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)

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)

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.

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

This paper is a discussion of efforts to manage real and potential conflicts of interest in university research in the United States. The focus is on the report by an Association of American Universities (AAU) task force that addresses both individual and institutional conflict of interest issues.

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)

Patient advocacy organizations provide patient- and caregiver-oriented education, advocacy, and support services. PAOs are formally organized nonprofit groups that concern themselves with medical conditions or potential medical conditions and have a mission and take actions that seek to help people affected by those medical conditions or to help their families. Examples of PAOs include the American Cancer Society, the National Alliance on Mental Illness, and the American Heart Association. These organizations advocate for, and provide services to, millions of people with (...) physical and mental conditions — such as cancer, mental illness, diabetes, and cardiovascular disease — via their outreach, meetings, counseling, websites, and published materials. A PAO usually seeks to raise public awareness of a disease’s symptoms, risk factors, and treatment options and promotes research to cure or to prevent that disease. (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)

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)

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This (...) approach reinforces a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable. (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 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)

The accelerated trend toward media cobranding, joint ventures, strategic alliances and mergers, and acquisitions with nonjournalistic companies raises new ethical concerns about the entanglements created in the name of synergy. As traditional media companies buy stakes in Internet companies in equity swaps, the cross-ownership of media creates vast potential for real or perceived conflicts of interest. Ethics scholarship routinely defines conflict of interest as an individual act, ignoring the rise of the media conglomerate. This article introduces the concept of (...) institutional conflict of interest. The problem with the traditional definition of conflict of interest, then, is that it assumes the interests of the institution are always good, and that only the journalist, acting individually can violate the norm. The article outlines how media consolidation creates new conflicts of interest by outlining the term's definitions in various professions and proposing a revised definition that encompasses institutional conflict of interest. (shrink)

To investigate the phenomenon of patient–physician mistrust in China, a qualitative study involving 107 physicians, nurses and health officials in Guangdong Province, southern China, was conducted through semi-structured interviews and focus groups. In this paper we report the key findings of the empirical study and argue for the essential role of medical professionalism in rebuilding patient-physician trust. Health professionals are trapped in a vicious circle of mistrust. Mistrust leads to increased levels of fear and self-protection by doctors which exacerbate difficulties (...) in communication; in turn, this increases physician workloads, adding to a strong sense of injustice and victimization. These factors produce poorer healthcare outcomes and increasingly discontented and angry patients, escalate conflicts and disputes, and result in negative media coverage, all these ultimately contributing to even greater levels of mistrust. The vicious circle indicates not only the crisis of patient-physician relationship but the crisis of medicine as a profession and institution. Underlying the circle is the inherent conflict of interest in the healthcare system by which health professionals and hospitals have become profit-driven. This institutional conflict of interest seriously compromises the fundamental principle of medical professionalism—the primacy of patient welfare—as well as the traditional Chinese ideal of “medicine as the art of humanity”. Patient trust can be restored through rectifying this institutional conflict of interest and promoting medical professionalism via a series of recommended practical measures. (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)

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)

: 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 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)

While procurement of organs from donors who are not "brain dead" does not appear to pose insurmountable moral obstacles, the social practice may raise questions of conflict of interest. Non-heart-beating organ donation opens the door for pressure on patients or families to forgo possibly beneficial treatment to provide organs to save others. The combined effects of non-heart-beating donation and organ shortages at major transplant centers brought about by the 1991 United Network for Organ Sharing (UNOS) local-use organ allocation policy (...) created potential conflicts, including the fact that candidates for organs become potential donors far more frequently than previously. Hospitals with a major emphasis on transplantation have economic and academic interests that may have been hurt by the relative organ shortage. Some may view non-heart-beating organ donation as a way to restore weakened programs and thus unconsciously compromise recognition of problems associated with non-heart-beating donation. (shrink)

Conflicts of interest in the university context are receiving growing attention, but the focus has been largely on problematic financial COI arising from university-industry relations, which clearly need to be avoided. The result, unfortunately, is a pejorative perception of COI as being equivalent to fraud and thus an issue of academic misconduct. In this paper, the aim is to show that while some financial and non-financial COI are particularly problematic and so should be avoided, many are pervasive and actually the (...) norm in academia even if they are still largely ignored and misunderstood. Through a reflection on my own experiences as a university professor, I describe a diversity of common financial, non-financial and institutional COI of varying degrees of risk, that arise in the day-to-day activities of a professor, in order to then consider how these COI can and should be managed in practice. It is essential to attend to the full range of COI and to think about appropriate policies, procedures, or guidelines to prohibit some COI and mitigate the risks of others; but these “hard” mechanisms are only part of the solution. This paper will focus on elucidating the various “soft” mechanisms – such as education, self-awareness, humility, and dialogue – that can empower professors to manage those COI that cannot be prevented or avoided. (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 case study presented by Winch and Sinnott (2011) shows not only how difficult it is for clinicians and researchers to identify conflicts of interest (COI), but also how damaging it can be when there are unin- formed and uncoordinated policy responses by senior administrators.

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

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

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an area that (...) is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection. (shrink)

On the Importance of the Institution and Social Self in a Sociology of Conflicts of Interest Content Type Journal Article Category Case Studies Pages 1-2 DOI 10.1007/s11673-012-9355-1 Authors Christopher Mayes, Rock Ethics Institute, The Pennsylvania State University, 201 Willard Building, University Park, PA 16802-1601, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529.

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. (...) It argues that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff. (shrink)

The author describes problems facing Armenia in reorganization of the structure of science in the post-socialist era with the aim of utilizing limited state resources more efficiently by reducing the number of separate scientific institutes, concentrating on essential core subjects required by the nation and encouraging all other projects to compete in the international arena for grant sponsorship.

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)

OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI (...) 32.2% to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors' Uniform requirements for ethical guidelines; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied. CONCLUSIONS: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of disclosure of COI. The ethical guidelines presented to authors need further clarification and standardisation. (shrink)

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain underreported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of interest can be mitigated and (...) trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly accessible registries for researcher conflicts of interest and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest; and the ability to automatically generate conflicts of interest statements for use in published articles. (shrink)

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

Although there is wide agreement that ethics consults are at risk for conflicts of interest, ethics consultants have limited guidance with regard to how to identify and approach COIs. We aim to address these concerns and provide practical guidance. We will define and consider four categories of COIs: consult type, team composition, dual clinical roles and other concerns. We will define and consider six actions available for ECs to take in response to COIs: no action, disclosure only, obtaining a second (...) opinion, referring to another EC, referring to an institutional ethics committee or seeking an outside consult. We will then propose a points-based algorithm for ECs to use to determine the appropriate response to COI. Finally, we will discuss the strengths and limitations of our proposed algorithm. (shrink)

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to (...) accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

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

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

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)

"Guanxi" involves interpersonal obligations, which may conflict with other obligations people have that are based on general or abstract moral considerations. In the West, the latter have been widely accepted as the general source of obligations, which is perhaps tied to social changes associated with the rise of capitalism. Recently, Western ethicists have started to reconsider the extent to which personal relationships may form a distinct basis for obligation. In administration and management, salient bases for decision-Making include deontological, consequentialist (...) and personalist ethics. The first may be reflected in a bureaucratic approach, the second in a price system, and the third in arrangements like "guanxi". Each has positive and negative aspects, but problems arise when they lead to conflicting obligations, as may occur for an office holder who has some obligations based in deontological considerations and others based in personal relationships. This is a type of conflict of interest. Such conflicts have been considered in the West, and remedies proposed. Problems arise especially in cases where it is not clear how to prioritise different obligations, and this has been noted as a difficulty in the Chinese legal system. Questions that need to be answered include not only questions about how to deal with conflicting obligations, but also questions about what institutions to accept as giving rise to obligations. Institutions themselves may be problematic not only because of their consequences for economic productivity, but because they are internally incoherent, and this may be manifested in frequent conflicts faced by office holders. (shrink)

Dependence in nanotechnology on external funding and academic-industry relationships has led to questions concerning its influence on research directions, as well as the potential for conflicts of interest to arise and impact scientific integrity and public trust. This study uses a survey of 193 nanotechnology industry and academic researchers to explore whether they share similar concerns. Although these concerns are not unique to nanotechnology, its emerging nature and the prominence of industry funding lend credence to understanding its researchers’ views, as (...) these researchers are shaping the norms and direction of the field. The results of the survey show general agreement that funding sources are influencing research directions in nanotechnology; many respondents saw this influence in their own work as well as other researchers’ work. Respondents also agreed that funding considerations were likely to influence whether researchers shared their results. Irrespective of their institutional affiliation or funding status, twice as many researchers as not considered financial conflicts of interest a cause for concern, and three times as many respondents as not disagreed financial conflicts of interest in nanotechnology were uncommon. Only a third was satisfied with the way that conflicts of interest are currently managed and believed current procedures would protect the integrity of nanotechnology research. The results also found differences in views depending on researchers’ institutional affiliation and funding status. (shrink)

Editors have increasing pressure as scholarly publishing tries to shore up trust and reassure academics and the public that traditional peer review is robust, fail-safe, and corrective. Hidden conflicts of interest may skew the fairness of the publishing process because they could allow the status of personal or professional relationships to positively influence the outcome of peer review or reduce the processing period of this process. Not all authors have such privileged relationships. In academic journals, editors usually have very specialized (...) skills and are selected as agents of trust, entrusted with the responsibility of serving as quality control gate-keepers during peer review. In many cases, editors form extensive networks, either with other professionals, industry, academic bodies, journals, or publishers. Such networks and relationships may influence their decisions or even their subjectivity towards a set of submitting authors, paper, or institute, ultimately influencing the peer review process. These positions and relationships are not simply aspects of a curriculum, they are potential COIs. Thus, on the editorial board of all academic journals, editors should carry a COI statement that reflects their past history, as well as actual relationships and positions that they have, as these may influence their editorial functions. (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)

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)

Editor's Note: On February 2, 2005, the National Institutes of Health changed course on conflicts of interest and prohibited its scientists from owning stock in or working as consultants with pharmaceutical or biotechnology companies. The following essay, sent to press before the new policy was announced, recommends a very different approach. The author stands by the recommendations.

The non-heart-beating cadaver donor procurement process might come in conflict with the organ sharing system by diverting organs from potential recipients. It might also have a negative effect on public attitudes about transplantation. The process could start society down a slippery slope leading to extending donor criteria. Some of these scenarios are merely theoretical, but the procedure should be monitored to avoid such problems.

In lieu of an abstract, here is a brief excerpt of the content:Conflicts—and Consensus—about Conflicts of Interest in MedicineMatthew K. Wynia and Bette–Jane Crigger*This fascinating collection of essays about individual experiences of conflict of interest leaves little doubt that physicians remain divided about the importance, impact and meaning of conflicts of interest in their work. These essays offer differing views about what conflicts of interest look and feel like “on the ground” and about whether specific conflicts of interest are (...) bad, just a fact of life, or maybe even good.Conflict, Conflict EverywhereThese essays situate conflict of interest in a variety of contexts: the treatment recommendations a physician makes for an individual patient; the relationship between teaching physician and medical student or practicing physician and health care organization; the interaction between academic researchers and industry collaborators or professional bodies and industry supporters. In this, the narratives taken together reflect the scope of concern about conflict of interest in medicine familiar in the literature. In his classic 1993 essay, Dennis Thompson noted that concerns about conflict of interest encompass issues of physician self–referral, risk sharing between physicians and health care institutions, gifts from industry, hospital purchasing practices, as well as sponsored research and research with patients (Thompson 1993). To that list have subsequently been added relationships with industry in medical education at all levels, physicians’ service as consultants to industry or members of industry speakers bureau, and development of clinical practice guidelines (Lo & Fields 2009).That almost none of these essays draw attention to some widely publicized situations of conflict of interest—for example, gifts to physicians or the provision of drug samples—should, we think, be seen more as an artifact of the authors’ varied individual experiences than as a failure by the authors to engage key concerns in the ongoing professional and public debate. It could also be that the authors, asked to submit personal stories, assumed that yet another essay about the ‘traditional’ issues in the conflicts of interest literature would be seen as redundant, routine or even boring. Or, there is the tantalizing possibility that the absence of some of the more familiar conflicts from these narratives is the early fruit of efforts to address these traditional issues through policies governing interactions between physicians and industry promulgated by academic medical centers and health systems, medical specialty societies, and industry.One significant area of concern that has emerged in recent years is conflict of interest in the development of clinical practice guidelines. E.g., Choudry et al. 2002; Sniderrman & Furberg 2009; Guyatt et al. 2010. Although none of the essays in this [End Page 101] collection address it head on, Perlmutter touches on several key issues. His depiction of how an FDA committee process limited the input he was able to provide as an expert, undermined his potential to contribute to the professional dialogue, and raised concerns about the objectivity of the drug approval process echoes concerns about objectivity, the role of expert opinion, and the presence on guideline development panels of individuals with financial interests in the recommendations to be developed that have been explored at some length in the literature, most recently by the Institute of Medicine in reports on evidentiary standards (Eden et al 2011) and principles for guideline development (Graham et al. 2011).Conflict of Interest or Dual Agency?Several essays set out physicians’ experience in navigating situations of diverging expectations. Bierut, for example, reflects on the disjunction between the goals and products of academic researchers and commercial sponsors. She saw herself advancing basic knowledge and was forced to grapple with the reality of sponsors’ goals to advance commercial ends as well. Nagldinne and Mikulec each recall struggles to reconcile their obligation to exercise professional judgment on behalf of patients with the demands of health care organizations focussed also on the bottom line. Cruz–Flores attests to the challenge of making recommendations for care when one is both a practicing clinician and a clinical investigator engaged in research that might offer benefit to a patient for whom there are limited options.Thompson defined conflicts of interest as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of... (shrink)

The recent committee report from the Institute of Medicine in Washington, DC, containing proposals for controlling conflicts of interest 1 reflects the medical profession’s limited understanding of the actual scope of the issues and demonstrates how reactive academic physicians have become to media and congressional priorities instead of those of the medical field. The near-exclusive focus on the compromising of medical decision-making by the receipt of fungible support from the commercial sector fails to identify critical interdependencies of the relationship between (...) academic physicians and capitalist industry, the historical and economic context in which it takes place and the other stakeholders in the process who are trying to, or should be trying to, manage similar issues of ethical prioritisation of manpower and resources, allegiances and alliances.In the process of protecting ourselves, our patients and our institutions from the scourge of the market and its undue influence, we are participating in a much larger discussion, which we are so far neglecting. In redefining academia–industry relations, we are also negotiating over the means of support for translational clinical research, our educational mission as experts and our capacity to serve at centres of excellence in healthcare. Even more fundamentally, the process of examining ourselves and our institutions for conflicts of interest that negatively impact on our ability to protect and to treat our patients, as well as on how we educate the next generations of healthcare workers, goes to the moral core of what it means to be healing arts professionals.The Institute of Medicine report has chosen to overlook the existing complex …. (shrink)

Conflicts of interest serve as a cipher for a radical rupture in the Flexnerian paradigm of medicine, and they can only be addressed if we recognize that health care is now practiced by institutions, not just individual physicians. By showing how "appropriate utilization of services" or "that which is medically indicated" is a function of socioeconomic factors related to institutional responsibilities, I point toward an administrative and organizational ethic as a needed component for addressing conflicts of interest. The argument (...) is developed by reviewing three important books. First, I consider Mark Rodwin's attempt to configure the economic structures of medicine so that classical fiduciary and scientific ideals can be fostered. Second, I consider E. Haavi Morreim's attempt to modify the classical ideals in order to account for new economic realities. Finally, by considering essays in a recent volume on conflicts of interest edited by Spece, Shimm, and Buchanan, I argue for a constructive dialectic between the approaches of Rodwin and Morreim. In order to properly address conflicts of interest, there must be a radical reassessment of medicine that accounts for the interrelation between scientific, ethical, and economic concerns. Until institutions come into view and professional ethics is developed to account for their role, legitimate interests and obligations of diverse parties cannot be harmonized. (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)

Disclosure is a common response to conflicts of interest; it is intended to expose the conflict to scrutiny and enable it to be appropriately managed. For disclosure to be effective the receiver of the disclosure needs to be able to use the information to assess how the conflict may impact on their interests and then implement a suitable response. The act of disclosure also creates an expectation of self-regulation, as the person with the conflicting interests will (...) be mindful of their own potential biases and aware that their decisions may be monitored. This article discusses some of the problems of relying on disclosure as a solution to address conflicts of interest in research, including the added complexities around institutional conflicts of interest. The case of Dan Markingson illustrates these issues and highlights the vulnerable position relying on disclosure as a solution leaves research participants in. (shrink)