Continuing Medical Education

The ability to offer Continuing Medical Education (CME) for chapter events, free of charge, is a benefit that is afforded to all ACS chapters.

Here are answers to some commonly asked CME questions:

What Financial Relationships need to be disclosed to the Accredited Provider of a Chapter Event?

Individuals need to disclose relationships with a commercial interest if both (a) the relationship is financial and occurred within the past 12 months and (b) the individual (or spouse/partner) has the opportunity to affect the content of CME about the products or services of that commercial interest.

Financial relationships are those relationships in which the individual (or spouse/partner) 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 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 for 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. The ACCME (Accreditation Council for Continuing Medical Education) 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.

When do relationships create conflicts of interest?

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.

Where is the conflict?

When the provider's interests are aligned with those of a commercial interest, the interests of the provider are in "conflict" with the interests of the public. The interests of the people controlling CME at an event must always be aligned with the best interests of the public.

How do these circumstances create a conflict of interest?

The potential for increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive to insert commercial bias. Commercial bias is prohibited in CME activities.

Do committee members need to sign a disclosure statement at each planning activity/meeting while for planning the same activity or event?

No. Compliance requires that disclosure is made once, prior to the start of planning process. Disclosing the same information repeatedly to the same provider is not necessary. With the original disclosure information, the provider is able to implement its mechanism to resolve any conflicts of interest. However, if an individual has dual roles (i.e. as a planner and a speaker), a separate disclosure form must be completed for each role.

What do we do when we appoint a person to speak at the last minute and when the person arrives at the activity they refuse to disclose relationship information?

You must not carry on with the individual's presentation under these circumstances. The person cannot participate in the CME event if they refuse to complete a disclosure form, because conflicts of interest can neither be identified nor resolved.

What is "commercial support"?

Commercial support is financial, or in-kind, contributions given by a commercial interest that is used to pay all or part of the costs of a CME activity.

Can a commercial supporter direct the content of CME?

No. The provider must ensure that the content of the CME truly remains beyond the control of the commercial supporter. The process to develop the CME must be independent of the commercial interest. Providers must not allow commercial supporters to directly or indirectly control the content of CME activities.

How does the CME provider pay for its services in the production and distribution of a CME activity? Can the provider take a portion of the grant monies to pay for activity-related expenses, e.g., certificates, mailings?

Yes. The funds from commercial support may be used by the provider to pay for the costs of the CME activity including, for example, the distribution of certificates or other mailings, as required.

Must the commercial support be given as a single lump-sum grant or payment?

No. Commercial support does not have to be a single payment or a grant.

Can a commercial supporter supplement its contributions to the activity by additional direct payments to people involved in the activity?

No. All commercial support must be stipulated by a written agreement and must flow through the provider and/or its educational partner. Only the provider and/or its educational partner can make payments to people for their role(s) in the activity.

Are mealtime speakers prohibited?

No. Working and learning through mealtime is an efficiency often included in CME activities. Alcohol is prohibited from being served during a College Sponsored Chapter CME event.

How can meals or social events take precedence over educational events?

Using commercial support to pay for modest meals and social events at CME activities has been allowed for years. However, providers must avoid planning meals or social events for longer time periods or more costly than the educational activity, for example.

Whose expenses can be paid for out of the commercial support?

Commercial support underwrites the provider's expenses for developing and presenting an activity. Commercial support can be used to pay for the expenses of teachers and authors, as well others, who are working for the provider on the activity.

Outside funding of an educational activity from a commercial source must be in the form of an unrestricted educational grant. "Gifts in kind," such as equipment for a course, are also a type of educational grant. Both types of commercial support must be formalized. As required by the ACCME, "the terms, conditions, and purposes of such grants must be documented by a signed agreement between the commercial supporter and the accredited provider."

Any company providing commercial support must sign an ACS letter of agreement (LOA). The LOA must be signed by both the commercial company and the Chapter Representative prior to the meeting. The money from the grant must be sent directly to the chapter. The allocation of grant money should be included in the post-CME program financial statement sent to the College after the meeting. The commercial supporter also has the right to request information on the expenditure of the funds provided to the chapter.

Commercial support of both types must be acknowledged in printed announcements and brochures. Suggested statements include:

"The American College of Surgeons gratefully acknowledges the unrestricted educational grant from (company name) in the amount of $10,000"

OR

"The American College of Surgeons Chapter_____ gratefully acknowledges…."

Acknowledgment for "gifts in kind" must also be made; however, the specific product should not be mentioned. For "mixed" commercial support, a list format can be used:

• "The American College of Surgeons gratefully acknowledges the following companies for their unrestricted educational grants and/or "gifts in kind":
• XXXX for equipment loan (e.g. used in surgical skills competition)
• XXXX for printing of annual meeting program
• XXXX for equipment loan and $10,000

There is some flexibility regarding the language of the acknowledgment. The acknowledgment may also include the mission and areas of clinical involvement of the company as well as the corporate logo if it is not product promotional in nature. No specific products may be referenced, even if they are not related to the topic of the program.

Commercially supported social events should not compete with educational sessions. Printed acknowledgment of commercially supported social events is limited to the program book/brochure and posters located adjacent to the events. Signs, table tents, podium signs and centerpieces regarding social events and commercial support are prohibited from being placed inside the education program room.

Commercial companies exhibiting at your activity are not considered commercial supporters. Exhibit fees are not educational grants. Therefore, exhibitors are not required to complete a commercial support agreement.

The funds from corporate advertisements do not constitute commercial support, and therefore it is not necessary for the advertiser to complete a commercial support agreement. However, such advertisements may only appear in publications of a non-educational nature, such as the general brochure. Advertisements are not allowed in materials of an educational nature, including course syllabi.

A satellite symposium is a course planned, executed, and sponsored by a commercial entity and offered during an educational activity accredited by the College. There are several restrictions regarding such an activity:

1. The College does not provide CME credit for the symposium. The company must find another accredited provider in order to offer their attendees CME credit.
2. The symposium must begin and end outside of the regular meeting hours of the ACS educational activity. Satellite symposia are usually offered before or after an education program. Other options within the meeting dates include "sunrise" sessions and evening hours, when no regular sessions are scheduled.
3. Neither the College's name nor logo may appear in the symposium materials. A disclaimer should be included in the promotional materials indicating that there is no ACS involvement.
4. All promotional materials must be approved by an ACS representative prior to print.

Collaboration between the medical industry and surgeons and surgical organizations has benefited health care delivery for years. Financial support from industry has enhanced surgical research and the continuing medical education (CME) of surgeons. However, the primary objective of professional interactions between surgeons or surgical organizations and industry should be the improvement of patient care. It is the responsibility of surgeons to ensure that this care is not inappropriately affected by collaboration with industry. Surgical organizations need to organize CME programs of the highest quality for their members, while maintaining costs at a fiscally responsible and reasonable level. These guidelines for industry support seek to maximize corporate participation in CME programs while maintaining the autonomy and impartiality of individual surgeons and surgical organizations. They are based on the principles of (1) openness, (2) quality of teaching and research as determined by experts, (3) freedom from conflict of interest, and (4) appropriate recognition for industry support.

General Guidelines: Meetings

Surgical organizations should have the ultimate responsibility for the planning and development of CME programs. Industry supporters of CME programs should not influence the planning, content, or implementation of an organization's CME program.

1. Industry supporters may not organize any functions involving attendees at a surgical organization's CME program that conflict with scientific sessions or social events. Industry exhibits should enhance the scientific activities of the CME program and not interfere with the scientific program.
2. Industry supporters may not use the surgical organization's name, logo, or seal in conjunction with advertising or promotion without written permission of the organization.
3. Written or recorded details of the scientific program may not be reproduced without the written consent of the surgical organization.
4. Industry sponsors may not offer direct payment to CME program organizers, participants, or attendees to cover travel, accommodations, or honoraria, nor may such individuals accept payments if offered. Support of CME programs shall be accepted only as unrestricted grants or as exhibitor registration fees.
5. No industry promotional materials should be displayed or distributed in the same room during scientific presentations of single session meetings. In larger meetings with multiple simultaneous sessions, the access to promotional materials shall be controlled by the surgical organization in order to avoid any appearance of a direct connection between the distribution of promotional materials and the scientific presentation.
6. Representatives of industry sponsors may not engage in sales or promotional activities during scientific sessions, social events, or business meetings.
7. Industry support of the meetings through educational grants or exhibitor fees may be acknowledged on promotional materials and/or in the agenda of the CME program. Scientific session moderators may recognize support during the announcements of the meeting.
8. Program committees may not be in a position of conflict of interest by virtue of an undisclosed relationship with industrial companies that fund CME activities or surgical research activities.
9. Presenters' lectures or posters shall disclose, as part of their presentation, any industry support related to the work being presented.

General Guidelines: Research /Grants/Fellowship Awards

1. Scholarships or other funds to permit medical students, residents, or fellows to attend educational events shall be permissible as long as the selection of participants for these funds is made by their academic institutions or by a surgical organization.
2. Selection of research grants and/or awarding of fellowships supported by industry shall be made by surgical organizations free of any influence from industry.
3. Industry support of research may be recognized in the minutes of business meetings. However, industry representatives may not occupy prominent positions at business meetings, scientific sessions, or social events.

Management of Funds from Industrial Sponsors

1. Decisions regarding funding arrangements for CME programs should be the responsibility of the chapter council or executive committee. Funds from industrial supporters shall be in the form of an unrestricted educational grant made payable to the chapter, or in the form of a CME program exhibitor registration fee. The terms, conditions, and purposes of such grants and funds shall be documented by a signed agreement between the industry supporter and the surgical organization. No funds from an industrial source should be paid to the members of the organization's board or executive committee or others involved in planning CME meetings.
2. Industrial support shall be disclosed in printed announcements and programs and in all manuscripts published of work supported with industrial funding; however, reference may not be made to specific products.

These guidelines concerning corporate participation of CME programs and research have been compiled based on the published guidelines of the American College of Surgeons, the American Medical Association, the Accreditation Council for Continuing Medical Education, the Canadian Medical Association, and the Royal College of Physicians and Surgeons of Canada.

Encouraged by the College's Advisory Council for General Surgery, these guidelines were developed by the College's Committee on Ethics. They were approved by the Board of Regents in October of 2000.