ICS-US Department of CME Guidelines,Practices & Policies
Policy on Commercial Support and Independence (Adopted 6/6/2012, Revised 9/30/12)
Guiding Principle
This policy is intended to insure that ICSUS Continuing Medical Education (CME) activities are free from and developed independent of commercial influence, based upon the best scientific evidence available, and focused on improving physician knowledge, competence, and performance in practice or patient outcomes.
How is commercial support defined?
Commercial support is defined as financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity.
What constitutes a commercial interest in relation to CME?
A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
Can commercial employees assist in CME activities?
No,except in rare circumstances, this is not permitted. When a commercial employee’s limited assistance to operate a piece of equipment enhances the educational mission of an activity, the employee may upon prior approval by the Executive Director or CME Committee Chair, be permitted to participate with the proviso that no marketing activities are permitted. Appropriate monitoring by course leaders will be required.
Can commercial employees serve as teachers in an ICSUS accredited CME course?
No, this is not permitted under any circumstance. While an employee may under certain circumstances seem to be the only one able to supply information with regard to a unique new product or cutting edge procedure, the employee relationship creates a situation whereby the ICSUS cannot control the content of the activity and therefore an irreconcilable conflict of interest is created. As such the employee cannot be allowed to participate.
Definition of an Employee
Anyone who performs services for a commercial interest is their employee if the commercial interest can control what will be done and how it will be done. This is true even when the commercial interest gives the employee freedom of action. What matters is that the commercial interest has the right to control the details of how the services are performed.
Note: The ACCME indicates that it believes the employer of an industry scientist controls the research, controls the results and controls the presentation of the science. If the research is reported in (the context of a) CME (activity) then the CME is not independent of the control of an ACCME-defined commercial interest. The ACCME has taken the position that persons who are employees of industry can control some content of some CME (activities). For example, in accredited CME scientists can teach, or report about biology, about pure science, but they cannot teach, or report about products. Also, executives can teach, or report about industry issues but not about their products.(Policy and Medicine Website – Article entitled, “ACCME Bans Corporate Scientists from Presenting Translational Research at CME Events.” 9/28/09)
Financial Disclosure and Conflict of Interest Policy (Revised 11/13/12)
Financial relationships are those 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.
Relevant financial relationships are financial relationships in any amount occurring within the past 12 months that create a conflict of interest (COI). ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.
Circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she (or their spouse/partner) has relevant financial relationship(s).
In order to begin the process of managing COI, ICSUS must know about ALL relevant financial relationships prior to the activity being developed and delivered to the learners. ICSUS must obtain from the planners, speakers, authors and peer-reviewers ALL disclosures of their financial relationships (Including those of their spouse/partner). This disclosure information is so important to the CME process that individuals who refuse to disclose relevant financial relationships are disqualified from having a CME role that will give them the opportunity to affect the development, management, presentation or evaluation of that CME activity.
Mechanism for the Identification and Resolution of Conflict of Interest in CME Activities
Submission and Review of Disclosure Forms
All planners, speakers, authors and peer-reviewers for a CME activity are required to submit FULL DISCLOSURE of all financial relationships prior to the CME activity. The Executive Director will review all completed forms for each activity to determine if any potential conflicts of interest exist. (Failure to submit a disclosure in a timely manner will result in the planner, speaker, author and peer-reviewer being removed from the program.) Planners, speakers, authors and peer-reviewers will be asked to provide the disclosure information as soon as they are identified for a CME activity.
Determination of Whether a Conflict of Interest Exists
From the ACCME’s perspective, a COI is present when a planner, speaker, author or peer-reviewer has both a current financial relationship with a commercial interest and the opportunity to affect content relevant to products or services of that commercial interest. Conflicts of interest are identified through an analysis of the information disclosed and an understanding of the planned content of the CME.
A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to ICSUS such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A conflict of interest depends on the situation, and not on the character or actions of the individual.
If a Conflict of Interest Exists
All planners, speakers, authors and peer-reviewers involved with the planning or teaching of a CME activity who disclose a relevant financial relationship (including those of their spouse/partner) are deemed to have a conflict of interest. ICSUS will resolve that conflict of interest prior to the CME activity using one or more of the following mechanisms:
1. Review of content to ensure presentation is balanced. (PowerPoint presentation, manuscript or any other materials that provide information about the content of the presentation)
2. Change the content of the person’s assignment.
3. Limit the content to a report without recommendations.
4. Replace the individual with a conflict.
5. Disqualify faculty if there is no other means with which to resolve conflict.
Non-Resolvable Conflicts of Interest
If unable to resolve conflict of interest and/or changes proposed are not accepted by faculty, they will be removed from the CME activity.
Evaluation & Overview
A planner, speaker, author and peer-reviewer disclosure recap report is distributed at the beginning of each CME activity that details the financial relationships (or lack thereof) of these individuals who are involved in the planning or teaching of CME content. Activity evaluations for each session ask all learners and moderators to evaluate whether any commercial bias is present. If commercial bias is detected, learners are asked to indicate specifics about commercial bias so it can be addressed post-activity.