The ACCME Standards of Commercial Support (SCS) describe six Standards: (1) independence (2) resolution of personal conflicts of interest (3) appropriate use of commercial support (4) appropriate management of associated commercial promotion (5) content and format without commercial bias and (6) disclosures relevant to potential commercial bias.  These Standards underscore continued voluntary self-regulation by the CME community, ensuring that physicians have opportunities to engage in commercially unbiased life-long learning facilitated by accredited providers.  The purpose of this policy is twofold:  [1] to establish guidelines and a mechanism for identifying and resolving conflicts of interest in CME educational activities as required in Standard 2 (see below), and [2] to be consistent with Tulane University’s institutional policy for resolving conflicts of commitment and interest.  

Standard 2: Resolution of Personal Conflicts of Interest in the 2004 Standards for Commercial Support requires the following of ACCME accredited providers –

• Documenting that everyone who is in a position to control the content of an education activity has disclosed to the provider all relevant financial relationships with any commercial interests in any amount within the past 12 months that creates a conflict of interest. (SCS 2.1)

• Disqualifying individuals who do not disclose from participating in a CME education activity. (SCS 2.2)

• Identifying and resolving all conflicts of interest prior to the education activity. (SCS 2.3)

Terms as defined by the ACCME:

1. Conflict of Interest:  when an individual’s interests are aligned with those of a commercial interest, the interests of the individual are in ‘conflict’ with the interests of the public.  The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest.  The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME activity, an incentive to insert commercial bias.

2. Commercial Interest:  any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

3. Financial Relationships: relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g. stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.  Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received or expected.  ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

4. Relevant financial relationships:  financial relationships with commercial interests in any amount occurring within the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CME activity that create a conflict of interest.

5. Individuals with potential for influence or control of CME content:  Planners and planning committee members, authors, teachers, educational activity director(s), educational partner(s), and others who participate, e.g. facilitators and moderators.

Procedure:

1. All individuals with potential for influence or control of content (defined in #4 above) must fill out a Tulane CCE Disclosure Form prior to the education activity as a condition of invitation and acceptance to participate.  CCE staff and CME Advisory Committee members will be required to fill out an annual disclosure form.

2. Program application and disclosure forms of activity director and/or planning committee members are reviewed by the CME Advisory Committee.

3. An independent and unbiased assessment of content will be documented by one of the following methods to identify and resolve COIs—

   1. Content review by the program planning committee consisting of at least one faculty member without the same commercial interests.

   2. Peer review committee not participating in the specific educational activity.

   3. Review of comprehensive questionnaire completed by speakers, activity director, planning committee members (when applicable), and others involved in the development of content as a confirmation of conflict resolution.

   4. Content review by an independent faculty expert in the discipline without commercial interests.

   5. Evidence-based medicine documentation or grounded in other accepted literature databases.

   6. Other review methods with prior CCE approval.

4. Disclosures of all individuals participating in the educational activity will be made known to the audience as required by the ACCME in addition to a disclosure by Tulane’s CCE that any COIs have been resolved with independence and without bias.

5. Speakers will be required to have a disclosure slide (1^st or 2^nd slide) identifying commercial relationships/interests in addition to any discussion of off-label use.

6. The audience will provide validation of absence of bias and COI for each speaker by the following summative methods:

1. Activity Evaluations

2. Focus Group Interviews (if applicable) or alternative immediate feedback method

3. Post-Activity survey

Consequences of non-adherence to the Tulane policy consist of:

• Disqualified from speaking if no disclosure form is completed (SCS 2.2)

• Warning letter if the activity evaluation by the audience indicates conflicts are present. (1^st occurrence)

• Not invited to speak or participate in any other role in a Tulane CME-certified educational activity. (2^nd occurrence)

(c) 2005 Tulane Center for Continuing Education  COI Policy 9/07