Conflict of Interest Policy Regarding CME Activities
It is the policy of the George Washington University Medical Center, Office of Continuing Education in the Health Professions to insure balance, independence, objectivity, and scientific rigor in all of its sponsored educational programs.
BACKGROUND:
Per the Accreditation Council on Continuing Medical Education (ACCME), all CME activities offered in September, 2005 and thereafter shall comply with Standard 2 of the new Standards for Commercial Support (SCS). The SCS reads, in part:
STANDARD 2: Resolution of Personal Conflicts of Interest
2.1 The provider must be able to show 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 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.
2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity.
2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.
Standard 2 contains three new requirements: 1) the ACCME SCS regarding disclosure have been expanded to apply not only to speakers at CME activities but also to content planners for the CME activities and others who are in a position to influence the content of a CME activity; 2) if a speaker or planner refuses or otherwise fails to disclose conflicts of interest, he or she MUST be recused from the activity; and 3) disclosed conflicts of interest must be "resolved" prior to participation in the planning or presentation of a CME activity.
POLICY:
To fulfill the intent of the ACCME Standards for Commercial Support regarding conflicts of interest for CME activities, The George Washington University Medical Center shall:
Require completion of the GW Office of Continuing Education in the Health Professions (OCEHP) Disclosure Form by all respective CME activity content planning committee members and speakers at an interval to be determined by the OCEHP on an activity-by-activity basis.
Disqualify from participation in all CME activity content planning committee members and speakers who refuse or otherwise fail to disclose conflicts of interest.
Resolve disclosed conflicts of interest prior to participation in the planning or presentation of a CME activity.
To fulfill these requirements, all of the following steps must be taken:
| 1. |
All persons in a position to influence or control CME content will complete and submit OCEHP's Conflict of Interest Form. This includes but may not be limited to course directors, program planning committee members, speakers, authors, and staff. |
| 2. |
Conflict of Interest Forms will be reviewed by the OCEHP to determine the appropriate course of action. This may include review by the course director, planning committee, and/or the Associate Vice President for Educational Resources. |
| 3. |
Conflicts of interest shall be resolved and documented by one or more of the following methods or such other plan as may be deemed appropriate:
Altering financial relationships. Individuals may change their relationships with commercial interests (e.g., discontinue contracted services) to eliminate the source of potential bias in the CME activity content.
Altering control over content. An individual's control of CME content can be altered in several ways to remove the opportunity to affect content related to the products and services of a commercial interest. These include the following:
| i. |
Assign the content that is the subject of potential bias to another individual who is free of potential conflict regarding that subject matter. |
| ii. |
Change the focus of the CME activity. The CME provider could change the focus of the activity so that the content is not about products or services of the commercial interest that is the basis of the conflict of interest. |
| iii. |
Alter the individual's assignment so that products or services of the commercial interest are no longer relevant. For example, an individual with a conflict of interest regarding products for treatment of a condition could address the pathophysiology or diagnosis of the condition, rather than therapeutics.
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| iv. |
Limit the individual's role in the CME activity to that of delivering a report without recommendations. For example, if a participating individual is funded in his or her work by a commercial company to perform research, that individual's participation in the CME activity may be limited to the presentation of data and results of the research. An alternate individual who is free of potential conflict regarding the subject matter could address broader implications and recommendations. |
| v. |
Limit the sources for recommendations. Limit an individual with a conflict of interest from selecting the evidence to be presented in the CME activity by restricting recommendations to those based on formal structured reviews of the literature with the inclusion and exclusion criteria stated (e.g. 'evidence-based'). For example, the individual could present summaries from the systematic reviews of the Cochrane Collaboration. |
Independent Content Validation - Conflict of interest may be resolved if the CME material is peer reviewed and:
| i. |
All the recommendations involving clinical medicine are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. |
| ii. |
All scientific research referred to, reported or used in CME in support or justification of patient care recommendations conforms to the generally accepted standards of experimental design, data collection and analysis. |
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| 4. |
Resolution of the conflict of interest and how it was resolved must be documented and to CME activity participants in writing in advance of the CME activity. |
| 5. |
The following statement and the relative disclosures must be provided to CME activity participants in writing prior to the commencement of the activity:
The George Washington University Medical Center has implemented a process where everyone who is in a position to control the content of an educational activity has disclosed all relevant financial relationships with any commercial interest. Potential conflicts of interest were resolved and documented by one or more of the following methods: 1) Altering the individual's financial relationships, 2) Altering the individual's control over content; or 3) Conducting an independent validation of the individual's presentation content. Individuals who refused to or otherwise failed to disclose potential conflicts of interest to The George Washington University Medical Center were disqualified from participation planning or implementing this CME activity. Potential conflicts of interest are disclosed below.
The following speakers/planners indicated they have no potential conflicts of interest to disclose:
[Insert Name 1]
[Insert Name 2]
[etc.]
The speakers/planners listed below have a relationship with an outside interest, as indicated. The potential conflicts of interest created by the stated relationship(s) were resolved by [insert description of mechanism]:
[Insert Name 3]. . . . . [insert disclosure information]
[Insert Name 4]. . . . . [insert disclosure information]
[Insert Name 5]. . . . . [insert disclosure information]
[etc.]
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