Abstract
Given the high profile of the Olivieri affair, one may be surprised to learn that the mainstream bioethics literature has not been greatly occupied with the topic of conflict of interest, except as it is applied to non-ethicists. This is as true in United States as it is in Canada, although that country has faced its own controversial cases. As Giles Scofield, a persistent critic of the professionalization movement within healthcare ethics, has stated:One need not embrace Scofield’s skepticism to conclude that this is an area that merits further exploration. A few years ago, however, practising healthcare ethicists Andrea Frolic and Paula Chidwick made a useful contribution to the field by soliciting stories from their Canadian colleagues about their direct experiences with COI. Although their sample size was modest—despite assurances of confidentiality, only 13 ethicists ultimately agreed to have their stories shared—their efforts yielded two papers containing detailed narratives that illustrated the variety of respondents’ experiences with direct and indirect pressures that they believed had threatened the independence of their judgements. In an effort to leave the meaning of conflict of interest open to interpretation, Frolic and Chidwick declined to provide their respondents with a definition of the concept. As a result, these healthcare ethicists relayed a variety of incidents that reflected their disparate understandings and experiences. COI was identified in all of the diverse domains within which they practised, including clinical consultation, organizational ethics consultation, and research ethics consultation and review. To preserve the anonymity of their participants the responses were rolled up into five composite cases that represented recurrent themes which the authors described as, “research funding conflicting with research ethics; disclosing ethical issues when ‘due process’ is absent; conflicts between organizational values and the personal values of the clinical bioethicist; promoting justice within organizations; and balancing competing loyalties and obligations within an organization.”
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Notes
- 1.
Giles R. Scofield. “What Is Medical Ethics Consultation?” The Journal of Law, Medicine & Ethics 36.1 (2008): 105.
- 2.
This type of research, especially when the response rate is low, nearly always prompts questions about the representativeness of results. It’s entirely possible that those who were willing to share their experiences of conflict of interest, however they defined it, self-selected so as to bias the findings in the direction of those who were the most or the least conflicted. However, absent resources that offer a broader scan of ethicists’ experiences regarding the topic we have only this study and a smattering of public reports to rely upon.
- 3.
Andrea Frolic and Paula Chidwick. “A Pilot Qualitative Study of ‘Conflicts of Interest and/or Conflicting Interests’ Among Canadian Bioethicists. Part 1: Five Cases, Experiences and Lessons Learned.” HEC Forum (2010) 22, 15.
- 4.
In addition, even in Canada’s busiest hospitals, with programs that employ a half-dozen ethicists or more, each practitioner typically bears sole or primary responsibility for the delivery of services at a particular institutional site or for a number of specialized programs. A director of ethics may lead such a program, and assist her team in establishing a reasonably unified direction, but practising healthcare ethicists are still, for the most part, lone wolves who can expect to practice with a significant degree of independence.
- 5.
It is interesting to note that practising healthcare ethicists often invoke academic freedom as a basis for asserting a right to take unpopular positions. Even in university-affiliated teaching hospitals, however, it is not clear whether or when employees have a right to invoke academic freedom, or how far that supposed right might protect them against institutional sanctions. This is further complicated by the fact that a great many practising healthcare ethicists hold appointments as sessional lecturers or as adjunct faculty in university departments and therefore may be able to publish or make public statements as members of the academy. Distinguishing their academic personae from their institutional identities may not be a straightforward matter, especially in an era where hospitals routinely encourage their staff members to publish in academic journals and maintain a lively presence on social media platforms. The purported academic freedom of hospital-based ethicists is a topic that could benefit from a rigorous analysis but it is not the focus of this project.
- 6.
Frolic and Chidwick, HEC Forum (2010b) 22, 10.
- 7.
Andrew Stark, Conflict of Interest in the Professions, 2001, p. 336.
- 8.
Coincidentally, Stark Law (more properly known as the Physician Self-Referral Act) is a set of American federal laws that prohibit a specific type of conflict of interest by physicians. The titular Stark is not Andrew Stark but Pete Stark, a congressman from California.
- 9.
Stark, 2001, p. 336.
- 10.
With respect to their methodology, Frolic and Chidwick stated that they “chose not to prescribe a definition at the outset of our interviews; by leaving the term open to their interpretation, we hoped to generate a more naturalistic view of how bioethicists experience conflicts of interest and conflicting interests (COI) in their roles.” Ibid. 20.
- 11.
Lisa A. Bero and Quinn Grundy. “Why Having a (Nonfinancial) Conflict of Interest is not a Conflict of Interest.” December 21, 2016, PLOS Biology, p. 1–8.
- 12.
Ibid., p. 2.
- 13.
Ibid.
- 14.
Bero and Grundy referencing K. Shawwa et al. “Requirements of Clinical Journals for Authors? Disclosure of Financial and Non-financial Conflicts of Interest: A Cross-sectional Study,” 1.
- 15.
Xavier Bosch et al, in The European Journal of Investigation, 663. The authors describe the move toward expanded disclosure as a positive trend and opine that the disclosures “have received comparatively little attention even though they may, at times, have a negative effect on the transparency of publication, the fairness of reviews and the honesty of reporting.”
- 16.
Bero, ibid., p. 2.
- 17.
Ed Quillen. “Origin of the Laundry List.” The Denver Post. (June 5, 2008) http://www.denverpost.com/2008/06/05/origin-of-the-laundry-list/. Accessed online: 7 July 2017.
- 18.
Bero, ibid., 3.
- 19.
PHEs, and especially healthcare ethics fellows, would rarely be the sole investigators on such a research project but for the sake of clarity, I have crafted an example that limits the number of relevant actors with complicating interests.
- 20.
For a very brief description of various theoretical approaches to public health ethics see “Ethical Analysis in Public Health” by Marc J Roberts and Michael R Reich in The Lancet, Vol. 359, March 23, 2002: Online: https://pdfs.semanticscholar.org/3cad/c70f93ea0f6e9f46bd2fc79c13e88cca45ad.pd. Accessed: February 19, 2018.
- 21.
Bero and Grundy reference the tobacco industry’s ability to undermine evidence concerning the effects of second-hand smoke and Coca-Cola’s distorting effect on nutrition research, but one can easily generate other equally compelling examples. In recent years the news media have been exposing evidence on the way that the sugar industry has systematically diverted the public’s attention away from their products by funding studies that focus on the risks of dietary fat. For a slightly older but more scholarly treatment of these latest revelations see Kearns et al, “Sugar Industry and Coronary Heart Disease Research: A Historical Analysis of Internal Industry Documents” in JAMA Intern Med., Nov. 2016.
- 22.
Ibid., p. 3.
- 23.
For a concise introduction to the social science literature on the relationship between sponsorship and unconscious bias see Dana and Loewenstein’s classic paper, “A Social Science Perspective on Gifts to Physicians from Industry.” Online: https://pdfs.semanticscholar.org/8b05/8d01e582e4bb06ac333b4bc740d6f29a104d.pdf. Accessed: April 20, 2018.
- 24.
Lisa A. Bero and Quinn Grundy. “Why Having a (Nonfinancial) Conflict of Interest is Not a Conflict of Interest.” December 21, 2016, PLOS Biology, p. 1–8.
- 25.
Bero, ibid., 4.
- 26.
Research ethics boards are often adamant that those who obtain consent from research participants not be in a position to compel or coerce enrollment. Research coordinators, or other non-clinical hospital staff members, often in the employ of the primary investigator, generally will obtain participants’ signatures on informed consent forms. The rationale is that patients who may be concerned about disappointing their treating clinicians will feel free to reject such overtures from an intermediary. Whether this is supported by good quality evidence is not entirely clear.
- 27.
It is becoming common for research ethics boards or hospital compliance officers to insist that principal investigators include disclaimers in informed consent documents that state that the investigator (and sometimes the sponsoring institution) has an interest in the research that potential participants are encouraged to disregard as they weigh the benefits and burdens of participation. Unfortunately, these statements are often vague enough to capture academic interests as well as financial entanglements, and the potential research participant (who frequently is also the investigator’s patient) has no way to distinguish between a researcher who is a shareholder in a corporation (which may be publically-held or for profit) and the researcher who is motivated by academic interests or a desire to find new treatment options for a patient population that has few or no alternatives to an inadequate standard of care. In addition, there is a literature that suggests that potential research participants are inclined to place greater trust in investigators who disclose their conflicts (whether or not that trust is warranted). Conflict of interest declarations may, therefore, exacerbate rather than diminish the problem that they are meant to address.
- 28.
Bero, ibid., p. 5.
- 29.
Ibid., p. 5. Bero and Grundy began their paper with a reference to a Scottish court case in which a judge expressed suspicion over the commitments of expert witnesses who had built their academic careers on establishing a relationship between smoking and cancer. According to the authors, the judge in McTear v. Imperial Tobacco “believed that the experts’ ‘nonfinancial’ interests constituted the greater risk to expert opinion.” For a discussion of this case see: “Why Having a (Nonfinancial) Interest is Not a Conflict of Interest,” p. 1.
- 30.
Bero, ibid., p. 6.
- 31.
Frolic and Chidwick 2010a, 15.
- 32.
By referencing the financial interests of the institution I do not mean to suggest that they function as a trump card or that they be assigned disproportionate weight. I merely acknowledge the fact that healthcare institutions must make decisions that take into account the resources that they have at their disposal. In Canada, hospitals are publically-funded institutions and if their boards and chief executive officers fail to deliver balanced budgets they may be subject to significant sanctions including, in the worst case scenario, being placed under the control of an external supervisor.
- 33.
Frolic and Chidwick, HEC Forum (2010a) 22:5–17, 8.
- 34.
Frolic and Chidwick, HEC Forum (2010b) 22:19–29, 23.
- 35.
Ibid., 9.
- 36.
Ibid., 10.
- 37.
Ibid., 11.
- 38.
The PHE’s suspicions may have been well founded but it should be noted that research ethics consultation is not without its own high stakes cases, and it too requires the exercise of judgement. If the PHE, however, was largely assigned administrative tasks related to research review (such as ensuring that protocols are consistent with well-established standards pertaining to informed consent or privacy protections) then it may be reasonable to infer that these new duties were designed to reduce her range of discretion and influence.
- 39.
Andrew Stark, “Comparing Conflict of Interest Across the Professions,” in Conflict of Interest in the Professions, 336.
- 40.
The tendency to believe that participation in research will be of benefit to patient-participants is a phenomenon that was helpfully captured by Paul Appelbaum and colleagues who coined the phrase “therapeutic misconception.” In recent decades an extensive and nuanced literature on this topic has been generated which is not necessarily relevant to this project, but it is important to recognize Appelbaum’s core insight which is that researchers and participants alike are inclined to minimize or deny the disadvantages associated with study participation.
- 41.
The legal profession has an interesting way of conceptualizing these kinds of conflicts.
If challenged, a lawyer must be able to demonstrate that the dual-representation can be categorized as a consentable conflict. For a lawyer’s conflict of interest to be consentable she must be able to establish both that the clients were fully informed of the nature of the conflict, and that she was able to fulfil her duties to each of them in a competent manner. For a helpful introduction to this topic see: Kevin H. Michels, “What Conflicts Can be Waived? A Unified Understanding of Competence and Consent,” Rutgers Law Review 65, no. 12 (2012): 109–172.
- 42.
Frolic and Chidwick, HEC Forum (2010a) 22:5–17, 11.
- 43.
Stark, 336.
- 44.
In cases of this kind it is common for opinions to be divided within teams and within families so the example need not imply a straightforward conflict between the interests of a family, or a patient’s decision maker, and the interests of a unified team.
- 45.
Stark, 336.
- 46.
I have not invoked this usage employed by John R. Boatright before, but meddlesome is a helpful shorthand for the various external interests (such as money, status, or professional advancement) that may distort a professional’s judgement in a case that involves a conflict of interest.
- 47.
Andrew Stark, “Comparing Conflict of Interest Across the Professions,” in Conflict of Interest in the Professions, ibid.
- 48.
Ibid., 343.
- 49.
Ibid., 342.
- 50.
Ibid., 345.
Bibliography
Frolic, Andrea, and Paula Chidwick. 2010a. A Pilot Qualitative Study of ‘Conflicts of Interests and/or Conflicting Interests’ Among Canadian Bioethicists. Part 1: Five Cases, Experiences and Lessons Learned. HEC Forum 22 (1): 5–17.
Frolic, Andrea, and Paula Chidwick. 2010b. A Pilot Qualitative Study of ‘Conflicts of Interests and/or Conflicting Interests’ Among Canadian Bioethicists. Part 2: Defining and Managing Conflicts. HEC Forum 22 (1): 19–29.
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Heesters, A.M. (2022). Conflicted Consultants: Surveying the Canadian Context. In: How Legal Theory Can Save the Life of Healthcare Ethics. The International Library of Bioethics, vol 101. Springer, Cham. https://doi.org/10.1007/978-3-031-14035-8_2
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