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.     

Introduction and overview: Global information ethics

This is an introduction to a set of papers on Computer Ethics from the conference ETHICOMP95. Taken as a whole, the collection of papers provides arguments and concepts to launch a new development in computer ethics: ‘Global Information Ethics’. A rationale for globalization is provided, as well as some early efforts which move in that direction. ETHICOMP95, an international conference on Computer Ethics, was held 28–30 March 1995 at De Montfort University, Leicester, UK. Co-directors were Terrell Ward Bynum and Simon Rogerson.     

A case study of conflicting interests: Flemish engineers involved in environmental impact assessment

This article reports of the activities of the working group, Ethics & Engineers, of the Royal Flemish Society of Engineers. More particularly, the ethical problems that engineers face in the preparation of an environmental report are illuminated. Irrespective to which party the engineer belongs, he or she is confronted with the difficult weighting of his or her personal interest, the interests of private companies and last but not least the common good. It is argued that the implementation of a code of ethics and the introduction of courses on engineering ethics into the education of engineers would strengthen the engineer in the fulfilment of his vocation. Dirk Holemans is a bio-engineer preparing a doctoral thesis on the social responsibility of engineers, Herman Lodewyckx teaches ethics and has research interests in professional and applied ethics.     

Geography and computer ethics: An Eastern European perspective

Several context-specific social and political factors in Eastern and Central Europe are described — factors that must be considered while developing strategies to introduce Computer Ethics. Poland is used as a primary example. GNP per capita, the cost of hardware and software, uneven and scant distribution of computing resources, and attitudes toward work and authority are discussed. Such “geographical factors” must be taken into account as the new field of Computer Ethics develops.     

A biopsychosocial therapeutic approach in a private outpatient clinic in Portugal

Patients with chronic stress and ambiguous symptoms are likely to be more frequent in primary care. Somatizers represent 75.8% of the patients in this study and executives 56% of the sample. Job stressors were present in 78.3% of executive men. This scenario suggests that the primary care physician has to be academically better prepared to fully understand and deal with stress problems in daily clinical practice. The physician must have skills to deal with stress at a curative and preventive level, extending those skills to the workplace.     

ISSUES AND IMPLICATIONS OF ESTABLISHING GUIDELINES FOR THE USE OF BEHAVIORAL TECHNIQUES

Several guidelines surrounding the use of behavioral procedures have recently appeared, the best of which is that of the National Association of Retarded Citizens (NARC). Some issues and implications of the establishment of guidelines are briefly reviewed in the context of the NARC guidelines. Issues include the factual versus opinion bases for guidelines and the need to continue the development of explicit behavioral criteria for assessing staff competence. Implications for programs include the impact of guidelines on professional boundaries, administrative decision-making, and budgeting, together with the dangers of expanding the regulatory bureaucracy. Several miscellaneous impacts are noted, including a potential for curbing innovative behavioral technology.     

个人化设计在临床研究中的应用——从个体角度研究个体差异

本文从有关研究证据的基础上,介绍了个人化设计的理论基础和实验设计,并在此基础上讨论了个人化设计在临床研究领域中的应用价值,总结出一种适合临床病人使用的研究程序。个人化设计允许对个体的个人价值进行分析,并能同时研究不同刺激信息的作用,在个体水平上分析个体差异。通过简化了的实验程序,个人化设计为解决临床研究中的问题提供了一种新的思维方式。文中还对相关研究法的局限进行了讨论。     

Differences in High and Low Anxiety Sensitive Women's Responses to a Laboratory‐Based Cold Pressor Task

Anxiety sensitivity (AS) has been linked to a variety of disabling chronic health conditions, including pain‐related conditions. A recent study has found that healthy women with high AS reported significantly higher levels of sensory and affective pain on an experimental cold pressor task compared to women with low AS. However, this study found no differences between AS groups for pain tolerance or pain threshold. In the present study, which was designed to replicate and extend these findings, 90 undergraduate university women were selected for inclusion in 1 of 2 AS groups (high or low) based on their screening scores on a 16‐item measure of AS. Participants were tested individually on a lab‐based cold pressor task using a variety of self‐report and observer‐measured variables. Data analyses revealed that, as expected, the high AS participants reported significantly more fear in response to the cold pressor on a relevant item of the McGill Pain Questionnaire – Short Form (SF‐MPQ) than did the low AS participants. Also as expected, the high AS participants reported more pain in response to the cold pressor on the Present Pain Index (PPI) of the SF‐MPQ than did the low AS participants. High AS participants did not differ from low AS participants on other aspects of the cold pressor response (e.g. pain threshold, pain tolerance, pain recovery). These results support the role of pain‐related fear as a mediating variable between AS and increased perceived pain intensity.     

美国高等临床药学教育体系宏观结构变迁研究（1965年～2015年）

研究了1965年~2015年美国高等临床药学教育体系的层次结构、形式结构和分布结构等宏观结构的变迁情况。从临床药学实践、药师动态短缺、产业结构基础、办学经费来源、人口地理分布等方面,对半个世纪以来美国临床药学教育体系宏观结构变迁情况进行归因分析。在总结并肯定美国高等临床药学教育体系极高的市场敏感性和较强的结构优化灵活性的同时,探讨了美国高等临床药学教育体系宏观结构变迁过程中需要注意的问题。     

关于实验动物运动模型建立的伦理思考

基于目前广泛应用的动物实验伦理3R和5F原则,通过深入分析已有运动干预文献中的动物运动模型构建方法,分别就运动模型建立前实验动物的选取,运动模式、运动剂量的确定,模型建立过程中不同阶段不同运动形式所涉及的伦理问题,以及实验动物安乐死等各个方面进行伦理分析,探讨伦理关怀在动物运动模型建立中的必要性和重要性。运动模型的构建作为研究运动干预的关键环节是极其重要的,此建立过程中涉及到诸多动物实验伦理问题。