Derek J. Jones, JD; Alan N. Barkun, MDCM, MSc (Clinical Epidemiology); Yidan Lu, MDCM; Robert Enns, MD; Paul Sinclair, MSc; Myriam Martel, BSc; Ian Gralnek, MD; Marc Bardou, MD, PhD; Ernst J. Kuipers, MD; Joseph Sung, MD, PhD; International Consensus Upper Gastrointestinal Bleeding Conference Group
Grant Support: The conference was underwritten by unrestricted, pooled funds from the Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Canadian Institutes of Health Research Institute of Diabetes, Metabolism, and Nutrition and arms-length contributions from AstraZeneca Mölndal (Sweden), Abbott Canada, and Olympus Canada. The Canadian Association of Gastroenterology also provided in-kind support and administered the meeting.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1984.
Requests for Single Reprints: Alan N. Barkun, MDCM, MSc (Clinical Epidemiology), Division of Gastroenterology, Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room D7-346, Montreal, Quebec H3G 1A4, Canada; e-mail, firstname.lastname@example.org.
Current Author Addresses: Mr. Jones: Research Group on Health and Law, McGill University Faculty of Law, 3664 Peel Street, Montreal, Quebec H3A 1W9, Canada.
Drs. Barkun and Lu: Division of Gastroenterology, Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room D7-346, Montreal, Quebec H3G 1A4, Canada.
Dr. Enns: St. Paul's Hospital, 770 1190 Hornby Street, Vancouver, British Columbia V6Z 2K5, Canada.
Mr. Sinclair: Canadian Association of Gastroenterology, #224, 1540 Cornwall Road, Oakville, Ontario L6J 7W5, Canada.
Ms. Martel: Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room T8-314, Montreal, Quebec H3G 1A4, Canada.
Dr. Gralnek: University of California, Los Angeles, Center for the Study of Digestive Health Care Quality and Outcomes, 11301 Wilshire Boulevard, Building 115, Room 318, Los Angeles, CA 90073.
Dr. Bardou: INSERM CIC-P 803, CHU de Dijon, Bâtiment du Pr Marion, 14 rue Gaffarel, BP 77908, 21079 Dijon Cedex, France.
Dr. Kuipers: Erasmus University Medical Centre, Room Ba-391, Box 2040, 3000 CA Rotterdam, the Netherlands.
Dr. Sung: Department of Medicine and Therapeutics, 9/F Clinical Science Building, Prince of Wales Hospital, Chinese University of Hong Kong, Sha Tin NT, Hong Kong. China.
Author Contributions: Conception and design: D.J. Jones, A.N. Barkun, R. Enns, I. Gralnek.
Analysis and interpretation of the data: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, M. Martel, E.J. Kuipers.
Drafting of the article: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, I. Gralnek, E.J. Kuipers.
Critical revision of the article for important intellectual content: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, I. Gralnek, M. Bardou, E.J. Kuipers.
Final approval of the article: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, I. Gralnek, M. Bardou, E.J. Kuipers, J. Sung.
Statistical expertise: A.N. Barkun, M. Martel.
Obtaining of funding: A.N. Barkun, E.J. Kuipers, J. Sung.
Administrative, technical, or logistic support: Y. Lu, P. Sinclair.
Collection and assembly of data: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, M. Martel, J. Sung.
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.
To manage FCOIs and examine whether an ethics framework with discussion recusal by experts with FCOIs affects deliberations and voting on a CPG.
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.
International consensus meeting to formulate a CPG in gastroenterology.
34 experts from 15 countries.
Counting the votes of experts with and without declared FCOIs and qualitative assessment of ethics discussions.
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.
Small participant numbers and application of the framework to only 1 meeting of 1 CPG.
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.
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.
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Jones DJ, Barkun AN, Lu Y, Enns R, Sinclair P, Martel M, et al. Conflicts of Interest Ethics: Silencing Expertise in the Development of International Clinical Practice Guidelines. Ann Intern Med. 2012;156:809-816. doi: 10.7326/0003-4819-156-11-201206050-00008
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Published: Ann Intern Med. 2012;156(11):809-816.
Ethics, Research and Reporting Methods.
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