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)

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)

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)

In the mid-1980s, social scientists compared outcome measures of related drug studies, some funded by private companies and others by nonprofit organizations or government agencies. The concept of a “funding effect” was coined when it was discovered that study outcomes could be statistically correlated with funding sources, largely in drug safety and efficacy studies. Also identified in tobacco research and chemical toxicity studies, the “funding effect” is often attributed, implicitly or explicitly, to research bias. This article discusses the meaning of (...) scientific bias in research, examines the strongest evidence for the “funding effect,” and explores the question of whether the “funding effect” is an indicator of biased research that is driven by the financial interests of the for-profit sponsor. This article argues that the “funding effect” is merely a symptom of the factors that could be responsible for outcome disparities in product assessment. Social scientists should not suspend their skepticism and choose as a default hypothesis that bias is always or typically the cause. (shrink)

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 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)

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)

Interactions between medicine and the pharmaceutical and device industries have become widespread in medicine. Despite their promise for improving patient care through innovation, there are ways in which these relationships may compromise patient care by creating conflicts of interest for physicians—both actual and perceived—that may result in delivery of poorly justified treatment, mistrust of doctors by the public, and an undermining of the integrity of the medical profession (IOM 2009). Conflicts of interest can arise in all arenas of medicine, due (...) to discord between the responsibility to patients and the opportunity for personal financial gain. But academic medicine presents an additional interest to protect: .. (shrink)

This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research.

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better (...) understanding of the complexities of non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest. (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)

In the last decade, there has been increased recognition of the importance of disclosing and managing non-financial conflicts of interests to safeguard the objectivity, integrity, and trustworthiness of scientific research. While funding agencies and academic institutions have had policies for addressing non-financial interests in grant peer review and research oversight since the 1990s, scientific journals have been only recently begun to develop such policies. An impediment to the formulation of effective journal policies is that non-financial (...) interests can be difficult to recognize and define. Journals can overcome this problem by providing guidance concerning the types of non-financial interests that should be disclosed, including direct research interests, direct professional interests, expert testimony, involvement in litigation, holding a leadership position in a non-governmental organization, providing technical or scientific advice to a non-governmental organization, and personal or professional relationships. The guidance should apply to authors, editors, and reviewers. (shrink)

In June 2017, Japanese and Korean authors published the results of the CREATE‐X trial in the New England Journal of Medicine (NEJM). After we identified their inadequate disclosures of Financial Conflict of Interests (FCOIs), the authors made a post‐publication correction of their FCOIs. The purpose of this study is to evaluate the accuracy of the post‐publication corrections by the Japanese authors of the CREATE‐X trial. All the Japanese authors of the CREATE‐X trial were included in the study. (...) We determined the payments received by these authors in 2016 using publicly available data published by 78 pharmaceutical companies based on the stipulated Japanese transparency guidelines. We retrieved the original and revised versions of the FCOI disclosures as published on the NEJM website, and compared the payments reported by the pharmaceutical companies and the original and revised FCOI disclosures of the authors. Of the 12 authors, nine received payments made by the drug manufacturer involved in the CREATE‐X trial. Of these nine, only three (33.3%) originally disclosed their relationships, and another three (33.3%) later disclosed such relationships in the post‐publication corrections. Similarly, of the 11 receiving at least one payment from other manufacturers of breast cancer products, none correctly disclosed the payments in the original or the revised disclosure. In the CREATE‐X trial, FCOIs with pharmaceutical companies were not properly disclosed by 11 of the 12 Japanese authors, even after the post‐publication corrections, which highlights the need to pay more attention to the accuracy of FCOI disclosures in academic publications. (shrink)

The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest. Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch. We analyzed all German guidelines at the highest methodological level that included recommendations for pharmacological therapy according to five criteria: declaration and assessment of COI, composition of (...) the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories. Most guidelines contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts were not externally reviewed via a public website. COI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development. (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.

This study explored how disclosure of financial conflicts of interest influences naïve or “lay” individuals’ perceptions of the ethicality of researcher conduct. On a between-subjects basis, participants read ten scenarios in which researchers disclosed or failed to disclose relevant financial conflicts of interest. Participants evaluated the extent to which each vignette represented a FCOI, its possible influence on researcher objectivity, and the ethics of the financial relationship. Participants were then asked if they had completed a college-level ethics (...) course. Results indicated that FCOI disclosure significantly influenced participants’ perceptions of the ethicality of the situation, but only marginally affected perceptions of researcher objectivity and had no significant influence on perceptions of the existence of FCOIs. Participants who had previously completed a college-level ethics course appeared more sensitive to the importance of FCOI disclosure than those who lacked such background. This result suggests that formal ethical training may help individuals become more critical consumers of scientific research. (shrink)

This collection explores the subject of conflicts of interest. It investigates how to manage conflicts of interest, how they can affect well-meaning professionals, and how they can limit the effectiveness of corporate boards, undermine professional ethics, and corrupt expert opinion. Legal and policy responses are considered, some of which (e.g., disclosure) are shown to backfire and even fail. The results offer a sobering prognosis for professional ethics and for anyone who relies on professionals who have conflicts of interest. The contributors (...) are leading authorities on the subject in the fields of law, medicine, management, public policy, and psychology. The nuances of the problems posedby conflicts of interest will be highlighted for readers in an effort to demonstrate the manyways that structuring incentives can affect decision making and organizations' financial well-being. (shrink)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, (...) the standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

Background: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants.Methods: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: self report of diagnosis by a health care professional and willingness to participate in clinical (...) trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents’ ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate—across seven widely discussed scenarios of financial conflicts of interest .Results: Majority responded that knowing conflict of interest information was “extremely” or “very” important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent . In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends.Conclusions: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants. (shrink)

Disclosure has become the preferred way of addressing the threat to researcher objectivity arising from financial conflicts of interest. This article argues that the effectiveness of disclosure at protecting science from the corrupting effects of FCOIs—particularly the kind of disclosure mandated by US federal granting agencies—is more limited than is generally acknowledged. Current NIH and NSF regulations require disclosed FCOIs to be reviewed, evaluated, and managed by officials at researchers’ home institutions. However, these reviewers are likely to have institutional (...) and personal interests of their own that may undermine the integrity of their evaluations. This paper presents experimental findings suggesting that such interests affect third-party assessments of FCOIs. Over 200 participants gauged the ethical significance of various hypothetical yet realistic FCOIs in academic research settings. Some of them were led to believe they had a small personal interest in allowing conflicted research... (shrink)

Increasingly, policymakers within biomedicine argue that “non-financial” interests should be given equal scrutiny to individuals’ financial relationships with industry. Problematized as “non-financial conflicts of interest,” interests, ranging from intellectual commitments to personal beliefs, are managed through disclosure, restrictions on participation, and recusal where necessary. “Non-financial” interests, though vaguely and variably defined, are characterized as important influences on judgment and thus, are considered risks to scientific objectivity. This article explores the ways that “non-financial (...) interests” have been constructed as an ethical problem and the implications for research integrity. I conducted an interpretive, qualitative study, which triangulated two data sources: documents (including published accounts of identifying and managing “non-financial” interests and conflict of interest policies) and in-depth interviews with 16 leaders within evidence-based medicine, responsible for contributing to, directing, or overseeing conflict of interest policy development and implementation. This article outlines how evolutions in the definition of conflict of interest have opened the door to include myriad “non-financial” interests, resulting in the generalisation of a statistical concept—risk of bias—to social contexts. Consequently, biases appear equally pervasive among participants while in reality, a politics of objectivity is at play, with allegations of conflict of interest used as a means to undermine others’ credibility, or even participation. Iterations of the concept of conflict of interest within biomedicine have thus consistently failed to articulate or address questions of accountability including whose interests are able to dominate or distort evidence-led processes and why. Consequently, current policy solutions meant to mitigate bias may instead serve exclusionary purposes under the guise of impartiality while remaining vulnerable to interference from powerful stakeholders. (shrink)

Background Much like academic-industry partnerships, industry financial support of patient advocacy organizations has become very common in recent years. While financial conflicts of interest between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. Main body The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation (...) of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO’s constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn’s & Colitis Foundation. Conclusions While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships. (shrink)

Conflicts of interest are rampant in the American medical community. Today it is not uncommon for doctors to refer patients to clinics or labs in which they have a financial interest (40% of physicians in Florida invest in medical centers); for hospitals to offer incentives to physicians who refer patients (a practice that can lead to unnecessary hospitalization); or for drug companies to provide lucrative give-aways to entice doctors to use their "brand name" drugs (which are much more expensive (...) than generic drugs). In Medicine, Money and Morals, Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change. (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.

(2013). Financial Journalism, Conflicts of Interest and Ethics: A Case Study of Hong Kong. Journal of Mass Media Ethics: Vol. 28, No. 1, pp. 15-29. doi: 10.1080/08900523.2012.746525.

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)

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. (shrink)

Volume 20, Issue 4, May 2020, Page 59-61.

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 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)

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)

Despite a decade of federal regulation and debate over the appropriateness of financial ties in research and their management, little is known about the actual decision-making processes of university conflict of interest (COI) committees. This paper analyzes in detail the discussions and decisions of three COI committees at three public universities in California. University committee members struggle to understand complex financial relationships and reconcile institutional, state, and federal policies and at the same time work to protect the (...) integrity of the scientific process, the autonomy and intellectual freedom of their faculty colleagues and students, and the financial interests of the university. (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)

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)

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)

: 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 movement in bioethics toward disclosure of financial conflicts of interest is well and good, most of the time. But in some cases, disclosure is not only unnecessary but destructive. When bioethicists advance arguments whose premises and logical moves are open to scrutiny, disclosure—far from clearing the air of bias—introduces bias.

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)

This article examines conflicts of interest in the context of scientific research related to regulation or litigation. The article defines conflicts of interest, considers how conflicts of interest can impact research, and discusses different strategies for dealing with conflicts of interest. While it is not realistic to expect that scientific research related to regulation or litigation will ever be free from conflicts of interest, society should consider taking some practical steps to minimize the impact of these conflicts, such as requiring (...) full disclosure of information required for independent evaluation of research, prohibiting financial relationships between regulatory agencies and the companies they regulate, and banning payments to expert witnesses for specific research results, testimony or legal outcomes. (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 (...) class='Hi'>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)