临床知情同意准则确立的伦理和法律意义

由于临床医生忽视病人知情同意权而引起的医疗法律纠纷案不断增多,成为医院医疗和管理工作的一个新的关注点。维护病人在医疗中享有的知情同意权是临床医疗的基本准则;病人的这种自主权利受到道德的支持和现行法律的保护,提高医院和医生对医疗中知情同意的意识和相关问题的敏感性在未来的医疗和医患关系中显得越来越重要。     

我国知情同意原则的医学实践状况分析

借助《中国生物医学文献光盘数据库》对国内近10年来有关知情同意的医学文献进行了统计。从文献的年代、期刊、区域、学科及内容分布等角度分析了知情同意原则在中国的医学实践状况。归纳了一些有代表性的观点，并就知情同意在我国的应用和发展趋势提出了看法。认为医患关系观念的转变、公民权益意识的建立、相关法律条文的明晰和可操作性是知情同意原则实施的必要条件。     

知情同意原则在社区卫生诊断调查中的应用探讨

社区卫生诊断是获取辖区卫生状况最直接、最有效的手段之一。在开展社区卫生诊断过程中所涉及到的伦理学,尤其是与伦理学中知情同意原则的具体结合和运用需要引起基层社区卫生服务工作者的足够重视。     

浅谈计划生育技术服务中的知情同意

计划生育技术服务包括避孕和节育的医学检查,计划生育技术并发和计划生育药具不良反应的诊断治疗;施行避孕节育,不育的其他生殖保健项目。知情同意是服务机构在提供优生健康检查和计划生育节育手术前必须完成的一项重要工作。知情用意包含初始要素,知情要素,同意要素三大要素和知情同意权。     

浅谈新药临床试验中的知情同意

从一个可能的受试者处获得知情同意书 ,也许是试验中研究者必须面临的最困难的工作之一。尽管如此 ,使每个受试者充分了解试验目的 ,预期他可能的受益和可能承担的风险与不便 ,仍是十分必要的。尽管已有许多有关知情同意的文章发表 ,但对研究者在临床试验中如何获得受试者的知情同意 ,却很少有指导性的文章。本文的目的不是讨论在临床试验中不获得受试者的知情同意是否符合伦理道德 ,而是对受试者明确的同意参加临床试验时 ,研究者如何获得知情同意提供一些实际帮助。一、认真研究实验设计要想获得受试者的知情同意 ,必须认真的研究实验设计…     

重视知情同意过程 防范医疗纠纷

知情同意权是病人在诊疗过程中享有的基本权利之一,尊重和保护病人的知情同意权是医务人员应尽的义务。本文从行使知情同意权的条件入手分析知情同意过程及其作用,以期达到改善医患关系,减少医疗纠纷的目的。     

医学临床研究中知情同意存在的问题和如何保护受试者的知情同意权

通过对北京大学第一医院临床研究伦理委员会审查的83份涉及人的临床科研项目知情同意书进行整理和分析,归纳和总结出主要存在问题：违反知情的“信息的充分告知”、“信息的充分理解”及违反“自由的、自主的同意”原则并提出改进建议。     

医院实施知情同意调查

知情同意作为医疗实践的一个基本原则越来越为人们所接受和认可,但是目前医院在实施知情同意的过程中还存在种种制约因素？本文通过调查某三甲医院医师94人及住院患者105人对知情同意的理解和看法,探讨当前在医院实施知情同意中存在的不足和问题,提出了建议与对策     

知情同意在医患沟通中的实践

医患沟通在现今提倡人文主义的医疗环境下，对于诊治疾病的效果以及避免医患纠纷的产生，显得尤为重要，而作为医患沟通的核心——知情同意的正确运用则成为了实现医患有效沟通的重要基础。文章通过理论价值和实践现状分析，对医患沟通在实际运用中存在的问题进行了探讨。     

医疗服务中的知情同意与告知义务

医疗服务是医疗机构及医务人员为病人提供防病治病服务的过程,在这一过程中,医疗机构不仅要考虑到获得较好的经济效益,更需要注重取得良好的社会效益。医疗机构的根本职责是通过提供医疗保健服务,保障人民的身心     

论生物医学研究中受试者知情同意权的保护

保护生物医学研究中受试者的知情同意权具有重要意义.本文从国内外法律依据、研究者的义务、伦理委员会的作用及受试者自身的维权等方面,探讨如何保护受试者的知情同意权.     

实施知情同意 防范医疗争议

医疗服务中，常有医患双方因为对服务期望的不同意见导致的矛盾冲突，甚至形成医疗争议，问题源于医患法律关系的基本定位及其特殊性。医患法律关系基本定位为民事法律关系，被视为医疗服务合同。与其他服务合同相比，由于医疗服务的个性化特点和损害特性，医疗服务合同在需要医患双方认识达成一致的合同标的、履行方式和数量频次、合同履行风险、以及服务所需时间期限和费用等主要的合同元素方面则是严重残缺的。为了维护医患双方的合法权益，作者提出了在医疗服务的各个不同阶段，通过知情同意对医疗服务合同进行完善和补充，以防范和减少医疗争议发生的思路，分析了知情同意的重要意义和目前存在的主要问题，并且就告知的内容、范围、主体、对象、方式、证据等具体操作和管理问题提出了切实可行的建议。     

患者知情同意权实施中的问题

从医学伦理学的角度，分析了知情同意权在实施过程中可能出现的一些问题，比如存在“知情同意”与繁复的医疗过程的矛盾、行使“知情同意权”与保护性医疗制度的矛盾、“知情同意”与医患双方医疗知识不平等的矛盾、患方选择与正常医疗行为的矛盾、特殊情况下患方权利人的“知情同意”与医生责任的矛盾等，同时还要考虑医生的因素、病情的因素及患者的因素等。     

Proposing modesty for informed consent

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.     

Changing constructions of informed consent: qualitative research and complex social worlds

Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.     

Risk perception and decision processes underlying informed consent to research participation

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.     

医疗技术人体试验中受试者的知情同意权

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则.受试者知情同意权包括知情权和同意权.对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担.     

Turkish and German patients' recall of diagnosis and therapy before and following informed consent

Objective. Adequate patient knowledge is essential for good compliance, effective doctor–patient communications and is the basis for informed consent. The purpose of the study was to examine differences in recall of informed consent procedures between patients with different ethnicity and to identify potential explanatory factors.

Design. We analyzed 579 patients, attending and released from a gynecology department in Berlin, Germany, between March 1997 and October 1998. To assess actual understanding of disclosure information, Turkish and German patients' perceptions were compared with documented data of their diagnoses and therapy.

Results. Overall, patients correctly identified 69% of their diagnosis and 76% of their therapy. On discharge overall patients' recall decreased significantly. Whereas German patients' knowledge increased, Turkish patients showed significant decreases in diagnosis and therapy recall.

Conclusion. The results reflect socio‐demographic differences between ethnic groups and indicate deficiency of the informed consent process for patients belonging to an ethnic minority.

Fragestellung. Ein ausreichend gutes und adäquates Wissen der Patienten ist wichtig für eine gute Compliance, eine effektive Arzt‐Patienten‐Beziehung und stellt die Basis für den sogenannten informed consent dar. Zielstellung der Studie war die Feststellung von Unterschieden im Wissensstand von Patientinnen verschiedener Ethnizität vor und nach der Aufklärung auf einer gynäkologisch‐operativen Station und die Identifizierung von Erklärungsfaktoren für eventuelle Differenzen.

Patientinnenkollektiv und Methodik. Es wurden 579 Patientinnen in die Studie einbezogen, die zwischen März 1997 und Oktober 1998 auf einer gynäkologischen Station in Berlin behandelt und mit einem Fragebogen befragt wurden. Zur Feststellung des jeweiligen aktuellen Informationsstandes wurden die Angaben der deutschen und der türkischstämmigen Patientinnen mit den dokumentierten Daten zu Diagnose und Therapie in den Krankenakten verglichen.

Ergebnisse. Insgesamt konnten 69% aller Patientinnen ihre Diagnose und 76% die Therapie richtig wiedergeben. Der Kenntnisstand am Ende des stationären Aufenthaltes war insgesamt signifikant schlechter als am Anfang. Während die deutschen Patientinnen besser Bescheid wussten, zeigten die türkischstämmigen Patientinnen signifikante Defizite hinsichtlich ihres Wissens über ihre Diagnose und Therapie.

Zusammenfassung. Die Ergebnisse reflektieren soziodemographische Unterschiede zwischen ethnischen Gruppen und zeigen Defizite im Informationsprozess vor und während des Klinikaufenthaltes insbesondere bei den Migrantinnen auf.     

Personal autonomy and informed consent

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.