Abstract
Conflict of interest (COI) describes a situation in which the impartiality of research may be compromised by the researcher standing to profit in some way from conclusions drawn in the research. This can be a conflict among roles as when a researcher takes on too many outside consulting duties and neglects mentoring students, or misses classroom teaching, or a conflict of trust when the ability to make money from offering a particular interpretation of findings distorts trust in the analysis or conclusions reached. COI can occur at individual, institutional, or industry level or in a particular case, at several of these levels at once. Conflicts can arise from financial, ideological, political, religious beliefs, or personal relationships. Transparency through the disclosure of financial COIs has been the main management technique for handling COI. But it is suboptimal because it provides no way to know for sure whether competing interests have compromised the research (Dunn et al. 2016). There is no detailed federal policy in the USA on identifying or managing institutional conflicts of interest. A survey by Resnik (2016) found that only 38% of top grant getting institutions had such policies.
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Conflict of interest (COI) describes a situation in which the impartiality of research may be compromised by the researcher standing to profit in some way from conclusions drawn in the research. This can be a conflict among roles as when a researcher takes on too many outside consulting duties and neglects mentoring students, or misses classroom teaching, or a conflict of trust when the ability to make money from offering a particular interpretation of findings distorts trust in the analysis or conclusions reached. COI can occur at individual, institutional, or industry level or in a particular case, at several of these levels at once. Conflicts can arise from financial, ideological, political, religious beliefs, or personal relationships . Transparency through the disclosure of financial COIs has been the main management technique for handling COI. But it is suboptimal because it provides no way to know for sure whether competing interests have compromised the research (Dunn et al. 2016). There is no detailed federal policy in the USA on identifying or managing institutional conflicts of interest . A survey by Resnik (2016) found that only 38% of top grant getting institutions had such policies.
Cases in this chapter and in the suggested supplementary readings provide examples of COI and how they might be handled. Historical evidence of an NIH institute being captured by the sugar industry while setting its research priorities yielded unfortunate results for controlling disease. Tactics were similar to those used by tobacco, lead, and other industries – using funding to divert the research agenda to protect their products (Kearns et al. 2015). In the case of the death of Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania, both individual and institutional conflicts of interest involving patents for vector technology were present. The principal investigator of that trial in various subsequent writings identified lessons learned, which included more rigorous restrictions to separate the investigator and physician caretaker roles and limitation of trial involvement by an investigator with a stake in a company whose value could be affected by the outcome of the trial (Wilson 2009). Elliott (2016) describes a complex web of conflicts by a university in its oversight role in the protection of human subjects. Review of this situation by an independent external group provided insights into best practices for minimizing conflicts including a greater role for those not affiliated with the institution on review committees.
Potential COIs can be found in many areas of research production, dissemination and oversight. Campbell et al. (2015) found industry COI on the part of 30% of IRB members and noted that 25% of conflicted members voted on a protocol on which they were conflicted, which is an ethical violation—they should have recused themselves. At the same time, since discussion of the commercial purpose of a study and researcher compensation are not part of IRB review, members cannot discuss how interests of the researcher may conflict with interests of the research subject (participant). Meta-analyses (MA) of antidepressant trials found 30% of authors to be employees of the drug manufacturer with a total of 79% of authors having industry links. Those with employee authors were much less likely than were other studies to have negative statements about the drug.
COIs do not automatically invalidate scientific work but rather raise a question about whether a scientist or institution has been careful in their role and impartial. Some COIs could be seen as inherent in certain structures (IRB action on proposals that bring money to the university that appoints IRB members ) but may be counterbalanced with benefits from this arrangement such as local knowledge of the trustworthiness of investigators.
Advice: Know how to identify potential COIs , how to evaluate evidence when they are present. Seek to minimize COI by not undertaking outside work that greatly interferes with your primary duties and never accepting support that is contingent on reaching a particular conclusion in your work. If you are evaluating your own work prior to publishing or that of others, do not be the only one to do so if you have COI. Always disclose any concerns you have about possible COI to editors, regulatory bodies, and colleagues.
11.1 Sugar Industry Influence on the Scientific Agenda of the National Institute of Dental Research’s 1971 National Caries Program: A Historical Analysis of Internal Documents
Cristin E. Kearns, Stanton A. Glantz, and Laura A. Schmidt
Kearns, C, Glantz, S, Schmidt, L. Sugar industry influence on the scientific agenda of the National Institute of Dental Research’s 1971 National Caries Program: A historical analysis of internal documents. PLoS Medicine 12(3), e1001798 (2015). Copyright: © 2015 Kearns et al.
11.2 Lessons Learned from the Gene Therapy Trial for Ornithine Transcarbamylase Deficiency
James M. Wilson
Wilson, J. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Molecular Genetics and Metabolism 96, 151–157 (2009). © 2009 Elsevier Inc.
Reprinted with permission from Elsevier.
11.3 Patient Perspectives on Physician Conflict of Interest in Industry-Sponsored Clinical Trials for Multiple Sclerosis Therapeutics
Andrew J. Solomon
Solomon, AJ, et al. Patient perspectives on physician conflict of interest in industry-sponsored clinical trials for multiple sclerosis therapeutics. Multiple Sclerosis Journal 21(12), 1593–1599 (2015). © The Author(s), 2015.
Reprinted with permission from Sage Publications.
11.4 Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?
William M. Tierney, Eric M. Meslin, and Kurt Kroenke
Tierney, W, Meslin, E, Kroenke, K. Industry support of medical research: Important opportunity or treacherous pitfall? Journal of General Internal Medicine 31(2), 228–233 (2015). © Society of General Internal Medicine 2015.
Figure 1 reproduced from The Anatomy of Medical Research: US and International Comparisons. Journal of the American Medical Association. 313 (2), 2015. With permission from the American Medical Association.
References
Campbell E, Bogeli C, Rao S, Abraham M, Pierson R, Applebaum S. Industry relationships among academic institutional review board members; changes from 2005 through 2014. JAMA Intern Med. 2015;175(9):1500–6.
Dunn A, Colera E, Mandl K, Bourgeois F. Conflict of interest disclosure in biomedical research: a review of current practices, biases, and the role of public registries in improving transparency. Res Integr Peer Rev. 2016;1:1.
Elliott C. Institutional pathology and the death of Dan Markingson. Account Res. 2016. Epub ahead of print.
Kearns C, Glantz S, Schmidt L. Sugar industry influence on the scientific agenda of the National Institute of Dental Research’s 1971 National Caries Program: a historical analysis of internal documents. PLoS Med. 2015;12(3):e1001798.
Resnik D. Institutional conflicts of interest policies at U.S. academic research institutions. Acad Med. 2016;91(2):242–6.
Wilson J. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Mol Genet Metab. 2009;96:151–7.
Additional Suggested Reading
Dunn A, Colera E, Mandl K, Bourgeois F. Conflict of interest disclosure in biomedical research: a review of current practices, biases, and the role of public registries in improving transparency. Res Integr Peer Rev. 2016;1:1. (A public registry of competing interests is needed in order to have a comprehensive view of COI.)
Elliott C. Institutional pathology and the death of Dan Markingson. Account Res. 2016. Epub ahead of print. (Apparent institutional regulatory oversight failure by a major public university is described. 2017 24(2):65–79)
Resnik D. Institutional conflicts of interest policies at U.S. academic research institutions. Acad Med. 2016;91(2):242–246. (Policy development for institutional conflicts of interest are incomplete.)
Yanagawa H. Current regulatory systems for clinical trials in Japan: Still room for improvement. Clin Res Regul Aff. 2014;31(2–4):23–28. (Describes how a country develops its research regulatory system including management of COI.)
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Caplan, A.L., Redman, B.K. (2018). Conflict of Interest. In: Caplan, A., Redman, B. (eds) Getting to Good. Springer, Cham. https://doi.org/10.1007/978-3-319-51358-4_11
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