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.     

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.     

临床试验中的利益冲突：伦理和政策问题

人们对于研究人员、赞助商和研究机构三者之间的经济利益关系给予越来越多的关注,人体试验研究中的经济利益与其他利益有所不同,这种经济利益会导致偏见或诱导不正当的行为,尤其是当有从研究中获益的机会存在时,将会影响到研究人员关于应该选择哪个受试者,应该提供给受试者什么样的医疗服务,甚至应该如何正确使用受试者保密的健康信息方面的判断,由经济利益引起的明显的风险同样也会威胁公众的学术机构研究使命的支持,从处理临床试验中利益冲突的准则,什么样的经济利益是研究中的重大经济利益。准则的实施等方面进行了详尽的叙述,最后指出没有潜在受试者和公众的信任,我们就不能有效地开展研究。     

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.     

医患关系面临的课题:利益的冲突

我国当前医患间存在利益冲突的现实,并呈现出种种特点。医患间相互戒备的加深和防御性医疗的出现,不利于融洽和互动医患关系的形成,医院在引入市场某些机制和扩展自身财力时,应尽力维护中低收入者的医疗保健权利,损害病人的利益,同时坚持医学伦理学的四项原则,建立相互间的诚信,充分运用社会调节和医疗诉讼的杠杆,实行医务公开,有望调节和平衡这种利益冲突,使医患双方的利益得到合理的归缩。     

Conflict of interest in biomedical research: a view from Europe

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine. The opinions here expressed are personal and do not commit the European Commission. An earlier version of this paper was delivered at a Conference on Conflict of Interest and Its Significance in Science and Medicine, 5–6 April, 2002, Warsaw, Poland. The author is a Scientific Officer in the Programme Science and Society dealing with ethics and science (Unit C.3).     

Delimiting the concept of research: an ethical perspective

It is important to be able to offer an account of which activities count as scientific research, given our current interest in promoting research as a means to benefit humankind and in ethically regulating it. We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema of activities, the similarities and differences between research activities and other activities become visible. It is also easier to show why some activities that do not count as research can sometimes be confused with research and why some other activities can be regarded only partially as research. Although the concept of research is important to delimit a class of activities which we might be morally obliged to promote, we observe that the class of activities which are regarded as subject to ethical regulation is not exhausted by research activities. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation.     

医院的社会责任：伦理学视角

讨论了评价医院管理行动的伦理框架,严峻的卫生形势,医院的社会责任,其中着重讨论参与全面建设小康社会;向社会提供公平的卫生保健服务;重建医患信托关系以及调整与企业关系防止利益冲突。     

临床代理决策中的利益冲突及其消解

对于限制/无行为能力患者的医疗决策采取代理决策模式,该模式奠基于社会习俗与习惯法。通常情况下,亲属能够更加准确地评判患者的个人价值取向和医疗决定偏好。但是,基于利益判断的主观性,代理决策中的道德冲突难以避免,其合理性辩护基于代理身份的合法性、“善意”与“患者利益”的标签、制度缺失,对于其批评在于代理者德性基础上的一致性不足。按照解决问题的逻辑进程,规避代理决策中利益冲突的方式有寻求共识的可能、临床伦理咨询与司法介入,其中伦理咨询与司法介入需要依托国家制度设计。     

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 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.     

Protecting people in research: a comparison between biomedical and traffic research

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed.     

Discourse on medicine: meditative and calculative approaches to ethics from an international perspective

Heidegger’s two modes of thinking, calculative and meditative, were used as the thematic basis for this qualitative study of physicians from seven countries (Canada, China, India, Ireland, Japan, Korea, & Thailand). Focus groups were conducted in each country with 69 physicians who cared for the elderly. Results suggest that physicians perceived ethical issues primarily through the lens of calculative thinking (76%) with emphasis on economic concerns. Meditative responses represented 24% of the statements and were mostly generated by Canadian physicians whose patients typically were not faced with economic barriers to treatment due to Canada’s universal health care system.     

Ethical issues in biomedical research: Perceptions and practices of postdoctoral research fellows responding to a survey

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. Preliminary results of this work were presented in part as a poster at the forumEthics, Values, and the Promise of Science, presented by Sigma Xi, The Scientific Research Society, 25–26 February 1993 in San Francisco, California, USA.     

Questionable research practices among Brazilian psychological researchers: Results from a replication study and an international comparison

Research on scientific integrity is growing in psychology, and questionable research practices (QRPs) have received more attention due to its harmful effect on science. By replicating the procedures of previous research, the present study aimed at describing the use of QRPs among Brazilian psychological researchers and to make an international comparison with previous studies in other countries—the US and Italy. Two hundred and thirty-two Brazilian researchers in the field of psychology answered questions related to 10 different QRPs. Brazilian researchers indicated a lower tendency to engage in two QRPs (failing to report all of a study's dependent measures; deciding whether to collect more data after looking to see whether the results were significant) when compared to their Italian and North American counterparts, but indicated a higher tendency to engage in two other QRPs (selectively reporting studies that “worked”; not reporting all of a study's conditions). Most of the sample did not admit integrity conflicts in their own research but indicated that others have integrity problems, as observed in previous studies. Those discrepancies could be attributed to contextual and systemic factors regarding different publication demands among the different nations. Further studies should focus on identifying the antecedents of QRPs.     

Attitudes and behavior: An information integration perspective

The relationship between attitudes, beliefs, and behavior was investigated in the context of a behavioral alternative model of attitudes and Anderson's information integration theory. Forty teenagers indicated their attitudes toward using each of seven methods of birth control. The attitudes were used to predict self-reports of contraceptive behavior. Functional measurement methodology was applied to understand the informational bases of the attitudes. In general, the data were supportive of the theoretical framework.     

Relationship of IQ to suicide and homicide rate: an international perspective

IQs were correlated with the z score of suicide rate minus z score of homicide rate using nine regions of the world--established market economies, formerly socialized Europe, India, China, other Asian nations, Sub-Saharan Africa, Latin America/Caribbean, Middle East Crescent, and the USA. Correlations were .85 and .83 with crude rates and age-adjusted rates, respectively. The homicide findings are consistent with previous research in individual countries showing that less intelligent persons commit homicide more often. However, the present findings of a positive correlation between IQ and suicide rates are the opposite of what has been found in the more definitive studies within countries. Explanations for the apparent paradox and for the findings more generally were offered.     

Individual and institutional conflict of interest: policy review by research universities in the United States

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. 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.     

Innovation,research integrity,and change: A conflict of interest management framework for program developers

Psychology and the social sciences have an important role to play in developing innovative solutions to pressing global mental health and social problems. Programs developed by psychologists and other social scientists have immense potential to alleviate suffering and to promote healthy human development across the lifespan. In order to realise this potential program developers must manage the research and development challenges involved in testing an intervention, evaluating, and then preparing it for wider dissemination and scaling. Particular challenges and conflicts can occur in managing the joint roles of being a program developer and a researcher evaluating an intervention or innovation. This article examines the management of various forms of conflicts of interest that have the potential to produce bias and decrease the confidence of policy makers, funders, practitioners, fellow researchers, and the public in the value of psychological interventions. We argue that best practice guidelines are needed to assist developers negotiate the predictable, sometime unavoidable but challenging conflicts of interest that arise in the research process.