用合同法诠释手术知情同意

依据合同法、执业医师法、医疗机构管理条例及其实施细则、医疗事故处理条例、病历书写规范等法律、法规、部门规章,诠释手术知情同意的法学渊源,旨在阐述手术知情同意的法律依据及规范手术知情同意,以保障医患双方的合法权益,减少医患纠纷.     

手术知情同意的实施及改进效果分析

目的探讨综合性三甲医院手术患者知情同意改进实践的干预效果,进一步确保医疗安全,改善医患关系。方法根据上一轮PDCA循环中手术患者知情同意过程的实施缺陷,使用六步法的医疗质量"闭环"管理,采用强化医学人文知识培训和医疗质控,选取一组医生两年同期手术患者的运行病历评估和患者态度调查,将改进前与改进后进行自身比较。结果在知情同意实践过程中,医生的法制意识、医患柔性沟通、知情同意书的执行、患者的满意度及依从性都有显著改进,大多数差异有统计学意义(P<0.05或P<0.01)。结论医疗知情同意的过程,需要外科医生注重与患者的柔性沟通,同时完善落实知情同意告知内容,最后达到规范知情同意书的刚性执行。     

泛知情同意概念在我国的引入与实践思考

近年来国外正在逐步推行泛知情同意来提升医疗数据和生物样本的利用率, 但泛知情同意可能面临着告知不完善而影响受试者权利等伦理问题。国外对于泛知情同意已有相关规定和实践。我国法律并未明确泛知情同意的概念, 目前在实践中生物样本的处理大致可分为4类, 存在泛知情同意的潜在适用空间。应明确泛知情同意的具体范围, 与捐献行为作出区分, 在保障受试者权利的基础上探索实施泛知情同意。     

建立以人为本的新型知情同意模式构建和谐医患关系

构建和谐医患关系是构建社会主义和谐社会的重要内容，而医患沟通不够、医患之间缺乏信任和理解等是影响医患关系的重要因素。知情同意是加强医患沟通、增强医患相互信任的重要方式。我们应从生物-心理-社会医学模式的要求出发，通过加强医务人员的医德修养，提高沟通技巧；建立和完善知情同意制度，深化知情同意的内涵；设置和完善心理咨询专科，加强人性化的知情沟通；探索新型知情同意模式；建立和完善医患沟通监督机制和投诉处理制度等．让患者作出更自主、更充分的知情选择，构建和谐的医患关系。     

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.     

妇科患者腹部手术后腹胀的护理分析

目的 探讨妇科腹部手术后患者腹胀的护理情况.方法 选取笔者所在医院2009年1～11月妇科收治腹部手术患者82例,遵照知情同意原则随机分为两组,对照组39例采用常规术后饮食护理,观察组43例进行早期进食和饮食指导.结果 观察组的肛门排气情况明显优于对照组,且腹胀发生率明显优于对照组,经统计学分析,差异有统计学意义（P〈0.05）.结论 对妇科患者腹部手术后在常规护理的基础上进行早期进食和饮食指导,能够有效地促进患者胃肠功能的恢复、减少腹胀发生率.     

论知情同意制度的不足以及术中改变术式的法律责任

知情同意制度贯穿于医疗活动的整个过程,尊重患者的知情同意权是医务人员的法定义务,国内诸多法律法规均对医疗活动中的知情同意做了原则性的规定。但是由于缺乏针对具体医疗行为如何适用知情同意制度的指引或者规范,导致医务人员常常不知如何正确的地履行知情同意程序。而且．当前的知情同意制度存在诸多不足,司法实践也对知情同意缺乏深入的研究．这为医务人员的执业活动带来了潜在的法律风险。     

论手术同意书的法律属性及其适用规范

手术同意书是一种特殊的医疗契约,可以作为医疗机构履行说明告知义务、患者和亲属行使其知情同意选择权的书面证据.认清手术同意书的法律属性,规范手术同意书适用中的格式内容、适用程序,界定变更手术范围和拒绝签署手术同意的条件,有助于医患沟通,减少医疗纠纷.     

对维护患者知情同意权的探讨

《中华人民共和国执业医师法》、《医疗事故处理条例》等国家法律、法规要求医疗机构及其医务人员在医疗活动中，应当维护患的知情同意权。章就医疗活动中，如何做好患知情同意权维护工作，患知情、同意的范围，实施方式，以及特殊情况的处理提出了相应的处理办法。通过实践，有效地预防了因知情同意问题而引发的医疗纠纷。阐明了医事法规在医疗工作中的地位和作用及其维护医患双方合法权益的客观要求。     

落实医疗知情权 防范医疗风险

医疗知情权是患者的基本权利之一，落实医疗知情权是确保医疗质量的重要措施。有效落实医疗知情权，应注意的问题是：医疗告知的时间、方式和对象，患者知情同意的范围，授权委托书的重要性及相关知情不同意的处理等。     

《侵权责任法》医疗知情同意实践问题研究

结合〈侵权责任法〉中关于医疗知情同意的具体医疗实践,明确了肇事司机不可以为受伤者签署知情同意书,＂三无＂患者知情同意应由本人签署,以及患者签署授权委托书等问题,为医疗机构正确行使知情同意提供法律依据.     

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.     

The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.     

浅谈护理工作中患者的知情同意权

目的:了解就诊惠者对护理工作中的知情同意需求,重视并履行告知义务.方法:探讨从护理工作中的五个方面满足患者的知情同意.结果:患者及家属对医疗护理工作中的知情同意有迫切要求,护理人员对此认识不足.结论:重视、满足患者的知情同意权是尊重患者的基本权力,有利于患者疾病的康复,减少医患矛盾.     

Informed consent: a pragmatic view

The author highlights some pragmatic aspects of informed consent, express consent and implied consent--by the cases of the Data Protection Commissioner of Hungary - that could help to bridge the gap between the currently valid legal requirements and the practical realities of providing medical information in Hungarian health-care settings. One of the crucial point of informed consent is whether the patient properly understood the provided medical information. Consequently, effective communication becomes an inevitable condition of providing informed consent. The author argues as well for creating more concrete and practically oriented guidelines concerning informed consent that would also help to increase the quality of medical information giving. These might help us approach the medical ideal that was conceptualised in the doctrine of informed consent.     

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.     

重视知情同意 减少医疗纠纷

探讨了医务人员对不同患者、不同病种应告知的内容、事项、告知方式等问题。在医疗活动中,医务人员应履行告知义务,保障患者的知情同意权。只有重视知情同意,执行和落实知情同意制度,加强医患沟通,才能保证医疗安全,减少因知情同意告知不全而引发的医疗纠纷。     

Informed well-considered consent ('informed consent'): an end or a means?]

Since World War II, all sorts of protective measures have been taken for people who receive medical care or who are involved in scientific research. More and more, informed consent has become the standard. In the field of experimental therapeutical research, informed consent is still a controversial subject; the individual person's interests versus general interests. But informed consent appears to have become such an absolute prerequisite for all types of observational research that the future of epidemiological research based on existing data is threatened. According to both the Declaration of Helsinki and the Dutch Law for Protection of Persons, it is possible to omit asking individual informed consent under certain circumstances. Permission for research could then be given by a supervisory board or a medical-ethical commission. After all, informed consent was never meant to be a goal of its own, but a means for self-protection and securing the right to autonomy. In situations where this right is curbed for other reasons, it appears that insisting on informed consent misses its target completely.     

Beyond informed consent

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.