Conflict of Interest Policy
Purpose
Wright State University Boonshoft School of Medicine ("School") is an Accreditation Council for Continuing Medical Education ("ACCME") accredited provider of continuing medical education ("CME"). It is the CME committee's policy to ensure balance, independence, objectivity and scientific rigor in all CME activities. The desired outcome of this policy is to conduct CME activities that are free of the appearance of or actual conflicts of interest ("COI") and the introduction/demonstration of bias in favor or against a commercial product, service, or device in return for known or unknown personal and professional gain. The intent of this policy is to ensure that any potential conflict will be identified openly so that the activity participants may form their own judgments about the presentation with the full disclosure of facts.
References
The CME program's policy to identify and resolve conflicts of interest is drawn from the School's Conflict of Interest Policy adopted November 2008 and the 2004 updated ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities ("SCS"). Further information about the Accreditation Council requirements may be on the ACGME web site.
Policy
The School's CME activities will adhere to the ACCME SCS.
All individuals in a position to influence the content of a certified CME activity must disclose any relevant financial relationship that might affect independent involvement in the proposed CME activity. Any speaker or planning committee member or activity chair who refuses to disclose financial relationships will be disqualified from participating in the planning and implementation of the activity.
The CME application requires complete documentation, including completion of all standard disclosure statements from the beginning stages of the educational process, indicating no COI or COIs that have been resolved.
Definitions
Conflict of interest: Circumstances create a COI when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship.
Relevant financial relationship: Financial benefit that the person involved in the CME activity, spouse, or a partner has had within the past 12 months. This pertains to salaries, royalties, intellectual property rights, consulting fees, honoraria, ownership interest or other financial benefits with pharmaceutical companies, biomedical device manufacturers or other corporations whose products or services are related to the subject matter of the presentation topic.
Procedure to determine and resolve COI
Required elements of avoiding conflict include:
- Thoughtful review of the planning and content of CME activities;
- Full disclosure of relevant financial relationships to CME participants; and
- Audience evaluation of potential bias in CME presentations.
- Planning Committee:
The ACCME requires that all members of an activity planning committee disclose any relevant financial relationships with any commercial interest to the CME provider.- At the first meeting of the planning committee, all members must disclose any relevant financial relationships. All members who have no relationships should be documented in the minutes of the committee meeting.
- In the event of an identified COI, appropriate action should be taken to ensure its resolution. If a planning committee member discloses a conflict interest, they must submit their Resume or CV and their involvement with the planning of the activity will be closely monitored by the Physician Course Chair. The Physician Course Chair will attest to monitoring the Planning Committee member in question by signing the Planning Committee Attestation Document. The Director of Continuing Medical Education will oversee the planning committee member(s) Conflict of Interest document, resume/ CV, and the activity application and will then determine the resolution. The application must include an evaluation that has a question asking if the audience perceived any bias throughout the activity.
- If the Physician Course Chair discloses a conflict of interest, they must submit the same materials as a planning committee member. The Director of Continuing Medical Education will oversee all application materials.
- Acceptable alternatives include:
- The member may withdraw from the planning committee.
- The member may be excluded from planning any portions of the activity which are related to the COI.
- The activity may be subject to peer review by the remainder of the planning committee to ensure the absence of bias in its content.
- The activity may be submitted for peer review by the School's director of CME. All actions to identify and resolve conflicts of interest among speakers should be documented in the minutes of the planning committee and submitted to the CME office.
- Speakers/Activity Faculty:
The ACCME requires that all speakers in an approved CME activity disclose any relevant financial relationships with any commercial interest to the CME provider.- When a speaker accepts the invitation to present at a CME activity, the planning committee must obtain disclosure of any relevant financial relationships.
- In the event of an identified COI, appropriate action should be taken to ensure its resolution. If the speaker discloses a conflict of interest, the speaker must submit their CV/ Resume and the presentation for the activity to the CME Coordinator and activity coordinator. At this time, the CME Coordinator and the CME Director will review the presentation for any bias. A Resolution will be provided to the activity coordinator and activity chair upon approval or disapproval of the presentation and/or content. Acceptable alternatives include:
- The speaker may withdraw from the activity.
- The content of the presentation may be subject to peer review by the planning committee to ensure the absence of bias in its content.
- Evaluation of best available evidence on the topic, to ensure that the content of the presentation is consistent with the current literature.
- The presentation may be submitted for peer review by the School's director of CME.
All actions to identify and resolve conflicts of interest among the planning committee should be documented in the minutes of the committee meeting and submitted to the CME office.
- Unresolved Conflicts of Interest:
If a COI is identified for any speaker or planning committee member and cannot be resolved by the mechanisms described above, further action must be taken to prevent the introduction of bias into the activity. Such actions may include:- Removal of the speaker or planning committee member from the activity.
- Withdrawal of CME credit for the activity.
- These requirements are also applicable to a speaker or planning committee member who refuses to disclose financial relationships. These individuals are considered to be in conflict until appropriate disclosures are completed. Planning committee disclosures should be included in the initial application packet submitted to the CME Office. Speaker disclosures must be submitted no later than two weeks prior to a CME activity.
Please note the following from the ACCME Standards for Commercial Support: “An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a presenter or an author of CME and cannot have control of, or responsibility for, the development, management, presentation or evaluation of a CME activity.”