关于药物临床试验伦理问题的思考

医学伦理学是伴随着科学技术的发展而产生的事物,药物临床试验在促进人类健康事业发展的同时,也涉及到与之相驳的伦理学问题,运用哲学的矛盾原理,浅析药物临床试验与医学伦理之间存在的矛盾及矛盾的两面性,以求解决目前药物临床试验中遇到的困难和问题.     

药物临床试验中科学原则、法规原则与伦理原则的权重与取舍

药物临床试验既要符合伦理学原则、法规原则,又要具备科学原则.伦理学原则要求受试者最大程度受益和尽可能避免伤害.在法规原则上也首先强调的是受试者的权益,然而试验设计的科学性原则有很多时候却对伦理学提出了挑战.当药物临床试验的科学性、法规性与伦理性发生矛盾时,我们应把伦理问题摆在首位.     

对外科急腹症诊疗中伦理学矛盾的探讨

由于外科急腹症的特殊性,产生了与其他科室不同的伦理学矛盾。本文探讨了急腹症诊疗中存在的伦理学矛盾和相应对策。在急腹症诊疗过程中,要重视伦理学矛盾产生的原因,完善急腹症诊疗中存在的流程问题,自觉实践医学伦理学的知情同意原则,有助于化解医患矛盾,减少医疗纠纷;同时也要减轻医生工作压力,加强团队合作精神。     

与改革开放同行:中国医学伦理学近40年发展的回顾与展望

改革开放以来,中国医学伦理学学科得到大发展,学术研究的开端和学科发展的某些标志性事件值得纪念。但反思以往的发展状况,该学科尚未成熟,诸如在研究对象的确定与表述,"医学道德"与"医学伦理"两个最基本概念的界定与使用,三个伦理学理论的理解与运用,以及生命神圣论、生命质量论和生命价值论的伦理阐释等方面并未达成共识。进入新时代,医学伦理学在繁荣有关学术、医学伦理教育教学、参与医学研究和临床试验、确立医疗卫生工作规范以及对敏感医学问题和社会关切的积极回应等方面,尽管面临着诸多挑战,但可以大有作为。     

检验医学的医学伦理学思考

检验医学发展迅速,然而对其医学伦理学的思考却常被人忽视。本文对日常检验工作中存在的伦理学问题进行了初步探讨,从检验机构设置、检验项目管理、日常检验工作及检验与,临床的沟通等方面思考了当今检验医学领域医学伦理学的现况。加强检验医学的医学伦理学建设,真正体现出对患者的人文关怀。     

检验医学的医学伦理学思考

检验医学发展迅速,然而对其医学伦理学的思考却常被人忽视.本文对日常检验工作中存在的伦理学问题进行了初步撂讨,从检验机构设置、检验项目管理、日常检验工作及检验与临床的沟通等方面思考了当今检验医学领域医学伦理学的现况.加强检验医学的医学伦理学建设,真正体现出对患者的人文关怀.     

抗肿瘤药物临床研究之得与失

药物临床研究是指在人体进行的以明确试验药物疗效及安全性的系统性研究。在循证医学时代,抗肿瘤药物发展迅速,相关药物临床研究数量剧增。本文旨在探讨抗肿瘤药物临床研究中,受试者在医学伦理学范畴之外的得与失,并分析临床研究结果判定中存在的问题,为更好地保护受试者权益、更客观地评价抗肿瘤药物临床研究结果提供借鉴。     

医学伦理学是否可教及其他--关于医学伦理学教育的再思考

医学伦理学是否可教?如果可教,应该教规范还是教价值?如何拉近医学伦理学教育与现实的距离?怎样评价医学伦理学教学的效果?不仅是临床医生和卫生管理工作者,即使作为医学伦理学研究工作的学者也都对这些问题存在着不同程度的误解,这影响了医学伦理学学科地位的确立.     

医学生妇产科临床见习渗透伦理学教学的意义

现代医生应是专业技能与人文素养兼备的形象,医学伦理学素质是医学生理应具备的品格.实践证明,医学伦理学临床见习是培养医学生医学伦理学素质的必要环节.医学伦理学的临床见习,能固化医学生的知识体系,有利于医学生医学伦理学素质的养成,帮助提高医学生分析和解决医学临床实践中面临的伦理困境.而妇产科室由于其特殊性,在临床见习中渗透伦理学教学的意义尤为重大,通过妇产科医学伦理学临床见习的设计与实施,科学合理地选择见习的内容,寻找最佳的见习方式和方法,完善见习的评定体系和考核形式,医学伦理学的教学效果立竿见影.     

随机临床试验中伦理问题的探讨

随着我国的药物临床试验过程逐渐完善,药物临床试验水平不断提高,但伦理学方面并不十分完善.临床研究者和受试者应该明确自己的权益和义务,并在药物随机临床试验中,使受试者的权益得到更好的保护.本文论述并总结了药物临床试验中出现的问题,并提出了改进措施.     

Standards,Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

ABSTRACT

A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.     

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Randomization is the "gold standard" design for clinical research trials, and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This paper analyzes the ethical tensions that arise from conducting these studies, and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.     

药物临床试验设计的伦理思考

目前广泛采用的药物临床试验设计中,由于不能使受试者最大限度的受益而在伦理学方面存在弊端。自适应设计方法的出现,为克服这一弊端提供了现实途径,可使药物临床试验的受试者能够最大程度的受益。本文从传统临床试验引发的伦理问题入手,阐述了自适应设计以人为本的特点,探讨了其在解决伦理与疗效冲突问题中的重要作用。     

Clinical Equipoise and Adaptive Clinical Trials

Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: (1) as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or (2) as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation makes it mandatory to minimize the number of patients receiving the treatment that will eventually be shown to be inferior by the trial. This requirement has led to the development of adaptive trials, i.e., trials in which treatment allocation is determined by data accumulated during interim analysis. Many statisticians argue that in some circumstances—typically with potentially high benefits, as in the much discussed ECMO trial—adaptive design is the only ethically permissible experimental design. Nevertheless, some proponents of clinical equipoise argue that adaptive trials are neither ethically required nor permissible. More specifically, they argue that clinical trials using adaptive designs fail to meet the moral requirement of clinical equipoise, since these trials presuppose an epistemic state that is incompatible with a physician’s duty of care to her subjects. This paper emphasizes that the debate is to a large extent resting on an epistemological confusion. Specifically, I argue that this response conflates two different conceptions of statistical evidence (i.e., frequentist and Bayesian), and that recognizing this distinction elucidates an epistemological framework in which adaptive trials are both consistent with and recommended by the moral requirement of clinical equipoise.

     

Evaluating the therapeutic misconception

The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.     

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Randomization is the “gold standard” design for clinical research trials and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This article analyzes the ethical tensions that arise from conducting these studies and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.     

The physician’s role in the protection of human research subjects

Responsibility for the protection of human research subjects is shared by investigators, research ethics committees, sponsors/funders, research institutions, governments and, the focus of this article, physicians who enrol patients in clinical trials. The article describes the general principles of the patient-physician relationship that should regulate the participation of physicians in clinical trials and proposes guidelines for determining when and how such participation should proceed. The guidelines deal with the following stages of the trial: when first considering participation, when deciding whether to enrol patients, when asking patients to participate, when the trial is underway and when it is completed.     

Phronesis in clinical ethics

This essay argues that while we have examined clinical ethics quite extensively in the literature, too little attention has been paid to the complex question of how clinical ethics is learned. Competing approaches to ethics pedagogy have relied on outmoded understandings of the way moral learning takes place in ethics. It is argued that the better approach, framed in the work of Aristotle, is the idea of phronesis, which depends on a long-term mentorship in clinical medicine for either medical students or clinical ethics students. Such an approach is articulated and defended.     

The survey of clinical human experimentation research in ethical review of postgraduates students

An anonymous questionnaire was used to investigate the status quo of ethics review of human subject experiments among postgraduate students in clinical practice with the main conclusions as follows: Human subject experiments make up a large ratio of clinical research; the construction of an ethics review has been initially formulated, but there exists a gap in ethics awareness between advisors and the postgraduates with the desperate need to receive ethics review. It is necessary to realize the importance of informed consent and to strengthen the strict supervision of placebo application.     

Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized,Controlled Educational Intervention

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics.