In 1990, an inter-organizational task force, the Task Force on CME and Industry Collaboration, was formed to foster better informed collaboration between commercial supporters and all major accredited sponsors of continuing medical education. Included in the membership of the Task Force on CME and Industry Collaboration are senior staff members of major pharmaceutical and device manufacturers, and leaders of continuing medical education in the United States.

The Task Force has blended the diverse knowledge, interests, and talents of its members to produce these Guidelines which address all aspects of continuing medical education, not just relationships with commercial supporters.

These Guidelines will provide a credible standard to which the health professions may compare their criteria for accrediting continuing medical education. The AOA believes that much mutual benefit will flow from the unity among the professions through application of these policies and procedures.

The AOA has adopted, with minor changes, the Uniform Guidelines for Accrediting Agencies of Continuing Medical Education. These Uniform Guidelines have been adopted as a part of the Continuing Medical Education Guide of the American Osteopathic Association.

Although members of the Task Force are associated with most of the major players in the CME and the health-related commercial interests in the U.S., the Task Force has no official status in government, industry, or education.

The AOA Council and its staff members are available to help with interpretation of the task force actions and implementation of the AOA guidelines.

I.  Introduction
The purpose of continuing medical education (CME) is to enhance the physician's ability to care for patients. It is the responsibility of the accredited sponsor of a CME activity to assure that the educational activity is designed primarily for that purpose.

Accredited sponsors often receive financial and other support from commercial organizations. Such support can contribute significantly to the quality of CME activities.

The purpose of the "Uniform Guidelines" is to describe appropriate behaviors expected of accredited sponsors in planning, designing, implementing, and evaluating CME activities. Further, the "Uniform Guidelines" apply to those continuing medical education activities for which an accredited sponsor receives commercial support.

II.  Management of CME Activities
    A.  Mission Statement
An accredited sponsor shall define the role, scope and intended audience of its educational functions by having a written statement of its CME mission formally approved by its governing body.
    B.  Management Support
An accredited sponsor shall provide evidence that management procedures and other necessary resources are available and effectively used to fulfill its CME mission.
    C.  Joint Educational Activities
An accredited sponsor that provides educational activities jointly with a non-accredited entity shall assure that such activities are conducted entirely according to these "Uniform Guidelines".
   D.  Enduring Materials
An accredited sponsor that offers instructional materials, that in themselves constitute a planned activity of CME, shall develop and administer those materials entirely according to these "Uniform
Guidelines."
    E.  Funding Arrangements
The ultimate decision regarding funding arrangements for CME activities must be the responsibility of the accredited sponsor. Funds from a commercial source should be in the form of an educational
grant for the support of programming made payable to the accredited sponsor. The terms of the grant must be set forth in a written agreement. There shall be no other funds paid to faculty, CME
program directors, or others involved with the supported program except as provided in the written agreement. All support associated with an educational activity must be made under the direction of, and with the full knowledge and Approval of, the accredited sponsor.

Payment of reasonable honoraria and reimbursement of out-of-pocket expenses for faculty is customary and proper.  Commercial support must be acknowledged in printed announcements and brochures; however, reference must not be made to specific commercial products. Following the CME activity, upon request, the accredited sponsor must be prepared to report to each commercial supporter, information concerning the expenditure of funds each has provided.
   F.  Marketing CME Activities
A CME sponsor may authorize a commercial supporter to disseminate to the medical community information about a CME activity. However, the content of such information must always be
explicitly approved by, but not necessarily prepared by, the accredited sponsor, and must always identify the educational activity as produced by the accredited sponsor.
    G.  Expenses for Attendees
In connection with an educational activity, it is not permissible to use funds originating from a commercial source to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty attendees. Subsidies for hospitality should not be provided outside of modest meals or social events that are held as a part of the educational activity.

Scholarship or other special funding to permit medical students, interns, or residents and fellows to attend selected educational conferences may be provided, as long as the selection of students,
interns or residents and fellows who will receive the funds is made either by the academic or training institution, or by the accredited sponsor, with the full concurrence of the academic or training
institution.

III.  Educational Standards and Practices
    A.  Needs Assessment
An accredited sponsor shall systematically identify the CME needs of prospective participants and use that information in planning CME activities.
    B.  Objectives
An accredited sponsor shall, for each CME event, develop objectives based on identified educational needs.
    C.  Educational Design
       1.  Objectives Influence Design An accredited sponsor shall use the objectives developed for an educational activity to select the content, and design the educational methods, for that activity.
       2.  Basic design requirements for CME activities In designing educational activities, the accredited sponsor must assure that the activities have the following characteristics:

They must be free of bias for or against any commercial product;

They must be designed and produced so that content
and educational methods are ultimately determined by
the accredited sponsor;

If the activities are concerned with commercial products,
the program must present objective information about
such products based on scientific methods generally
accepted in the medical community.

       3.  Independence of Accredited Sponsors The design and production of educational activities shall be the ultimate responsibility of the accredited sponsor. Commercial supporters of such activities shall not control the planning, content or execution of the activity. To assure compliance with the "Uniform Guidelines" the following requirements must be adhered to:
           a.  Help with the preparation of educational materials
The content of slides and reference materials must remain the ultimate responsibility of the faculty of
accredited sponsor. This responsibility may be shared with the faculty of the accredited sponsor. The accredited sponsor may ask a commercial supporter to help with the preparation of conference related educational materials, but these shall not specifically promote the proprietary interests of the commercial supporter.
           b.  Assistance with Educational Planning
An accredited sponsor must maintain responsibility for and control over the selection of content, schedule, faculty, attendees, and educational methods and materials in all of its CME activities.

An accredited sponsor may obtain information that will assist in planning and producing an educational activity from any outside source whether commercial or not. However, acceptance by an accredited sponsor of advice or services concerning speakers, invitees or other educational matters, including content, shall not be among the conditions for the provision of support by a
commercial organization.
            c.  Distribution of advertising
No commercial promotional materials shall be displayed or distributed in the same room immediately before, during, or immediately after an accredited educational activity. Representatives of commercial supporters may attend an educational activity for which they have provided support, but may not engage in sales activities while in the room where the educational activity takes place.
            d.  Exhibits
When commercial exhibits are part of an overall program, arrangements for these must not influence
educational planning or interfere with the presentation of CME activities. Exhibit placement must not be a condition of support for a CME activity.
            e.  Proprietary Names of Products
While the use of proprietary names of products is permissible during educational activities, generic names should be used by the faculty whenever possible.  Moreover, it is the responsibility of the accredited sponsor to assure that presentations give a balanced view of diagnostic, therapeutic, or appliance options. If proprietary names are used, those of several companies that make relevant products must be used rather than only those of a single company.

IV.  Other Guidelines for Relationships between Accredited Sponsors and Commercial Supporters of CME
    A.  Communicating Results of Scientific Research
Objective, rigorous, scientific research conducted by commercial companies is an essential part of the process of developing new pharmaceutical or other medical products or devices. It is highly
desirable that direct reports of such research be communicated to the medical community. An offer by a commercial supporter to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation which shall be used by the accredited sponsor to confirm the scientific objectivity of the presentation. Such information must conform to the generally accepted standards of experimental design, data collection and analysis.
    B.  Disclosure
An accredited sponsor shall have a policy requiring disclosure of the existence of any significant financial interest or other relationship a CME faculty member or the sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation.  All approved CME activities shall conform to this policy.

Such faculty or accredited sponsor relationship with commercial supporters shall be disclosed to participants prior to educational activities in brief statements in conference materials such as brochures, syllabi, exhibits, poster sessions and post meeting publications.

In the case of a regularly scheduled event, such as grand rounds, disclosure shall be made by the moderator of the activity after consultation with the faculty member or a representative of the
accredited sponsor. Written documentation that disclosure information was given to participants shall be entered in the file for that activity.
    C.  Off-label uses of products
When an off-label use of a product, or an investigational use not yet approved for any purpose, is discussed during an educational activity, the accredited sponsor shall require the speaker to disclose that the product is not labeled for the use under discussion, or that the product is still investigational. Discussions of such uses shall focus on those uses that have been subject of objective investigation.
   D.  Activities that are repeated many times
An accredited sponsor that offers educational activities that repeat essentially the same information each time they are given, must demonstrate that every iteration of that activity meets all of the
provisions found in these "Uniform Guidelines."
    E.  The accredited sponsor's use of educational activities or materials prepared by organizations other than the accredited sponsor
When an accredited sponsor offers an educational activity based on concepts or materials prepared by an outside organization, that activity must adhere to these "Uniform Guidelines" in all respects,
especially in regards to the provisions concerning the independence of the accredited sponsor in planning, designing, delivering, and evaluating all of its educational activities offered for credit.