对《涉及人的生物医学研究伦理审查办法》的解读

解读国家卫生和计划生育委员会《涉及人的生物医学研究伦理审查办法》出台背景及特点,分析该办法强制要求有关医疗机构设立伦理委员会后,带来离体样本及信息的生物医学研究难题、伦理有关人才的需求增加而任职标准缺位、政府多部门的沟通协作有待推进、医疗机构之间的多中心伦理审查及医疗机构内部的伦理体系构建等实施问题,期待多方合力,加强沟通,落实监管,完善医学伦理组织建设,推动医学研究的长远发展。     

医学研究生医学研究伦理审查的探讨

介绍了国内医学研究生医学研究伦理审查的重要性和特点,并结合广东省中医院伦理委员会近年来伦理审查的实践,对医学研究生医学研究提交伦理的初次审查、跟踪审查、研究者的资质以及提交材料的质量和经费等问题进行了初步探讨并提出了相应的解决措施。提出通过设立专门的审查委员会,做好伦理审查指引工作,并通过各部门之间的沟通协作,加强对导师、研究生伦理知识的培训,促进医学研究生科研的规范化发展。     

伦理委员会的建设与运作——涉及人的生物医学研究伦理问题国际研讨会综述

随着生物医学研究的飞速发展,伦理问题的重要性备受关注.为规范伦理委员会的建设与运作,充分发挥伦理审查的作用,上海医药临床研究中心、上海市医学伦理学会和上海交通大学医学院附属瑞金医院于2009年12月10日～12日在上海共同主办了以"涉及人的生物医学研究伦理问题-伦理委员会的建设与运作"为主题的国际研讨会.     

伦理审查中的行政权与伦理权谁大?——“换头术”伦理审查的思考

以哈尔滨医科大学任晓平实施的"换头术"为例,探讨在我国现有的伦理委员会伦理审查制度下,为何不经伦理审查,可以行"换头术"的缘由,包括了伦理委员会缺乏独立性、伦理审查中行政权力的干预和研究者对伦理审查的不重视。同时分析了伦理委员会工作现状中的不足。从而提出改进措施:完善制度、加强监督、提升能力、宣传教育和提高认识。只有在伦理审查工作中优先行使伦理权,严格执行伦理审查制度,才能让伦理审查工作发挥其功效,将伦理审查真正地落到实处。     

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。     

基因编辑技术临床应用的伦理问题与审查制度规制

针对"基因编辑婴儿"事件暴露出的我国伦理监管体系漏洞,尤其是伦理审查制度的缺陷,通过借鉴国外先进经验,提出构建对医疗机构伦理委员会的初次审查进行两次独立复审的行政监管制度,即"地方-国家"二级独立伦理审查制度。该制度由医疗机构等基层单位的伦理委员会进行初次审查,然后由省级行政主管部门的伦理委员会进行第一次独立审查,再由国家卫生健康委员会的伦理委员会进行第二次独立审查。二级独立伦理审查制度较为符合我国的实际情况,有助于规范生物医学研究活动秩序,实现基因编辑技术与伦理监管体系的良性互动与协调发展。     

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。     

提高生命科学研究中的伦理审查质量的思考

我们曾经的生物医学研究中,有些研究者往往只注重自己研究的目的,违犯如《纽伦堡法典》,《赫尔辛基宣言》,《贝尔蒙报告:保护人体受试者伦理学原则及准则》等伦理原则.通过建立健全伦理评审系统,规范伦理审查程序,建立对伦理委员会的审查评估系统,期望使生物医学研究更加符合保护和促进人类健康的目的.     

提高生命科学研究中的伦理审查质量的思考

我们曾经的生物医学研究中,有些研究者往往只注重自己研究的目的,违犯如《纽伦堡法典》,《赫尔辛基宣言》,《贝尔蒙报告:保护人体受试者伦理学原则及准则》等伦理原则。通过建立健全伦理评审系统,规范伦理审查程序,建立对伦理委员会的审查评估系统,期望使生物医学研究更加符合保护和促进人类健康的目的。     

首届中欧研究伦理会议在京举行

首届中欧国际合作研究伦理问题研讨会于2007年3月9日～10口在北京台湾饭店举行。这是中欧合作项目的一部分,也是中欧在研究伦理方面合作的第一次会议。中欧研究伦理合作项目有两个主要目的：一是对巴西、中国、印度和南非四个国家管理涉及人的生物医学研究条例有一个正确而可靠的了解,并在此基础上提出最优伦理审查程序的建议;二是向决策者、伦理委员会委员和研究人员提供一个详尽而全面的指导文件,可用作国际合作研究政策的框架。     

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.