercial supporter or not, may not compete with or overtake the CME activity. AAGL permits only modest meals or receptions at its CME activities for the purpose of promoting interaction and exchange between faculty and learners.
6. Transparency to Learners
- AAGL acknowledges the receipt of educational grants from commercial interests. Such information is made transparent to learners by publishing this information for all in-kind and actual support grants in the general information pages located at the beginning of the syllabus or handouts.
Separation of Education from Promotion
1. Promotion of Proprietary Interest of Commercial Interests
- AAGL assures that activities do not promote the interests of product manufacturers through the following safeguards:
- Activities Linked to Analyses of Learner Gaps and Other Needs—CME activities are planned based on clear gaps in knowledge and/or performance, the expert opinions of recognized experts in the field, national guidelines or authorities’ description of best practices.
- Content Validation Practices—The content of CME activities is vetted by independent so as to assure that commercial bias is not present and that the material is scientifically accurate, based on evidence acceptable to the profession, and that treatments discussed are appropriate. AAGL has a standard form for this purpose.
- Retrospective Learner Feedback—Evaluation mechanisms always contain questions that serve to demonstrate that learners did not perceive commercial bias in the materials from a specific teacher/author. If a bias is perceived, this information is provided to the planners, faculty and others so that an improvement plan can be determined and outcomes of the improvements monitored.
2. Commercial Exhibits
- AAGL permits exhibits to be presented in the context of a CME activity. However, exhibit space is rented or otherwise provided to the commercial exhibitor in contrast to the provision of a marketing strategy. AAGL does not engage in any marketing practices or services-for-hire for a commercial supporter.
- Exhibits are not permitted in the educational room, or in the case of enduring materials or Internet-based CME, within the space of educational content.
- Exhibits are never a condition for the receipt of an educational grant. Should an exhibit be requested, a separate agreement is entered into with the appropriate party from the commercial interest. A fee will be charged for securing exhibit space, and the fee will be consistent for any exhibitor regardless of the organization’s involvement in the provision of an educational grant for the CME activity.
- In live activities—A commercial interest is not permitted to advertise its products within the confines of a CME activity. Any advertising or promotion is confined to formal exhibits. AAGL does not permit subtle advertising by having book bags, pens, or other accoutrement that bears the name of the manufacturer and/or its products within the educational space.
- In Enduring Materials—Advertising is not permitted whatsoever in any enduring material, which by definition contains the course content for a CME activity.
- In Internet-Based Activities—Advertising may be present on general web pages, but in that case the learner must act to formally enter the educational space by knowingly click to enter that space. Messages relating to this process shall be explicit, and thereafter no advertisements are permitted.
- In Journal-Based Activities—Advertising is permitted in journals containing articles certified for AMA PRA Category 1 credit, but those ads cannot be within the confines of the certified article or on any partial page of that article. Furthermore, advertising is not permitted in other parts of the official CME activity, such as post tests, evaluations, and general CME information pages.
4. Appearance of Product Group Messages in Course Materials
- No product group messages are permitted in any CME activity certified by AAGL. Given the nature of how learners perceive such messages, steps taken to assure compliance with this policy include:
- Use of generic scientific names for product descriptions instead of product names.
- Insistence of fair balance in discussion of treatment options in which all drugs in a class are compared and contrasted, with treatment recommendations being reviewed by content reviewers to assure that recommendations made are based on verifiable studies and in the public interest.
- Logos from commercial interests are never permitted on any course materials including slides, syllabus materials, and other non-educational interventions.
5. The Role of the Commercial Interest or Supporter in the Provision of CME to Learners
- The supporter of an activity has no role in the provision of CME to learners. They are always acknowledged for their educational grant, and in addition, may provide promotional brochures or flyers to prospective learners as long as those materials clearly delineate AAGL as the provider of the activity and the supporter as provider of the educational grant.
Collection and Resolution of Conflicts of Interest and Transparency to Learners
1. Collection of COI Information
- AAGL collects financial relationship information from all persons in a position to influence the content of CME in any amount from (a) faculty, (b) planners, (c) reviewers, (d) advisors, and (e) staff from AAGL or any educational partner. Information requested is obtained through a standard COI Information Document that is distributed to all concerned parties prior to an educational activity. Information from disclosure forms is analyzed by staff under the direction of the Executive Director and a mechanism to resolve reported conflicts is selected.
2. Resolution of Reported COI
- AAGL requires that everyone who is in a position to control the content of an educational activity discloses all relevant financial relationships with any commercial interest. The ACCME defines “’relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. When COI is present, course materials such as slides and syllabus material are reviewed by the Professional Education Manger and Medical Director. Should resolution not be possible through content review, presenters may be asked to limit their presentation to the presentation of scientific information only, or in some cases the presenter may be replaced by another expert with less COI. Resolution of COI, including changes that were identified in materials, is maintained in the files for the activity.
3. Transparency to Learners
- COI information for each presenter, reviewer, planner, and anyone in a position to influence the content is made transparent to learners. COI disclosure is made on the second slide following each PowerPoint presentation and is published in course syllabus or handouts so that it may be viewed by learners prior to the start of the activity.