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ORIGINAL RESEARCH Addressing Within-Role Conflicts of Interest in Surgery Wendy A. Rogers & Jane Johnson Received: 29 March 2012 / Accepted: 10 December 2012 / Published online: 22 March 2013 # Springer Science+Business Media Dordrecht 2013 Abstract In this paper we argue that surgeons face a particular kind of within-role conflict of interests, re- lated to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed con- sent. The standard remedies for conflicts of interest are transparency and recusal, which are unlikely to ad- dress this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. Keywords Conflicts of interest . Surgery . Ethics . Surgical innovation Introduction Conflicts of interest are a hot topic in contemporary health care, with concerns that widespread and poten- tially serious financial conflicts affect many areas of clinical practice and research. In contrast, non-financial conflicts have received less attention. In this paper, we argue that surgery poses special challenges when it comes to conflicts of interest and that non-financial conflicts are particularly vexing. Whilst traditional fi- nancial conflicts can arise, the very nature of surgical practice and its attendant obligations generate external and within-role conflicts that are inadequately discussed in the literature. Although standard remedies such as disclosure and recusal may go some way to addressing these conflicts, we propose that more general and sys- temic change may be required to meet some of the particular challenges that arise in surgery. In this paper we describe the nature of conflicts of interest and the standard remedies that are intended to address them, consider the special challenges generat- ed by surgery, and conclude with a discussion of how such challenges may be met. What Are Conflicts of Interest? Conflicts of interest are well-recognised phenomena in medicine. Increasingly complex relationships between practitioners, the institutions where they work, and the companies who make the products they use create Bioethical Inquiry (2013) 10:219225 DOI 10.1007/s11673-013-9431-1 A version of this paper was presented at the annual conference of the Australasian Association of Bioethics and Health Law in July 2011. Research toward this paper was partly supported by an Australian Research Council grant (LP110200217). W. A. Rogers (*) Philosophy Department and Australian School of Advanced Medicine, Macquarie University, Sydney, NSW 2109, Australia e-mail: [email protected] J. Johnson Philosophy Department, Macquarie University, Sydney, NSW 2109, Australia

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Page 1: Addressing Within-Role Conflicts of Interest in Surgery

ORIGINAL RESEARCH

Addressing Within-Role Conflicts of Interest in Surgery

Wendy A. Rogers & Jane Johnson

Received: 29 March 2012 /Accepted: 10 December 2012 /Published online: 22 March 2013# Springer Science+Business Media Dordrecht 2013

Abstract In this paper we argue that surgeons face aparticular kind of within-role conflict of interests, re-lated to innovation. Within-role conflicts occur whenthe conflicting interests are both legitimate goals ofprofessional activity. Innovation is an integral part ofsurgical practice but can create within-role conflicts ofinterest when innovation compromises patient care invarious ways, such as by extending indications forinnovative procedures or by failures of informed con-sent. The standard remedies for conflicts of interest aretransparency and recusal, which are unlikely to ad-dress this conflict, in part because of unconscious bias.Alternative systemic measures may be more effective,but these require changes in the culture of surgery andaccurate identification of surgical innovation.

Keywords Conflicts of interest . Surgery . Ethics .

Surgical innovation

Introduction

Conflicts of interest are a hot topic in contemporaryhealth care, with concerns that widespread and poten-tially serious financial conflicts affect many areas ofclinical practice and research. In contrast, non-financialconflicts have received less attention. In this paper, weargue that surgery poses special challenges when itcomes to conflicts of interest and that non-financialconflicts are particularly vexing. Whilst traditional fi-nancial conflicts can arise, the very nature of surgicalpractice and its attendant obligations generate externaland within-role conflicts that are inadequately discussedin the literature. Although standard remedies such asdisclosure and recusal may go some way to addressingthese conflicts, we propose that more general and sys-temic change may be required to meet some of theparticular challenges that arise in surgery.

In this paper we describe the nature of conflicts ofinterest and the standard remedies that are intended toaddress them, consider the special challenges generat-ed by surgery, and conclude with a discussion of howsuch challenges may be met.

What Are Conflicts of Interest?

Conflicts of interest are well-recognised phenomena inmedicine. Increasingly complex relationships betweenpractitioners, the institutions where they work, and thecompanies who make the products they use create

Bioethical Inquiry (2013) 10:219–225DOI 10.1007/s11673-013-9431-1

A version of this paper was presented at the annual conferenceof the Australasian Association of Bioethics and Health Law inJuly 2011. Research toward this paper was partly supported byan Australian Research Council grant (LP110200217).

W. A. Rogers (*)Philosophy Department and Australian School of AdvancedMedicine, Macquarie University,Sydney, NSW 2109, Australiae-mail: [email protected]

J. JohnsonPhilosophy Department, Macquarie University,Sydney, NSW 2109, Australia

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financial and other rewards, many of which have thepotential to affect practice. At its simplest, a conflict ofinterest occurs when professional decision-making in-volving a primary interest may be affected by a sec-ondary interest (Thompson 1993; Lo and Field 2009;Emanuel and Thompson 2008).

Primary interests are role-related (e.g., acting in thebest interests of patients), while secondary interests arenot directly related to fulfilling the role in question(e.g., receiving a fee for enrolling patients into aclinical trial). The secondary interest may in itself belegitimate; the problem arises when the secondaryinterest influences the practitioner in a way thatthreatens to compromise the primary interest. It isimportant to note that, while it is possible that suchconflicts exert their influence on decision-making in aconscious way, conflicts of interest frequently operateat a subconscious level due to innate self-servingbiases which lead to discounting evidence aboutunwelcome propositions such as one’s own suscepti-bility to conflicts of interest (Schwarze 2009; Zipkinand Steinman 2005; Morgan et al. 2006). This opti-mism bias about one’s own behaviour (“bias blindspot,” cf., Dana 2009) is notoriously difficult to ad-dress due to its unintentional and unconscious nature.

Traditional approaches to resolving conflicts of in-terest are transparency or disclosure and recusal(Thompson 1993; Lemmens 2008). So, for example,in the case of a doctor receiving a fee for enrolling apatient into a drug trial, these approaches would re-quire that, at a minimum, the doctor should inform thepatient that she will receive a fee for enrolling him inthe trial. Best practice might also require using anindependent third party to provide information aboutand enrol the patient in the trial, where the third partyhas no financial or other interest in the outcome. Inthis sense, financial conflicts of interest are straight-forward: The primary interest is clear (acting for thegood of the patient) and the financial interest caneasily be identified as secondary, rather than central,to the role of providing high-quality medical care.

Challenging questions arise when there is no cleardistinction between primary and other interests; whenthe role in question has more than one legitimate goal,yet pursuing one rather than another may lead toundesirable consequences for the patient. These are“within-role” conflicts, in contrast to more obviouslyexternal conflicts such as personal financial gain(Brody and Miller 2003). Lo and Field (2009) use

the terminology of conflicts of obligation to describewithin-role conflicts. They argue that conflicts of ob-ligation do not entail a conflict of interest as bothobligations are primary interests. In contrast, by refer-ring to within-role conflicts, we aim to capture a widerrange of interests, all of which are legitimate, but notall of which can plausibly be described as primary in aparticular circumstance. Surgical innovation providesone such example of complicated and potentiallyconflicting within-role interests.

We focus on innovation related to changes in tech-nique or procedure, rather than innovations involvingthe development of new devices or tools, as the lattermay involve commercial interests with the attendantpotential for straightforward financial conflicts of in-terest.1 Cases where a surgeon changes his or hertechnique or develops a new surgical approach maynot lead to any financial conflicts of interest, yet thesurgeon’s focus on the patient’s welfare may becompromised. Before exploring this issue in detail,we ground our claim that innovation is a legitimatepart of a surgeon’s role, rather than an externalinterest.

Conflicts of Interest in Surgery

As clinicians, surgeons have the same ethical obliga-tions as other medical practitioners, to act for the goodof their patients, to support and respect patient de-cisions, to take account of their own role in the justprovision of health care, and so forth. But surgeonsalso have other obligations not shared by many otherclinicians, and these have the potential to generatewithin-role conflicts of interest.

A major difference between surgeons and othernon-procedural branches of medicine is that the sur-geon is both diagnostician and the instrument of ther-apy.2 Surgeons make the diagnosis and recommend anintervention, which they then implement—theytherefore have an interest and play a vital role in

1 If surgical techniques could be patented, then they too wouldinvoke more traditional financial conflicts of interest. It is alsopossible that surgeons or hospitals advertising particular inno-vative procedures may attract patients on this basis, therebycreating potential financial conflicts of interest.2 This dual role may lead to financial conflicts of interest—forexample, through over-servicing—but this is not our concernhere.

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ensuring the quality of the surgical intervention.Whereas a physician, having made a diagnosis, isresponsible for prescribing the correct drug, she isnot personally responsible for the quality of thatdrug, nor does she have any control over how thepatient uses it. In contrast, a surgeon is personallyresponsible for the quality of the operation that heperforms. It is not enough to make the correctdiagnosis and recommend an appropriate opera-tion; he must also perform it to the highest possi-ble standard in order to meet the requirements ofbeneficence.3

This dual role of diagnostician and instrumentof treatment creates a prima facie obligation tostrive constantly for the best possible technique,making innovation an ethical duty for surgeons. Atthe very least, surgeons need to innovate in thedelivery of routine care, for example where theyencounter an anatomical anomaly in a patient.Sometimes these variations are a “one-off” solu-tion for an individual patient. But at other times, asurgeon may implement a change in his technique,such as a novel approach or a different method ofwound closure across a cohort of patients. In othercases, a technique or procedure may emerge as aresponse to an emergency or individual anatomicalabnormality that the surgeon then adopts or furtherdevelops as his or her preferred way of performingthe surgery. The kinds of innovations we have inmind are, for example, variations in the laparo-scopic removal of kidneys for transplantation (re-movals may be hand-assisted or use differentincision sites) or using a novel approach in spinalsurgery involving a change in surgical approach tothe spine and in the location of the incision.

Fulfilling this obligation to constantly refine andimprove one’s surgical technique through innovationis challenging for three reasons. First, it is not alwayspossible to know in advance whether or not a newtechnique will benefit patients. For example, left mam-mary artery ligation for angina was an unsuccessful

innovation, and the uptake of laparoscopic or “key-hole” surgery delivered initially variable results(Frader and Caniano 1998).4 Second, adopting newtechniques often involves a learning curve, wherebyoutcomes for the first patients exposed to the newtechnique are likely to be worse than for patientstreated once the surgeon has fully mastered any newskills required (Ramsay et al. 2001; Zevin, Aggarwal,and Grantcharov 2012). Third, while some forms ofinnovation are clearly variations in practice aimed atbenefitting the patient (such as responding to an ana-tomical anomaly), more systematic innovations (suchas the introduction of novel techniques for weight losssurgery) are at the research end of the spectrum. In thelatter case, a different set of obligations may arise, asthe surgeon’s primary role is that of researcher ratherthan clinician (Brody and Miller 2003). However, thedistinctions between variations in routine practice,innovation, and research are not well-defined(Reitsma and Moreno 2006; Miller 2005). This meansthat a surgeon who is innovating may be unclear as towhether her primary obligations are clinical orresearch-related.

The obligation to innovate in surgery has the po-tential to generate a number of conflicts of interest.Being an innovator in surgery can be highly presti-gious, reaping rewards of peer recognition, journalpublications, or public acclaim (Mastroianni 2006).To this extent the kudos attached to innovation mayact like a financial conflict of interest. However, aconflict of interest may also occur when a surgeon’sconfidence in the benefits of an innovation compro-mises patient care even in the absence of such externalrewards. Surgeons may become convinced that theirinnovation is superior to recognised alternatives orsuffer from optimism bias about their skills, theircomplication rates, and the benefits of their innovation(Frader and Caniano 1998).5

Thus, a surgeon’s obligation to innovate combinedwith his or her optimism or confidence about the value

3 There are other areas of non-surgical health care practicewhere similar issues arise; for instance, interventional radiologyor cardiology, psychology, or dentistry.4 Of course, surgeons are not alone in taking up new procedureswithout good evidence. For instance, bone marrow transplanta-tion was used to treat breast cancer for more than 10 years inspite of inadequate evidence regarding its effectiveness (Welchand Mogielnicki 2002).

5 For example, 40 years ago it became popular to perform ananastomosis between the common bile duct and duodenum atthe time of removing the gall bladder on the basis that anygallstones remaining in the biliary tree could thereby easily enterthe gastrointestinal tract. This procedure did not involve anyexternal commercial interests such as device manufacturingcompanies. Surgeons were, however, keen to perform the oper-ation to showcase this new technique. Unfortunately, the out-comes for patients were poor due to long-term complicationsfrom biliary tract infection.

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of any particular innovation may impact upon a sur-geon’s primary obligation of beneficence in a numberof ways. First, this positive view of surgical innova-tion, due to a bias blind spot, may lead to an over-inclusive approach to indications for the procedure. If,for example, a surgeon believes that his newly modi-fied procedure avoids a recognised complication of thestandard procedure, he may advise intervention wherepreviously, because of the complication, he mighthave advised conservative treatment. This would wid-en the pool of patients (or, from the surgeon’s perspec-tive, offer more patients the opportunity to benefitfrom his innovation). Second, and related, his viewsabout the superiority of the innovation might lead thesurgeon to discount alternatives, including the stan-dard procedure. Finally, in relation to planned innova-tions, the quality of informed consent may becompromised.6 The surgeon may fail to properly in-form the patient that his or her version of procedure Xdiffers from the standard version of the procedure inimportant ways, or that, being a new procedure, he orshe has only performed it a limited number of times.As with any new procedure, there will be inadequatedata about safety and efficacy, yet the surgeon maybelieve or imply that this new version will have asimilar safety and efficacy profile to the original pro-cedure and provide the patient with that information,rather than describe the novelty of the procedure andconsequent lack of data. And, as noted, the consentprocess may not contain a balanced discussion of thealternatives, including conservative treatment.

Thus we have the situation in which a legitimatepart of the surgical role—developing (and hopefullyimproving) procedural techniques through innova-tion—can lead to external conflicts of interest andwithin-role conflicts, both of which have the poten-tial to compromise patient care. Since patients havea prima facie assumption that their surgeon will beacting in their interests, it is unlikely that they willchallenge advice about having a particular proce-dure, especially if they are unaware that this is anew version of the procedure specific to their sur-geon (cf., Mastroianni 2006 who discusses patientdeference to surgeon decision-making). There is

also the risk that if the surgeon discloses that theprocedure (or an aspect of it) is novel, patients willfall prey to a “technological misconception,” believ-ing that newer is always better, especially if thesurgeon is (over)enthusiastic in describing the apparentvirtues of his or her innovation. This phenomenon offalsely equating newness with superiority has at timesled patients to demand innovative surgical treatments(see Mastroianni 2006).

Addressing Conflicts of Interest

The standard remedies for external conflicts of interestare disclosure and recusal; how might these operate inthe case of within-role conflicts of interest arisingfrom surgical innovation? In theory, disclosure hasthe potential to address some of the concerns relatedto informed consent. There are two elements to this.The first is providing information about the innovationitself. At a minimum, the surgeon should explain:How the new procedure differs from the standardversion; the potential risks and the lack of data aboutsafety and efficacy; the number of times that he or shehas performed the procedure; and any other pertinentinformation, although it may not always be clear be-forehand what will constitute pertinent information.However, patients seeking surgical care are vulnerablein a number of ways that militate against the calmconsideration of complex information. In particular,anxiety and stress impede understanding, and patientsmay not perceive the importance of information abouttreatment options (Kessels 2003). Second, the surgeonshould disclose his or her relationship to the innova-tion (i.e., inventor) and his or her potential conflict ofinterest. However, social science research indicatesthat, paradoxically, disclosure of interests increasesrather than decreases bias in advice (Loewenstein,Sah, and Cain 2012). For the innovator surgeon, thismay mean that, having disclosed one’s interests, he orshe presents a more, rather than less, biased account ofthe likely benefits and harms. The bias blind spot mayextend to not recognising that the surgeon is, forexample, broadening the indications for the procedureor not giving a balanced account of the alternatives. Asecond paradox occurs in that, while disclosure aboutconflicts of interest can cause patients to mistrustadvice, it also can increase pressure on patients tocomply with the mistrusted advice. One postulated

6 We note that where innovation occurs in relation to unexpect-ed anatomical anomalies or intra-operative events, it is notpossible to halt the operation and awaken the patient to explainthe new situation. In these cases, emergency innovation fallswithin the discretionary scope of clinical practice.

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mechanism for this is insinuation anxiety, whereby thepatient becomes anxious about the doctor thinkingthat, because of the declared conflict, the patient doesnot trust him or her and therefore accepts the advice toavoid signalling distrust (Loewenstein, Sah, and Cain2012). Finally, disclosure about novelty may trigger atechnological misconception in patients so that theybecome equally convinced about the benefits of thenew technique. For these reasons, it seems that disclo-sure, in and of itself, will not address the problem ofwithin-role conflicts leading to biased advice aboutinnovative procedures.

Recusal is a second recognised response to con-flicts of interest. In relation to surgical innovations,the surgeon could recuse him- or herself from theconsent process and utilise a third party to explainand describe the procedure and seek informed consent.This is a technique sometimes used in research toavoid any real or potential coercion if patients areenrolled into trials by their treating clinicians whoare also researchers. It is possible that this wouldovercome some of the problems that we have identi-fied. Third-party consent has the advantage of ensur-ing that disclosure has the intended effect of providingless-biased advice and also allows for the patient toconsider the advice and make a decision out of thepresence of the treating doctor (Loewenstein, Sah, andCain 2012). Nevertheless, there are some potentialhazards. First, there is a moral responsibility for theperson who will perform the procedure to ensure thatthe patient has fully understood and agreed to it; thisresponsibility should not be shifted to a third party.However, this problem could be overcome by a two-stage consent following the initial consultation anddiagnosis by the surgeon; in the first stage, the patientwould see an independent third party who explains thekey points of difference between the innovation andstandard procedure and so forth, and then, if the pa-tient agrees to the surgery, a second stage in which thesurgeon him- or herself explains the procedure andconfirms the patient’s consent. Second, third-partyconsent may undermine the surgeon–patient relation-ship. Patients would recognise third-party consent asunusual, and this may lead them to doubt the skills orhonesty of their surgeon in ways that were notwarranted. This concern could be assuaged if third-party consent became standard procedure. Third, it isnot clear who would provide third-party consent andhow their independence would be assured. If practice

nurses took on the role of obtaining third-party con-sent, it is possible that there would be more or lesssubtle pressures on them to obtain the consent, as it isunlikely that a surgeon would want to retain a practicenurse who failed to obtain consent for his or her novelprocedures. If third parties were external to the sur-geon’s rooms and staff, their independence is likely tobe more robust, but the patient must then go to adifferent place to meet with a new professional, whichpotentially involves temporal, financial, or other costsfor the patient.

Like third-party consent, second opinions seek toreduce bias by involving an independent person with-out the conflicts of the innovating and treating sur-geon. One approach could be to mandate compulsorysecond opinions from independent surgeons in casesof innovative surgery. This would counter any bias inpresenting information about alternatives and wouldserve to double-check whether the innovating surgeonhas, wittingly or otherwise, expanded the usual indi-cations for the procedure or glossed over potentialcomplications. On the other hand, this process would,like third-party consent, incur temporal and financialcosts for patients and have the potential to underminetheir relationship with the treating surgeon. In addi-tion, it would be hard to guarantee that the surgeonproviding the second opinion is unbiased: He or shemay have unjustified confidence in the superiority ofthe standard procedure or be swayed by professionaljealousy to undermine the innovating surgeon. Facedwith conflicting opinions, the patient would have totake his or her own leap of faith or seek a thirdopinion.

If we look beyond the standard remedies for con-flicts of interest, there are other potential alternativesthat are general and systemic rather than aimed at thesituation of individual surgeons and patients. First, itmay be possible to alter the balance of power betweenpatient and surgeon, so that the patient or his or heradvocate is better able to assess the operation on offer.This kind of approach occurs in some situations, suchas surgery for deep brain stimulation where patientsand their caregivers may be offered counselling, sup-port groups, resources centres, and advice on navigat-ing online information in order to support theirdecision-making (Bell, Mathieu, and Racine 2009).Use of independent third parties such as clinical ethi-cists or patient advocates may also support patients inaccessing and understanding relevant information.

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These approaches may enable patients to ask the kindsof questions that will uncover the novelty of the pro-posed procedure, the surgeon’s experience, and theavailability of information about safety and efficacy.One way of embedding these practices into clinical carewould be to develop a checklist of questions for patientsand to normalise the asking of such questions bymakingthe provision of checklists a part of assessments ofquality of care or by auditing the use of checklists. Wenote, however, that asking questions does not in and ofitself guarantee that the surgeon will disclose all relevantinformation in an unbiased manner, nor that the patientwill necessarily be able to assess the information he orshe receives (cf., Kessels 2003).

Alongside patient empowerment, seeking secondopinions could be encouraged as a sign of due diligence,rather than as a sign of lack of faith in a surgeon, and theprocesses for obtaining second opinions made easierthrough measures such as reimbursement through pri-vate or public health insurance schemes, and profession-al acceptance that providing second opinions is alegitimate and valuable part of practice, rather than asign of distrust.

One way to address optimism bias is to requireregistration of all innovations, with collection of out-comes data that can be used to provide patients with thebest possible information about safety and efficacy. Thisis not an original suggestion (Barkun et al. 2009; Erginaet al. 2009; McCulloch et al. 2009), but its potential foraddressing conflicts of interest has not been explored.The challenges in implementing this measure lie first indefining and identifying innovation, which is not aninsignificant challenge (Biffl et al. 2008), and second,in setting up and funding such a venture. However, itmay be possible to implement local or institutionalregisters of innovative procedures and their outcomes,building upon existing review structures such as newinterventions committees. Such committees exist in atleast some local health districts in Australia, and there isa range of guidance documents on the assessment andintroduction of new procedures (e.g., NSWHealth 2003and Royal Australasian College of Surgeons/ASERNIP-S 2008. These might function in a manner similar toinstitutional review boards (human research ethics com-mittees) set up to review research. Such committeeswould be able to stipulate conditions for informed con-sent, such as mandatory third-party provision of infor-mation, and monitor the introduction of innovationsthrough collection of outcomes data. Conversely, such

processes are costly to set up and run (for example,collecting and collating information in ways that areuseful and relevant for patients) and rely upon surgeonsthemselves to identify when they are innovating.

In conclusion, we have argued that conflicts of inter-est may arise in surgery when innovations are intro-duced. These conflicts may involve external interestsor may be regarded as inevitable within-role conflicts.Either way, there is potential for the conflicts to affectthe way that care is offered to the patient and for harmsto occur. The standard remedies of disclosure and recus-al work imperfectly in the case of innovative surgery.Systemic measures such as empowering patients,normalising second opinions, and institutional reviewof and data collection about procedural innovations maybe more successful in addressing within-role conflicts,but these measures require resources and also hinge, to agreater or lesser extent, around the problematic issue ofidentifying just when surgical innovation occurs.

Acknowledgements We thank the audience at the annualconference of the Australasian Association of Bioethics andHealth Law in July 2011 for helpful comments; we also thankmembers of the INCISIVE working group on conflicts of inter-est for feedback and comments.

Disclosure of Competing Interests The authors have no fi-nancial or professional relationships that may pose a competinginterest in relation to the content of this paper.

Funding Research towards this paper was partly supported by anAustralian Research Council (ARC) Linkage Grant (LP110200217),“On the Cutting Edge: Promoting Best Practice in SurgicalInnovation.” The ARC had no control or influence over the decisionto submit the final version of the manuscript for publication.

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