Virtual Mentor. June 2006, Volume 8, Number 6: 416-419.
Independence in Continuing Medical Education
A physician outlines the role of the ACCME and its responsibility to successfully manage the boundary between continuing medical education and the commercial support, commercial interests, promotion and advertising related to it.
Murray Kopelow, MD, MSC, FRCPC
Approximately 70 percent of the physicians in the United States are required by their state medical licensing boards to participate annually in formal, structured continuing medical educational activities to meet licensure requirements . Among the details of these regulations are requirements that the education activity be designated for credit according to standards described within the American Medical Association's Physician Recognition Award  and provided by an institution or organization accredited by the Accreditation Council for Continuing Medical Education (ACCME) .
A large proportion of the funding for this accredited continuing medical education (CME) comes from commercial interests (proprietary entities like pharmaceutical companies or biomedical device manufacturers that produce health care goods and services consumed by, or used on, patients). ACCME-accredited providers use approximately $1 billion of direct or in-kind support from commercial interests to finance their accredited CME activities .
Accredited CME is not the only interaction with physicians that commercial interests fund. Among their other activities, they fund nonaccredited organizations to create live events or printed materials for physicians using the same formats as those used by CME, but these are designed and offered as promotion for the their specific products. In medical education in the U.S., compliance with the ACCME Standards for Commercial Support distinguishes approved, independent CME from activities that are promotion events created by commercial interests .
The Standards for Commercial Support of Continuing Medical Education include "Standards for Independence in CME," which are the medical profession's mechanism to manage the boundary issues created by the coexistence of continuing medical education with commercial support, commercial interests, promotion and advertising .
Standards for Independence in CME
The standards address independence, identifying and resolving personal conflicts of interest, management of commercial support, separation of promotion from education, and ensuring improvements in health care.
Standard 1—independence—requires the CME provider to ensure that critical decisions involved in the planning of a CME activity are made free of the control of a commercial interest. Specifically these decision points are identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content of the CME, selection of educational methods, and evaluation of the activity. So as to not undermine this independence, ACCME stipulates that a commercial interest cannot take the role of nonaccredited partner in a joint sponsorship relationship that has been established to design and present a CME activity.
Standard 2—resolution of personal conflicts of interest—is new to the 2004 updated "Standards for Commercial Support" and undergirds the independence in CME. To be compliant with this standard 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 entity. The ACCME defines "relevant financial relationships" as financial relationships in any amount occurring within the past 12 months that create a conflict of interest . The provider must take the steps necessary to identify and resolve all conflicts of interest prior to delivery of the education activity to learners. Disclosure is critical to being able to identify and resolve any conflicts of interest. Therefore, an individual who refuses to disclose relevant financial relationships must 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 a CME activity.
Standard 3—appropriate use of commercial support—ensures that commercial support is spent on the costs of the education. The provider may not use commercial support to pay for travel, lodging, honoraria or personal expenses for nonteacher or nonauthor participants of a CME activity. This standard requires the presence of written agreements that document source of the funds, the terms of support, that funds are not used to pay the learners' personal expenses and that the provider can produce an accounting of how the funds are expended. Education is the priority. Social events or meals at CME activities cannot compete with or take precedence over the educational events. Independence must be preserved. A provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors or participants, or other education matters including content from a commercial interest as conditions of contributing funds or services.
Standard 4—appropriate management of associated commercial promotion—guides the provider in keeping commercial promotion separate from continuing medical education. Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Whether live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. The standards provide specific strategies that keep advertising and education separated for print, computer-based and live face-to-face CME activities. For print CME, advertisements and promotional materials cannot be interleaved within the pages of the CME content. For computer-based CME, advertisements and promotional materials cannot be visible on the screen at the same time as the CME content. For live, face-to-face CME, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during or after a CME activity. Providers cannot allow representatives of commercial interests to engage in sales or promotional activities while in the space or place of the CME activity. Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities.
Standard 5—content and format without commercial bias—directs providers to ensure that CME activities promote improvements or quality in health care and not a specific proprietary business interest or a commercial interest. Presentations must give a balanced view of therapeutic options. This is the essence of the difference between accredited CME and those events planned and presented by commercial interests. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, several companies' trade names should be used, where available—not just trade names from a single company.
Standard 6—disclosures relevant to potential commercial bias—invokes transparency as a strategy in continuing medical education. Prior to the beginning of the education activity learners must be provided with information about relevant financial relationships and the source of all support from commercial interests. Even when contributions are "in-kind," the nature of the support must be disclosed to learners. For an individual teacher with no relevant financial relationships, the learners must be informed that no relevant financial relationships exist. This helps learners distinguish "missing information" from "no relevant relationships," which ACCME believes is an important distinction to make.
New Standards Take Effect Soon
It is critical to ACCME that continuing medical education is presented in a context of independence from the commercial interests that fund a good part of the CME enterprise. In November 2006 ACCME begins making accreditation decisions based on these standards, adopted in 2004.
Next, ACCME will focus on accreditation that promotes learning and change  in the context of practice-based change and improvement .
Murray Kopelow, MD, MSC, FRCPC, is the chief executive and secretary of the Accreditation Council for Continuing Medical Education, which has its offices in Chicago, Ill.
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