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)

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)

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 (...) class='Hi'>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)

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).

Continued scientific and medical progress in Central and Eastern Europe depends on the development of an atmosphere that is conducive to implementing the changes that are necessary to bring better health and longer lives for everyone. Privatization and commercialization are threatening the objectivity of clinical research and the availability of health care because uncontrolled market mechanisms focused on profit are nurturing conflict of interest that generate bias and unreliability into research and medicine. Changes are needed that address the (...) following: – The amount of public support for basic and clinical research and health care, – standards for the conduct of clinical trials and delivery of health care, – administrative procedures for responding to the conflict of interest problem. (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)

Launched in 2007, the American Medical Students Association PharmFree Scorecard is an annual ranking of conflict of interest policies at American medical centres; it focuses on COIs that may occur when medical education seems likely to be influenced by university-industry relationships, especially those with the pharmaceutical and medical device industries. The PharmFree Scorecard has proven influential in stimulating changes in policy regarding the management of COI at American medical institutions, thus it provides a useful jumping off point for (...) reflection on how and why medical education institutions in other countries – and for our purposes, Canada – should pay more attention to the appropriate identification and management of COI. The PharmFree Scorecard methodology examines a diversity of factors and interests that could influence medical education; as such, it is an interesting approach to analysing the COI policies of medical schools. To test its utility or applicability outside the US, we decided to apply the PharmFree Scorecard to the COI policies of the 16 Canadian universities hosting medical schools. Overall, Canadian institutions rank very poorly, especially in ensuring that education and training tools are provided to staff, students and faculty members to enable the identification and management of COI. However, differences between the US and Canadian medical education contexts, e.g., with regards to the governance and funding of universities, limit to some extent the direct applicability of the AMSA ranking. Canadian medical schools – and their host universities – nonetheless have much to learn from insights provided by the AMSA PharmFree Scorecard ranking, although they can and should go further in developing their own COI policies and procedures. (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)

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)

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.

The bioethics literature on managed care has devoted significant attention to a broad range of conflicts that managed care is perceived to have introduced into the practice of medicine. In the first part of this paper we discuss three kinds of conflict of interest: conflicts of economic incentives, conflicts with patient and physician autonomy, and conflicts with the fiduciary character of the physician–patient relationship. We argue that the conflicts are either not as serious as they are often alleged (...) to be or not unique to managed care. In part two we argue that managed care represents a new paradigm for medical care that features a new concept of management. We discuss three types or levels of management that managed care highlights, namely, administrative, clinical, and resource, which together offer a more sophisticated vantage point from which to assess patient care. We do not endorse managed care, but attempt to highlight some of the positive changes brought by managed care that were difficult to attain under traditional reimbursement systems. (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)

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to (...) universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. (shrink)

Economists and legal scholars routinely posit an implicit contract between Japanese firms and their principal lender. Under this arrangement, the bank implicitly agrees to rescue the firm when times turn bad. Out of court, it rescues the firm from insolvency. Not only does it save the investments specific to the troubled firm, it lowers the use of costly bankruptcy proceedings and cuts the costs of those bankruptcy procedures firms do occasionally invoke. Given the creditor-shareholder conflicts of interest that arise (...) as firms approach insolvency, such arrangements would seem unstable. Yet according to a long sociological tradition, conflicts of interest matter less in Japan than in the West. According to the emerging economic and legal tradition, Japanese economic actors do face those conflicts, but keep them in check through reputational concerns, close-knit ties, and government supervision. Using two datasets of troubled firms from the 1970s and 1980s, we ask whether Japanese main banks in fact rescue distressed borrowers. We find no evidence that they do: large Japanese firms fail; when large firms approach insolvency, main banks do not increase the share of the firm’s debt they bear; stronger ties between distressed firms and their main bank do not facilitate loans; and troubled firms do not try to preserve their main bank relationship. All told, the claim that Japanese banks ever implicitly agreed to rescue firms is sheer myth. That Japanese banks let troubled firms fail is no recent development; it has been thus for decades. Conflicts of interest do indeed matter in Japan and long have. They matter enough to prevent precisely the incentive-incompatible rescue deals that scholars in the field so routinely posit. (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)

There is an emerging awareness of the possibility of conflicts of interest in the practice of medicine in Croatia. The paper examines areas within the medical profession where conflicts of interest can and have occurred, probably not only in Croatia. Particularly addressed are situations when a doctor may have dual obligations and how independent ethics committees can help in decreasing the influence of a conflict of interest. The paper also presents extracts from the Croatian Code of (...) Ethics for the medical profession that address problems of conflict of interest. (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)

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)

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)

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified.

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)

It is often claimed that managed care organizations involve physicians in conflicts of interest by creating financial incentives for physicians to refrain from ordering treatments or making referrals. Such incentives, the argument goes, force the physician to balance the patient's health interests against the MCO's interests and the physician's own financial interest. I assume, for the sake of argument, that such arrangements at least provide reason to believe that physicians in MCOs are involved in conflicts of interest. (...) Two approaches have evolved for dealing with these conflicts. On one approach, MCOs disclose the financial arrangements under which their physicians work so that patients can consent to the managed care plan and thereby to the plan's limitations. The chief proponent of this approach is Mark Hall, whose recent book Making Medical Spending Decisions applies prior consent to a variety of decisions regarding medical financing and allocation. The other approach is simply to forbid conflicts of interest through regulations. (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.

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)

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 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)

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)

This study presents and develops test methods for assessing sensitivity to conflict of interest (COIsen). We are aware of no study assessing COIsen, but note that some popular methods for assessing ethical sensitivity and related constructs (which include COIsen) are flawed in that their presentation of stimulus material to subjects actually guides subjects to attend to ethical (or related) issues. The method tested here was designed to avoid this flaw. Using adaptations of two existing cases, a quota sample (...) of 12 students was interviewed. Our method used funnel-sequenced, open-ended interviews that were audiotaped and transcribed, then subjected to a form of cognitive mapping. These maps revealed the presence of “indicators” of COIsen. We found that COIsen can be measured and that the global COIsen score generated by our method is able to reveal much variation across subjects, making it a worthwhile candidate for further consideration. (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)

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)

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)

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)

The 6th Consensus Statement on Concussion in Sport is authored by the Concussion in Sport Group (CiSG) and intends to provide evidence-based recommendations on concussion management for the welfare of sports participants. However, the authors of the Consensus Statement have declared many competing links to third-party groups. While the declaration of an author’s competing interests is now a widely accepted practice within academic publishing aimed at greater transparency and research integrity, it is not a measure to remove the potential influence (...) of third-party links. In the case of the Consensus Statement, this leaves uncertainty about how the potential sources of third-party bias declared by individual members of the CiSG may have influenced the CiSG’s interpretation of the existing state of evidence on concussion management and impacted the content of the recommendations contained with the Consensus Statement. Openly declaring third-party links falls short of securing trustworthiness in the Consensus Statement recommendations since it leaves end-users of the Consensus Statement with the task of interpreting the impact(s) of these competing interests with little information to guide them. This is because the authors themselves offer neither explanation nor guidance concerning potential bias arising from the competing interests that they have declared, which impinges upon the ability of readers to evaluate the trustworthiness of the content. The status quo could be improved by excluding researchers who have conflicts of interest. Nevertheless, if authors with competing interests are permitted to be part of the CiSG (as is the status quo), then I propose a novel option for increasing transparency that would require authors of the Consensus Statements to provide a reflexive explanation, not simply a declaration, of their competing interests. (shrink)

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified.

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)

Academic-industry collaborations and the conflicts of interest (COI) arising out of them are not new. However, as industry funding for research in the life and health sciences has increased and scandals involving financial COI are brought to the public’s attention, demands for disclosure have grown. In a March 2008 American Council on Science and Health report by Ronald Bailey, he argues that the focus on COI—especially financial COI—is obsessive and likely to be more detrimental to scientific progress and public (...) health than COI themselves. In response, we argue that downplaying the potential negative impact of COI arising out of academic-industry relationships is no less harmful than overreacting to it. (shrink)

As the debate over how to manage or discourage physicians? financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of ?conflict of interest? itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on (...) further analysis. Those concerned about conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying ?conflict of interest? is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence. (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)

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)

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)

Conflicts of Interest and the Future of Medicine: The United States, France, and Japan Content Type Journal Article Category Book Review Pages 383-386 DOI 10.1007/s11673-011-9326-y Authors Adam Licurse, Division of Internal Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA Aaron S. Kesselheim, Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St. Suite 3030, Boston, MA, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal (...) Volume Volume 8 Journal Issue Volume 8, Number 4. (shrink)

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)

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)

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)

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)