Conflicts of interest ethics: silencing expertise in the development of international clinical practice guidelines.
BACKGROUND
It is unclear whether global experts with financial conflicts of interest (FCOIs) should be included in, be excluded from, or have a limited role in developing international clinical practice guidelines (CPGs). Optimal management of FCOIs to ensure independent, expert CPGs remains ethically contested.


OBJECTIVE
To manage FCOIs and examine whether an ethics framework with discussion recusal by experts with FCOIs affects deliberations and voting on a CPG.


METHODS
Development of an ethics framework grounded on transparency and proportional management of COIs, including self-recusal, evaluation of the effect on COIs and CPG process by quantification of voting on recommendations, and qualitative assessment of experts' ethics dialogue.


METHODS
International consensus meeting to formulate a CPG in gastroenterology.


METHODS
34 experts from 15 countries.


METHODS
Counting the votes of experts with and without declared FCOIs and qualitative assessment of ethics discussions.


RESULTS
62% of experts reported at least 1 FCOI. Eight out of 21 recommendations presented potential FCOIs. Experts with conflicts recused themselves from discussing 6 of the 8 recommendations, leaving a majority of nonconflicted discussants (median, 22; range, 19 to 26) for the 6 recommendations. Recusals did not affect voting outcomes but may have diluted the richness of the discussions. Ethics dialogue revealed accord on transparency but underscored challenges to proportional management of COIs beyond basic disclosure. Concerns about bias, COI definitions, expertise, and integrity express important international ethics questions.


CONCLUSIONS
Small participant numbers and application of the framework to only 1 meeting of 1 CPG.


CONCLUSIONS
An ethics framework may help to identify and manage COIs and catalyze both ethics dialogue and innovative COI standards that seek to balance impartiality and expertise for trusted CPGs. Optimal balancing remains contested. Recommendations include frameworks, interdisciplinary analysis, and international policy initiatives to better manage COIs in the CPG process.


BACKGROUND
Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Institute of Diabetes, Metabolism, and Nutrition of the Canadian Institutes of Health Research.
Division of Gastroenterology, Montreal General Hospital Site, McGill University Health Centre, Montreal, Quebec, Canada.
Derek J
DJ
Jones
Alan N
AN
Barkun
Yidan
Y
Lu
Robert
R
Enns
Paul
P
Sinclair
Myriam
M
Martel
Ian
I
Gralnek
Marc
M
Bardou
Ernst J
EJ
Kuipers
Joseph
J
Sung
D016265:Conflict of Interest; D017041:Ethics Committees; D005069:Evaluation Studies as Topic; D005378:Financial Support; D005762:Gastroenterology; D006291:Health Policy; D017410:Practice Guidelines as Topic; D012952:Societies / Q000191:economics