临床均势原则辨析——对临床科研方法的伦理思考

随机对照试验作为一种评价新疗法的可靠设计方法,开始逐渐被世界范围内的临床医生所广泛接受和采用,成为目前最重要的试验方法之一。RCT的运用应该遵循一定的伦理准则,即临床均势原则。围绕临床均势原则这一主题,对随机对照试验的方法论进行较为深入的伦理学思考。并对临床均势的内涵、伦理意义,以及这一伦理要求在实践中所引发的各种伦理争论加以探讨。     

临床试验安全性均势伦理探讨

均势原则是临床试验中的一项方法规则,同时也是临床试验研究的伦理规则。均势原则指导下的临床试验仍然存在设计缺陷、忽视安全风险评估、均势判定主体失当等方面的安全性伦理问题。这需要进一步确立安全性均势伦理准则,以强调在临床均势试验研究中不能对受试者造成生命健康方面的明显伤害,包括风险受益全面合理性评估原则、受试者生命安全底线原则以及利益相关者安全责任原则。落实安全性均势伦理原则需要采取多学科协作评估、优化均势判定主体结构及明确判定标准等基本规范策略。     

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.     

临床研究生科研人体试验的伦理审查状况调查

采用匿名问卷调查的方法对临床研究生进行关于科研人体试验的伦理审查状况的调查研究.研究表明,人体试验在临床科研中比重很大;伦理审查制度建设已初具规模,存在导师及研究生伦理意识的差距,接受伦理审查相关培训的需求强烈;要进一步正确认识知情同意的意义,应加强对安慰剂使用的严格监管.     

论临床试验中的治疗性误解及对策

研究和临床治疗在根本目的、基本方法、风险的正当性,以及应遵循的伦理原则等多方面都存在着根本性的区别.在临床试验的理论与实践中,混淆治疗与研究两者的区别,就会造成治疗性误解,从而违背科研伦理的知情同意原则,损害受试者的利益.以研究和治疗的区分为出发点,对治疗性误解的原因、引起的主要伦理问题及对策加以讨论.     

传统伦理向当代转换的可能性

当代伦理道德重构必然涉及传统伦理资源的开发与运用.开发、运用传统伦理资源,所涉及的一个前提性问题是传统伦理资源向当代有效转换如何可能?对这一前提问题的求证,既涉及到重新审查传统伦理的视域范围,也涉及到对传统伦理的实质构成内容、本质规定和价值导向的重新确认,更涉及到传统伦理资源向当代转换的原则确立与方法探讨.此三者,构成本文讨论的基本内容,并企图通过这种讨论,为传统伦理资源的当代转换提供认知视域、价值原则和宏观操作方法.     

临床试验的科学性和伦理问题

提出了临床试验中7种不符合伦理的情况,并以实例说明.同时介绍了符合伦理的临床试验的一种新的设计方法--动态设计以及实施动态设计所需要建立的独立数据检查委员会.最后讨论了动态设计的中文译名.     

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。     

我国人体临床试验和研究中有关伦理审查的若干问题

目前我国对涉及人体的临床试验与研究进行伦理审查时,存在的主要问题是:(1)对伦理审查的目的、意义不是足够清楚;(2)伦理委员会的构成不符合要求,缺少独立性;(3)有盲目运用伦理准则或方法,忽视文化、心理的差异的倾向.这些影响了伦理审查的效用,需要有针对性地加以改进.     

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.     

经验合作教学对教师课堂教学影响的实验研究

以"经验合作教学"的校本教师培训的新思路为依据,采用实验组、控制组前后测实验设计,选取初中语文和数学教师共33人,以年级学科组为单位施以为期8个月的经验合作教学干预,运用教育实验法考察经验合作教学对教师课堂教学(包括教学效能感、课堂情绪体验、教学效果)的影响。研究表明:(1)实验学校教师在一般教育效能感和教学效能感两个维度上的得分均较实验前有所提高,且个人教学效能感的提高量大于一般教育效能感;(2)实验学校教师轻松、愉快、满意的积极情绪体验的出现频率提高,失望的消极情绪出现频率降低;(3)实验学校教师在学生评价的课堂教学策略与互动、教学信息的总体把握与反馈两个维度的得分较实验前有所提高。     

Effects of practice on variability, effects of variability on transfer

Five experiments examined how practice early in skill acquisition affected variability and accuracy during skill retention (Experiments 1-5) and skill transfer (Experiments 3, 4, 5). Lag constraints required that each path from apex to base of a computer-generated pyramid display differ from some number (the lag) of immediately prior paths. Location constraints specified end points at which paths must exit the pyramid. In all experiments, an early optimal period for acquiring a variability level was identified. Both low and high levels of variability were sustained during retention; high levels facilitated transfer. The results suggest that (a) early practice that requires high variability sensitizes learners to changes in condition and (b) such perception-performance links facilitate transfer by activating appropriate alternative strategies/schema or initiating their construction.     

The uninterpretability of categories on degenerated scales: A comment on howard on comparisons

Results of Howard (1980) on analogue versus category encodings of occupational status comparison judgements are shown to be compatible with an alternative scaling model that makes no assumptions about hierarchical orderings of strategies, but instead uses some local distance properties on a continuum. It is indicated that the univariate case chosen by Howard cannot be unequivocally identified from the data and assumptions given, but that some ancillary postulates and experimental results would be needed. An alternative empirical system without the properties of social status or class ratings could be a better object of study.     

Influence of training on maintenance of equilibrium on a tilting platform

To assess the influence of training on the maintenance of equilibrium on a tilting platform, 13 young healthy male athletes aged 19 to 33 years were randomly divided into experimental (n=7) and control (n=6) groups. Two experimental sessions were performed before and after a specific 4-wk. training by the experimental group. Subjects stood upright on a tilting platform. The athletes were asked to maintain the platform as horizontal as possible during a 30-sec. test. The three-dimensional movements of the platform versus the ground were recorded by using a computerized optoelectronic digitiser. The platform plane was calculated and its directrix computed. The area of oscillation and instantaneous angular velocity of the directrix at standardized height were calculated. In both groups the area of oscillation and the angular velocity were reduced in Session 2, but the reduction was significant only in the experimental group. Specific training can significantly improve skill at maintaining equilibrium in young healthy sport performers.