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)

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.

This study examines the extent to which scientific and biomedical journals have adopted conflict of interest (COI) policies for authors, and whether the adoption and content of such policies leads to the publishing of authors’ financial interest disclosure statements by such journals. In particular, it reports the results of a survey of journal editors about their practices regarding COI disclosures. About 16 percent of 1396 highly ranked scientific and biomedical journals had COI policies in effect during 1997. (...) Less than 1 percent of the articles published during that year in the journals with COI policies contained any disclosures of author personal financial interests while nearly 66 percent of the journals had zero disclosures of author personal financial interests. Nearly three fourths of journal editors surveyed usually publish author disclosure statements suggesting that low rates of personal financial disclosures are either a result of low rates of author financial interest in the subject matter of their publications or poor compliance by authors to the journals’ COI policies. (shrink)

The current proxy voting system in the United States has become the subject of considerable controversy. Because institutional investment managers have the authority to vote their clients’ proxies, they have a fiduciary obligation to those clients. Frequently, in an attempt to fulfill that obligation, these institutional investors employ proxy advisory services to manage the thousands of votes they must cast. However, many proxy advisory services have conflicts of interest that inhibit their utility to those seeking to discharge their fiduciary (...) duties. In this article, we describe the current proxy advisory network as an example of how current notions of conflicts of interest fall short when explaining the behavior of an interconnected set of market players whose remit is to act in the best interests of their investors. We discuss what participants in this system should do to bring transparency and accuracy to the proxy advice industry. (shrink)

The heart of the matter -- The evolution of the French medicine -- Coping with physicians' conflicts of interest in France -- The rise of a protected medical market : the United States before 1950 -- The commercial transformation : the United States, 1950-1980 -- The logic of medical markets : the United States, 1980 to the present -- Coping with physicians' conflicts of interest in the United States -- The evolution of Japanese medicine -- Coping with physicians' (...) conflicts of interest in Japan -- Reforms -- Professionalism reconsidered. (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)

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.

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).

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)

The potential for financial conflicts of interest (COIs) to damage the credibility of scientific research has become a significant social concern, especially in the wake of high-profile incidents involving the pharmaceutical, tobacco, fossil-fuel, and chemical industries. Scientists and policy makers have debated whether the presence of financial COIs should count as a reason for treating research with suspicion or whether research should instead be evaluated solely based on its scientific quality. This paper examines a recent proposal to develop criteria (...) for evaluating the credibility of research without considering its source of funding. It concludes that proposals of this sort are likely to be either ineffective or impractical in many cases. Nevertheless, this does not imply that all research funded by those with an interest in the outcome must be placed under a cloud of suspicion; there are conditions under which research is at much more serious risk of being corrupted than in other cases, and attention to these conditions can guide productive responses to financial COIs. (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)

Sports medicine clinicians face conflicts of interest in providing medical care to athletes. Using a survey of college football players, this study evaluates whether athletes are aware of these conflicts of interest, whether these conflicts affect athlete trust in their health care providers, or whether conflicts or athletes' trust in stakeholders are associated with athletes' injury reporting behaviors.

Why do physicians have financial conflicts of interest? They arise because society expects physicians to act in their patients’ interest, while simultaneously, financial incentives encourage physicians to practice medicine in ways that promote their own interests or those of third parties. Because physicians’ clinical choices, referrals, and prescriptions affect the fortune of third parties, these third parties may offer physicians financial incentives to make income-driven clinical choices. In the past, physicians and scholars typically conceived of conflicts of (...) class='Hi'>interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine. Conflicts of interest, therefore, are as much matters of public policy and management as individual choices or social norms. (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)

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)

Conflicts of interest have an erosive effect on trust in science, damaging first the attitude of the public toward scientists and their research, but also weakening the trusting interdependence of scientists. Disclosure is recognized as the key tool for management of conflicts, but rules with sanctions must be improved, new techniques for avoidance of financial conflicts by alternative funding of evaluative research must be sought, and there must be new thinking about institutional conflicts of interest. Our profession is (...) education, and both the public and research professionals of all ages would benefit from greater understanding of how science should and does work. (shrink)

The primary claim of this paper is that intellectual conflicts of interest (COIs) exist but are of lower ethical priority than COIs flowing from relationships between health professionals and commercial industry characterized by financial exchange. The paper begins by defining intellectual COIs and framing them in the context of scholarship on non-financial COIs. However, the paper explains that the crucial distinction is not between financial and non-financial COIs but is rather between motivations for bias that flow from relationships and (...) those that do not. While commitments to particular ideas or perspectives can cause all manner of cognitive bias, that fact does not justify denying the enormous power that relationships featuring pecuniary gain have on professional behaviour in term of care, policy, or both. Sufficient reason exists to take both intellectual COIs and financial COIs seriously, but this paper demonstrates why the latter is of higher ethical priority. Multiple reasons will be provided, but the primary rationale grounding the claim is that intellectual COIs may provide reasons to suspect cognitive bias but they do not typically involve a loss of trust in a social role. The same cannot be said for COIs flowing from relationships between health professionals and commercial industries involving financial exchange. The paper then assumes arguendo that the primary rationale is mistaken and proceeds to show why the claims that intellectual COIs are more significant than relationship-based COIs are dubious on their own merits. The final section of the paper summarizes and concludes. (shrink)

This paper has two distinct objectives. (1) I defend an analysis of the concept of a conflict of interest. On my analysis the concept of a conflict of interest is broader than is generally supposed. I argue that a very large class of cases not ordinarily regarded as conflicts of interest should be so regarded. Conflicts of interest are an integral feature of many professional relationships and do not (as is often supposed) require the (...) existence of external financial or personal relationships. (2) I defend and explain the commonsense view that conflicts of interest areprima facie wrong and argue that in ordinary cases it is wrong, all things considered, to allow an avoidable conflict of interest to occur. I attempt to establish these claims on the basis of weak and relatively noncontroversial assumptions. (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)

Policies and processes dealing with institutional conflict of interest lag well behind those dealing with individual COI. To remediate this, academic institutions must develop strategies for addressing some of the unique challenges in iCOI, including: clarifying the definition of iCOI that addresses the range of individuals potentially involved; implementing a well-designed electronic database for reporting and managing iCOI across multiple leadership constituencies; and providing ongoing education to appropriate institutional officials that communicates the importance of managing iCOI.

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)

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 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)

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)

: Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, publication standards, and government regulation, but "intrinsic conflicts of interest"—conflicts of interest inherent in all clinical research—have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and (...) both academic and financial incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest. (shrink)

The last years have seen a surge of scandals in financial intermediation. This article argues that the agency structure inherent to most forms of financial intermediation gives rise to conflicts of interest. Though this does not excuse scandalous behavior it points out market imperfections. There are four types of conflicts of interest: personal-individual, personal-organizational, impersonal-individual, and finally, impersonal-organizational conflicts. Analyzing recent scandals we find that all four types of conflicts of interest prevail in financial intermediation.

There is an increasing emphasis on clear disclosure of conflict of interest in medical communities, following repeated scientific frauds in clinical trials. However, incomplete COI statements continue to be prevalent in the medical community, as appears to have occurred in the Capecitabine for Residual Cancer as Adjuvant Therapy trial, which was recently published in the New England Journal of Medicine. The authors of the article did not clearly report the roles of the Japan Breast Cancer Research Group, a (...) sponsor and funder of the study, although a majority of the Japanese authors served in important positions in the organization. Furthermore, the conflict of interest related to Chugai Pharmaceutical Company, a Japanese distributor of capecitabine, was not correctly disclosed. More transparent statements of conflict of interest and clarification of sponsors and funders’ roles, as well as rigorous review by academic journals are required to fairly interpret the findings of clinical trials, including and beyond the single case of the CREATE-X trial. (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)

Private industry funds more than half of all medical research in the United States. While industry involvement in research has benefits, it can also create conflicts of interest. The most common policies adopted to address conflict of interest in medical research are focused primarily on the ways in which industry sponsorship may undermine a clinician’s judgment regarding patient care. Insufficient attention has been given to the ways in which industry sponsorship may undermine judgment relative to the goal (...) of scientific integrity in research. The most common conflict of interest policies do not adequately address this problem. Disclosure policies alone will not remove or ameliorate all conflicts. Further, severing or monitoring ties between clinicians and industries will not adequately address the problem, since in many cases it is not the clinicians who are making the relevant research judgments. In order to address the problem of conflict of interest inindustry-sponsored research, fundamental changes in strategy and practice must be adopted which either remove the power to make research decisions from industry employees, or increase the review of those decisions by independent investigators. (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)

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)

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)

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.

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, (...) and Johns Hopkins University.At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center. (shrink)

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)

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)

This volume features a distinguished, international group of scholars and practitioners who provide a comparative account of ethics regulations across four Western democracies: the United States, the United Kingdom, Canada, and Italy. They situate conflict-of-interest regulations within a broader discourse involving democratic theory; identify the structural, political, economic, and cultural factors that have contributed to the development of these regulations over time; and assess the extent to which these efforts have succeeded or failed across and within different branches (...) and systems of government. Collectively, they provide an invaluable survey of the development, function, and impact of conflict-of-interest regimes in public life. (shrink)

In spite of recent efforts to promote cooperation between universities and industry, Germany still lacks a sufficient legal framework for regulating potential conflicts of interest resulting from university-industry cooperation. Prospective regulation of conflicts of interest has to take into account specific constraints imposed by the German constitution. It has to follow stringent procedural and material requirements and carefully weigh the individual researcher’s right to academic freedom against the public demand for objectivity in research. Because of this cautious consideration (...) of the conflicting interests constitutionally mandated in Germany, a potential regulation legitimate in this country may serve as a model for other countries facing the need of the adoption of such a regulation. (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)

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.

The increasing interconnectedness of academic research and external industry has left research vulnerable to conflicts of interest. These conflicts have the potential to undermine the integrity of scientific research as well as to threaten public trust in scientific findings. The present effort sought to identify themes in the perspectives of faculty researchers regarding conflicts of interest. Think-aloud interview responses were qualitatively analyzed in an effort to provide insights with regard to appropriate ways to address the threat of conflicts (...) of interest in research. Themes in participant responses included disclosure of conflicts of interest, self-removal from situations where conflict exists, accommodation of conflict, denial of the existence of conflict, and recognition of complexity of situations involving conflicts of interest. Moral disengagement operations are suggested to explain the appearance of each identified theme. In addition, suggestions for best practices regarding addressing conflicts of interest given these themes in faculty perspectives are provided. (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)

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)

At least since the time of Hippocrates, the physician-patient relationship has been the paradigmatic ethical arrangement for the provision of medical care. Yet, a physician-patient relationship does not exist in every professional interaction involving physicians and individuals they examine or treat. There are several “third-party” relationships, mostly arising where the individual is not a patient and is merely being examined rather than treated, the individual does not select or pay the physician, and the physician's services are provided for the benefit (...) of another party. Physicians who treat NFL players have a physician-patient relationship, but physicians who merely examine players to determine their health status have a third-party relationship. As described by Glenn Cohen et al., the problem is that typical NFL team doctors perform both functions, which leads to entrenched conflicts of interest. Although there are often disputes about treatment, the main point of contention between players and team physicians is the evaluation of injuries and the reporting of players’ health status to coaches and other team personnel. Cohen et al. present several thoughtful recommendations that deserve serious consideration. Rather than focusing on their specific recommendations, however, I would like to explain the rationale for two essential reform principles: the need to sever the responsibilities of treatment and evaluation by team physicians and the need to limit the amount of player medical information disclosed to teams. (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)

Patient visits are an important opportunity for general practitioners to discuss the risks of smoking and cessation strategies. In Australia, the guidelines on cessation published by the Royal Australian College of General Practitioners represent a key resource for GPs in this regard. The predominant message of the Guidelines is that pharmacotherapy should be recommended as first-line therapy for smokers expressing an interest in quitting. This, however, ignores established evidence about the success of unassisted quitting. Our analysis of the Guidelines (...) identifies a number of potential conflicts of interest which may have affected the advice provided. These include extensive funding by the pharmaceutical industry of sources cited to support the recommendations, and relations between members of the Guidelines Content Advisory Group and the pharmaceutical industry. Recommendations issued by professional bodies have enormous potential impact upon public health and there is a need for the highest levels of scrutiny and transparency in their development. Information about research cited in guidelines should include funding sources, and developers should be free of obvious conflicts of interest. Smoking remains the leading preventable cause of global mortality. Concerns related to pharmaceutical industry funding of research, scientific integrity and recommendations on smoking cessation by medical advisory groups clearly have implications beyond Australia. (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 U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms of (...) novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings. (shrink)

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts’ degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec’s immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts’ (...) level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers. (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)