Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator and to (...) professional organizations. The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

The growing commercialization of science has raised concerns about financial conflicts of interest (COIs). Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential (...) research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim. (shrink)

The actuarial profession has a long history of providing critical expertise to society. The services delivered are some of the most complex and mysterious to outsiders of all professions but little has been written about the professional responsibilities of actuaries in the academic literature beyond that of the profession itself. This paper makes the case that the issues surrounding professional independence of actuaries are, in principle, similar to those that faced the audit profession before the scandals and resultant regulatory changes (...) early this century. It is argued that, despite the position taken by the actuarial profession and management, the status quo raises genuine concerns about conflicts of interest and independence and that the risks that arise are of sufficient magnitude that they should at least be the subject of a full debate. (shrink)

Financial relationships in academic research can create institutional conflicts of interest because the financial interests of the institution or institutional officials may inappropriately influence decision-making. Strategies for dealing with institutional COIs include establishing institutional COI committees that involve the board of trustees in conflict review and management, developing policies that shield institutional decisions from inappropriate influences, and establishing private foundations that are independent of the institution to own stock and intellectual property and to provide capital to start-up companies.

A core value of Judaism is leading an ethical life. The Talmud, an authoritative source on Jewish law and tradition, has a number of discussions that deal with honesty in business and decision-making. One motive that can cause individuals to be unscrupulous is the presence of a conflict of interest. This paper will define, discuss, and review five Talmudic concepts relevant to conflict of interest. They are (1) Nogea B’Davar (being an interested party), (2) V’hiyitem N’keyim (behaving to (...) ensure that one is above suspicion) (3) Lifnei Iver (placing a stumbling block before the blind), (4) Shokhad (accepting a bribe), and (5) Geneivat Da’at (deception and undeserved goodwill). Case examples will be used to apply these Talmudic principles to contemporary business practice. This will include discussion of these Talmudic concepts as it applies to specific contemporary business examples relevant to the boardroom, accounting firms, investment banking, politics, and government. It may be impossible to eliminate all conflicts of interest. However, knowledge and awareness of these Talmudic principles can help individuals in business settings better address the ethical issues that they confront. (shrink)

This article summarizes the April 5–6, 2002 conference on Conflict of Interest and Its Significance in Science and Medicine. Several themes are identified and addressed, including the globalization of science, the widespread presence of conflicts, the increased interest and involvement in conflict of interest by a number of organizations, the difference between academic research and research conducted by industry, and the tension between science and medicine. At the heart of the matter lies objectivity in research and (...) the need for transparency to ensure objectivity. Several future activities were discussed, including the need to share specific examples of how conflict has been managed, and the need for behavioral research to provide a sound empirical understanding of the best ways to provide informed consent for research subjects. (shrink)

This paper looks at conflicts of interest in the not-for-profit sector. It examines the nature of conflicts of interest and why they are of ethical concern, and then focuses on the way not-for-profit organisations are especially prone to and vulnerable to conflict-of-interest scandals. Conflicts of interest corrode trust; and stakeholder trust (particularly from donors) is the lifeblood of most charities. We focus on some specific challenges faced by charitable organisations providing funding for scientific (...) (usually medical) research, and examine a case study involving such an organisation. One of the principal problems for charities of this kind is that they often distribute their funds within a relatively small research community (defined by the boundaries of a small region, like an American state or Spanish Autonomous region, or a small country), and it often proves difficult to find high-level researchers within the jurisdiction to adjudicate impartially the research grants. We suggest and recommend options appropriate for our case study and for many other organisations in similar situations. (shrink)

Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized “the pharmaceutical industry,” citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its (...) mission is to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck’s approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere. (shrink)

Neuroscience research has improved our understanding of the long term consequences of sports-related concussion, but ethical issues related to the prevention and management of concussion are an underdeveloped area of inquiry. This article exposes several examples of conflicts of interest that have arisen and been tolerated in the management of concussion in sport (particularly professional football codes) regarding the use of computerized neuropsychological (NP) tests for diagnosing concussion. Part 1 outlines how the recommendations of a series of global (...) protocols for dealing with sports-related concussions (the 1st, 2nd and 3rd Consensus Statements on Concussion in Sport) have endorsed the use of NP testing. The development of these protocols has involved experts who have links with companies that sell computerised NP tests for concussion management. Part 2 describes how some professional football leagues—in particular the National Football League (NFL), the Australian Football League (AFL) and the National Rugby League (NRL)—have mandated specific NP testing products. They have done so on the basis of these international guidelines and by engaging experts who have conflicts of interest with NP testing companies. These decisions have also been taken despite evidence that casts doubt on the reliability and validity of NP tests when used in these ways. (shrink)

What is a conflict of interest? What is morally problematic about one? Beginning with the definition, this paper organizes the core literature and creates two continuums—one devoted to the more specific definition of ‘interest,’ and the other to that of ‘duty’. Each continuum places the authors according to the narrowness or broadness of their positions, which facilitates the understanding of the debate as well as what is at stake when defining conflicts of interest. The paper then (...) develops a moral analysis that leads to the sought-for definition and to an explanation of why we should treat conflicts of interest carefully. While doing so, the paper discloses the criterion to judge whether a definition is right and presents the duties that makes conflicts of interest special as ‘tertiary’ duties of morality. (shrink)

Due to their financial incentive, clinicians who earn income from a firm that markets medical devices, pharmaceuticals, tests, etc. might inappropriately prescribe their products or services. The Cleveland Clinic’s conflict of interest (CI) policy creates rules governing clinicians who accept compensation from outside firms that market products they prescribe or use in their practice (hereafter, covered financial relationships). The CI policy is implemented by the Innovation Management and Conflict of Interest Program (IM&COI) (hereafter the Committee).

The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict (...) of interest that can arise in the practice of medicine are outlined. (shrink)

Recently a great deal of attention has been paid to conflicts of interest in medical research, and the Institute of Medicine has called for more research into this important area. One research question that has not received sufficient attention concerns the mechanisms of action by which conflicts of interest can result in biased and/or flawed research. What discretion do conflicted researchers have to sway the results one way or the other? We address this issue from the (...) perspective of selective inertia, or an unnatural selection of research methods based on which are most likely to establish the preferred conclusions, rather than on which are most valid. In many cases it is abundantly clear that a method that is not being used in practice is superior to the one that is being used in practice, at least from the perspective of validity, and that it is only inertia, as opposed to any serious suggestion that the incumbent method is superior, that keeps the inferior procedure in use, to the exclusion of the superior one. By focusing on these flawed research methods we can go beyond statements of potential harm from real conflicts of interest, and can more directly assess actual harm. (shrink)

The Cleveland Clinic Innovation Management and Conflict of Interest (“IM&COI”) Program implemented a policy on Conflicts of Interest in Clinical Practice in 2013. The policy requires review of financial interests greater than $20,000 in a year, or more than 5% equity in a company, when the clinician is prescribing or using products of the company with which they have a relationship. The IM&COI Committee developed definitions for low, medium and high levels of annual compensation and risk and (...) uses a “Matrix” to guide disclosure based on these factors. (shrink)

A recent study by Olivieri et al, published in PLOS ONE, reports that between 2009 and 2015 a third of patients with thalassaemia in Canada’s largest hospital were switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy. Based on retrospective data from patient records, the PLOS Study reports that patients treated with deferiprone, either as monotherapy or in combination with first-line drugs, suffered serious adverse effects. The data reported by Olivieri et al (...) give rise to a number of ethical issues. These ethical issues are identified, placed in historical context and analysed. For purposes of this analysis, reliance is placed on two core principles of research ethics, harm minimisation and informed consent, and also on the hospital’s mission statement. Then a mystery is explored: How and why did it happen that Toronto’s University Health Network treated large numbers of patients with an unlicensed drug over a period of many years? ‘Institutional conflict of interest’ is considered as a possible explanatory hypothesis. (shrink)

An area where conflicts of interest can take place in Estonia is in the conduct of clinical trials. The paper lists the main areas where such conflicts of interest can occur. The author also briefly discusses Estonia’s current position with regard to regulating genetic information and the commencement of the Estonian Genome Project.

Extensive conflicts of interest at both individual and institutional levels are identifiable in scientific research and healthcare in China, as in many other parts of the world. A prominent new case from China is He Jiankui’s experiment that produced the world’s first gene-edited babies and that raises numerous ethical, political, socio-cultural, and transnational questions. Serious financial and other COI were involved in He’s genetic adventure. Using He’s infamous experiment as a case study, this paper explores the wider issue (...) of financial and other COI in scientific research and healthcare in China, especially institutional conflict of interest and policy-related COI. Taking a socio-ethical perspective, it examines China’s state policies and its massive efforts to transform and commercialize scientific research, the lack of policies and oversight mechanisms for regulating COI, as well as major ethical issues arising from COI including the undermining of public trust. Some practical suggestions are offered for institutional reform and institutional development so that COI, particularly ICOI, can be avoided or more effectively managed in scientific research in China. (shrink)

Conflicts of interest in corporate law can be addressed by two main alternatives: a requirement of a majority of the minority vote or the imposition of duties of loyalty and fairness. A comparison of Delaware, the UK, Canada, and Israel reveals that while the conflicts of interest problem within publicly-traded corporations receives different treatment in the different jurisdictions — either a fairness rule or a majority of the minority rule — closely-held corporations receive the same treatment (...) of an imposition of duties of loyalty and fairness. This article explains this finding, demonstrating that determining which of these rules is adopted is, in fact, a choice between liability rule protection and property rule protection. This choice depends on the total and relative transaction costs. These costs include both the negotiation costs attendant upon a property rule, as well as the adjudication costs associated with a liability rule. The sum of these costs is influenced by the efficacy of the judicial system and of extralegal mechanisms such as the market for corporate control, the capital market, and the types of investors active in the market. Because the different jurisdictions have different relative costs, due to differences in the economy and the legal systems, publicly-traded corporations are treated differently in each system. However, sometimes conflict of interest situations share the same main characteristics — as with closely-held corporations—leading to the domination of one solution, and thus the same solution is applied for closely-held corporations in the different jurisdictions. (shrink)

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address (...) CoI in the authorisation process of research and clinical protocols of biomedicine. (shrink)

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to (...) exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. (shrink)

Goldberg notes that the relationship is a component of Conflicts of Interests. Networks of relationships and the simultaneous presence of several interests are not negative per se but become so when they generate a conflict that undermines impartiality. The solution to the problem of COIs, therefore, cannot be to abolish relationships and the interests that they necessarily express but rather to verify whether those relationships are such as to unduly affect an individual’s judgement. The evolution of an Italian legislation (...) about COIs is eloquent in this regard. (shrink)

Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of bioethics. In (...) this study, we examined the availability and comprehensiveness of COI policies for authors, peer reviewers, and editors of bioethics journals. Methods: After developing a codebook, we analyzed the content of online COI policies of 63 bioethics journals, along with policy information provided by journal editors that was not publicly available. Results: Just over half of the bioethics journals had COI policies for authors (57%), and only 25% for peer reviewers and 19% for editors. There was significant variation among policies regarding definitions, the types of COIs described, the management mechanisms, and the consequences for noncompliance. Definitions and descriptions centered on financial COIs, followed by personal and professional relationships. Almost all COI policies required disclosure of interests for authors as the primary management mechanism. Very few journals outlined consequences for noncompliance with COI policies or provided additional resources. Conclusion: Compared to other studies of biomedical journals, a much lower percentage of bioethics journals have COI policies and these vary substantially in content. The bioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship. (shrink)

Scientific journals can promote ethical publication practices through policies on conflicts of interest. However, the prevalence of conflict of interest policies and the definition of conflict of interest appear to vary across scientific disciplines. This survey of high-impact, peer-reviewed journals in 12 different scientific disciplines was conducted to assess these variations. The survey identified published conflict of interest policies in 28 of 84 journals (33%). However, when representatives of 49 of the 84 journals (58%) completed (...) a Web-based survey about journal conflict of interest policies, 39 (80%) reported having such a policy. Frequency of policies (including those not published) varied by discipline, from 100% among general medical journals to none among physics journals. Financial interests were most frequently addressed with relation to authors; policies for reviewers most often addressed non-financial conflicts. Twenty-two of the 39 journals with policies (56%) had policies about editors’ conflicts. The highest impact journals in each category were most likely to have a published policy, and the frequency of policies fell linearly with rank; for example, policies were published by 58% of journals ranked 1 in their category, 42% of journals ranked third, and 8% of journals ranked seventh (test for trend, p = 0.003). Having a conflict of interest policy was also associated with a self-reported history of problems with conflict of interest. The prevalence of published conflict of interest policies was higher than that reported in a 1997 study, an increase that might be attributable to heightened awareness of conflict of interest issues. However, many of the journals with policies do not make them readily available and many of those policies that were available lacked clear definitions of conflict of interest or details about how disclosures would be managed during peer review and publication. (shrink)

The medical profession is under a state of increasing scrutiny. Recent high profile scandals regarding substantial industry payments to physicians, surgeons, and medical researchers have raised serious concerns over conflicts of interest. Amidst this background, the public, physicians, and policymakers alike appear to make the same assumption regarding conflicts of interest; that doctors who succumb to influences from industry are making a deliberate choice of self-interest over professionalism and that these doctors are corrupt. In reality, (...) a myriad of evidence from social science indicates that influence from conflicts of interest often occurs on a subconscious and unintentional level. This poses an important issue, since such conflicts can steer wellintentioned physicians away from their primary professional goal to provide the best medical advice and treatment possible. (shrink)

The tobacco industry’s involvement in the electronic cigarette research that informs public health policy is controversial. On the one hand, some are concerned that their involvement presents conflicts of interest that bias research outputs and invalidate the policies that use them. On the other hand, some have argued that the tobacco industry may support valid research and contribute to the goals of public health, for instance, if the interests of the e‐cigarette industry could be part of a tobacco (...) smoking cessation policy. We approach this debate from the ethical perspective of the public interest and the public good, considering how legitimate researchers can square their expert opinion with validating tobacco industry‐funded research, given the perfidy of the tobacco industry and paucity of robust, conclusive evidence on the public health impacts of liberalizing e‐cigarette use. (shrink)

As President, Donald Trumps faces two sorts of conflict of interest. The first are conflicts of interest other Presidents also faced, though Trump’s are “writ large.” These seem—as a practical matter—unavoidable now, hard to escape, not to be much changed by disclosure, and not even much subject to management. The other sort of conflict of interest seems to be without resolution even in principle while Trump remains both President and the person he is. These conflicts (...) of interest are the product of the same life that made him President. He cannot be both chief executive of a republic (as his oath of office requires him to be) and the royal autocratic central to his business brand. (shrink)

This paper examines Romanian bioethics regulations for biomedical sciences, looking in particular at the genetics area as a source for conflict of interest. The analysis is focused on the organizational level, national regulations, the sources for generating conflicts of interest, and management of conflicts. Modern biotechnology and gene technology are among the key technologies of the twenty-first century. The application of gene technology for medical and pharmaceutical purposes is widely accepted by society, but the same cannot (...) be said of the development and application of gene technology in agriculture and food processing. Because the use of a technology in the production and processing of food is regarded more sceptically than in the production of biomedical products, there can be areas of conflict in many cases when communication is undertaken about gene technology in the agro-food sector. Ethical concerns play an important factor in this, but a society’s attitude to a developing technology is an amalgam of many effects which are beyond ethics as such. (shrink)

A conflict of interest is a situation in which a person has competing loyalties or interests that make it difficult to fulfil his or her duties impartially. Conflict of interest is not categorically improper in itself but requires proper management. A SCOPUS literature search was performed for publications on the efficacy/safety of Phospho-Di-Esterase Inhibitors for treating erectile dysfunction. A categorization tool was used to review and classify the publications as supportive/not-supportive for the discussed active ingredient and reporting or (...) not reporting a COI for that specific drug or for the remaining PDEIs. Multivariable binary logistic regression was performed. In the 419 selected records the prevalence of supportive opinions was higher when a COI for the index label was declared. The CoOpCaT showed good internal consistency, discriminative validity and intra/inter-rater agreement. The strongest predictor for a supportive opinion was the total number of financial COIs for the index label. A mild protective effect of the total number of financial COIs for any competitor label was noted. Financial COIs have frequently been associated with bias, and the measures currently adopted to restrain it lack effectiveness. Some evidence for monitoring and/or compensating this bias is reported here, but the ultimate solution remains distant. (shrink)

This paper critically examines the proliferation of conflicts of interest discourse and how the most common conceptions of COI presuppose a hierarchy of primary and secondary interests. I show that a form of professional virtue or duty is commonly employed to give the primary interest normative force. However, I argue that in the context of increasingly commercialized healthcare neither virtue nor duty can do the normative work expected of them. Furthermore, I suggest that COI discourse is symptom (...) of rather than solution to the problems of market forces in contemporary medicine. I contend that COI, as it is commonly conceived, is an inadequate concept through which to attend to these problems. It is used as a procedural short-cut to address ethico-political problems. That is, it is an economic and policy concept expected to do significant moral and political work. Like most short-cuts, this one also leads to entanglements and winding roads that fail to reach the destination. As such, I suggest that we need a different set of ethico-political tools to address normative fluidity of medical practice in the absence on a primary interest. (shrink)

The policy changes governing the relations between the pharmaceutical, medical device and service industries and academic clinical research physicians, recommended by the Institute of Medicine,1 the American Academy of Medical Colleges,2 and much discussed in the media and on our campuses, aim to create some protective ethical firewalls. However, some potentially critical consequences of these steps are missed if we do not acknowledge what else is on the table, and who is sitting at it. By only reacting defensively to the (...) juggernaut of righteous indignation over the loss of purity in a faculty physician's approach to medical problem solving, we are allowing the process to blind us to the difficulties in establishing fair and equitable management of all of the potential conflicts of commitment and conflicts of interest we incur, not only as faculty members, but also as departments and academic medical centres . Critically, this involves all sources of revenue—private, commercial and public—that support our professional and institutional commitments as well as our personal finances.i To counter the present crackdown on inappropriate financial relationships effectively, we will need to reframe the questions, and convince all stakeholders to the process that there is more to this crisis than can be resolved through our public confessions of commercial largesse obliged. The Phrma Code guidelines3 have resulted in what is believed to be a defensible, if as yet legally untested, compartmentalisation of the commercial sector's marketing, medical education and research sponsorship activities. We at the AMC are a long way from understanding how those same missions, as they emanate from our multifarious commitments, can be isolated and individually managed. Defining the parameters for establishing institutional conflicts of interest and commitment are beyond our essay's scope, but with the very public emphasis on capitalist subversion of …. (shrink)

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

Conflicts of interest represent one of the defining problems of our time, and yet a clear definition of what constitutes a conflict of interest remains elusive. To move us closer to resolving this problem, this article first reviews and critiques attempts to define conflicts of interest, and, second, uses these critiques to ground a more conceptually consistent and practically useful definition. This definition builds on, but also breaks away from Michael Davis’s definition of conflicts (...) of interest. Specifically, it articulates and defends defining conflicts of interest in terms of their threat to good judgment but does so in the broadest terms. Defining it in this way expands the domain of conflicts of interest, but also avoids unnecessary conceptual distractions and practical difficulties. (shrink)

The University of Pittsburgh policy for procuring organs from non-heart-beating cadaver donors recognizes the potential for conflicts of interest between caring for a "hopelessly ill" patient who has forgone life-sustaining treatment and caring for a potential organ donor. The policy calls for a separation between those medical personnel who care for the gravely ill patient and those involved with the care of transplant recipients. While such a separation is possible in theory, it is difficult or impossible to attain (...) in practice. However, such a separation of duties would be unnecessary if an arbitrator were appointed to monitor the proceedings as they take place on a case-by-case basis. In this way, the biases—real or potential—of the individuals involved could be identified, and the harmful effects of the unavoidable conflicts of interest could be minimized. (shrink)

The past presidential election reinvigorated interest in the applicability of conflict of interest legislation to the executive branch. In § 2, we survey various approaches to conflicts of interest, paying particular attention to 18 U.S.C. § 208. Under 18 U.S.C. § 202, this conflict of interest statute is straightforwardly inapplicable to the President. We then explore the normative foundations of such an exemption in § 3. While these sections are ultimately lenient, we go on to (...) consider the Emoluments Clause of the United States Constitution in § 4. In §§ 5–6, we apply the Emoluments Clause to the presidency, arguing that it complements conflict-of-interest regimes with regards to foreign affairs, but with more substantial restrictions. (shrink)

Toward a Sociology of Conflict of Interest in Medical Research Content Type Journal Article Category Case Studies Pages 389-391 DOI 10.1007/s11673-011-9332-0 Authors Sarah Winch, School of Medicine, The University of Queensland, Queensland, Australia 4072 Michael Sinnott, School of Medicine, The University of Queensland, Queensland, Australia 4072 Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 8 Journal Issue Volume 8, Number 4.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is (...) also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

An interest in economic development has been extended to a set of research universities which since the late nineteenth century had been established, or had transformed themselves, to focus upon discipline-based fundamental investigations.21 The land-grant model was reformulated, from agricultural research and extension, to entrepreneurial transfers of science-based industrial technology by faculty members and university administrators.The norms of science, a set of values and incentives for proper institutional conduct,22 have been revised as an unintended consequence of the second revolution. (...) This has happened through an accretion of gradual organisational changes that often go unnoticed, and through conflict that disrupts the status quo and makes change evident. The two forms of normative change became apparent in the emergence of group research and in controversies over conflicts of interest. With extensive financial support from government, large research groups began to replace the traditional form of professor and graduate student—still commonplace in the humanities—as the typical way of organising research, although group leaders were called “individual investigators”.23 Possessing many of the characteristics of a small business, apart from the profit motive, some of these research groups or “quasi firms” are only a short step away from turning into companies when the opportunity arises.Disputes about conflicts of interest are a step towards the transformation of norms. How they are resolved suggests the shape of the new norm; their continuation indicates that the outcome is still in question; their intensification increases the likelihood that a practice will be defined as deviant. Some conflicts of interest will be resolveable as norms change; others will be defined as fraud and be dealt with by the legal system. Conflicts of commitment may also be amenable to resolution, for example, by granting leave to establish a company. Integrating campus and company research reduces some of the potential for conflict, especially when the university holds the intellectual property rights in question.Under these new normative conditions what is left of the idea of the university as a source of disinterested expertise? As molecular biology departments have developed a complex network of industrial ties a new critical discipline of environmental science has grown up in academia. Universities are flexible institutions, capable of reconciling many diverse missions. (shrink)

Despite the presumed frequency of conflicts of interest in scientific peer review, there is a paucity of data in the literature reporting on the frequency and type of conflicts that occur, particularly with regard to the peer review of basic science applications. To address this gap, the American Institute of Biological Sciences conducted a retrospective analysis of conflict of interest data from the peer review of 282 biomedical research applications via several onsite review panels. The overall (...) conflicted-ness of these panels was significantly lower than that reported for regulatory review. In addition, the majority of identified conflicts were institutional or collaborative in nature. No direct financial conflicts were identified, although this is likely due to the relatively basic science nature of the research. It was also found that 65 % of identified conflicts were manually detected by AIBS staff searching reviewer CVs and application documents, with the remaining 35 % resulting from self-reporting. The lack of self-reporting may be in part attributed to a lack of perceived risk of the conflict. This result indicates that many potential conflicts go unreported in peer review, underscoring the importance of improving detection methods and standardizing the reporting of reviewer and applicant conflict of interest information. (shrink)

American universities are increasingly proactive in dealing with conflict of interest problems of their faculty. Changing social norms, publicized scandals, and more have made both university administrators and faculty extra alert to the dangers of faculty infidelity to their roles as teachers and scholars. Personal interests — both financial and non-financial — appear increasingly to pressure faculty to behave inappropriately. Most faculty members resist those pressures. Yet, enough conduct that either is, or appears to be, improper has occurred to (...) prompt the adoption by universities of an ever-more complex regulatory regime. This regime no longer relies primarily upon threats of after-the-fact punishment for gross deviations from professorial norms. Instead, universities have also enacted a wide array of in-advance restrictions. These include required disclosures by faculty members of certain private interests, prohibitions of specific faculty behavior, and specified instances in which faculty members must temporarily withdraw from their professorial roles in light of their private interests. This article draws especially upon the author’s experience at the University of California to illustrate the new system of regulation. (shrink)

An area where conflicts of interest can take place in Estonia is in the conduct of clinical trials. The paper lists the main areas where such conflicts of interest can occur. The author also briefly discusses Estonia’s current position with regard to regulating genetic information and the commencement of the Estonian Genome Project.

Social attitudes toward usury (here defined using the archaic meaning as the taking of interest on loans) have changed dramatically over the centuries. From antiquity until the Protestant Reformation, usury was regarded as an inherently evil activity. Today, with few exceptions, usury is met with moral indifference. Modern objections to usury are limited to protest against "excessive" interest rates rather than interest per se. With this change in focus, the very meaning of the term "usury" has also (...) changed. Many early pronouncements against the taking of interest emphasized the plight of the poor, but ironically, the poor actually pay the highest rates of interest in the modern American economy. Despite the universality of usury, some socio-economic subcultures still manage to avoid the taking or giving of interest. Orthodox branches of both Judaism and Islam have maintained bans on usury throughout the centuries and up to the present time. This is especially interesting in the case of Judaism, given the popular cultural image of the Jew as usurer. Jewish free loan systems may actually offer a model for modern loan programs that can be designed to aid poor borrowers, who are frequently shut out of mainstream financial services. (shrink)

This paper synthesises the research related to managing conflict of interests in professional accounting firms. The main purpose is to provide information about the current state of knowledge on this topic and to highlight the areas requiring further research. The extant research has been reviewed by developing a framework through the integration of Risk Management Framework by ISO 31000:2009 and the International Code of Ethics for Professional Accountants. Specifically, literature has been classified across the establishment of context, assessment, treatment, control (...) and monitoring of conflict of interests. The literature reveals that there is a lack of understanding about how the conflict of interests operates at the level of an individual accounting professional. Addressing this gap will help to develop behavioural interventions for strengthening the professionals’ independence in fact and, thereby, facilitating the management of conflict of interests. The key message this synthesised research provides for professional accounting firms and the regulators is that, for effective management of conflict of interests, behavioural interventions should be informed by the professionals’ unconscious as well as their conscious cognitive processes. This study is the first one to view the conflict of interests in a professional accounting environment through the lens of behavioural risk management. Moreover, the framework adopted for reviewing the extant literature provides a comprehensive view of the issues surrounding the ineffective management of the conflict of interests. (shrink)

Due to the enormous disparity of power in the child welfare professional-client relationship, a high level of trust is necessary for this relationship to achieve its intended benefits, including protecting, caring for, terminating parental rights to, and finding appropriate adoptive homes for, abused and neglected children. This paper first defines conflicts of interest as necessarily including the exercise of judgment, and then argues that contractual relationships between private child welfare agencies and public departments of child welfare often betray (...) their fiduciary responsibilities through conflicts of interest inherent in these contracts, particularly as regarding incentives for and against finding permanent homes for abused and neglected children. Finally, I propose an evidence-based strategy to ameliorate conflicts of interest when making permanent placement decisions for foster children. (shrink)

Conflicts of interest pose special problems for the professions. Even the appearance of a conflict of interest can undermine essential trust between professional and public. This volume is a comprehensive and accessible guide to the ramifications and problems associated with important issue. It contains fifteen new essays by noted scholars and covers topics in law, medicine, journalism, engineering, financial services, and others.

Drawing on calls by researchers to examine corporate scandals involving potential conflicts of interest or compromise to professional independence involving the actuarial profession, this article outlines one such case. The consulting actuaries – to a large Australian listed company, James Hardie Industries Limited – found themselves advising two parties in a corporate restructuring where the interests of each were sometimes competing and the interests of the public appeared to be ignored. The James Hardie case is instructive in a (...) number of ways: first, it demonstrates the subtlety with which conflicts of interest or pressures on professional independence can arise; second, it demonstrates how important professional issues can be obfuscated by more obvious and pressing financial and strategic issues; and finally it demonstrates that adherence to professional codes of conduct and the ease with which professional ethics can be compromised when those codes are vague and transgressions are rarely actionable. The James Hardie case highlights structural issues in the employment of consulting actuaries which presents risks to the profession. It demonstrates that the combination of an aggressive corporate management with a strategic agenda reliant on consulting actuaries that have a vested interest in promoting and maintaining valuable relationships, both financially and professionally, results in ethical challenges. (shrink)

Community-based healthcare organisations manage competing, and often conflicting, priorities. These conflicts can arise from the multiple roles these organisations take up, and from the diverse range of stakeholders to whom they must be responsive. Often such conflicts may be titled conflicts of interest; however, what precisely constitutes such conflicts and what should be done about them is not always clear. Clarity about the duties owed by organisations and the roles they assume can help identify and (...) manage some of these conflicts. Taking divisions of general practice in Australia as an example, this paper sets out to distinguish two main types of conflicts of interest, so that they may be more clearly identified and more effectively managed. (shrink)

The continuous growth of the pharmaceutical industry is expected to require a considerable output of new drugs, with speedy development and approval processes. This profit-driven expansion of the drug market may broaden the already established erosion of the role of academia in favor of commercial clinical research organizations. Less and less control on the clinical trial design, its conduct and the resulting publication[s] is the likely consequence. Academic medicine and governments should find means to sustain the development of independent clinical (...) research. (shrink)

It should come as no surprise that a music and arts festival dogged by scandal would lead to two separate documentaries that each raise ethical concerns. The 2017 demise of the Fyre Festival, a would-be luxury music event in the Bahamas targeted at millennials, inspired late-night comedians’ jokes, social media schadenfreude and so far, two documentaries detailing how things went so wrong. Both films detail the maddening twists and turns during the preparations for the Fyre Festival and make it clear (...) to viewers that it was doomed from the start. Both films also contain potential conflicts of interest that are notable, and notably absent from discussion or clarification in either film. (shrink)