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Published in: Health Research Policy and Systems 1/2006

Open Access 01-12-2006 | Review

Improving the use of research evidence in guideline development: 4. Managing conflicts of interests

Authors: Elizabeth A Boyd, Lisa A Bero

Published in: Health Research Policy and Systems | Issue 1/2006

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Abstract

Background

The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fourth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.

Objectives

We reviewed the literature on conflicts of interest to answer the following questions:
1. What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests?
2. How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?
3. When a conflict of interest is identified, how should the conflict be managed?
4. How could conflict of interest policies be enforced?

Methods

We searched PubMed, the Cochrane Methodology Register and selectively searched for the published policies of several organizations, We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.

Key questions and answers

What is the best way to obtain complete and accurate disclosures on financial ties and other competing interests?
• Although there is little empirical evidence to guide the development of disclosure forms, minimal or open-ended formats are likely to be uninformative. We recommend the development of specific, detailed, structured forms that solicit as much information as possible about the nature and extent of the competing interests.
How to determine when a disclosed financial tie or other competing interest constitutes a conflict of interest?
• There is no empirical evidence to suggest that explicit criteria are preferable to ad hoc committee decisions when deciding if a disclosed financial tie is a conflict of interest. However, explicit criteria may make decision-making easier.
When a conflict of interest is identified, how should the conflict be managed?
• Descriptive studies suggest that appropriate management strategies are best determined on a case-by-case basis. Thus, WHO should use a wide range of management strategies to address disclosed conflicts of interest, with public disclosure of conflicts associated with each meeting as a minimum and recusal of conflicted individuals as the other extreme.
How could conflict of interest policies be enforced?
• Although there are no empirical studies of the enforcement of conflict if interest policies, descriptive studies of other organizations and institutions suggest that WHO convene a standing committee to review all financial disclosure statements prior to the commencement of committee meetings/hearings and to make management recommendations when necessary. A standard policy requiring all financial ties to be made public (i.e., recorded into the meeting minutes) should reduce the number of problematic cases. In instances where the conflicts seem intractable, a recommendation of recusal may be necessary to protect the greater interests of WHO and its constituents.
Literature
1.
go back to reference Barnes DE, Bero LA: Why review articles on the health effects of passive smoking reach different conclusions. Jama. 1998, 279 (19): 1566-1570. 10.1001/jama.279.19.1566.CrossRefPubMed Barnes DE, Bero LA: Why review articles on the health effects of passive smoking reach different conclusions. Jama. 1998, 279 (19): 1566-1570. 10.1001/jama.279.19.1566.CrossRefPubMed
3.
go back to reference Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA. 2003, 289 (454-65):CrossRefPubMed Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA. 2003, 289 (454-65):CrossRefPubMed
4.
go back to reference Cho MK, Bero LA: The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996, 124 (5): 485-489.CrossRefPubMed Cho MK, Bero LA: The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996, 124 (5): 485-489.CrossRefPubMed
5.
go back to reference Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Bmj. 2003, 326 (7400): 1167-1170. 10.1136/bmj.326.7400.1167.CrossRefPubMedPubMedCentral Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Bmj. 2003, 326 (7400): 1167-1170. 10.1136/bmj.326.7400.1167.CrossRefPubMedPubMedCentral
6.
go back to reference Wilson D, Heath D: He saw the tests as a violation of 'trusting desperate human beings'. The Seattle Times. 2001, Seattle Wilson D, Heath D: He saw the tests as a violation of 'trusting desperate human beings'. The Seattle Times. 2001, Seattle
7.
go back to reference Wilson D, Heath D: Uninformed consent: they call the place Mother Hutch. The Seattle Times. 2001, Seattle Wilson D, Heath D: Uninformed consent: they call the place Mother Hutch. The Seattle Times. 2001, Seattle
8.
go back to reference Dana J: Harm avoidance and financial conflict of interest. Journal of Medical Ethics. 2003, Online Electronic Version: 1-18. Dana J: Harm avoidance and financial conflict of interest. Journal of Medical Ethics. 2003, Online Electronic Version: 1-18.
9.
go back to reference Bero LA: Tobacco industry manipulation of research. Public Health Rep. Bero LA: Tobacco industry manipulation of research. Public Health Rep.
10.
go back to reference Montori VM, Jaeschke R, Schunemann HJ, Bhandari M, Brozek JL, Devereaux PJ, Guyatt GH: Users' guide to detecting misleading claims in clinical research reports. BMJ. 2004, 329: 1093-1096. 10.1136/bmj.329.7474.1093.CrossRefPubMedPubMedCentral Montori VM, Jaeschke R, Schunemann HJ, Bhandari M, Brozek JL, Devereaux PJ, Guyatt GH: Users' guide to detecting misleading claims in clinical research reports. BMJ. 2004, 329: 1093-1096. 10.1136/bmj.329.7474.1093.CrossRefPubMedPubMedCentral
11.
go back to reference Friedman PJ: The impact of conflict of interest on trust in science. Science and Engineering Ethics. 2002, 8 (3): 413-420.CrossRefPubMed Friedman PJ: The impact of conflict of interest on trust in science. Science and Engineering Ethics. 2002, 8 (3): 413-420.CrossRefPubMed
12.
go back to reference Drazen JM, Koski G: To protect those who serve [editorial]. The New England Journal of Medicine. 2000, 343: 1643-1645. 10.1056/NEJM200011303432212.CrossRefPubMed Drazen JM, Koski G: To protect those who serve [editorial]. The New England Journal of Medicine. 2000, 343: 1643-1645. 10.1056/NEJM200011303432212.CrossRefPubMed
13.
go back to reference Baltimore D: The worsening climate for biological research; is the public losing faith in science?. Technology Review. 1989, 92 (4): 22-PubMed Baltimore D: The worsening climate for biological research; is the public losing faith in science?. Technology Review. 1989, 92 (4): 22-PubMed
14.
go back to reference Haerlin B, D. P: How to restore public trust in science [commentary]. Nature. 1999, 400: 499-10.1038/22867.CrossRefPubMed Haerlin B, D. P: How to restore public trust in science [commentary]. Nature. 1999, 400: 499-10.1038/22867.CrossRefPubMed
15.
go back to reference Cohen JJ: Trust us to make a difference: Ensuring public confidence in the integrity of clinical research. Academic Medicine. 2001, 76 (2): 209-214. 10.1097/00001888-200102000-00028.CrossRefPubMed Cohen JJ: Trust us to make a difference: Ensuring public confidence in the integrity of clinical research. Academic Medicine. 2001, 76 (2): 209-214. 10.1097/00001888-200102000-00028.CrossRefPubMed
16.
go back to reference DeAngelis CD: Conflict of interest and the public interest. Journal of the American Medical Association. 2000, 284 (17): 2237-2238. 10.1001/jama.284.17.2237.CrossRefPubMed DeAngelis CD: Conflict of interest and the public interest. Journal of the American Medical Association. 2000, 284 (17): 2237-2238. 10.1001/jama.284.17.2237.CrossRefPubMed
17.
go back to reference Fretheim A, Schünemann HJ, Oxman AD: Improving the Use of Research Evidence in Guideline Development: 3. Group composition and consultation process. Health Research Policy and Systems. 2006 Fretheim A, Schünemann HJ, Oxman AD: Improving the Use of Research Evidence in Guideline Development: 3. Group composition and consultation process. Health Research Policy and Systems. 2006
18.
go back to reference Fretheim A, Schünemann HJ, Oxman AD: Improving the Use of Research Evidence in Guideline Development: 5. Group processes. Health Research Policy and Systems. 2006 Fretheim A, Schünemann HJ, Oxman AD: Improving the Use of Research Evidence in Guideline Development: 5. Group processes. Health Research Policy and Systems. 2006
19.
go back to reference World Health Organisation: Regulations for Expert Advisory Panels and Committees. 2003, 101-109. World Health Organisation: Regulations for Expert Advisory Panels and Committees. 2003, 101-109.
20.
go back to reference World Health Organisation: Global Programme on Evidence for Health Policy, Guidelines for WHO Guidelines. 2003, 15- World Health Organisation: Global Programme on Evidence for Health Policy, Guidelines for WHO Guidelines. 2003, 15-
21.
go back to reference World Health Organisation: Draft Guidelines for Declaration of Interest (WHO Experts). 2005 World Health Organisation: Draft Guidelines for Declaration of Interest (WHO Experts). 2005
22.
go back to reference Godlee F: Tobacco industry's smoke screen blown. The Scientist. 2000 Godlee F: Tobacco industry's smoke screen blown. The Scientist. 2000
23.
go back to reference World Health Organisation: WHO/ISH Hypertension Guidelines. 2003 World Health Organisation: WHO/ISH Hypertension Guidelines. 2003
24.
go back to reference Oxman AD, Fretheim A, Schünemann HJ: Improving the Use of Research Evidence in Guideline Development: Introduction. Health Res Policy Syst. 2006 Oxman AD, Fretheim A, Schünemann HJ: Improving the Use of Research Evidence in Guideline Development: Introduction. Health Res Policy Syst. 2006
26.
go back to reference Cochrane Collaboration: Cochrane Collaboration policy on commercial sponsorship. 2004 Cochrane Collaboration: Cochrane Collaboration policy on commercial sponsorship. 2004
27.
go back to reference National Institute for Clinical Excellence: Review of code of practice on declaration of conflicts of interest. National Institute for Clinical Excellence: Review of code of practice on declaration of conflicts of interest.
28.
go back to reference Draft guidance on disclosure of conflicts of interest for special government employees participating in FDA product special advisory committees. 2002, U.S. Food and Drug Administration Draft guidance on disclosure of conflicts of interest for special government employees participating in FDA product special advisory committees. 2002, U.S. Food and Drug Administration
29.
go back to reference Policies and procedures for handling conflicts of interest with FDA advisory committee members, consultants, and experts. 2005, U.S. Food and Drug Administration Policies and procedures for handling conflicts of interest with FDA advisory committee members, consultants, and experts. 2005, U.S. Food and Drug Administration
30.
go back to reference Policy on committee composition and balance and conflcits of interest for committees used in the development of reports. 2003, The National Academies Policy on committee composition and balance and conflcits of interest for committees used in the development of reports. 2003, The National Academies
31.
go back to reference Krimsky S: Science in the Private Interest. 2003, Lanham, Maryland , Rowan & Littlefield, 247- Krimsky S: Science in the Private Interest. 2003, Lanham, Maryland , Rowan & Littlefield, 247-
32.
33.
go back to reference Association of American Medical Colleges: Protecting subjects, preserving trust, promoting progress: Guidelines for developing and implementing a policy concerning individual financial interests in human subjects research. 2001, Philadelphia Association of American Medical Colleges: Protecting subjects, preserving trust, promoting progress: Guidelines for developing and implementing a policy concerning individual financial interests in human subjects research. 2001, Philadelphia
34.
go back to reference U.S. Department of Health and Human Services: Objectivity in research. 1995, 60 Federal Register, 35810 (codified at 42 CFR 50: U.S. Department of Health and Human Services: Objectivity in research. 1995, 60 Federal Register, 35810 (codified at 42 CFR 50:
35.
go back to reference Boyd E, Lipton S, Bero L: Implementation of financial disclosure policies to manage conflicts of interest. Health Affairs. 2004, 23 (2): 206-214. 10.1377/hlthaff.23.2.206.CrossRefPubMed Boyd E, Lipton S, Bero L: Implementation of financial disclosure policies to manage conflicts of interest. Health Affairs. 2004, 23 (2): 206-214. 10.1377/hlthaff.23.2.206.CrossRefPubMed
36.
go back to reference Sprecker K: How involvement, citation style, and funding source affect the credibility of university scientists. Science Communication. 2002, 24 (1): 72-97.CrossRef Sprecker K: How involvement, citation style, and funding source affect the credibility of university scientists. Science Communication. 2002, 24 (1): 72-97.CrossRef
37.
go back to reference Kim SYH: Potential research participants' views regarding researcher and institutional financial conflicts of interest. Journal of Medical Ethics. 2003, Online Electronic Version: p. 1-18 Kim SYH: Potential research participants' views regarding researcher and institutional financial conflicts of interest. Journal of Medical Ethics. 2003, Online Electronic Version: p. 1-18
38.
go back to reference Glaser B, Bero L: Attitudes of Academic and Clinical Researchers toward Financial Ties in Research. Science and Engineering Ethics. 2005, 11: 553-573. Glaser B, Bero L: Attitudes of Academic and Clinical Researchers toward Financial Ties in Research. Science and Engineering Ethics. 2005, 11: 553-573.
39.
go back to reference Schroter S, Morris J, Chaudhry S, Smith RD, Barratt H: Does the type of competing interest statement affect readers' perceptions of the credibility of research? A randomized trial. BMJ. 2004, 328: 742-743. 10.1136/bmj.38035.705185.F6.CrossRefPubMedPubMedCentral Schroter S, Morris J, Chaudhry S, Smith RD, Barratt H: Does the type of competing interest statement affect readers' perceptions of the credibility of research? A randomized trial. BMJ. 2004, 328: 742-743. 10.1136/bmj.38035.705185.F6.CrossRefPubMedPubMedCentral
40.
go back to reference Boyd EA, Bero LA: Assessing Faculty Financial Relationships with Industry. Journal of the American Medical Association. 2000, 284 (November 1, 2000): 2209-2238. 10.1001/jama.284.17.2209.CrossRefPubMed Boyd EA, Bero LA: Assessing Faculty Financial Relationships with Industry. Journal of the American Medical Association. 2000, 284 (November 1, 2000): 2209-2238. 10.1001/jama.284.17.2209.CrossRefPubMed
41.
go back to reference Boyd EA, Cho MK, Bero LA: Financial conflict-of-interest policies in clinical research: issues for clinical investigators. Academic Medicine. 2003, 78 (8): 769-774. 10.1097/00001888-200308000-00002.CrossRefPubMed Boyd EA, Cho MK, Bero LA: Financial conflict-of-interest policies in clinical research: issues for clinical investigators. Academic Medicine. 2003, 78 (8): 769-774. 10.1097/00001888-200308000-00002.CrossRefPubMed
42.
go back to reference Krimsky S, Rothenberg, LS., Stott, P., Kyle, G: Financial interests on authors in scientific journals: a principal investigator lot study of 14 publications. Science and Engineering Ethics. 1996, 2 (4): 395-410.CrossRefPubMed Krimsky S, Rothenberg, LS., Stott, P., Kyle, G: Financial interests on authors in scientific journals: a principal investigator lot study of 14 publications. Science and Engineering Ethics. 1996, 2 (4): 395-410.CrossRefPubMed
43.
go back to reference Shamoo AE, Resnik DB: Responsible Conduct of Research. 2003, New York , Oxford University Press, 345- Shamoo AE, Resnik DB: Responsible Conduct of Research. 2003, New York , Oxford University Press, 345-
44.
go back to reference Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2005, International Committee of Medical Journal Editors, Available at: http://www.icmje.org Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. 2005, International Committee of Medical Journal Editors, Available at: http://​www.​icmje.​org
45.
go back to reference Krimsky S, Rothenberg LS: Conflict of interest policies in science and medical journals: Editorial practices and author disclosures. 2001, 7: 205-218. Krimsky S, Rothenberg LS: Conflict of interest policies in science and medical journals: Editorial practices and author disclosures. 2001, 7: 205-218.
46.
go back to reference Gross CP, Gupta AR, Krumholz HM: Disclosure of financial competing interests in randomised controlled trials: cross sectional review. BMJ. 2003, 326: 526-527. 10.1136/bmj.326.7388.526.CrossRefPubMedPubMedCentral Gross CP, Gupta AR, Krumholz HM: Disclosure of financial competing interests in randomised controlled trials: cross sectional review. BMJ. 2003, 326: 526-527. 10.1136/bmj.326.7388.526.CrossRefPubMedPubMedCentral
47.
go back to reference Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002, 287 (5): 612-617. 10.1001/jama.287.5.612.CrossRefPubMed Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002, 287 (5): 612-617. 10.1001/jama.287.5.612.CrossRefPubMed
48.
go back to reference Papanikolaou GN, Baltogianni MS, Contopoulos-Ioannidis DS, Haidich AB, Giannakakis IA, Ioannidis JPA: Reporting of conflicts of interest in guidelines of preventive and therapeutic interventions. BMC Medical Research Methodology. 2001, 1 (3): Papanikolaou GN, Baltogianni MS, Contopoulos-Ioannidis DS, Haidich AB, Giannakakis IA, Ioannidis JPA: Reporting of conflicts of interest in guidelines of preventive and therapeutic interventions. BMC Medical Research Methodology. 2001, 1 (3):
49.
go back to reference Jansen LA, Sulmasy DP: Bioethics, conflicts of interest, and the limits of transparency. Hastings Center Report. 2003, 33: 40-43. 10.2307/3528379.CrossRefPubMed Jansen LA, Sulmasy DP: Bioethics, conflicts of interest, and the limits of transparency. Hastings Center Report. 2003, 33: 40-43. 10.2307/3528379.CrossRefPubMed
50.
go back to reference Rothman K: Conflict of interest: The new McCarthyism in science. JAMA. 1993, 269: 2782-2784. 10.1001/jama.269.21.2782.CrossRefPubMed Rothman K: Conflict of interest: The new McCarthyism in science. JAMA. 1993, 269: 2782-2784. 10.1001/jama.269.21.2782.CrossRefPubMed
51.
go back to reference Duderstadt J: A university for the 21st century. 2000, Ann Arbor , University of Michigan PressCrossRef Duderstadt J: A university for the 21st century. 2000, Ann Arbor , University of Michigan PressCrossRef
52.
go back to reference Barnes D, Bero L: Why review articles on the health effects of passive smoking reach different conclusions. Journal of the American Medical Association. 1998, 279: 1566-1570. 10.1001/jama.279.19.1566.CrossRefPubMed Barnes D, Bero L: Why review articles on the health effects of passive smoking reach different conclusions. Journal of the American Medical Association. 1998, 279: 1566-1570. 10.1001/jama.279.19.1566.CrossRefPubMed
Metadata
Title
Improving the use of research evidence in guideline development: 4. Managing conflicts of interests
Authors
Elizabeth A Boyd
Lisa A Bero
Publication date
01-12-2006
Publisher
BioMed Central
Published in
Health Research Policy and Systems / Issue 1/2006
Electronic ISSN: 1478-4505
DOI
https://doi.org/10.1186/1478-4505-4-16

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