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.     

Medical Ethics Research Between Theory and Practice

The main object of criticism of present-day medical ethics is the standard view of the relationship between theory and practice. Medical ethics is more than the application of moral theories and principles, and health care is more than the domain of application of moral theories. Moral theories and principles are necessarily abstract, and therefore fail to take account of the sometimes idiosyncratic reality of clinical work and the actual experiences of practitioners. Suggestions to remedy the illnesses of contemporary medical ethics focus on re-establishing the connection between the internal and external morality of medicine. This article discusses the question how to develop a theoretical perspective on medical ethical issues that connects philosophical reflection with the everyday realities of medical practice. Four steps in a comprehensive approach of medical ethics research are distinguished: (1) examine health care contexts in order to obtain a better understanding of the internal morality of these practices; this requires empirical research; (2) analyze and interpret the external morality governing health care practices; sociological study of prevalent values, norms, and attitudes concerning medical-ethical issues is required; (3) creation of new theoretical perspectives on health care practices; Jensen's theory of healthcare practices will be useful here; (4) develop a new conception of bioethics that illuminates and clarifies the complex interaction between the internal and external morality of health care practices. Hermeneutical ethics can be helpful for integrating the experiences disclosed in the empirical ethical studies, as well as utilizing the insights gained from describing the value-contexts of health care practices. For a critical and normative perspective, hermeneutical ethics has to examine and explain the moral experiences uncovered, in order to understand what they tell us.     

山东省医疗机构医学伦理委员会运行现状调查

为了解山东省医疗机构医学伦理委员会的运行现状、人员构成和任免情况、伦理审核状况和运行情况,课题组对山东省17地市58家医疗机构进行了问卷调查.结果显示,成立医学伦理委员会的有27家,占46.55％,其中12家成立了多种类别的伦理委员会,且大部分成立时间较短.医院伦理委员会成员的总人数平均为19.89人,本单位成员占94.77％,96.30％的主任委员由行政领导兼任.调查发现,目前仍存在成员结构需完善、培训交流较欠缺、相关政策支持力度不够、伦理审核能力有待加强等问题.     

流行病学实践与研究相关的伦理学视角与思考

随着社会的发展,公共卫生领域的伦理学问题不断显露,有必要对其重新审视。探讨了目前在公共卫生领域流行病学实践与研究中存在和涉及到的一些伦理问题,有传染病报告、隔离、免疫规划、艾滋病防治、传染病应急机制、流行病学调查和试验研究等,并就公共卫生领域中的伦理实践原则进行了概括。     

The Science and Ethics of Placebo in Pediatric Psychopharmacology

Pediatric psychopharmacology is a relatively new science. Although the use of psychotropic medications in children has risen in the past decade, there are few standard treatments for serious psychiatric or developmental disorders of childhood. The relative absence of standard treatments is further complicated by the fact that many of the agents used in pediatric psychopharmacology have been adapted from other fields. Therefore, investigators have a responsibility to make incremental progress from concept through pilot studies and large-scale, multisite efficacy and safety trials. Thus, although there is a pressing need to conduct medication trials that can guide clinical practice, there are scientific and ethical considerations to bear in mind when designing clinical trials in pediatric psychopharmacology. This article reviews essential ethical and scientific issues that are relevant to designing clinical trials in children with psychiatric and developmental disorders. Using examples from recently published literature, the article describes the challenges and pitfalls of various clinical trial study designs. The application of sound ethical and scientific principles is necessary to ensure that clinical trials are properly conducted and to guard against ambiguous results that can not guide practice.     

Ethics education in science and engineering: The case of animal research

Conclusion The past one hundred fifty years of debate over the use of animals in research and testing has been characterized mainly byad hominem attacks and on uncritical rejection of the other sides’ arguments. In the classroom, it is important to avoid repeating exercises in public relations and to demand sound scholarship. This paper is a modification of material originally included in the handbook which accompanied the American Association for the Advancement of Science (AAAS) Seminar “Teaching Ethics in Science and Engineering”, 10–11 February 1993.     

Ethics in Research

Summary

This article presents an overview of the history of efforts to protect human subjects in research. It discusses the establishment of international, national, organizational, and institutional procedures designed to protect human participants. The article provides a detailed summary of the principal ethical codes for research and their origins. It includes discussions of the most frequently encountered ethical issues ranging from the initial decision to undertake the project, through the selection and application of the various research procedures, to the analysis and interpretation of the data.     

The Regulation of Animal Research and the Emergence of Animal Ethics: A Conceptual History

The history of the regulation of animal research is essentially the history of the emergence of meaningful social ethics for animals in society. Initially, animal ethics concerned itself solely with cruelty, but this was seen as inadequate to late 20^th-century concerns about animal use. The new social ethic for animals was quite different, and its conceptual bases are explored in this paper. The Animal Welfare Act of 1966 represented a very minimal and in many ways incoherent attempt to regulate animal research, and is far from morally adequate. The 1985 amendments did much to render coherent the ethic for laboratory animals, but these standards were still inadequate in many ways, as enumerated here. The philosophy underlying these laws is explained, their main provisions are explored, and future directions that could move the ethic forward and further rationalize the laws are sketched.     

我所了解的英国医学伦理学教育

英国的医学伦理学教学强调病人的主体化和“去客体化”．关注病人权利,尤其是弱势群体的权益。融入法律等其他学科的内容,注重跨学科的教学与交流。这样一种教学理念是符合医学伦理学的人文属性。值得我们借鉴。     

Clinical Audit and Reform of the UK Research Ethics Review System

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.     

临床研究结果发布的伦理审查辨析

《涉及人的生命科学和医学研究伦理审查办法》对于临床研究结果的发布提出了伦理审查和知情同意告知的要求。探讨临床研究的结果发布可以最大程度实现临床研究的价值,包括有利于实现临床研究的透明性,有利于增强公众的信赖,有利于落实研究参与者的知情权,并分析了研究结果发布在隐私保护、发布形式、发布时间、科研诚信和学术不端方面带来的潜在伦理问题。建议伦理委员会从隐私风险最小化、发布形式规范化、发布时间合理化三方面进行伦理审查,同时给出了加强多部门协作和跟踪审查以及参与学术不端治理的伦理审查策略建议。

     

Punctuated Equilibrium,Moral Panics and the Ethics Review Process

A review of the literature and ethnographic data from Australia, Canada, New Zealand, the United States, and the United Kingdom on the research ethics review process suggest that moral panics can become triggers for punctuated equilibrium in the review process at both the macro and microlevel, albeit with significantly different levels of magnitude and impact. These data suggest that neither the development of the ethics review process nor the process itself proceeds gradually, but both are characterized by periodic major shifts evoked by particular events or situations that result in varying levels of moral panic. One way to deal with this moral panic is to increase the regulation of research and the depth or intensity of the scrutiny of applications under ethics review. Moral panics at the macrolevel influence those at the microlevel and, if the moral panic evoked at the local or microlevel is not satisfactorily resolved, it will evoke action at a higher level. Understanding the evolution of research ethics review processes from this perspective might help make actions by ethics committees and policy makers more understandable and help explain why attention to research ethics are heightened at particular points in time. It may also provide a basis for developing recommendations for adaptations to the ethics review process and policy at both the local and macrolevel.     

Ethics in Publication

Summary

This article highlights ethical issues in publication. It addresses the provenance of ideas, problems with joint authorship, plagiarism, and the practice of duplicate submission of material for publication. Confidentiality and privacy matters, and the protection of human subjects in publication of research and clinical case studies are also discussed. The article further examines biases in literature reviews, and in the biased selection of one's best results for publication, intentional misinterpretation of data and the slanting of discussion, summary, and conclusions. Finally, the article deals with ethical problems that can arise in the publication of sponsored research, and the ethical responsibilities of editors and readers.     

Is Anonymity an Artifact in Ethnographic Research?

While anonymity is a widely-held goal in research-ethics review policies, it is a virtually unachievable goal in ethnographic and qualitative research. This paper explores how anonymity is undermined in the data-gathering, analysis, and publication stages in ethnography. It also examines problems associated with maintaining a collective identity. What maintains anonymity, however, are the natural accretions of daily life, the underuse of data, and the remoteness of place and time between the gathering-data stage and the eventual publications of findings.     

德性伦理与规范伦理在生命伦理中的契合

在生命伦理领域中,规范伦理与德性伦理都曾发挥重要作用,然而,德性伦理没有受到人们足够的重视,重新厘定传统德性伦理的现代价值显得尤为重要。初步探究在生命伦理迅速发展的情况下,德性伦理与规范伦理相结合的模式。     

韦伯命题的合理性与中国企业伦理的建构

回答新教伦理与资本主义精神的内在生成关系的韦伯命题一直是人们讨论的热点,本文考量了韦伯命题关于伦理与现代化的关系和"精神转型"的合理性,寻求其在改变人们心智模式、重估企业伦理的作用力以及运用"精神转型"建构中国企业伦理的方法论启示。     

医学科研与医学科研伦理的辩证思考

医学科研中出现许多伦理问题。其必然性在于科学与伦理的不同：即属性不同、评价标准不同、变革速度不同。医学伦理可以告诉人们什么样的医学科研活动是善的,什么样的科研行为是应该做的。医学科研中要把握医学伦理观,体现医学科技观,富有医学创新观。     

The Risks,Benefits, and Ethics of Trauma-Focused Research Participation

With the rising interest in the field of trauma research, many Institutional Review Boards, policymakers, parents, and others grapple with the impact of trauma-research participation on research participants' well-being. Do individuals who participate in trauma-focused research risk experiencing lasting negative effects from participation? What are the potential benefits that may be gleaned from participation in this work? How can trauma research studies be designed ethically, minimizing the risk to participants? The following review seeks to answer these questions. This review indicates that most studies in this area have found that only a minority of participants experience distress when participating in trauma-focused research. Furthermore, these negative feelings tend to dissipate quickly over time, with the majority of participants self-appraising their participation as positive, rewarding, and beneficial to society. Design characteristics that may serve to minimize participants' risk of experiencing distress are discussed, as well as implications for public policy and future research.     

和谐伦理精神探析

和谐社会是一种和而不同的动态的理性社会,它需要一种全新的和谐伦理精神来支撑。这种和谐伦理精神主要体现在公平正义、诚信友爱、尊重自然等三个方面。公平正义是构建社会主义和谐社会制度的首要美德;诚信友爱是协调和谐人际关系的道德基石;尊重自然是实现人与自然和谐相处的生态伦理精神。这三种伦理精神的统一体现了社会、人和自然的统一。     

西方政治伦理思想的历史流变及其启示

自古至今,西哲们紧跟时代的脚步,不断把西方的政治伦理观推陈出新:美德政治伦理、神性政治伦理、非道德主义的政治伦理、权利政治伦理。全面、系统地梳理和展现西方政治伦理思想的演变及其价值诉求,对于理解和把握政治伦理学中的一些重要理论问题具有重大的启迪意义。