This National Academies of Sciences, Engineering, and Medicine (the National Academies) committee recognizes the importance of considering conflicts of interest in contributing to and detracting from the public’s trust in the development of guidelines. To supplement previous evidence reviews and to identify additional resources for consideration, the committee conducted a focused literature review guided by the following preliminary questions:
- How are conflicts of interest managed in guideline development and/or in advisory committees? This may include but is not limited to the following:
- Evidence review
- Expert group or advisory committee formation
- Translation to recommendations or practice
- Project funding
- Are there any conflict-of-interest practices specific to nutrition or diet research and guidelines?
The main finding was significant variation of conflict-of-interest policies and practices across organizations and within guideline development processes, and limited empirical evidence linking these policies and practices to desired outcomes. This search was not intended to be a comprehensive review, but rather to identify relevant and recent publications for consideration.
A keyword search was run through Web of Science, PubMed, and Scopus. Keywords included conflict of interest, conflicts of interest, conflicting interest, competing interest, financial conflicts, commercial conflicts, funding, disclosure, guideline, guidelines, guidelines as topic, practice guidelines, committee, committees, advisory committee, committee membership, review literature, organizational policy, policy, policies, nutritional policy, and industry. The search was restricted to English language.
More than 800 unique articles were found, 62 of which met inclusion criteria of describing or managing conflicts of interest in the development of guidelines and advisory committees. The narrow focus of the search excluded conflicts of interest in areas not directly applicable (e.g., conflicts of interest in human subject research), while noting that many articles would be relevant to this National Academies committee’s second report. Two reviewers independently screened selected titles and abstracts for inclusion in the full-text review. An additional scan of the reference lists of relevant publications and previous Institute of Medicine publications (IOM, 2009, 2011) led to the identification and ad-hoc inclusion of additional articles. Some articles were determined not to be relevant and were excluded based on the full-text review. In total, 62 references were included and are listed below.
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Amiri, A. R., K. Kanesalingam, S. Cro, and A. T. Casey. 2014. Does source of funding and conflict of interest influence the outcome and quality of spinal research? Spine Journal 14(2):308-314.
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Bero, L. 2014. What is in a name? Nonfinancial influences on the outcomes of systematic reviews and guidelines. Journal of Clinical Epidemiology 67(11):1239-1241.
Billi, J. E., B. Eigel, W. H. Montgomery, V. M. Nadkarni, and M. F. Hazinski. 2005. Management of conflict of interest issues in the activities of the American Heart Association Emergency Cardiovascular Care Committee, 2000-2005. Circulation 112(24 Suppl.):IV204-IV205.
Bindslev, J. B., J. Schroll, P. C. Gotzsche, and A. Lundh. 2013. Underreporting of conflicts of interest in clinical practice guidelines: Cross sectional study. BMC Medical Ethics 14:19.
Boyd, E. A., and L. A. Bero. 2006. Improving the use of research evidence in guideline development: 4. Managing conflicts of interests. Health Research Policy and Systems 4.
Boyd, E. A., S. Lipton, and L. A. Bero. 2004. Implementation of financial disclosure policies to manage conflicts of interest. Health Affairs (Millwood) 23(2):206-214.
Boyd, E. A., E. A. Akl, M. Baumann, J. R. Curtis, M. J. Field, R. Jaeschke, M. Osborne, and H. J. Schunemann. 2012. Guideline funding and conflicts of interest: Article 4 in integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proceedings of the American Thoracic Society 9(5):234-242.
Campsall, P., K. Colizza, S. Straus, and H. T. Stelfox. 2016. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: A cross-sectional study. PLoS Medicine 13(5):e1002029.
Chartres, N., A. Fabbri, and L. A. Bero. 2016. Association of industry sponsorship with outcomes of nutrition studies: A systematic review and meta-analysis. JAMA Internal Medicine 176(12):1769-1777.
Choudhry, N. K., H. T. Stelfox, and A. S. Detsky. 2002. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. Journal of the American Medical Association 287(5):612-617.
Cosgrove, L., H. J. Bursztajn, D. R. Erlich, E. E. Wheeler, and A. F. Shaughnessy. 2013. Conflicts of interest and the quality of recommendations in clinical guidelines. Journal of Evaluation in Clinical Practice 19(4):674-681.
Eccles, M. P., J. M. Grimshaw, P. Shekelle, H. J. Schunemann, and S. Woolf. 2012. Developing clinical practice guidelines: Target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest. Implementation Science 7:60.
Esposito, K., A. Ceriello, S. Genovese, and D. Giugliano. 2014. Cardiovascular guidelines: Separate career may help attenuate controversy. Cardiovascular Diabetology 13(1):66.
Evans, I. 2002. Conflict of interest: The importance of potential. Science and Engineering Ethics 8(3):393-396.
FDA (U.S. Food and Drug Administration). 2014. Guidance for the public, FDA advisory committee members, and FDA staff: Public availability of advisory committee members’ financial interest information and waivers. Silver Spring, MD: U.S. Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm (accessed October 5, 2017).
George, J. N., S. K. Vesely, and S. H. Woolf. 2014. Conflicts of interest and clinical recommendations: Comparison of two concurrent clinical practice guidelines for primary immune thrombocytopenia developed by different methods. American Journal of Medical Quality 29(1):53-60.
Gessner, B. D., P. Duclos, D. DeRoeck, and E. A. S. Nelson. 2010. Informing decision makers: Experience and process of 15 national immunization technical advisory groups. Vaccine 28(Suppl 1):A1-A5.
Gibbons, R. J., S. Smith, and E. Antman. 2003. American College of Cardiology/American Heart Association clinical practice guidelines: Part I. Where do they come from? Circulation 107(23):2979-2986.
Glodé, E. R. 2002. Advising under the influence?: Conflicts of interest among FDA advisory committee members. Food and Drug Law Journal 57(2):293-322.
Graham, T., P. Alderson, and T. Stokes. 2015. Managing conflicts of interest in the UK National Institute for Health and Care Excellence (NICE) clinical guidelines programme: Qualitative study. PLoS ONE 10(3):e0122313.
Grisso, T., E. Baldwin, P. D. Blanck, M. J. Rotheram-Borus, N. R. Schooler, and T. Thompson. 1991. Standards in research: APA’s mechanism for monitoring the challenges. American Psychologist 46(7):758-766.
Guyatt, G., E. A. Akl, J. Hirsh, C. Kearon, M. Crowther, D. Gutterman, S. Z. Lewis, I. Nathanson, R. Jaeschke, and H. Schünemann. 2010. The vexing problem of guidelines and conflict of interest: A potential solution. Annals of Internal Medicine 152(11):738-741.
Haines, I. E., and I. N. Olver. 2008. Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry? Medical Journal of Australia 189(5):263-266.
Holloway, R. G., C. J. Mooney, T. S. D. Getchius, W. S. Edlund, and J. O. Miyasaki. 2008. Invited article: Conflicts of interest for authors of American Academy of Neurology clinical practice guidelines. Neurology 71(1):57-63.
IOM (Institute of Medicine). 2009. Conflict of interest in medical research, education, and practice. Washington, DC: The National Academies Press.
IOM. 2011. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press.
Jones, D. J., A. N. Barkun, Y. Lu, R. Enns, P. Sinclair, M. Martel, I. Gralnek, M. Bardou, E. J. Kuipers, and J. Sung. 2012. Conflicts of interest ethics: Silencing expertise in the development of international clinical practice guidelines. Annals of Internal Medicine 156(11):809-816.
Kassirer, J. P. 2009. Commentary: Disclosure’s failings: What is the alternative? Academic Medicine 84(9):1180-1181.
Khalil, B., K. Aung, and I. A. Mansi. 2012. Reporting potential conflicts of interest among authors of professional medical societies’ guidelines. Southern Medical Journal 105(8):411-415.
Lesser, L. I., C. B. Ebbeling, M. Goozner, D. Wypij, and D. S. Ludwig. 2007. Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Medicine 4(1):e5.
MacKenzie, R., and W. Rogers. 2015. Potential conflict of interest and bias in the RACGP’s smoking cessation guidelines: Are GPs provided with the best advice on smoking cessation for their patients? Public Health Ethics 8(3):319-331.
Mendelson, T. B., M. Meltzer, E. G. Campbell, A. L. Caplan, and J. N. Kirkpatrick. 2011. Conflicts of interest in cardiovascular clinical practice guidelines. Archives of Internal Medicine 171(6):577-584.
Mühlhauser, I. 2010. From authority recommendations to fact-sheets—A future for guidelines. Diabetologia 53(11):2285-2288.
Mühlhauser, I., and G. Meyer. 2013. Evidence base in guideline generation in diabetes. Diabetologia 56(6):1201-1209.
Nathanson, I. 2013. Guidelines and conflicts: A new twist. Chest 144(4):1087-1089.
Neumann, I., E. A. Akl, M. Valdes, S. Bravo, S. Araos, V. Kairouz, H. Schünemann, and G. H. Guyatt. 2013a. Low anonymous voting compliance with the novel policy for managing conflicts of interest implemented in the 9th version of the American College of Chest Physicians antithrombotic guidelines. Chest 144(4):1111-1116.
Neumann, I., R. Karl, A. Rajpal, E. A. Akl, and G. H. Guyatt. 2013b. Experiences with a novel policy for managing conflicts of interest of guideline developers: A descriptive qualitative study. Chest 144(2):398-404.
Newton, A., F. Lloyd-Williams, H. Bromley, and S. Capewell. 2016. Food for thought? Potential conflicts of interest in academic experts advising government and charities on dietary policies. BMC Public Health 16(1):735.
Norris, S. L., H. K. Holmer, L. A. Ogden, and B. U. Burda. 2011. Conflict of interest in clinical practice guideline development: A systematic review. PLoS ONE 6(10):e25153.
Norris, S. L., H. K. Holmer, B. U. Burda, L. A. Ogden, and R. Fu. 2012a. Conflict of interest policies for organizations producing a large number of clinical practice guidelines. PLoS ONE 7(5):e37413.
Norris, S. L., H. K. Holmer, L. A. Ogden, S. S. Selph, and R. Fu. 2012b. Conflict of interest disclosures for clinical practice guidelines in the national guideline clearinghouse. PLoS ONE 7(11):e47343.
Norris, S. L., H. K. Holmer, L. A. Ogden, B. U. Burda, and R. Fu. 2013. Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus. PLoS ONE 8(10):e75284.
Pham-Kanter, G. 2014. Revisiting financial conflicts of interest in FDA advisory committees. Milbank Quarterly 92(3):446-470.
Qaseem, A., F. Forland, F. Macbeth, G. Ollenschlager, S. Phillips, and P. van der Wees. 2012. Guidelines international network: Toward international standards for clinical practice guidelines. Annals of Internal Medicine 156(7):525-531.
Reardon, R., and S. Haldeman. 2008. Self-study of values, beliefs, and conflict of interest: The bone and joint decade 2000–2010 task force on neck pain and its associated disorders. Spine 33(4 Suppl):S24-S32.
Ridker, P., and J. Torres. 2006. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000–2005. Journal of the American Medical Association 295(19):2270-2274.
Riechelmann, R. P., L. Wang, A. O’Carroll, and M. K. Krzyzanowska. 2007. Disclosure of conflicts of interest by authors of clinical trials and editorials in oncology. Journal of Clinical Oncology 25(29):4642-4647.
Rosenberg-Yunger, Z. R. S., and A. M. Bayoumi. 2014. Transparency in Canadian public drug advisory committees. Health Policy 118(2):255-263.
Rowe, S., N. Alexander, F. M. Clydesdale, R. S. Applebaum, S. Atkinson, R. M. Black, J. T. Dwyer, E. Hentges, N. A. Higley, M. Lefevre, J. R. Lupton, S. A. Miller, D. L. Tancredi, C. M. Weaver, C. E. Woteki, and E. Wedral. 2009. Funding food science and nutrition research: Financial conflicts and scientific integrity. American Journal of Clinical Nutrition 89(5):1285-1291.
Rowe, S., N. Alexander, C. M. Weaver, J. T. Dwyer, C. Drew, R. S. Applebaum, S. Atkinson, F. M. Clydesdale, E. Hentges, N. A. Higley, M. E. Westring, and International Life Sciences Institute. 2013. How experts are chosen to inform public policy: Can the process be improved? Health Policy 112(3):172-178.
Schroter, S., J. Morris, S. Chaudhry, R. Smith, and H. Barratt. 2004. Does the type of competing interest statement affect readers’ perceptions of the credibility of research? Randomised trial. British Medical Journal 328(7442):742-743.
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Schünemann, H. J., M. Osborne, J. Moss, C. Manthous, G. Wagner, L. Sicilian, J. Ohar, S. McDermott, L. Lucas, and R. Jaeschke. 2009. An official American Thoracic Society policy statement: Managing conflict of interest in professional societies. American Journal of Respiratory and Critical Care Medicine 180(6):564-580.
Smith, J. C., D. E. Snider, and L. K. Pickering. 2009. Immunization policy development in the United States: The role of the advisory committee on immunization practices. Annals of Internal Medicine 150(1):45-49.
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Tibau, A., P. L. Bedard, A. Srikanthan, J. L. Ethier, F. E. Vera-Badillo, A. J. Templeton, A. Ocana, B. Seruga, A. Barnadas, and E. Amir. 2015. Author financial conflicts of interest, industry funding, and clinical practice guidelines for anticancer drugs. Journal of Clinical Oncology 33(1):100-106.
Viswanathan, M., T. S. Carey, S. E. Belinson, E. Berliner, S. M. Chang, E. Graham, J.-M. Guise, S. Ip, M. A. Maglione, D. C. McCrory, M. McPheeters, S. J. Newberry, P. Sista, and C. M. White. 2014. A proposed approach may help systematic reviews retain needed expertise while minimizing bias from nonfinancial conflicts of interest. Journal of Clinical Epidemiology 67(11):1229-1238.
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Yank, V., D. Rennie, and L. A. Bero. 2007. Financial ties and concordance between results and conclusions in meta-analyses: Retrospective cohort study. British Medical Journal 335(7631):1202-1205.