伦理审查委员会规范化建设和质量提升策略

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我国药物临床试验伦理审查能力建设发展趋势

我国药物临床试验的深入广泛开展,促进了药物临床试验伦理审查水平的提高,伦理审查能力建设也取得了长足进步。但我国药物临床试验伦理审查能力建设面临系统的评估标准及体系、持续性培训和信息化程度缺乏等问题。加强药物临床试验伦理审查能力建设是我国医药领域进一步推进的重要工作,也是继续探索研究的热点内容及医学伦理审查工作者的自身需求。     

药物临床试验伦理审查存在的问题及对策研究

依据GCP药物临床试验管理规范,分析我国药物临床试验伦理审查工作中存在的问题,从如何保障受试者知情同意、加强伦理委员伦理知识培训、全程伦理监督及引入伦理验收、加强监管力度和完善监督体制等4个方面对药物临床试验伦理审查工作提出针对性建议,以逐步完善我国药物临床试验伦理审查工作。     

干细胞研究的伦理问题

人类胚胎干细胞研究的伦理问题来自两个方面。首先,胚胎干细胞是从人类胚胎中获得的,这样就冲破了对人胚胎研究的禁区。其次,胚胎干细胞的研究将不可避免地涉及克隆人的技术,因而使人们不得不切实地面对克隆人的问题。     

医学功能学科实验融入动物伦理教育的思考与探究

医学功能学科实验是医学实验课程体系的重要构成,主要研究对象为实验动物。针对动物实验中不符合动物伦理的现象,基于实验动物伦理教育的内涵和要求,探究将其融入医学功能学科实验的必要性、路径和措施,把实验动物法制化、标准化管理与知识育人、立德树人有机结合,引导学生遵守法纪和技术标准、恪守科技伦理规范要求、善待敬畏生命和关心关爱患者。     

结合科研项目开展科技活动与创新实验的探索与实践

教师结合科研项目,将其中与生物学基础知识关联较多的研究内容归纳整理成小课题,供生物专业学生开展科技活动和创新实验.这些课题不仅能拓宽创新实验的广度,还能使学生通过课题研究及时了解本学科的最新进展,培养学生的自学能力、创新能力、分析总结能力,促进老师和学生参与科技活动与创新实验的积极性.     

PBL+LBL教学模式在留学生医学微生物学教学中的实践

由于留学生的特殊性导致他们对传统教学模式的不适应,医学微生物学的课程特点使留学生学习掌握相关知识较困难,有必要探索好的教学方法,提高教学质量。我国传统的LBL教学模式和国际上流行的PBL教学模式各有优缺点,我们融合PBL和LBL的优点,互补其缺点,对留学生医学微生物学课程采取PBL+LBL教学模式,既发挥PBL教学法打破学科界限,容易调动学生学习积极性,注重培养学生自主学习和团结协作能力的特点,又结合LBL教学法传授知识系统、完整,培养学生基础理论扎实等优势。教学实践证明,PBL+LBL教学法运用于留学生医学微生物学教学,能激发留学生学习兴趣,在增强留学生对医学微生物学基础理论和基本技能掌握的同时,培养留学生知识整合的能力及创新思维的医学综合能力,提高教学质量。     

医学模拟教学结合以问题为导向的教学模式在重症医学教学中的应用研究

目的:探讨医学模拟教学结合以问题为导向(PBL)的教学模式在重症医学教学中的应用价值。方法:选取2015年1月~2017年1月在我院重症医学科轮转实习的五年制医学生64人作为研究对象。按随机数字表法将64名医学生分为PBL组(n=32)和结合教学组(n=32)。PBL组采用PBL教学,结合教学组采用医学模拟结合PBL教学。分别在入科时和轮转实习结束时对两组学员进行理论考试和技能操作考核,记录成绩并比较。理论考试和技能操作考核后采取发放问卷进行调查的形式获得学员对教学效果的主观评价。结果:轮转实习结束时,两组理论考试分数差异无统计学意义(P0.05);而结合教学组技能操作考核成分数显著高于PBL组,差异具有统计学意义(P0.05)。两组学员在教学方法接受度高、学习兴趣提升、自学能力提升和临床诊疗水平提高所占比例差异无统计学意义(P0.05);结合教学组学员在团队协作能力提高、沟通能力与人文关怀提高和技能操作水平提高所占比例高于PBL组,差异有统计学意义(P0.05)。结论:与单独PBL教学相比较,医学模拟教学结合PBL的教学模式应用于重症医学教学对学员技能操作的掌握有更好的效果,同时能提高学员团队协作能力、沟通能力以及对患者的人文关怀,且受到学员的认同与喜爱,应在重症医学的教学实践中逐步完善并进一步推广应用。     

Human genome diversity: Ethics and practice in Australia

Researchers who propose projects about the human past frequently fail to distinguish between scientific value and the impact of both the proposal and the possible outcome for participant groups. It is only in recent years, and still in relatively few cases, that Aboriginal Australians have been directly involved in projects about themselves. The legacy of previous research experiences is a lingering distrust of ‘white’ researchers who visit communities briefly, take material/information, publish papers, and are rarely seen again. This distrust is understandable but in turn becomes a barrier which many well-intentioned researchers are unable or unwilling to overcome. The expectations of the scientific community, particularly in the field of molecular biology, simply do not make allowances in terms of time or funding to build a trusting relationship between the researchers and the researched. Sensitivity to indigenous rights and expectations with regard to scientific research brings obligations to scientific investigators with which few are well prepared to deal. The direct involvement of indigenous people in research about themselves is essential to the development of trusting working relationships likely to result in valuable outcomes for all participants and increased opportunities for ongoing research. Well negotiated, co-operative research can provide information of value to both scientific investigators and local participants, but adequate and ongoing consultation, as well as the return of results to the communities in an accurate and appropriate form must be part of research strategy. For example, information about mitochondrial DNA studies may assist Indigenous Australian people, whose families were dispersed during colonisation by Europeans, to trace links with the past, find ‘stolen children’ and by association with other anthropological, linguistic and archaeological data, repossess some remnants of traditional knowledge, but researchers must ensure that participants have a realistic understanding of the limitations of the research.     

全球化背景下医学伦理学教学改革的探索

医学伦理学理论和实践根植于一定时期的社会经济、文化和教育,并随之发生改变和发展。随着全球经济一体化的进展完善,不同国家的文化和教育已在全球范围内互联互通并进而影响异乡本土医学文化。从目前我国医学伦理学教育和实践看,医学伦理学教学及评价体系已不能满足日新月异的全球化医学发展进程。本文从传统医学文化和医学伦理学的理论渊源入手,针对我国医学伦理学教学实践中存在的德性培育重视不足、临床决策能力培养缺失、标准化评价体系缺失等主要问题,探析教学改革的路径,以促进医学伦理学教学理论和实践的发展。     

人类疾病动物模型是医药创新研究的前沿

人类疾病动物模型对医药研究起着支撑作用,是进行医药研究的必备工具之一.本文阐述了人类疾病动物模型在医药研究中所能发挥的作用,以及在医药研究的历史中所做出的贡献.最后,对疾病动物模型在医药创新研究中应用的前沿进行了展望.     

Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi‐structured, in‐depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply‐rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.     

The context of embryonic development and its ethical relevance

Research on human stem cells and embryos creates ethical issues. Here I discuss ten frequently used arguments against research and point out their weaknesses. These arguments include the possessed potentiality of the embryo per se and, in contrast to other cell systems, the "slippery slope" argument, the right of disposal of parents, totipotency versus pluripotency, the burden of proof for research, natural versus artificial, and three arguments based on the precaution principle (the open biological questions, uncertainty regarding clinically applicable therapies, and the problem solving rule). I finally suggest a different answer to the ethical questions concerning research on human embryos and embryonic stem cells, which takes into consideration their biological context.     

老年糖尿病健康教育的临床伦理学思考

在糖尿病健康教育中,老年糖尿病健康教育的特殊性却常被忽视。从医学伦理学角度出发,分析了老年糖尿病健康教育的特殊性常被忽视的原因有:患者错误的医疗观念和临床医务工作者对老年糖尿病健康教育的认识不足。对这类老年糖尿病健康教育的医德要求有:首先医务工作者要对老年糖尿病健康教育有正确的认识;其次正确处理与协调医患关系和科室间关系;最后正确选择老年糖尿病健康教育的伦理道德观。