FREQUENTLY ASKED QUESTIONS ABOUT COMMERCIAL SUPPORT
FOR CONTINUING EDUCATION ACTIVITIES
DISCLOSURE
Is it necessary to have a Disclosure Form on file for every planner or faculty member
who participates in a CE activity, even if the program is not receiving any commercial
support or the speaker is not a physician?
Yes, a disclosure statement is required from every planner, activity director and speaker.
This includes pharmacists, physicians, other professionals and para-professionals and is
required regardless of the source of funding for the event or the topic(s). The intent of this
policy is not to prevent anyone with a potential conflict of interest from planning an activity
or making a presentation. It is intended that any potential conflict of interest be identified
openly and resolved in advance of the activity, so that the listeners may form their own
judgments about the activity or presentation with full disclosure of the facts.
Must I have a planner or faculty member fill out a new Disclosure Form each time
he/she plans an activity or presents at a CE activity?
Generally yes, planners or faculty must complete new disclosure forms each time they speak
or are involved in the planning of a new activity. The only exception is for faculty/planners
involved in a non-clinical activity (i.e. legal issues). For faculty/planners involved in a nonclinical program, the same disclosure form may be used for up to one year (subject to
approval from the Office of CPE). You must ensure that a signed copy of the disclosure form
is included in the CE file for each speaker and planner for each CE activity and document that
disclosure was made to participants at each CE activity.
Does disclosure apply only to relationships with pharmaceutical companies or does it
also apply to relationships with other companies?
If there is any possibility that a relevant financial relationship exists with a company or
organization that could bias the planner or speaker in any way, it is essential that this
relationship be disclosed (e.g. a partner in a law firm making a presentation regarding a legal
topic should disclose his relationship with the law firm).
What is a commercial interest?
A commercial interest is any entity producing, marketing, re-selling, or distributing health
care goods or services consumed by, or used on, patients.
Are speakers allowed to discuss off label or investigational uses of a medication in a CE
presentation?
Discussion of off-label uses are certainly allowed in CE activities. However, providers are no
longer required to have a mechanism in place to ensure that off-label or investigational uses
are disclosed as such. The ACCME adopted content validation statements in 2002 that are
expectations of providers with regard to any recommendations for clinical care. Specifically,
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“all the recommendations involving clinical medicine in a CME activity [are] based on
evidence that is accepted within the profession of medicine as adequate justification
for their indications and contraindications in the care of patients. All scientific research
referred to, reported or used in CME in support or justification of a patient care
recommendation [conforms] to the generally accepted standards of experimental design, data
collection and analysis.” You are responsible for communicating these expectations to your
speakers/faculty.
What constitutes a “relevant financial interest”?
In most cases, the individual should consider what others might perceive to be a potential
conflict of interest, such as ownership of stock, research grants, serving on a speaker’s
bureau, or receiving consulting fees.
What are my options for ways to disclose financial interests to the audience?
Disclosure may be made in the handouts, as a power point slide at the beginning of an
activity/presentation or verbally from the podium. There must be documentation in the CE
file that disclosure was made prior to the faculty member’s presentation. Disclosure should
include: a) name of company and nature of the relationship if relationships are present, or b)
state that no relationships are present if that is the case.
With respect to the documentation of verbal disclosure at CE activities:
1. a representative of the provider who was in attendance at the time of the verbal disclosure
must attest, in writing: a) that verbal disclosure did occur; and b) itemize the content of
the disclosed information (Standards for Commercial Support); or that there was nothing
to disclose (Standards for Commercial Support).
2. The documentation that verifies that adequate verbal disclosure did occur must be
completed within one month of the activity.
I have requested that a planner/speaker return a Disclosure Form several times but
have not been able to get one. What should I do?
An individual who refuses to disclose relevant financial relationships will be disqualified
from being a planning committee member, a teacher, or an author of CE, and cannot have
control of, or responsibility for the Education, management, presentation or evaluation of the
CE activity. (Standards for Commercial Support)
EXHIBITORS AT CE ACTIVITIES
Must I have a Commercial Support Agreement Form signed by an exhibitor at my CE
activity?
No. As exhibits are an arrangement for which the company receives something tangible in
return for their exhibit fee, it is not the same as an unrestricted educational grant.
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What limitations are there on exhibits at a CE activity?
Exhibits must be located in a different room from where the educational program is being
conducted. No promotional materials from a commercial supporter may be distributed in the
meeting room, including pencils, pads of paper, or company newsletters. There must be a
clear separation of marketing activities from the educational program.
May exhibitors and/or pharmaceutical reps attend a CE activity?
Yes, they may attend but may not engage in sales activities while in the room where the
activity takes place. It is up to you if you wish to charge the individual the standard
registration fee to attend the event.
UNRESTRICTED EDUCATIONAL GRANTS
If a pharmaceutical company is giving you support for an activity, who makes the
decision about the amount of the honorarium?
Decisions about the amount of honorarium to be paid are the responsibility of the planning
committee/activity director. You should determine what constitutes a “reasonable”
honorarium for invited speakers and negotiate directly with the speaker. If the speaker does
not wish to accept the amount offered, an alternative speaker should be identified. It is NOT
appropriate for the pharmaceutical company providing an educational grant to determine the
size of the honorarium.
May I use educational grants to support the cost of meals or other social events
associated with my CE activity?
The AMA Guidelines on gifts to physicians state that social events should be conducive to
discussion and exchange of ideas. The cost of these social events should be “modest” and the
number of hours devoted to the educational activity should substantially outweigh the number
of hours of the social event. Social events, such as dinners in conjunction with a CE activity,
should be paid for by those planning the program and not directly by a pharmaceutical
representative.
Are funds received from organizations that are not pharmaceutical companies
considered to be commercial support?
A commercial supporter is defined as any entity providing funds or resources in support of
CE activities with the exception of governmental entities. Therefore, funds received from law
firms, hospitals (excluding your own dept’s funds), the Robert Wood Johnson Foundation, or
the American Cancer Society are considered to be commercial support. Funds received from
the Ohio Department of Health or the Akron Metropolitan Housing Authority are not
considered to be commercial support.
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What is the best way to acknowledge a company who provided an educational grant?
Accrediting agencies require that participants be informed of who provided educational
grants in support of the activity. Acknowledgment may state the company’s name, mission
and areas of clinical involvement. The company’s logo and slogans may also be included if
they are not product promotional in nature. Acknowledgment may be made on the front of the
handouts, in a slide at the beginning of an activity, from the podium, on an easel by the
entrance door(s) to the meeting room, or in the conference brochure. The method of
acknowledging commercial support must be documented in the CE file. Note that those
providing commercial support are NOT to be called “sponsors” as the sponsor of a program
refers specifically to the accredited CE provider.
Can a commercial supporter give physicians invitations to your CE activity?
Yes, but only the accredited provider may authorize a commercial supporter to disseminate
information about a CE activity to the medical community. The content of the promotional
material is the responsibility of the provider.
Is it acceptable for a joint sponsor of a CE activity to receive the commercial support
funds in place of the accredited provider?
Yes, the accredited provider may delegate this responsibility to the joint sponsor as long as
the Letter of Agreement is between the accredited provider and the commercial supporter and
as long as the accredited provider maintains documentation of the funds in the CE file for the
activity (signed agreement form, copies of checks received, etc).
Since the new guidelines regarding commercial support went into effect for the
pharmaceutical industry, I have been asked to return agreement forms designed by the
pharmaceutical companies. What should I do?
Accrediting agencies Standards For Commercial Support require that seven elements be
included in these agreements: which CE activity is being supported, who are the funds going
to and which person is responsible for the CE activity, which company is providing the
support, how is the support to be used (i.e. unrestricted educational grant), what are the
conditions and requirements that will be followed (i.e. limitations on company’s involvement
with the program), signatures of company rep/ the person responsible for the activity, and the
person in the Continuing Professional Education Office responsible for oversight of the
activity. As long as this information is included in the company’s letter of agreement, it may
supersede the provider’s agreement form. However, be advised that the letter of agreement is
to be between the pharmaceutical company and the accredited sponsor of the CE credit
(NOT between the company and the joint or co-sponsor).
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ENSURING THAT CE CONTENT IS FAIR AND BALANCED
Is there anything wrong with selecting a CE speaker from a “speaker’s list” provided by
a pharmaceutical company?
There is no reason to request suggestions or topics from commercial interests since it is
unacceptable to act upon their suggestions. Accrediting bodies state that providers cannot
receive any advice or guidance, either nuanced or direct, on the content of educational
activities or on who should deliver educational content.
How can you assure that a CE activity is free of commercial bias?
You and your planning committee should maintain complete control over all aspects of the
educational planning and implementation process, including selection of topics and speakers,
and control of funding.
Must generic names always be used in discussions of products and treatments?
Generally, yes. In order to decrease the chances of promotional intent, generic names are
preferred. In practice, it is sometimes necessary to use generic AND product names because
generic names may not be recognized by participants. However, presentations must be
balanced, with discussion of both benefits and risks of the treatment, as well as alternative
products and therapies.
May a commercial supporter pay a speaker directly?
No, direct payment of an honorarium or speaker’s expenses establishes a relationship
between the speaker and the company which creates the potential for bias in a presentation.
In addition, direct payment of expenses is in violation of the pharmaceutical industry’s new
guidelines.
MISCELLANEOUS
Is it okay to give a list of participants for a CE activity to the commercial supporters or
exhibitors for my activity?
There is no accrediting agency policy prohibiting distribution of participant lists. However,
does your own organization have policies on privacy or sharing physician’s information?
Distribution of names and addresses for future marketing campaigns by pharmaceutical
companies may be in violation of your organization’s internal policies and/or ethical
guidelines.
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