The impact of conflict of interest on trust in science

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. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

The council of Europe’s instruments on biomedical research: how is conflict of interest addressed?

Conflict of interest is an issue that has been put in the spotlight by the commercial application of the new biomedical technologies. This paper presents the approach of the Council of Europe and the binding legal instruments to deal with this problem. The main focus is on the Convention on Human Rights and Biomedicine, and its draft additional Protocol on Biomedical Research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The views expressed are personal and do not necessarily reflect any official position of the Council of Europe.     

The continuing need for disinterested research

For scientific knowledge to be trustworthy, it needs to be dissociated from material interests. Disinterested research also performs other important non-instrumental roles. In particular, academic science has traditionally provided society with reliable, imaginative public knowledge and independent, self-critical expertise. But this type of science is not compatible with the practice of instrumental research, which is typically proprietary, prosaic, pragmatic and partisan. With ever-increasing dependence on commercial or state funding, all modes of knowledge production are merging into a new, ‘post-academic’ research culture which is dominated by utilitarian goals. Growing concern about conflicts of interest is thus a symptom of deep-seated malaise in science and medicine. An expanded version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict of interest: the importance of potential

The UK Medical Research Council (MRC) takes the issue of conflict of interest very seriously. The overall aim is to preserve a climate in which personal and organisational innovation can flourish while ensuring that potential conflicts are disclosed and identified and conflicts are either avoided or managed with integrity. The approach needs to encompass the MRC’s various responsibilities and the levels at which conflicts might arise: MRC staff (scientists and administrators); the governing Council; research Boards and committees; external peer-reviewers; and applicants for funding. To achieve its goals, the MRC has issued practical guidance on various aspects of conflict of interest. For the future, the MRC has identified the continuing commercialisation of science and the increasing involvement of lay people in scientific decision-making as special challenges in this area. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Managing financial conflicts of interest in clinical research

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. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict of interest and its significance in science and medicine Warsaw,Poland, 5–6 April, 2002

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

On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. This revised version was published online in August 2006 with corrections to the Cover Date.     

Conflict of interest in Croatia: doctors with dual obligations

There is an emerging awareness of the possibility of conflicts of interest in the practice of medicine in Croatia. The paper examines areas within the medical profession where conflicts of interest can and have occurred, probably not only in Croatia. Particularly addressed are situations when a doctor may have dual obligations and how independent ethics committees can help in decreasing the influence of a conflict of interest. The paper also presents extracts from the Croatian Code of Ethics for the medical profession that address problems of conflict of interest. An earlier version of this paper entitled was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict of interest in medical research in Estonia

An area where conflicts of interest can take place in Estonia is in the conduct of clinical trials. The paper lists the main areas where such conflicts of interest can occur. The author also briefly discusses Estonia’s current position with regard to regulating genetic information and the commencement of the Estonian Genome Project. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Competing interests: The need to control conflict of interests in biomedical research

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. This paper is adapted from a lecture presented to a Symposium on Scientific Integrity, Warsaw, Poland, 23 November 1995. Daniel Steiner was Vice-President and General Counsel of Harvard University (1972–92) and in that capacity became familiar with conflict of interest issues. He is currently Counsel to the Boston law firm. Ropes and Gray, and is Adjunct Lecturer in Public Policy at the John F. Kennedy School of Government. Harvard University.     

Conflict of interest and its significance in science and medicine: a view from Eastern Europe

Conclusions  Continued scientific and medical progress in Central and Eastern Europe depends on the development of an atmosphere that is conducive to implementing the changes that are necessary to bring better health and longer lives for everyone. Privatization and commercialization are threatening the objectivity of clinical research and the availability of health care because uncontrolled market mechanisms focused on profit are nurturing conflict of interest that generate bias and unreliability into research and medicine. Changes are needed that address the following:

A Troubled Dance: Doing the Work of Research Ethics Review

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation.     

Searching for a (Post)Foundational Approach to Philosophy of Science: Part I

This paper represents an attempt to articulate the basic principles of a hermeneutic philosophy of science. Throughout, the author is at pains to show that both (i) overcoming epistemological foundationalism and (ii) insisting on the multiplicity, patchiness, and heterogeneity of the discursive practices of scientific research do not imply a farewell to an analysis of the constitution of science's autonomous cognitive structure. Such an analysis operates in two directions: “continuous weakening” of epistemological foundationalism and “hermeneutic grounding” of a cognitive structure. Carrying out the analysis in both directions leads to a (post) foundational picture of science. The main thrust of the first part of the paper is to outline the tenets of a constitutional analysis of scientific research. This part focuses especially on the notion of “unified narrativestructures” which refers to the “effective histories” of the main epistemic types of science. This revised version was published online in August 2006 with corrections to the Cover Date.     

Conflict of interest as seen from a researcher's perspective

The continuous growth of the pharmaceutical industry is expected to require a considerable output of new drugs, with speedy development and approval processes. This profit-driven expansion of the drug market may broaden the already established erosion of the role of academia in favor of commercial clinical research organizations. Less and less control on the clinical trial design, its conduct and the resulting publication[s] is the likely consequence. Academic medicine and governments should find means to sustain the development of independent clinical research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

“Ethics wars”: Reflections on the Antagonism between Bioethicists and Social Science Observers of Biomedicine1

Social scientists often lament the fact that philosophically trained ethicists pay limited attention to the insights they generate. This paper presents an overview of tendencies in sociological and anthropological studies of morality, ethics and bioethics, and suggests that a lack in philosophical interest might be related to a tendency among social scientists to employ either a deficit model (social science perspectives accommodate the sense of context that philosophical ethics lacks), a replacement model (social scientists have finally found the “right way” of doing ethics), or a dismissal model (ethics should be abandoned all together as a misconstrued veil of power). Increased awareness of differences in styles of reasoning and objects of research interest might help to overcome the hostility, and an anthropological project is presented as an invitation to a dialogue informed by awareness of such differences.This paper was first presented at the 4S/EASST Conference in Paris, August 25–28,2004 in a panel co-convened with Richard Tutton, who came up with ‘‘Ethics Wars’’ as the appropriate title for the state of affairs we wanted to discuss. Bryn William-Jones contributed to the panel and provided detailed and very useful comments to the paper. The project on which the article reports was financially supported by the Swedish Ethics in Healthcare Programme (Grant 2000/56) and the Danish Social Science Research Council (Grant 24-03-0219).     

Conflicts of interest in science and medicine: the physician's perspective

The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict of interest that can arise in the practice of medicine are outlined. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The World Medical Association (WMA) is a global federation of National Medical Associations representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavours to achieve the highest possible standards of medical care, ethics, education and health-related human rights for all people.     

Beyond conflict of interest: the responsible conduct of research

This paper reports data and scholarly opinion that support the perception of systemic flaws in the management of scientific professions and the research enterprise; explores the responsibility that professional status places on the scientific professions, and elaborates the concept of the responsible conduct of research (RCR). Data are presented on research misconduct, availability of research guidelines, and perceived research quality. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland, 5–6 April, 2002. The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency.     

Conflicts of interest in Germany: A legal perspective

In spite of recent efforts to promote cooperation between universities and industry, Germany still lacks a sufficient legal framework for regulating potential conflicts of interest resulting from university-industry cooperation. Prospective regulation of conflicts of interest has to take into account specific constraints imposed by the German constitution. It has to follow stringent procedural and material requirements and carefully weigh the individual researcher’s right to academic freedom against the public demand for objectivity in research. Because of this cautious consideration of the conflicting interests constitutionally mandated in Germany, a potential regulation legitimate in this country may serve as a model for other countries facing the need of the adoption of such a regulation. The ideas presented in this paper are developed in detail in the author’s dissertation, Rechtsfragen der Kooperation zwischen Hochschulen und Wirtschaft — Ein Rechtsvergleich: Deutschland — USA, Verlag Vahlen, München, 2002. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict or harmony? Clinical research and the medical press in Russia

The author relates conditions for conducting clinical trials in Russia, current experiences of ethics committees, areas where conflicts of interest can occur regarding publishing the results of clinical trials in medical journals and the state of medical journalism in Russia today. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The author is a science editor of Meditsynskaya Gazeta.     

Funding,objectivity and the socialization of medical research

There has been a sharp rise in private funding of medical research, especially in relation to patentable products. Several serious problems with this are described. A solution involving the elimination of patents and public funding administered through extended national health care systems is proposed. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.