药物临床试验伦理委员会规范化管理的探讨——广州军区广州总医院的经验

针对以往本院药物临床试验伦理委员会伦理评审工作中存在的一些常见问题及目前伦理委员会的工作情况,提出了应依据《药物临床试验管理规范》来加强完善伦理委员自身建设,规范伦理审查过程。同时根据自身的经验为促进伦理委员会的科学规范发展提出了几点体会和建议。     

药物临床试验伦理审查的跟踪审查程序研究

为了保护受试者的合法权益,药物临床试验的伦理审查必须规范化进行.通过走访哈尔滨医科大学附属医院伦理委员会了解到,伦理审查程序缺乏相对完整性,特别是跟踪审查程序还在完善过程中,没有形成统一具体的操作规程.对此,结合我国实际情况,借鉴国外先进经验,提出构建药物临床试验跟踪审查程序的建议.     

药物临床试验伦理审查的跟踪审查研究

伦理委员会对药物临床试验的跟踪审查是保障药物临床试验质量,保护受试者权益的核心手段。通过对伦理审查中跟踪审查的含义、类别、内容和形式的阐述,以及对跟踪审查意义的探讨和研究,结合我国近年来伦理委员会跟踪审查的难点进行分析。在建立伦理委员会的监管机制,完善跟踪审查操作规程,加强对伦理委员会委员及研究者的继续教育和培训,完善伦理审查信息管理几方面提出切实可行的建议。     

我国实验动物伦理委员会建设的现状及问题分析

我国动物实验的伦理审查工作在不断地进步,但大多数实验动物伦理委员会还存在管理不规范、人员培训缺乏、资金投入不足、监管不力等方面的问题.对我国实验动物伦理委员会的建设现状和存在的问题进行了分析,并对如何加强我国实验动物伦理委员会建设提出了一些建议.     

药物临床试验初始伦理审查规范化程度研究

伦理审查是药物临床试验中保护受试者安全与权益、保证药物临床试验伦理合理性的重要措施之一。初始伦理审查是药物临床试验所有审查的重中之重。对73家医院药物临床试验的初始伦理审查管理制度及883个审查项目的执行情况进行调查。结果显示,初始伦理审查中存在着伦理成员构成不合理、伦理审查流程不完善、审查内容缺乏一致性等问题。结合实际工作情况和既有的研究成果,提出提高伦理审查能力、完善审查制度、完善伦理审查内容等措施。     

多中心临床研究的伦理审查——"2010年上海生物医学研究伦理审查能力建设高峰论坛"综述

"多中心临床研究"折射着全球化进程在经济、文化和政治领域中所带来的机遇和挑战.从药物研发角度而言,研究质量,即数据的真实性,曾一度是药监部门的监管重点.而随着法规执行力度的加强,包括各研究机构在质量管理方面的投入以及研究者素质和能力的提高,临床研究是否符合研究伦理原则越来越受到关注.对于多中心临床研究的伦理审查工作,需要加强各伦理审查委员会之间的沟通与合作,建立切实可行的伦理审查体系,对各伦理审查委员会的审查工作加以规范协调,并对各研究中心的研究者、申办方和政府监管部门提出的伦理问题予以更多的关注.     

上海市伦理审查地方标准的制定和执行

为使不同机构伦理委员会统一伦理审查标准,缩小审查质量差距,亟需更细化的标准操作规程指导伦理委员会工作。首个《涉及人的生物医学研究伦理审查规范》的上海市地方标准,对伦理审查基本流程、类型等作了详细规定,尤其对伦理审查工作中使用的各种工作用表、模板和文件清单作了规定,为上海市各级医疗机构和科研院校等伦理委员会规范伦理审查工作提供了参考标准,同时也成为了上海市卫生管理部门对伦理委员会督查评估的标准,对地方伦理工作起到了较大的推动作用,规范了流程,提升了审查质量。     

守护受试者的权益--对"药物研究与应用的伦理监督"

如何保障和守护临床试验研究中受试者的权益?这既是医生、患者(受试者)、工业界与公众注目的问题,也是医院伦理委员会工作面临并要解决的基本而至关重要的问题.从华西医院伦理委员会工作角度出发,分析了临床试验研究中的权益冲突和对受试者权益的科学、伦理与政策守护的要素,论述了如何保障受试者权益问题.     

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.     

研究者发起的临床研究之伦理跟踪审查探究

随着近年来中国临床研究的快速增长,研究者发起的临床研究(IIT)成为关注热点,而IIT的伦理跟踪审查是伦理委员会工作的一个薄弱环节。文章从政策支持不足、审查标准差异、伦理培训欠缺、工作量大而缺乏激励措施以及缺乏信息平台5个方面对IIT伦理跟踪审查的难点进行阐述,并从规范顶层设计、规范伦理跟踪审查程序、提高研究者伦理自律、加强伦理委员会建设和搭建伦理信息平台5个方面提出了应对措施,以规范IIT的伦理跟踪审查工作,促进受试者权益的维护。     

自伤青少年的冲动性

以自我报告、行为学和脑电为指标, 检验自伤青少年的冲动性。研究1, 对820名普通中学生和72名工读生进行问卷调查, 探讨自伤行为与情绪调节困难、冲动性的关系。结果表明, 冲动性能够预测自伤行为, 且预测效应量大于情绪调节困难。研究2, 采用Go/Nogo范式的ERPs实验, 检验自伤组与对照组冲动控制的行为学与脑电差异。结果表明, 自伤组Nogo正确反应的N2波幅显著高于对照组, N2潜伏期在部分电极点处高于对照组。脑电地形图显示两者的脑电差异主要体现在前额叶区。结论：自伤青少年的冲动性高于同龄普通青少年。     

Certification in Testing in Canada

This article presents a brief outline of a program developed by the Canada Employment and Immigration Commission (CEIC) for certifying employment counselors to use tests in Canada Employment Centres (CECs).     

儿童Graves'病研究进展

Grave's病(GD)是导致儿童甲亢最常见的病因,其易感性80%决定于基因因素.ATD治疗是最常推荐的初始治疗手段,但长期缓解率仅为30%.ATD诱导儿童GD缓解的合适用药时间尚不明确.最佳治疗方式(ATD、RAI或手术)的选择还存在重大争议.药物治疗复发的预测非常重要,最近建立了一种复发风险评分,通过种族、年龄、诊断时FT4、TRAb水平、ATD预期治疗持续时间将GD儿童分成低中高三类风险人群,对其复发风险作出评估,对于确定GD儿童在初始治疗时选择何种方案更为适合意义重大.     

Sex differences in relational aggression in preschool children in Iran

The purpose of this study was to compare scores on a Relational Aggression Questionnaire for preschool boys and girls in Iran. The questionnaire was developed here, and its reliability and validity were assessed. Teachers' reports of relational aggression in 258 children ages 3 to 7 years was studied. Sex differences in relational aggression were not observed and was not significantly different across age groups.     

Occupational Stress in Workers and Managers in Steelworks in China

Occupational stressors and strains of 121 Chinese steelwork employees and 122 managers were measured using the Chinese version of the Occupational Stress Indicator (OSI). It was found that factors intrinsic to the job, Type A behavior, logic, and organizational structure and climate were the main predictors of mental ill-health and physical ill-health in managers. Organizational structure and climate and relationships with other people were important predictors for workers. Management processes and organizational forces were the strongest predicting factors of job satisfaction in both samples. On certain OSI scales and subscales, managers scored statistically higher than workers. It is proposed that these results reflect the enormous economic and social changes currently taking place in China, together with certain features inherent in Chinese organizational and managerial processes.     

Hemifacial differences in the in‐group advantage in emotion recognition

Some researchers have interpreted findings of in‐group advantage in emotion judgements as ethnic bias by perceivers. This study is the first linking in‐group advantage to subtle differences in emotional expressions, using composites created with left and right facial hemispheres. Participants from the USA, India, and Japan judged facial expressions from all three cultures. As predicted, in‐group advantage was greater for left than right hemifacial composites. Left composites were not universally more recognisable, but relatively more recognisable to in‐group members only. There was greater pancultural agreement about the recognition levels of right hemifacial composites. This suggests the left facial hemisphere uses an expressive style less universal and more culturally specific than the right, and that bias alone does not cause the in‐group advantage.     

Changes in Sexual Orientation and Object Choice in Midlife in Women

Changes in sexual orientation or object choice in midlife can represent many different dynamics. Understanding these involves recognition of the psychological developmental issues of this period, such as changes in self concept, identity, the awareness of time, and changes in expectations and goals, such as the wish to create a family. Other needs, for intimacy and emotional richness, or the revival of wishes for closer ties to one's mother, can then become dominant and be expressed sexually. Earlier, more conventional choices can be abandoned, particularly after children are born. For some women an early homosexual relationship is replaced temporarily or permanently by a heterosexual one. This can represent permission to move outside the world of women, or a wish for a family and children. Fluidity of choice may be more characteristic for women than men and may be related to characteristics of the female body.     

Ethics in Research in Mathematics Education

Most scientific domains have guidelines concerning ethics in research. These guidelines are designed to enable researchers to conduct good research while avoiding potential harm to research participants. This paper examines the bases for ethical codes in research and discusses how these codes are operationalized in research conducted in the field of mathematics education.