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Position paper on current aspects of sponsoring in accredited CME

Authors:
  • Praxis Rheingalerie

Abstract

This position paper is the result of a collaborative approach of several European Specialty Accreditation Boards (ESABs) and, has been stimulated by their current experience in accreditation regarding roles and responsibilities assumed by sponsors of accredited continuing medical education (CME). The suggestions made in this paper aim to preserve the fundamental principle in CME accreditation that the physician in charge of the programme has sole responsibility for the selection of topics, speakers, content and format, as well as mode of presentation, and that sponsors will under no circumstances interfere with this principle. This is considered as a responsibility of an individual physician (or physicians), which cannot be delegated, even in part, to third parties. This responsibility has been extended to include all communication before and after the event. The paper also identifies undecided issues, about which ESABs are committed to elaborate proposals in the future.
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Position paper on current aspects of sponsoring in
accredited CME
Daiana Stolz, Reinhard Griebenow, Andre Tichelli, Andrew J. Ullmann,
Richard W. Costello, Lampros Michalis, Margarita Guenova, Sandy Sutter,
Fabiola De Andrade & Robert Schaefer
To cite this article: Daiana Stolz, Reinhard Griebenow, Andre Tichelli, Andrew J. Ullmann, Richard
W. Costello, Lampros Michalis, Margarita Guenova, Sandy Sutter, Fabiola De Andrade & Robert
Schaefer (2017) Position paper on current aspects of sponsoring in accredited CME, Journal of
European CME, 6:1, 1312062, DOI: 10.1080/21614083.2017.1312062
To link to this article: https://doi.org/10.1080/21614083.2017.1312062
© 2017 The Author(s). Published by Informa
UK Limited, trading as Taylor & Francis
Group.
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Published online: 28 Apr 2017. Submit your article to this journal
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POSITION PAPER
Position paper on current aspects of sponsoring in accredited CME
Daiana Stolz
a,b
, Reinhard Griebenow
c,d
, Andre Tichelli
e,f
,AndrewJ.Ullmann
g,h
, Richard W. Costello
a,i
,
Lampros Michalis
c,j
, Margarita Guenova
e,k
,SandySutter
a,l
, Fabiola De Andrade
e,m
and Robert Schaefer
c,n
a
on behalf of the European Board for Accreditation in Pneumology (EBAP), Lausanne, Switzerland;
b
Department for Pneumology, University
Hospital Basel, Basel, Switzerland;
c
on behalf of the European Board for Accreditation in Cardiology (EBAC), Cologne, Germany;
d
Municipal
Hospital Cologne-Merheim, Department II for Internal Medicine II, University of Cologne, Cologne, Germany;
e
on behalf of the European Board
for Accreditation in Haematology (EBAH), The Hague, Netherlands;
f
Department for Haematology, University Hospital Basel, Basel, Switzerland;
g
on behalf of the European Board for Accreditation in Infectious Diseases (EBAID);
h
Department II for Internal Medicine, University Hospital
Wuerzburg, Wuerzburg, Germany;
i
Royal College of Surgeons in Ireland, Education and Research Centre, Beaumont Hospital, Dublin, Ireland;
j
Department II for Cardiology, University Hospital Ioannina, Ioannina, Greece;
k
National Specialised Hospital for Active Treatment of
Hematological Diseases, Sofia, Bulgaria;
l
EBAP, Lausanne, Switzerland;
m
EBAH, The Hague, Netherlands;
n
EBAC, Cologne, Germany
ABSTRACT
This position paper is the result of a collaborative approach of several European Specialty
Accreditation Boards (ESABs) and, has been stimulated by their current experience in accredita-
tion regarding roles and responsibilities assumed by sponsors of accredited continuing medical
education (CME). The suggestions made in this paper aim to preserve the fundamental principle
in CME accreditation that the physician in charge of the programme has sole responsibility for the
selection of topics, speakers, content and format, as well as mode of presentation, and that
sponsors will under no circumstances interfere with this principle. This is considered as a
responsibility of an individual physician (or physicians), which cannot be delegated, even in
part, to third parties. This responsibility has been extended to include all communication before
and after the event. The paper also identifies undecided issues, about which ESABs are com-
mitted to elaborate proposals in the future.
ARTICLE HISTORY
Received 25 February 2017
Accepted 15 March 2017
KEYWORDS
European Specialty
Accreditation Boards;
independent CME;
sponsoring; transparency;
professional congress
organiser (PCO); medical
education company;
information material
For more than 15 years, European Specialty Accreditation
Boards (ESABs) have striven to provide an element of
quality assurance to the European medical community by
offering accreditation of continuing medical education
(CME) and continuing professional development (CPD).
Recent developments in the field of organisation and
sponsoring of CME have stimulated this position
paper, which does not replace any of the rules in
force, but seeks to amend and specify existing princi-
ples and rules in the accreditation of CME.
For accreditation of CME/CPD programmes, major
accreditors, including the ESABs, have mandated that
the physician in charge of the programme (physician
course director,physician organiseretc.) has the
sole responsibility for selection of topics, speakers, con-
tent and format, as well as mode of presentation, and
that sponsors will under no circumstances interfere
with this principle. We consider this a responsibility
of an individual physician (or physicians), which can-
not be delegated, even in part, to third parties,
including, in particular, professional congress organi-
sers (PCOs), so-called medical education companies
(PCOs with a focus on organisation of CME/CPD) or
sponsors.
Sponsoring, by definition, needs something in
return from the beneficiaries of sponsoring. This is
achieved by making sponsoring transparent through
mentioning the name and logo of the sponsor
(1) on the last page of the programme (live events),
(2) on the last slide (e-learning materials, links to
the sponsor not allowed), or
(3) at the end of the article (CME in print media).
In addition, the sponsors should be offered the
opportunity to present their promotional material at a
site outside the room in which the CME/CPD activity
takes place (and all other rules issued by ESABs still
apply).
CONTACT Reinhard Griebenow griebenow@online.de Municipal Hospital Cologne- Merheim, Department II for Internal Medicine II, University of
Cologne, Ostmerheimer Str. 200, Cologne 51058, Germany
This article was originally published with errors. This version has been corrected/amended. Please see Corrigendum (http://dx.doi.org/10.1080/21614083.
2017.1354505).
Supplemental data for this article can be accessed here.
JOURNAL OF EUROPEAN CONTINUING MEDICAL EDUCATION, 2017
VOL. 6, 1312062
https://doi.org/10.1080/21614083.2017.1312062
© 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ESABs also encourage mentioning the amount of
money provided by the sponsor together with the
name and logo at the sites indicated above. Further
acknowledgements (product trade names, etc.) are not
allowed, and use of terms like platinum sponsor, etc.,
instead of exact amounts, is discouraged. Sponsors
should not claim any further return on sponsoring.
All communication to (potential) participants
should be totally unambiguous and should emphasise
the complete independence of the accredited activity.
In this regard, ESABs
(1) strongly discourage the use of sponsorsservices for
registration of participants (website, organisation
secretariat),
(2) do not allow promotion of an accredited activity
on the website of the sponsor(s) (though hyper-
linking is allowed), and
(3) allow sponsor(s), as well as PCOs, to distribute
CME programmes to potential participants, but
consider sending programmes by post, showing
the logo of the sponsor to be inappropriate.
It is mandatory that all accredited CME/CPD is available
to the whole medical community. However, should any
accredited live event address a highly selected audience,
exclusion of participants must always be based on a physi-
cian (organiser)-to-physician (participant) interaction, and
sponsors or PCOs must not play any role in this process.
Transparency is a key prerequisite for identification of
potential sources of bias based on conflicts of competing
interests. Thus, ESABs strongly encourage all initiatives
that aim to implement strategies for achieving timely,
comprehensive and relevant transparency with regard to
all stakeholders involved in design, planning and delivery
of CME/CPD.
Currently, recommendations on how to declare and
manage conflicts of interest focus on physicians in their
role as members of an organising committee/congress
programme committee or faculty member. Major accredi-
tors all require that interests of members of this group
should be comprehensively declared and, in addition,
offer forms to be used for declaration [1]. Furthermore,
providing no declaration at all is one of the few reasons for
exclusion from a faculty or other position involved in the
planning and/or delivery of CME/CPD (besides being an
employee of a commercial interest, including PCOs).
In contrast, identification and management of
interests of organisations has received much less
attention. ESABs would like to stimulate a discussion
on how to design declarations of conflicts of interest
to be used by all organisations involved in hosting,
planning and delivery of CME/CPD, including PCOs,
and academic and non-academic medical centres
(some of which have institutional cooperation agree-
ments with companies acting as sponsors in CME/
CPD).Forthetimebeing,ESABsclaimtherightto
see all contracts between PCOs and sponsors or
faculty, in order to find out whether agreements
have been reached that contravene their accreditation
rules. ESABs strongly discourage direct contractual
agreements between members of scientific/organising
committees and sponsors.
Since ESABs consider mono-sponsored CME/CPD
activities to have the highest risk of undue influence by
the sponsor, they would like to open a debate on which
additional information, obtained from the provider,
might demonstrate the independence of the CME
programme.
Undecided issues raised in this paper will be further
discussed by ESABs to formulate proposals, which
might then be implemented in their accreditation pro-
cedures. For that purpose, this position paper will be
revised on a regular basis.
Disclosure statement
Declarations of interest are available as supplementary mate-
rial to this article.
ORCID
Reinhard Griebenow http://orcid.org/0000-0002-6430-
0665
Andrew J. Ullmann http://orcid.org/0000-0002-8191-6517
Richard W. Costello http://orcid.org/0000-0003-1179-
6692
Sandy Sutter http://orcid.org/0000-0002-7606-7426
Fabiola De Andrade http://orcid.org/0000-0003-1472-2824
References
[1] Griebenow R, Campbell C, Qaseem A, et al. Proposal for
a graded approach to disclosure of interests in accredited
CME/CPD. J Eur CME. 2015;4:29894. DOI:10.3402/
jecme.v4.29894
This paper has also been endorsed by the Accreditation
Council of Oncology in Europe (ACOE).
2D. STOLZ ET AL.
... In their paper [2] published in this issue of JECME, the authors describe four scenarios of continuing medical education (CME) (Categories A-D) with varying involvement of industry in planning and delivery of CME. The authors fail to point out that their Category D scenario describes the already defined setting of sponsored CME, widely accepted for accreditation by major accreditors for many years, under the condition that funding does not imply any influence of the sponsor on selection of topics, content, speakers or educational format [3,4]. ...
... Even more importantly, this separation of roles [3,4] constitutes the only way of maintaining the credibility of the medical profession in its patient-physician relations in the pursuit of better health outcomes. ...
... In recent years, there have been several initiatives, which have addressed selected aspects of the framework and practice of CME-CPD accreditation, e.g. the International Academy for CPD Accreditation [8], an informal network of accreditors with global attendance, and also informal collaboration of so-called European Speciality Accreditation Boards [9], or the Cologne Consensus Conference [10], and the UEMS-EACCME Education Conference. Thus, the mission of CME-EA is to devote its activities to offering a platform to all organisations/individuals involved in accreditation on the national level, to meet for dialogue and to work on consensus. ...
... (2) Finances: Accreditors finance themselves by fees paid by those seeking accreditation. Donations from any commercial interest in medicine (including individuals representing or having a role in a commercial interest [9], as well as from providers) are not acceptable. Donations from any public authority or professional political body or scientific organisation may be acceptable as long as they do not compromise the independence of decisionmaking by the accreditor. ...
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Disclosing conflicts of interest (COIs) is an important step in the management of COIs and is considered to be crucial to the trustworthiness of presenters. There are significant variations in disclosure procedures regarding the following:a. How COI is assessed in declaration forms (e.g. type of question, respondent awareness)b. Type of relationshipsc. Detailing of information to program committee membersThese variations in procedures have in effect led toa. Underreporting of COIb. Reducing the informational value of declared COI to participantsThus, it has been the aim of the authors to propose a basic formula for a minimum standard declaration of financial COI, with the potential to be applicable to all types of accredited continuing medical education (CME) as well as to all individuals (e.g. speakers, authors) involved in planning and conduct of CME activities. This approach should also serve as basis for more elaborate disclosures as well as strategies for management of conflict of interests adapted to the risk of bias.Furthermore, we also propose a basic set of items to be declared as nonfinancial interests.