生物医药研究伦理审查的体制机制建设

生物医药研究伦理审查在项目设计、论证和科学研究过程的审查,以及伦理委员会特别是伦理审查的评价方面较薄弱.要提高伦理审查的整体水平,需实现道德建设与法治建设、各级各类规定、科技监管与伦理监管的密切配合;伦理审查应始自科研设计、立项,强化跟踪审查,加强对伦理委员会工作的检查、评估,进而提高伦理审查能力培训的实际效果.     

Publication Ethics in Biomedical Journals from Countries in Central and Eastern Europe

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union. The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals.     

提高生命科学研究中的伦理审查质量的思考

我们曾经的生物医学研究中,有些研究者往往只注重自己研究的目的,违犯如《纽伦堡法典》,《赫尔辛基宣言》,《贝尔蒙报告:保护人体受试者伦理学原则及准则》等伦理原则.通过建立健全伦理评审系统,规范伦理审查程序,建立对伦理委员会的审查评估系统,期望使生物医学研究更加符合保护和促进人类健康的目的.     

提高生命科学研究中的伦理审查质量的思考

我们曾经的生物医学研究中,有些研究者往往只注重自己研究的目的,违犯如《纽伦堡法典》,《赫尔辛基宣言》,《贝尔蒙报告:保护人体受试者伦理学原则及准则》等伦理原则。通过建立健全伦理评审系统,规范伦理审查程序,建立对伦理委员会的审查评估系统,期望使生物医学研究更加符合保护和促进人类健康的目的。     

Animals in Biomedical Research: The Undermining Effect of the Rhetoric of the Besieged

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertion of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science is good (and some especially so), and the belief that an ethical consensus can never really be reached between the parties.     

The Biomedical Disciplines and the Structure of Biomedical and Clinical Knowledge

The relation between biomedical knowledge and clinicalknowledge is discussed by comparing their respectivestructures. The knowledge of a disease as a biologicalphenomenon is constructed by the interaction of factsand theories from the main biomedical disciplines:epidemiology, diagnostics, clinical trial, therapydevelopment and pathogenesis. Although these facts andtheories are based on probabilities andextrapolations, the interaction provides a reliableand coherent structure, comparable to a Kuhnianparadigma. In the structure of clinical knowledge,i.e. knowledge of the patient with the disease, notonly biomedical knowledge contributes to the structurebut also economic and social relations, ethics andpersonal experience. However, the interaction betweeneach of the participating ``knowledges' in clinicalknowledge is not based on mutual dependency andaccumulation of different arguments from each, as inbiomedical knowledge, but on competition and partialexclusion. Therefore, the structure of biomedicalknowledge is different from that of clinicalknowledge. This difference is used as the basis for adiscussion in which the place of technology,evidence-based medicine and the gap between scientificand clinical knowledge are evaluated.     

Feminist Resources for Biomedical Research: Lessons from the HPV Vaccines

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or “study up” scientific phenomena from the perspectives, interests, and conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location “visible,” or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible.     

Correctable Myths About Research Misconduct in the Biomedical Sciences

Science and Engineering Ethics - A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here...     

多巴胺与帕金森病早期研究——生物医学研究领域的一个生动案例

多巴胺作为一种重要神经递质,其研究历史与帕金森病发展史紧密相随.早期的多巴胺功能研究直接推动了帕金森病发病神经生化机制的阐明,并带来帕金森病治疗上的重大突破--多巴胺替代治疗.这段研究历史曲折、丰富,堪称生物医学研究领域中的生动案例.对这段历史作一回顾并就其对生物医学研究启示作用略作分析.     

多巴胺与帕金森病早期研究——生物医学研究领域的一个生动案例

多巴胺作为一种重要神经递质,其研究历史与帕金森病发展史紧密相随。早期的多巴胺功能研究直接推动了帕金森病发病神经生化机制的阐明,并带来帕金森病治疗上的重大突破——多巴胺替代治疗。这段研究历史曲折、丰富,堪称生物医学研究领域中的生动案例。对这段历史作一回顾并就其对生物医学研究启示作用略作分析。     

涉及人的生物医学研究伦理审查标准化操作的实践与体会

针对目前医疗机构在医学科研中涉及人的生物医学研究的伦理审查在申报、实施和监督等环节较难同步的现状,探索医院伦理委员对生物医学研究伦理审查的标准化操作规程,认为在审查实践中应加强伦理委员会持续教育,抓关键环节的伦理监督,不断提高委员的伦理审查能力;重视信息化管理,建立多渠道的沟通方式,重视加强对科研人员伦理导航的重要性.     

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.     

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。     

A Review of the Types of Scientific Misconduct in Biomedical Research

Biomedical research has increased in magnitude over the last two decades. Increasing number of researchers has led to increase in competition for scarce resources. Researchers have often tried to take the shortest route to success which may involve performing fraudulent research. Science suffers from unethical research as much time, effort and cost is involved in exposing fraud and setting the standards right. It is better for all students of science to be aware of the methods used in fraudulent research so that such research can be detected early. Biomedical research is one area that seems to have attracted maximum numbers of fraudulent researchers; hence this article devotes itself to biomedical research scenario.     

Reassessing the Role of the Biomedical Research Ethics Committee

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review.     

加强我国卫生领域科研诚信建设的重要性

近几年来,我国的科研不端案例呈不断上升趋势.科技部、教育部、中国科学院,国家自然科学基金委员会、中国科学技术协会等部门或机构已发布了关于科研不端行为的处理规定,然而在我国卫生领域科研不端行为的处理和科研诚信建设方面尚未出台相关政策或指导意见.加强我国卫生领域的科研诚信建设具有重要意义.     

The Importance of Spirituality in Well-Being for Jews and Christians

There is a well-known association between religion and happiness, although it is not known which particular aspects of religiosity correlate with life satisfaction, or if the correlates are different for people of different religions. In three studies, the correlations of different facets of religiosity with happiness or life satisfaction were explored. In different samples and with different measures, congregational support and public practice of religion appear to correlate similarly with measures of life satisfaction for members of different religions. However, spirituality, religious coping, and religious belief were better predictors of happiness and quality of life for Protestants and Catholics than for Jews. It is therefore contended that religion should be an important consideration, along with religiosity, in study of satisfaction with life, and that the link between spirituality and life satisfaction be followed up, particularly among Christians.     

The Importance of Pleasure in the Moral for Kant's Ethics

I argue for a new reading of Kant's claim that respect is the moral incentive; this reading accommodates the central insights of the affectivist and intellectualist readings of respect, while avoiding shortcomings of each. I show that within Kant's ethical system, the feeling of respect should be understood as paradigmatic of a kind of pleasure, pleasure in the moral. The motivational power of respect arises from its nature as pleasurable feeling, but the feeling does not directly motivate individual dutiful actions. Rather, the feeling is motivational in the sense that, after an agent has acted in a morally good way, the pleasure that results from that action contributes to the cultivation of virtue in the agent and, consequently, morally good actions in the future. Understanding the feeling of respect to be moral pleasure not only gives us insight into how finite rational beings develop virtue, but also a new way of understanding respect as an incentive.