伦理审查委员会的法律地位初探

伦理审查委员会(IRB)的法律地位是一个崭新的课题.通过解读我国现行的伦理审查规范,对我国IRB伦理审查活动的合法性、伦理审查结果的法律效力、IRB及研究人员的法律责任等关乎IRB法律地位的问题进行了探讨.考察了美国和瑞典的伦理审查法规,提出应该提高我国伦理审查规范的法律位阶,推行注册制度的建议.     

医学伦理审查实践中存在的主要问题与对策

医学伦理审查对规范医学研究和医疗实践,保护受试者或患者权益有重要意义.通过总结医院医学伦理审查实践经验,指出医学伦理审查存在职能交叉、独立性不强、管理不完善、协同性不够、受试者损害补偿机制不明确等问题,提出从健全组织机构、建立指导原则、加强伦理培训、规操作流程、完善补偿机制等方面予以改进.     

医学伦理审查如何适应转化医学的要求

随着转化医学的兴起,医学伦理审查面临前所未有的机遇与挑战.如何使医学伦理审查工作更好地适应转化医学发展的需要,提高审查质量,成为亟需解决的问题.在分析当前我国医学伦理审查工作现状和主要问题的基础上,进一步探讨了可行的解决方法,如进一步明确和强化管理部门服务功能、保证伦理委员会成员多样性和重视伦理审查多视角、强化伦理委员会后续跟踪审查、规范伦理审查委员的培训与继续教育等,为我国医学伦理审查工作的规范化发展和医学伦理审查质量的进一步提高提供参考.     

国外伦理委员会的监管对我国的启示

我国伦理审查委员会监管上的滞后导致各级伦理审查委员会的伦理审查能力良莠不齐、伦理审查工作得不到权威评价与考核,已经不能满足伦理审查委员会建设及生物医学科研发展的需要.分析比较了美国、英国、瑞典伦理委员会监管机制中的共性与特色,结合其先进经验,指出了我国伦理审查委员会监管体制中存在的具体问题,并就如何加强对伦理审查委员会的监管提出了几点思考.     

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.     

关于建立医学伦理审查监管体制的探究

医学伦理审查监管体制的框架包括:卫生行政部门对医学伦理委员会的认证和视察;伦理委员会对研究方案的审查;伦理委员会对试验安全性和科学性的监管;伦理委员会对受试者权益的保护及对利益冲突问题的管理;伦理委员会对自身的监管以及爱试者对医学伦理审查的监管;卫生行政部门和伦理委员会对投诉接待的管理.     

天津市伦理委员会现状调查分析

通过对天津地区部分医院的伦理委员会设立与运行情况的调查问卷分析,发现其在设立、职能多元化、工作主动性、审查监督等方面有了提升;同时,也存在需要改进之处.建议强化关于伦理委员会伦理价值的教育,呼吁临床医师向患方提出伦理咨询的建议,强化审查外的其他职能,设立伦理委员会专家库制度,强化对伦理委员会的检查与评估.     

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.     

器官移植伦理审查委员会实践难题的伦理思考

器官移植伦理审查委员会在器官移植技术的临床应用中意义重大,但其在实践中面临着缺乏明确的伦理原则和沟通技巧、对需要审查内容的理解不深刻等难题,这影响了其伦理使命的充分实现.为此,伦理审查委员会必须制定明确的伦理原则、深入理解需审查的内容、在伦理学知识、行动纲领和沟通技巧方面对其成员进行培训.     

提高医药伦理审查质量、促进生物医药科技发展

人类发展生物医药科学技术,需要提高伦理审查的质量,以把握其发展符合人类伦理价值的方向.中国的单位制社会已成为历史,但单位制社会意识依然影响着人们的行为,制约着伦理审查质量的提高.提高伦理审查的质量需要我们全面清理单位制的"遗产",需要消解在长期的单位制社会下所固化在人们思想中的单位制社会意识.     

伦理导向人力资源管理实践的跨层次作用机制:基于社会情境与社会认知理论

伦理 ¹( ¹ 与组织管理领域的常规做法一致, 本文将伦理与道德看作同义概念, 交替使用。)危机给企业经营带来巨大挑战, 现有文献较多关注微观视角的伦理行为, 缺乏从中观视角对人力资源管理制度开展研究, 导致在实践上无法形成有效的制度化抓手。人力资源管理实践作为中观视角的企业伦理实践之一, 正是针对伦理问题的有效回应。立足于人力资源管理与企业伦理领域的交叉点, 从三个方面构建伦理导向人力资源管理实践的研究框架:(1)基于社会情境理论探讨伦理导向人力资源管理实践对组织伦理绩效的影响机制; (2)基于社会认知理论探讨伦理导向人力资源管理实践对团队伦理建言的跨层次影响机制; (3)基于社会认知理论探讨伦理导向人力资源管理实践对个体伦理建言的跨层次影响机制。研究将丰富人力资源管理理论, 并为企业有效实施伦理导向人力资源管理实践提供启示与帮助。     

Ethical Problems in Planning for and Responses to Pandemic Influenza in Ghana and Malawi

Ethical problems are addressed in various ways within countries in planning for and response to pandemic influenza. Here we report on a qualitative study, in which 46 policymakers in Malawi and Ghana were interviewed on how they identified and resolved ethical problems. The study results revealed that ethical problems involving conflicts of values and choices were raised in reference to the extent and role of resources (inequities) and nature of public health interventions (intrusive measures), including the extent and processes of decision making, reasoning, and justification. There is a need for an ethical framework within pandemic preparedness plans to resolve and avert these problems.     

Ships in the Rising Sea? Changes Over Time in Psychologists’ Ethical Beliefs and Behaviors

Beliefs about the importance of ethical behavior to competent practice have prompted major shifts in psychology ethics over time. Yet few studies examine ethical beliefs and behavior after training, and most comprehensive research is now 30 years old. As such, it is unclear whether shifts in the field have resulted in general improvements in ethical practice: Are we psychologists “ships in the rising sea,” lifted by changes in ethical codes and training over time? Participants (N = 325) completed a survey of ethical beliefs and behaviors (Pope, Tabachnick, &; Keith-Spiegel, 1987). Analyses examined group differences, consistency of frequency and ethicality ratings, and comparisons with past data. More than half of behaviors were rated as less ethical and occurring less frequently than in 1987, with early career psychologists generally reporting less ethically questionable behavior. Recommendations for enhancing ethics education are discussed.     

Doing Ethics or Changing for the Better?

In this paper, classical pragmatism is used as a method, not as a substantial ethical theory, to develop “moral pragmatics.” Moral pragmatics offers a constructive approach for making progress where traditional ethical theories converge, and it innovates ethical deliberation. Assuming widespread agreement that real moral problems need practical solutions, the paper addresses two related problems: the missing link between ethical theories and moral practice, and the question of who is in charge of finding such solutions. It argues that “conscience” can create a link between ethical knowledge and moral practice, and that this partly discharges “the ethicist” from the task of solving problems that are not really, or not only, hers. Two specific methodological innovations are suggested that go beyond admonitions to render ethics sensitive to context. Instead, a reevaluation of “casuistry” and a sensitivity for “finding the right words” give an idea of how to achieve this goal.     

肤纹学研究的伦理问题

医学伦理学和遗传伦理学的原则同样适合肤纹学的研究.知情同意是肤纹学研究中必须要存在的程序和手续.对于肤纹学研究的检查、分析和保存所涉及的伦理学问题提出了意见.     

Creating an ethical organizational environment: The relationship between ethical leadership,ethical organizational climate,and unethical behavior

The purpose of this research is to provide a richer lens on the ethical organizational environment by examining the relationship between ethical leadership and unit-level unethical behavior through ethical organizational climate (EOC), with collective moral identity as a boundary condition. In testing our theoretical model, we first develop and validate a measure of EOC to address concerns with existing measures of ethical climate. Second, we examine the role of collective moral identity as a moderator of the relationship between EOC and unit unethical behavior. We discuss implications regarding the importance of developing a more comprehensive conceptualization of EOC.     

Before the rules are written: navigating moral ambiguity in performance enhancement

In 1984, a number of US cyclists used blood transfusions to boost their performance at the Los Angeles Olympic Games. The cyclists broke no rules and dominated the Games, yet were later maligned as cheaters and dopers—they had, it seemed, violated some important norm, albeit one which was neither an official rule nor otherwise easily identifiable. Their case illustrates the moral ambiguity that arises when a performance enhancement is employed in a sport that has not addressed it. This article takes up the crucial question posed by such moral ambiguity: is it ethical to enhance performance through a substance or technology when no rules exist to prohibit it? We first examine ordinary ethical obligations that athletes carry based on their status as moral agents. We conclude that such obligations provide some guidance, but cannot resolve the issue. We then examine arguments that take sport as a unique social practice that presents its own moral obligation not to use performance enhancers. We argue that these ‘spirit of sport’ arguments, developed by McNamee and Loland and Hoppeler cannot resolve the issue either. We conclude that when the rules governing sport are silent on the issue of performance enhancement the constraints on its ethical use are limited at best.     

道德信仰的发生机制

道德信仰的发生机制至少包括三个方面 ,即 :需要的体认机制 ;伦理义务的内化机制 ;道德心理的整合机制。需要的体认机制涉及到对人性、人生的价值、人的使命等问题 ,它是道德信仰形成的主体基础 ;伦理义务的内化机制涉及到人的社会伦理关系、社会规定性和制约性、社会价值、社会道德规范及其教化等问题 ,它是道德信仰形成的客观条件 ;道德心理的整合机制涉及到道德认知、道德情感、道德意志和道德人格等问题 ,它是道德信仰形成的主、客观方面的动态的统一。     

The Ethics of Enhanced Interrogations and Torture: A Reappraisal of the Argument

This article critically reviews what is known about the ethical status of psychologists’ putative involvement with enhanced interrogations and torture (EITs). We examine three major normative ethical accounts (utilitarian, deontic, and virtue ethics) of EITs and conclude, contra the American Psychological Association, that reasonable arguments can be made that in certain cases the use of EITs is ethical and even, in certain circumstances, morally obligatory. We suggest that this moral question is complex as it has competing moral values involved, that is, the humane treatment of detainee competes with the ethical value/duty/virtue of protecting innocent third parties. We also suggest that there is an ethical duty to minimize harm by making only judicious and morally responsible allegations against the psychologists alleged to be involved in EITs. Finally, we make recommendations regarding completing the historical record, improvements in the professional ethics code, and the moral treatment of individuals accused in this controversy.     

Evaluating Ethical Tools

This article reviews suggestions for how ethical tools are to be evaluated and argues that the concept of ethical soundness as presented by Kaiser et al. (2007) is unhelpful. Instead, it suggests that the quality of an ethical tool is determined by how well it achieves its assigned purpose(s). Those are different for different tools, and the article suggests a categorization of such tools into three groups. For all ethical tools, it identifies comprehensiveness and user‐friendliness as crucial. For tools that have reaching a decision in a democratic context as a main purpose, it identifies transparency, guiding users toward a decision and justification of the decision‐supporting mechanism. For tools that aim to engage the public, it identifies procedural fairness as essential. It also notes that the scope of use for ethical tools is limited to the same moral community, and that this feature is frequently overlooked.