对知情同意书和知情同意过程的探讨

在《医疗事故处理条例》实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程。签字的知情同意书不等于知情同意,知情同意书不等于“生死契约”。知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得。因此知情同意过程应该重要于知情同意书。医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式。     

浅谈肺癌手术的知情同意

手术在肺癌治疗中占有重要地位。胸外科医生充分告知手术利弊、患者和／或代理人充分理解告知内容是顺利完成知情同意的重要步骤。本文就肺癌手术知情同意的意义、临床工作中存在的问题及解决办法进行了初步的探讨。     

浅析脑胶质瘤临床试验中知情同意的问题

通过对医院目前开展的脑胶质瘤临床试验知情同意过程中的观察,综合科室脑胶质瘤临床试验的开展情况,针对不同类型脑胶质瘤病人尤其是功能区受损以及伴有认知功能受限的病人,分析签署知情同意过程中存在的问题,经探讨并提出整改及解决办法。通过规范的签署知情同意,针对病情不同的脑胶质瘤受试者采取个体化签署知情同意,充分尊重受试者意愿,保证临床试验顺利进行,使受试者权益得到充分保障,促进临床试验规范、安全、有序的开展。

     

Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities.     

急诊医疗中的知情同意问题

急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除。这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同。其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步。真正的原因是,知情同意在急诊治疗中往往以特殊或不同的形式表现出来。     

知情同意在我国临床医疗中的实施

知情同意在我国至少已倡导与实践了20年,由伦理要求上升到法律准则无疑是一个跨越式的进步。当前,医院落实知情同意的实践滞后于患者要求,除了主观方面的原因外,客观上存在知情同意与保护性医疗,病人自主权与医生处置权、医学对疾病的已知与未知等诸多盾与难点。要使知情同意在我国临床医疗中真正落实尚有许多工作要做;提高医务人员尊重病人权利的意识;完善执行知情同意的方式与程序;细化与知情同意的实施原则;营造良好的社会氛围,探索非西方环境下知情同意实现途径。     

The Effect of Emotion on Visual Attention to Information and Decision Making in the Context of Informed Consent Process for Clinical Trials

The aim of this study was to examine the influence of emotion on visual information processing and decision making in the context of informed consent. Researchers are ethically obligated to ensure informed consent in clinical trials; however, many volunteers have unrealistic expectations about the value of an experimental therapy. Moreover, suboptimal participation rates for clinical trials may be partially attributable to perceptions that ethical obligations to volunteers are not met. This study examines whether discrete negative emotions (fear, anger, and sadness) differentially influence information processing, visual attention, and decisions in the context of clinical trial informed consent. Community participants completed a standard emotion induction (or control) and then read an actual consent form from a clinical trial while eye movements were tracked. Fear and anger produced the most prominently different patterns of systematic processing and visual attention, such that fear induced longer fixations to information presented, whereas anger induced shorter fixations. Moreover, among women only, fear increased decisions to participate, compared with anger and neutral emotion. Examinations of associations between eye‐tracking variables and self‐reported outcomes indicated that for angry participants only, less systematic processing was associated with greater decisions to participate. Negative emotions of any kind decreased accurate perceptions of trial benefit. These patterns suggest a complex interplay among emotion, processing style, and decision making. Future research is necessary to further probe these effects among potential clinical trial volunteers. Published 2016. This article is a U.S Government work and is in the public domain in the USA.     

临床麻醉中知情同意的思考

临床麻醉工作中,尊重患者自主权是知情同意的基础,知情同意反映了患者自主权与医学干涉主义之间的相互妥协。在信任基础上的知情同意,是患者自主权的最佳体现,也是对医学干涉主义的尊重,从而为患者的利益提供服务。     

口腔临床医疗实践中知情同意的实现

知情同意是一项重要的伦理学原则和患者自主权的具体表现形式。本文分析了在口腔临床医疗实践中知情同意存在的突出问题和原因,并探讨了实现的方法和途径。本文认为只有遵循全面、精确、真实的告知原则,让患者在充分理解的基础上做出自主地选择,才能保障知情同意原则的实现。     

A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest.     

知情同意的临床实践存在的问题及对策

临床医疗实践中贯彻实施知情同意原则旨在保护病人的权益不受侵犯,然而知情同意原则实施起来并不简单,它常常会受到主客体两方面种种因素的制约,陷入意想不到的困境。分析了知情同意原则在实施过程中可能出现的一些难以回避的问题,并针对这些问题探讨了若干对策。     

知情同意—患者的权利与困境

知情同意是目前被广为认可的一项病人权利。从历史渊源看,它可以分为出于医生权威的知情同意与出于尊重患者人格、尊严、个性化权利的知情同意。尽管东西方对权利主体的强调不一致,但都是出于医疗行善的目的。这并不一定能保证病人的真正利益。现实中,有必要对这一权利做一定的限制。     

Toward a Model Informed Consent Process for BRCA1 Testing: A Qualitative Assessment of Women's Attitudes

As an initial part of a project to develop a model informed consent process for BRCA1 testing, we conducted a series of focus groups. At the groups, women initially expressed great interest in testing, but their interest diminished after learning more. If offered testing, women would most want to learn about test accuracy, practical details of testing, and management options if the result was positive. Perceived benefits of testing included gaining information leading to risk reduction, relief of uncertainty, more responsible parenting, and assisting in research. Perceived risks included the discomfort and cost of the testing process itself, and anxiety after a positive result. The risk of possible insurance discrimination was rarely mentioned spontaneously. Many women would want their providers to make recommendations, rather than be nondirective about testing. We observed that women vary greatly in their informational and counseling needs, and suggest that the informed consent process should be individualized, taking into account a woman's perception and her preferences for how testing decisions should be made.     

浅析知情同意权在我国立法中的不足

分析了我国在知情同意问题上的法律规则,指出我国现有法律存在四方面的立法缺陷,即对医生同时柯加告知义务与不告知义务,使医生陷入两难处境;在病人同意权方面只要求实验性和特殊诊疗措施征得病人同意,同意的主体上多且乱,过份强调病人家属的同意,侵害或剥夺了病人的自主权;对知情同意权的含义认识不清;知情权与同意权相分离而没有形成完整统一的病人知情同意权,在此基础上,提出完善我国立法的建议。     

正确理解知情同意

知情同意最初由美国于18世纪末19世纪初提出,随着社会不断进步,医学科学的不断发展,人们权力意识的不断增强,知情同意作为患者享有的一项权力,医务人员在医疗过程中应遵循的一条原则已日益到人们的关注。然而在现实的医疗实践中人们对这一的理解和认识还存在一定的偏差。正确理解,践行知情同意既是尊重患者的权利,贯彻“以病人为中心”的原则的保证,也能有效地保护医务人员的合法权益。     

病人、医生与知情同意

医务人员应当视病人为治疗疾病过程中的参与者.知情同意的目的是,使病人充分理解他的困境后做出理性的决定.医生与病人分享信息、分担责任与做出决定,以保持良好的医患关系.     

基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题.通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢.     

重视手术委托知情同意 预防小儿外科医疗纠纷

造成小儿外科医疗纠纷的重要因素是医患沟通不够、缺乏信任和理解。知情同意是加强医患沟通和信任的重要方式。深入理解并实现患儿及家属的知情同意权,重视和做好手术委托知情同意书的签署,合理履行告知说明义务,让家属在充分知情基础上做出自主的理性的选择,可缓解紧张的医患关系,减少医疗纠纷的发生。     

Psychology of the Informed Consent Process: A Commentary on Three Recent Articles

In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.     

论医师的告知说明义务

患者知情同意权的真正实现有赖于医师告知说明义务的履行,医师此义务要在诊疗中又因所处不同阶段在法律中有不同的性质。在具体治疗前为取得患者有效承诺的告知说明义务在医疗契约中为从给付义务,而实施完具体诊疗后,就有关康复、服药等注意事项所作的告知说明属于附随义务。实践中医师对此两阶段的义务都应当给与同样的重视,以利于维护患者的利益。