供精治疗的管理

辅助生殖技术应用产生的伦理问题很多,所引起的争论是前所未有的。人类辅助生殖技术伦理原则包括有利于患者、知情同意、保护后代、社会公益、保密、严防商业化及伦理监督7个方面。而供精人工授精存在的伦理观念的冲突更加明显。如果不对其进行规范化的管理,就会导致涉及社会、伦理等重大后果。沈阳东方医疗集团菁华医院通过近5年的临床实践,在供精管理方面进行了许多有益的尝试,在知情同意、随访、冷冻精液等方面形成了系列的管理体系,取得一些实效。     

接受供精辅助生殖技术治疗夫妇知情同意与生育伦理知识调查研究

目的：探讨接受供精辅助生殖技术（ART）治疗夫妇对知情同意和生育伦理的认知、行为和态度。方法：对在广东省计划生育专科医院登记接受供精人工授精技术治疗的92例对象进行自填式问卷调查。内容包括一般信息、生育压力、知情同意和生育伦理的认知、态度和行为。资料处理方法采用描述性统计。结果：对象面临强烈的生育渴求和巨大的生育压力,且主要来源于对象自己、社会和父母。对供精人工授精技术治疗有比较充分的知情,但仅有75%的对象知道ART后代可能发生出生缺陷。在接受供精人工授精技术治疗时,如果可以选择供精者生物学特征时,58%的对象优先选择供精者身高,其次是相貌和学历。对象支持在治疗前签署知情同意书。结论：对接受供精ART治疗的夫妇,在治疗前应做好知情同意的全过程。     

接受供精辅助生殖技术治疗夫妇知情同意与生育伦理知识调查研究

目的：探讨接受供精辅助生殖技术（ART）治疗夫妇对知情同意和生育伦理的认知、行为和态度。方法：对在广东省计划生育专科医院登记接受供精人工授精技术治疗的92例对象进行自填式问卷调查。内容包括一般信息、生育压力、知情同意和生育伦理的认知、态度和行为。资料处理方法采用描述性统计。结果：对象面临强烈的生育渴求和巨大的生育压力,且主要来源于对象自己、社会和父母。对供精人工授精技术治疗有比较充分的知情,但仅有75%的对象知道ART后代可能发生出生缺陷。在接受供精人工授精技术治疗时,如果可以选择供精者生物学特征时,58%的对象优先选择供精者身高,其次是相貌和学历。对象支持在治疗前签署知情同意书。结论：对接受供精ART治疗的夫妇,在治疗前应做好知情同意的全过程。     

临床医学科研中的知情同意之我见

结合临床医学科研伦理管理中的经验,对知情同意的要素、知情同意的方式、知情同意的主体、知情告知的主要内容、知情告知的过程、知情同意书的签署、知情同意书的保存等方面进行了探讨,提出了一些见解、体会和经验,供广大医学科学研究工作者和医学科研管理人员参考.     

配子捐赠指征界定与伦理思考

新兴发展的辅助生殖技术（ART）为不孕不育者带来了福音,亦为遗传病患者与高龄女性带来了为人母的希望。由于ART所涉及的不仅有不孕不育夫妇的利益,尚有家庭、后代及社会问题,因此伴随着供精、供卵等新的ART衍生技术的实施,相关伦理问题日益突出,ART的应用与发展面临新的挑战。探讨卵子捐赠以及几种特殊情况下供精指征。     

配子捐赠指征界定与伦理思考

新兴发展的辅助生殖技术（ART）为不孕不育者带来了福音,亦为遗传病患者与高龄女性带来了为人母的希望。由于ART所涉及的不仅有不孕不育夫妇的利益,尚有家庭、后代及社会问题,因此伴随着供精、供卵等新的ART衍生技术的实施,相关伦理问题日益突出,ART的应用与发展面临新的挑战。探讨卵子捐赠以及几种特殊情况下供精指征。     

人类辅助生殖技术和人类精子库伦理原则

一、人类辅助生殖技术伦理原则人类辅助生殖技术是治疗不育症的一种医疗手段。为安全、有效、合理地实施人类辅助生殖技术 ,保障个人、家庭以及后代的健康和利益 ,维护社会公益 ,特制定以下伦理原则。(一 )有利于患者的原则1 .综合考虑患者病理、生理、心理及社会因素 ,医务人员有义务告诉患者目前可供选择的治疗手段、利弊及其所承担的风险 ,在患者充分知情的情况下 ,提出有医学指征的选择和最有利于患者的治疗方案 ;2 .禁止以多胎和商业化供卵为目的的促排卵 ;3.不育夫妇对实施人类辅助生殖技术过程中获得的配子、胚胎拥有其选择处理方式…     

供精人工授精随访管理经验

<正>随着人类辅助生殖技术的不断发展,供精人工授精(AID)成为治疗男性不育症的手段之一。卫生部《人类辅助生殖技术和人类精子库伦理原则》和《人类辅助生殖技术规范》规定实施AID的随访率必须是100%,来自同一名自愿供精者的精液至多只能供5名妇女妊娠。为了保护母婴健康,维护后     

男性不育的伦理学困境

针对男性不育这一愈来愈突出的社会现象,首先阐述了其定义和患病原因,然后主要从伦理学方面对其进行了分析。包括两部分,即男性患有不育症后的伦理学问题和诊断治疗中的伦理学问题。男性辅助生殖技术可实现患者的正常生育,但在供精上存在着诸多伦理学问题,而且对受孕女方也有一定的风险。最后介绍了精原干细胞移植法的研究现状及治疗男性不育中存在的伦理问题。     

关于人类辅助生殖技术的伦理问题

人类辅助生殖技术的飞速发展,在给众多不孕不育家庭带来希望和幸福的同时,也不可避免地对人类原有的社会伦理观念产生了巨大的冲击。本文在对人类辅助生殖技术伦理问题进行总结和分析的基础上,提出了人类辅助生殖伦理调节原则,并探讨了该原则的应用。     

Informed Consent in School Health Research: Why, How, and Making It Easy

The obligation to obtain informed consent for student participation in health-related research creates a complex set of legal, ethical, and administrative responsibilities because the interests of research integrity are delicately balanced against protection of human subjects. Even the term itself sparks a range of responses depending on one's perspective and stake in the process. This paper traces the historical impetus behind obtaining informed consent, identifies key elements comprising informed consent, and reviews types of consent procedures used in schools. The authors suggest 20 ways to boost response rates while providing a realistic level of informed consent for school-based studies.     

2007年首都医学发展科研基金申请书伦理自评及管理状况调查

目的评价2007年首都医学发展科研基金伦理管理现状。方法采用现况调查方法对基金申请标书做描述性分析,评价基金申请人对临床研究伦理问题的认知和基金伦理管理现状。结果652份申请书覆盖北京地区14区2县128家医院。申请者对伦理问题有一定认识的占88．7％;标书中考虑了受试者知情同意的占72．5％;考虑研究工作可能对受试者造成伤害的潜在风险的占62．0％;说明研究工作将保护受试者个人隐私的占49．4％;但进行受益／风险评估的仅有28．7％。三级医院申请者对伦理问题有一定认识的比例（90．2％）高于二级医院和一级医院（84．6％）。教学系统附属医院申请者对伦理问题有一定认识的比例（93．9％）高于军队系统医院（80．2％）。55岁及以上申请者对伦理问题有一定认识的比例（70．0％）低于其他年龄段申请者（89．2％）。描述性研究和病因学研究申请者对伦理问题的认识低于其它类型的研究者。578份申请书填写了医院伦理委员会或科研管理部门伦理审查意见,其中62．6％的填写基本规范。结论2007年北京地区临床研究基金申请者中多数对l临床研究涉及的伦理问题已有初步认识,但认识水平亟需提高。医院伦理委员会或科研管理部门已开始对临床研究基金申请进行伦理审查管理。在临床研究基余中开展伦弹管理的外部条件已初步具备。     

The informed consent aftermath of the genetic revolution. An Italian example of implementation

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.     

Ethical problems of recording physician-patient interactions in family practice settings

Recordings of actual physician-patient interactions are an important tool for family medicine education and research. Their use, however, poses two sets of ethical problems: one dealing with privacy and confidentiality, and another related to limitations upon informed consent in the context of ordinary medical care. Experience with audiotaping and videotaping led to engaging in a "principle-based" method of ethical reasoning in which problems generated by difficult cases were examined in light of both current rules or guidelines and four fundamental ethical principles. Through this approach specific policies were developed for voluntary, informed consent and for protection of privacy, while recognizing that each case must be judged in the light of the physician's obligation to do the best for each patient.     

患者知情同意权保护的两难问题研究

患者知情同意权的保护在医疗活动中受到越来越多的重视，这是社会进步的表现。患者有多种权利，我们不能单纯保护其知情同意权而忽视其他权利的保护。在现实的医疗活动中，医护人员往往面临权利保护冲突的两难困境，诸如知情同意权与隐私权保护的冲突；知情同意权与生命权保护的冲突等。在两难境地，医护人员需平衡患者的权利进而做出适当的选择。在缺少法律明确规定的情况下，要求医务人员做出选择，但在其选择出现不利结果时承担责任是有失公允的。因此，需要制定和完善法律以避免权利保护的冲突或者明确权利保护的优先性，帮助医护人员摆脱两难，更好地保护患者的权利。     

整形美容手术中知情同意的伦理探讨

目的 明确知情同意在整形美容行业中的必要性和重要性,探讨其中隐藏的伦理学意蕴,用知情同意这一重要的伦理原则规范医务人员的行为.方法 使用文献检索法、专家咨询法、抽样调查等方法对整形美容手术中的知情同意情况进行调查,分析实施过程中的规范化情况和遇到的难点和伦理困境.结果 整形美容医师牢牢把握了知情同意这一原则,作为术前常规工作执行,但在实际操作过程中还有些难点.结论 整形美容医生应规范履行知情告知义务,尊重患者的知情权;院方须制定一系列的制度来规范知情同意这一原则.     

Ethics of Informed Consent for Pragmatic Trials with New Interventions

Objectives: Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the “real world” nature of such trials. Specifically, we examine to what extent modifications (waivers or alterations) to regulatory consent for EPTs would be ethical. Methods: We first identify broadly accepted necessary conditions for modifications of informed consent (namely, the research involves no more than minimal risk of harm, the research is impracticable with regulatory consent, and the alternative to regulatory consent does not violate legitimate patient expectations) and then apply those criteria to the premarket and early postmarket contexts. Results and Conclusions: The analysis shows that neither waivers nor alterations of regulatory consent for premarket EPTs will be ethically permissible. For postmarket EPTs with newly approved interventions, waivers of consent will be ethically problematic, but some studies might be conducted in an ethical manner with alterations to regulatory consent.     

Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.     

医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。