Essential Area 3: Administration
Element 3.3
Present CME activities in compliance with the
MMS's policies for disclosure and commercial support.
There are two components in this Essential Area
including use of commercial support and faculty disclosure. First a
group must decide if they want to accept commercial support and what
responsibilities come with that. Each source of outside funding must be
documented with a written commercial support agreement form. There are
several reasons to document the process of obtaining outside funds. One,
it is important to know the source and amount of the funds that are
being provided for the CME activity. All financial support must be in
the form of an educational grant. It is also important that the
supporter does not expect to influence the content of the
presentation(s). For this reason, the written commercial support
agreement form must state that the provider will be in charge of content
and speaker selection. The educational grant helps to offset expenses of
the CME activity and must be acknowledged to the audience verbally or in
writing. It is helpful to acknowledge the support in a written
format in the event a conference attendee arrives after verbal
recognition is given.
The second component, faculty disclosure, states
that every presenter must provide information about his or her
relationships with industry that are relevant to a presentation(s). That
disclosure also includes providing information that the presenter has no
relationships. The two pieces of information that are necessary for
disclosure are: what company does the presenter have a relationship with
and what is the nature of the relationship. For example: Dr. John Doe
has funding from XYZ Pharmaceutical Company for a research grant. The
relationships cover the 12 months prior to the presentation. Each
reported relationship is assumed to be a potential conflict of interest
until resolved.
Providers must have a mechanism to resolve
conflicts of interest. If a faculty member refuses to disclose
relationships, or the relationships present a conflict, the speaker must
not present the CME activity. If a conflict is present, the provider may
determine that a different presentation does not provide a conflict, or
that the speaker must be replaced. As with commercial support, faculty
disclosure must be communicated to the audience either verbally or in
writing. It may be helpful to acknowledge the support in written
format in the event a conference attendee arrives after verbal
disclosure is given.
Communication of commercial support and faculty
disclosure information allows the audience to determine if there is bias
in the content of the presentation(s). The provider must document that
faculty disclosure and commercial support acknowledgement were made to
the audience.
Next Page: Element 3.4
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