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Q1. Does the AACME have a position on the use of the terms "restricted"
or "unrestricted" educational grants?”
Answer:The academy does not have a position on these
terms and would refer to as supported by an independent
grant from (here listing the commercial supporter).
Q2. Can you please provide a statement of your interpretation of
commercial interest.
Answer:
Here the challenge is to more clearly describe
the term marketing. After a thorough review of ACCME
policies and interpretations, this could be seen as
anyone that performs any function for a commercial
interest which is not a certified activity. Marketing
could be perceived as advisory boards, investigator
meetings, promotional speakers bureaus and so on. The
Academy with the North American Association of Medical
Education and Communication Companies NAAMECC and the
Coalition for Healthcare Communication are in regular
communication with ACCME for further clarification here,
though we feel that this will remain very restrictive.
Q3.
Does the firewall need to rise above the content and creative staff,
and effect the managing partners or strategic leaders of
the two companies?
Answer:
As long as managing partners or strategic
leaders are not involved in the planning, programming or
content of individual activities either in promotion or
education then we would say no.
Q4.
Re firewalls: Can you please comment on staffers involved in art?
Production? Project management? (when project
management is logistically oriented)?
Answer:
Great care will be needed to ensure that these
departments are truly only logistically orientated. It
would be very easy for an art department, production
group or project manager to become biased if they work
on any ‘educational’ program component, such as a
diagrammatical representation of a mechanism of action
or with an overlap in speaker selection in production.
The acceptability of this will be dependent on its
individual set up and will need to be determined on a
case by case basis.
Q5. With regard to level of evidence, how do you view abstracts or
posters presented at scientific meetings?
Answer:
Though these have been allowed in the past, the
Academy will no longer allow to be used as reference
unless they have been subject to peer review and
approved for presentation at
a scientific meeting.
Q6. With the newly issued guidance from the ACCME, how do you believe
this will impact educational funding from commercial
supporters?
Answer: In large the funding from commercial supporters
does seem to be in decline, though some sources are
clearly rising. We believe much of this decline is from
a failure to provide educational outcomes data in terms
that supporters can use to justify the expenditure. The
Academy will be engaging in discussion here to explore
values that will be acceptable across all educational
communities, patient, learner, teacher and supporter.
Q7. How do you balance the needs of a Commercial Interest to fund
education that furthers (rather than refutes) their
product/service with the need to not allow CI's to
influence content?
Answer:
We will not allow the commercial interest to
influence content. However commercials supporters have
the right to only support activities in areas where they
have an interest.
We should be looking for support in areas where
there is an overlap between independently identified
patient and healthcare provider needs, a performance
gap, and therapeutic interests in that same area from a
commercial supporter. Other supporters, which could be
defined as non-commercial should also be considered
where this overlap may also occur.
Q8.
Cognizant of the amount of time is needed to prepare proposals. How
much time should be planned for development and
submission?
Answer:
Ideally, as much time as possible. In many
cases we should ideally be determining an overall
educational strategy to facilitate change, towards
narrowing a healthcare gap. This will often require
collaborative efforts, which with the support of the
Academy can be effectively facilitated.
In saying this we also have to consider the
budget cycles of supporters and the inevitable fast
track requirements under some circumstances. If
possible a prior ‘heads-up’ to the Academy will help
facilitate a rapid cycle.
Q9. How about writers – independent contractors? Can they work on both
CME and non-CME material?
Answer:
Unfortunately, this is not as yet clear; we have
a query with the ACCME and are awaiting a response. Our
‘gut’ feeling is that this will not be acceptable.
Q10.
Most commercial supporters inquire about "reach" during grant review,
how do you define "reach"? Is it simply based on "hits"
or "activity completions?
Answer:
There are two common questions here; firstly,
what is the target audience number to whom the activity
will be announced. The second is how many individuals
are expected to participate in the program. Now
participation needs to be further defined, did the
individual just browse content or did they complete the
program.
The Academy defines reach by completion, and the
number of certificates issued, we do understand that
this is very likely to be an underestimation as not all
participants who complete a program will request
certification. The Academy will also be exploring
further aspects in regard to reach on web based
programming where a learner’s movement through the site
may be a better indication of applicability.
Q11.
What if you receive funding prior to developing a comprehensive
proposal?
Answer:
As the funding is provided as an independent
grant, it is assumed that the supporter considered the
proposal in sufficient detail to approve and fund. We
have not encountered where a grant was provided prior to
approval of a proposal.
Q12.
Do you foresee some type of standardization of pricing? For example a
satellite symposium. Also do you foresee an industry
standard for the ratio of development costs to pass
through costs?
Answer: No, though costing breakdowns are being
examined for areas where certain costs are expected. As
grant reviewers see a great number of programs they do
become familiar with the costs of program components,
such as room hires at particular venues, AV charges and
so on.
Q13.
How can MECCs identify when they are being asked to submit a grant to
simply have it used for "vetting" purposes? More and
more, commercial supporters have identified an academic
provider they intend to provide funding to but often are
required internally to receive/review upward of 3-to-5
grants or more.
Answer:
This will be very difficult to determine,
although it would be acceptable to query the commercial
interest on how the review process is managed and if in
fact the requirement exists requiring multiple
organizations submitting proposals.
Q14.
One large pharma company has included an outcomes vendor in their
LOA. Is this compliant?
Answer: According to ACCME, this is not acceptable.
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