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:

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.     

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.     

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. 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 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).     

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.     

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.     

浅析基因治疗临床试验中的"利益冲突"

基因治疗临床试验中的"利益冲突"问题多聚焦在如何规范利益冲突的不良后果上,却忽视了一些更基本的问题,如临床试验中的不同"利益",利益冲突的表现及防范等.以基因治疗为例,归纳了临床试验中的不同利益和利益冲突形式,并指出"公开经济利益安排"是解决冲突的基本对策.     

医学研究者的经济利益冲突对临床试验的影响——美国的经验与启示

研究者的经济利益冲突对医学临床试验可能会产生消极影响。本文依据美国的研究成果,利用大量的统计数据和真实的案例,分析了研究者在临床试验中的主要经济利益,揭示了这些经济利益如何对研究的设计、执行和报告产生影响,以及可能造成的危害。     

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.     

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.     

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.     

浅议生物医学研究中不同主体的利益冲突

作为医学伦理学研究的重要内容,生物医学研究中的利益冲突问题日益受到公众、研究机构和管理部门的关注。探讨生物医学活动中研究者、研究机构、学术期刊三种不同主体利益冲突的表现、危害及其特点,以期有针对性地促进人们对该领域利益冲突问题的认识。     

Medical journals' conflicts of interest in the publication of book reviews

The purpose of the study was to assess medical journals’ conflicts of interest in the publication of book reviews. We examined book reviews published in 1999, 2000, and 2001 (N=1,876) in five leading medical journals: Annals of Internal Medicine, British Medical Journal (BMJ), Journal of the American Medical Association (JAMA), Lancet, and New England Journal of Medicine. The main outcome measure was journal publication of reviews of books that had been published by the journal’s own publisher, that had been edited or authored by a lead editor of the journal, or that posed another conflict of interest. We also surveyed the editors-in-chief of the five journals about their policies on these conflicts of interests. During the study period, four of the five journals published 30 book reviews presenting a conflict of interest: nineteen by the BMJ, five by the Annals, four by JAMA, and two by the Lancet. These reviews represent 5.8%, 2.7%, 0.7%, and 0.7%, respectively, of all book reviews published by the journals. These four journals, respectively, published reviews of 11.9%, 25.0%, 0.9%, and 1.0% of all medical books published by the journals’ publishers. Only one of the 30 book reviews included a disclosure statement addressing the conflict of interest. None of the journals had a written policy pertaining to the conflicts of interest assessed in this study, although four reported having unwritten policies. We recommend that scientific journals and associations representing journal editors develop policies on conflicts of interest pertaining to book reviews. Disclosure: R.M. Davis was North American editor of the BMJ from 1998 to 2001, and is a member of the Board of Trustees of the American Medical Association, which publishes JAMA. The opinions expressed in this paper are those of the authors and do not reflect the official policy of any organization with which the authors have been affiliated.     

Physicians,entrepreneurism and the problem of conflict of interest

This paper examines the ethical issues of conflict of interest raised by the burgeoning development of physician involvement in for-profit entrepreneurial activities outside their practice. After documenting the nature and extent of these activities, and their potential for conflicts of interest, the paper assesses the major arguments for and against physicians' referral of patients to facilities they own or in which they invest. The paper concludes that an outright ban on such activity seems ethically warranted.     

国际多中心药物试验伦理审查中的冲突与防控策略

国际多中心药物临床试验既包括新药上市前的临床试验, 也包括对药物上市使用后所做的进一步研究, 以证实或揭示试验用药物的作用, 不良反应及其吸收、分布、代谢和排泄的规律。其发展折射着全球化进程在医药卫生领域的快速发展, 目前我国的国际多中心药物临床试验日渐增多, 伦理审查中出现的伦理冲突也愈发明显, 主要表现在伦理标准、试验参与各方的利益、本地化和国际性、审查的质量差异、试验方法与伦理原则等方面。对此, 应提高各中心伦理委员会的素质和能力;注重协调各中心利益;加强中心之间的有效沟通。     

医生与药业的关系：利益冲突重要根源

药业与医生的关系在最近40年日益受到医学界与社会的重视。药业以并不昂贵的馈赠及其他手段,资助学术交流、医学教育和医学研究,深刻地影响着临床医生的行为和诊治决策,从而危及医学的科学性和医学职业精神,加重了病人的负担,且祸及病人健康。药业与医生的这种关系,是道德与金钱关系的赤裸表现,是资本对医学的无情侵略。从道德、法律、行业管理等诸多方面正确规范行业与医生的相互关系,避免当前面临的种种弊端,维护医学的科学性,保护病人与社会公众的利益,刻不容缓。     

医生与药业的关系:利益冲突重要根源

药业与医生的关系在最近40年日益受到医学界与社会的重视。药业以并不昂贵的馈赠及其他手段,资助学术交流、医学教育和医学研究,深刻地影响着临床医生的行为和诊治决策,从而危及医学的科学性和医学职业精神,加重了病人的负担,且祸及病人健康。药业与医生的这种关系,是道德与金钱关系的赤裸表现,是资本对医学的无情侵略。从道德、法律、行业管理等诸多方面正确规范行业与医生的相互关系,避免当前面临的种种弊端,维护医学的科学性,保护病人与社会公众的利益,刻不容缓。     

Personality traits of Russians from the observer's perspective

Data were collected by the members of the Russian character and personality survey from 39 samples in 33 administrative areas of the Russian Federation. Respondents (N = 7065) identified an ethnically Russian adult or college‐aged man or woman whom they knew well and rated the target using the Russian observer rating version of the Revised NEO Personality Inventory, which measures neuroticism, extraversion, openness to experience, agreeableness and conscientiousness. Factor analyses within samples showed that the factor structure of an international sample combining data from 50 different cultures was well replicated in all 39 Russian samples. Sex differences replicated the known pattern in all samples, demonstrating that women scored higher than men on most of the neuroticism, openness, agreeableness and conscientiousness facet scales. Cross‐sectional analyses demonstrated consistent age differences for four factors: Older individuals compared to younger ones were less extraverted and open but more agreeable and conscientious. The mean levels of traits were similar in all 39 samples. Although in general personality traits in Russians closely followed the universal pattern, some reliable culture‐specific effects were also found that future studies can help interpret. Copyright © 2009 John Wiley & Sons, Ltd.