医疗器械软件设计及应用的伦理考量

通过收集2017年~2021年北京某三甲医院开展的14项医疗器械软件的软件说明书、技术要求和注册检验报告等临床试验资料,从医学伦理的角度对产品的功能和技术标准涉及的共性问题进行分析归纳,重点探讨了医疗器械软件的标准参考情况、数据管理和风险控制措施方面的相关问题,提出了医疗器械软件在设计和使用过程中应当考虑适用范围泛化、预警和交互等可能衍生伦理学问题的因素,加强软件风险管理,从而减少因软件缺陷产生的严重不良事件。

     

Theological and Ethical Reflections on Men and Violence: Toward a New Understanding of Masculinity

Abstract

This paper explores the reasons why men express violence against women, children and other men, suggesting that men's violence represents one of the darkest features of masculinity. The way men are socialized and conditioned requires and produces violent behaviors that are destructive to men themselves as well as to women, children, and the earth. The author proposes the need to re-envision masculinity to enable men and women to create communities in which people are encouraged to participate in ‘adventurous partnering for peace’.     

“学界热”与“行业冷”：医学伦理学落地医疗实践之思

医学伦理学是医学人文教育的基础阵地,中国过去40年医学伦理学科建设有成绩也有不足。当前医学伦理学落地医疗实践成为问题的焦点。从伦理学界的热点问题出发,描述热中有冷、冷热交加的伦理现象：应用伦理热、科研伦理热、医学伦理热,分析现象背后的原因可能是伦理观念与意识不足,理论与实践脱节及实践深度与广度不够。以此为基点寻生根之径,知的层面要自上而下多层保障;行的层面要理论联系实践,要深化内化转化;最终达到知行合一,入脑入心入行,加速医学伦理学落地生根。

     

伦理即服务之可能性——以护理机器人的伦理设计为例

基于“平台即服务”框架的“伦理即服务”(ethics as a service, EaaS)概念旨在解决抽象道德准则与人工智能实践间的转化鸿沟。当前护理机器人的伦理设计存在伦理服务者定位模糊、伦理设计简单化、伦理设计智能化误区与伦理场景单一化困境等不足。将EaaS框架运用到当前护理机器人的伦理设计活动中,有助于构建多方协调的伦理服务体系,实现多抽象层次的伦理设计审查,构建模块化的伦理情境,开展自发性的伦理定制服务。服务化和过程化的EaaS伦理设计,有助于实现伦理原则与具体应用之间的协调与统一,但也会对服务过程中的责任划分与隐私保提出更高要求。

     

Ethical and economic issues in the use of zero-emission vehicles as a component of an air-pollution mitigation strategy

The air pollution generated by motor vehicles and by static sources is, in certain geographic areas, a very serious problem, a problem that exists because of a failure of the marketplace. To address this marketplace failure, the State of California has mandated that by 2003, 10% of the Light-Duty Vehicle Fleet (LDV) be composed of Zero-Emission Vehicles (ZEVs). However, the policy-making process that was utilized to generate the ZEV mandate was problematic and the resulting ZEV mandate is economically unsound. Moreover, an ethical analysis, based primarily upon the work of John Rawls, suggests that implementation of the California ZEV mandate is—in spite of the wide latitude that ought to be given to policy decision makers—unethical. A more ethical and economically efficient approach to the pollution caused by marketplace failure is one that relies on market incentives and thereby achieves the desired improvement in air quality by appealing both to the self-interest of motorists and to those businesses that are directly or indirectly involved with the automobile industry. Such an approach would take better advantage of the creative forces of the market and improvements in technology over time and avoid the infringements on individual liberty and fairness embodied in the ZEV mandate.     

Reflections of a reluctant clinical ethicist: Ethics consultation and the collapse of critical distance

The obvious appeal and growing momentum of clinical ethics in academic medical centers should not blind us to a potential danger: the collapse of critical distance. The very integration into the clinical milieu and the processes of clinical decision making, that clinical ethics claims as its greatest success, carries the seeds of a dilution of ethics' critical stance toward medicine and medical education. The purpose of this paper is to suggest how this might occur, and what potential contributions of ethics to medicine might be sacrificed as a result. Medical sociology will be used for comparison. Sociologists have found that they may function either as students and critics of established medical practices and educational philosophies, or as collaborative participants in them — but rarely both. It may be that professional ethics is most effective when it plays the role of stranger rather than insider, and is continually able to question the most basic assumptions and values of the enterprise with which it is associated. As with medical sociology, ethics and humanities must ask to what extent their desire for acceptance in the clinic requires their acceptance of the clinic: specifically, acceptance of basic assumptions about optimal ways of organizing medical education, socializing physicians-in-training, providing care, and even of defining medical ethics itself. The paper concludes by recommending that ethics reassert its strangeness in the medical milieu even as it assumes a more prominent role within the medical center.     

医疗机器人的伦理风险与治理探析——基于“医−患−机”分析框架

基于“医−患−机”分析框架,医疗机器人的不断发展面临主体资质复杂、责任认定困难等责任伦理风险,医患关系重构、医患信任危机等医患伦理风险,数据质量与数据隐私等数据伦理风险,算法安全与算法偏见等算法伦理风险以及医疗资源分配正义风险。医疗机器人的伦理治理要以医学伦理和机器人伦理准则为依据,建立多元伦理治理体制,推动学术共同体的构建,探索自愿型、调节型与管制型等伦理治理工具的组合运用,加快医疗机器人伦理治理的法治化发展。

     

Ethical and institutional frameworks for interactional justice in public organizations: a comparative analysis of selected Western and Chinese sources

This paper explores both differences and points of contact between selected contemporary theories of public ethics in the West and China. China is in a greater state of flux in this connection, with new, eclectic approaches to ethical justification for moral agency gaining prominence. There are thematic parallels between East and West in their distinct strains of institutionalism (in which neither individual moral agency nor the justice claims of individuals have much play). However, there are recent Chinese theoretical proposals – many incorporating Western sources – that address this quandary, namely the institutional overdetermination of moral agency. These proposals are joined to contributions from feminist and liberation ethics in a critical reconsideration of overridingness in formal ethics. Contemporary Chinese ethics connect moral claims to kin, community, and reciprocity networks, particularly as traditional philosophy is recovered in new theoretical syntheses. The grounding of Confucian ethics in kin and community offers an instructive contrast to formal Western ethical systems, as do radical strains of Western ethics that suggest that transcendence is found in the self's extension toward others in need. This paper considers these ethical themes in connection with hypothetical instances of interactional justice in organizations.     

Ethical challenges in the COVID-19 research context: a toolkit for supporting analysis and resolution

ABSTRACTCOVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the ethical challenges in COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19.     

Building a Better WarBot: Ethical Issues in the Design of Unmanned Systems for Military Applications

Unmanned systems in military applications will often play a role in determining the success or failure of combat missions and thus in determining who lives and dies in times of war. Designers of UMS must therefore consider ethical, as well as operational, requirements and limits when developing UMS. I group the ethical issues involved in UMS design under two broad headings, Building Safe Systems and Designing for the Law of Armed Conflict, and identify and discuss a number of issues under each of these headings. As well as identifying issues, I offer some analysis of their implications and how they might be addressed.

Confucian Dynamism,the Role of Money and Consumer Ethical Beliefs: An Exploratory Study in Taiwan

Consumer ethics is the moral principles and standards that guide consumers to determine the certain consumption behaviors are ethically right or wrong. Whereas cultural and personal dimensions are crucial constructs affecting individual ethical attitudes and behaviors, few studies consider Confucian dynamism and the role of money in consumer ethics. Confucian dynamism, a cultural dimension based on Confucianism, has played a central role in guiding moral obligations and ethics in human relations in several East Asian countries. Thus, this study tested its hypotheses using a sample of 521 respondents obtained via a systematic random sampling technique. The authors find that individuals with a higher tendency to Confucian dynamism are less tolerant of unethical practices. These findings also show that the role of money partially influences consumer ethical beliefs. Finally, we examine the impact of demographic variables and find age and education affect consideration of ethical values.     

某三甲医院五年科研项目伦理审查情况分析

通过对国内某三甲医院五年科研伦理审查情况进行分析,探讨科研项目伦理审查工作的重点、难点及对策。汇总2013年~2017年经医学伦理委员会会议审查的科研项目,分析研究者的学历、职称、学科与通过率关系。近5年医学伦理委员会共审查科研项目285项,通过238项,未通过47项,其中内科通过率高于外科(P<0.05),副高以上职称通过率高于中级(P<0.05),研究生以上学历通过率高于本科及以下学历(P<0.05)。只有强化伦理意识,规范审查形式,健全监管机制,才能保证科研伦理工作健康规范发展。     

医学期刊载文的伦理学审查情况分析——以《中国学校卫生》为例

通过查阅《中国学校卫生》近5年纸质期刊,查看文章“对象与方法”中有无“知情同意”或“获得伦理学审查”等信息。结果显示,获得伦理学审查或知情同意的文章884篇,各年份获得伦理学审查、知情同意及总体检出率差异均有统计学意义(χ²=366.29,43.58,219.83,P<0.01)。各年份获得伦理学审查、知情同意的心理学研究及总体检出率(χ²=107.55,16.80,58.66);获得伦理学审查的干预性研究及总体检出率(χ²=44.40,18.46);获得伦理学审查的涉及生物样本的研究检出率(χ²=17.47),差异均有统计学意义(P<0.01)。今后应不断加强引导和教育,加强科研人员及编辑的伦理意识。     

Ethical Academic Judgments and Behaviors: Applying a Multidimensional Ethics Scale to Measure the Ethical Academic Behavior of Graduate Students

Using Reidenbach and Robin's Multidimensional Ethics Scale, this study investigated the relationships between background variables and students' ethical evaluations, judgments, and behavioral intentions using 3 scenarios involving dilemmas related to academic dishonesty. The sample included 436 master's students and 142 doctoral students. The study found that the participants used a combination of ethical philosophies to make ethical decisions. The respondents judged improper citations more harshly than acts of inappropriate authorship or the falsification of data. The doctoral students generally considered behaviors related to plagiarism and falsification to be more unethical than the master's students did, though no gender differences were found.     

An Examination of the Effects of Sport Involvement on Ethical Judgments in Sport and Business

Popular press headlines frequently reveal unethical or illegal activity in business and sports. Given these parallel ethical lapses in business and sport, our study examines potential relationships between student sport involvement (active and passive) and ethical judgments regarding issues in sport and business. Our results, based on a sample of 202 undergraduates in an upper-division management class, indicate a significant negative relationship between high passive sport involvement and ethical judgments about sport issues as well as a consistent significant positive relationship between female gender and ethical judgments about sport and business issues.     

Ethical selfhood and the status of the secular: Muslim identity in Mumbai

As part of a larger project, this essay contributes to the current anthropological rethinking of categories such as ‘religion’, ‘secularism’ and ‘politics’ in relation to social processes and subjects: a series of ventures that are related, in the Indian context, to modernity and liberal conceptions of statehood, sovereignty and personhood. In discussing everyday phenomena such as piety and religious authority, gender and childraising, and political and professional pursuits in Mumbai, I demonstrate that the ostensibly ‘religious’ domain of Islam is not necessarily the only, or even primary, basis for achieving a self-consciously ethical selfhood for even those who identify as observant and devout Muslims. I argue that the religious domain of Islam in this context is defined as such and intersected by discourses and practices of the self as a political and economic agent defined largely in terms of political modernity.     

Reflections on the use of patient records: Privacy,ethics, and reparations in the history of psychiatry

One of the most common questions we get asked as historians of psychiatry is “do you have access to patient records?” Why are people so fascinated with the psychiatric patient record? Do people assume they are or should be available? Does access to the patient record actually tell us anything new about the history of psychiatry? And if we did have them, what can, or should we do with them? In the push to both decolonize and personalize the history of psychiatry, as well as make some kind of account or reparation for past mistakes, how can we proceed in an ethical manner that respects the privacy of people in the past who never imagined their intensely personal psychiatric encounter as subject for future historians? In this paper, we want to think through some of the issues that we deal with as white historians of psychiatry especially at the intersection of privacy, ethics, and racism. We present our thoughts as a conversation, structured around questions we have posed for ourselves, and building on discussions we have had together over the past few years. We hope that they act as a catalyst for further discussion in the field.     

Ethical issues in biomedical research: Perceptions and practices of postdoctoral research fellows responding to a survey

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. Preliminary results of this work were presented in part as a poster at the forumEthics, Values, and the Promise of Science, presented by Sigma Xi, The Scientific Research Society, 25–26 February 1993 in San Francisco, California, USA.     

注重全人群、全方位、全过程——论受试者知情同意伦理审查的强化

通过对医药学研究人体试验受试者知情同意的伦理审查发展现状的说明,分析现阶段知情同意伦理审查工作中存在流于形式,审查结果不够科学、客观和公正等问题。再结合医药学研究的发展需要,说明知情同意伦理审查的工作情况和不断发展的要求。提出对知情同意做到全人群、全方位、全过程的伦理审查的覆盖。并通过实施全人群、全方位、全过程的伦理审查的过程,提高人体试验受试者知情同意伦理审查水平,促进医药学研究和社会医学的发展。     

Resolving Ethical Dilemmas in a Tertiary Care Veterinary Specialty Hospital: Adaptation of the Human Clinical Consultation Committee Model

Technological advances in veterinary medicine have produced considerable progress in the diagnosis and treatment of numerous diseases in animals. At the same time, veterinarians, veterinary technicians, and owners of animals face increasingly complex situations that raise questions about goals of care and correct or reasonable courses of action. These dilemmas are frequently controversial and can generate conflicts between clients and health care providers. In many ways they resemble the ethical challenges confronted by human medicine and that spawned the creation of clinical ethics committees as a mechanism to analyze, discuss, and resolve disagreements. The staff of the North Carolina State University Veterinary Hospital, a specialty academic teaching institution, wanted to investigate whether similar success could be achieved in the tertiary care veterinary setting. We discuss the background and rationale for this method, as well as the approach that was taken to create a clinical ethics committee.