患者知情同意权主体的演变探析

知情同意权是患者的基本权利,帮助患者实现知情同意权是医务人员必须履行的基本义务.文章介绍了知情同意权的内涵,对确立知情同意权主体的法律法规进行分类阐述,探析知情同意权主体归属现状及努力方向,以及患者的近亲属代为行使知情同意权的特定情形.     

论患者知情同意权的行使主体

知情同意权是患者的一项基本权利，但在我国医疗实践中关于该权利行使主体的规定却比较模糊。本文从公民民事权利能力的角度出发，分析我国目前知情同意权行使的现状及原因，认为患者知情同意权权利主体应仅为患者，但行使主体则不在此限；并分析在特定的情形下，患者的法定代理人、近亲属、卫生行政主管部门代患者行使知情同意权的情况。     

浅析医疗行为中"代为同意"法律问题——英美法相关规定简介

知情同意理论在法律界和医务界已经引起了足够的关注.但是作为前提,患者必须具备相应的同意能力,因此在患者不具备这种能力时,便有代为同意的必要.主要探讨了与代为同意相关的一些法律问题,涉及到同意能力有无的判断标准,代为同意人的选任,代为同意权的行使等内容.     

急危患者知情不同意的医疗处置研究

知情不同意是患者行使知情同意权的一种结果,医务人员应尊重患者知情不同意的权利.患方的知情不同意决定可能危及患者生命.急危情况下,患者本人尤其是其代理人的不同意决定危及患者生命时,患者的知情同意权应让位于其生命权.法律应赋予医务人员紧急救治权,患方不能以其不同意为由要求医务人员对此后果承担法律责任.     

侵权责任法与知情同意立法的日臻完善

<侵权责任法>第55条、第56条对知情同意制度作出了许多新规定.主要包括:强调了医疗风险、替代医疗方案的说明义务;患方对医疗措施的选择必须有"书面同意";患者是知情同意权的唯一权利人;不宜向患者说明病情的,应向由患者的近亲属(而不是原来的"家属或关系人")说明;知情同意权与法律责任的规定;只有"抢救生命垂危的患者等紧急情况"下,且无法取得患方意见的,才可以通过负责人批准的方式获得医疗处置权.     

谈知情同意在临床实践中存在的问题及对策

1行使知情同意权存在的问题尽管知情权的实施在我国从20世纪80年代就已经开始,但在实践中由于侵犯知情同意权而导致的医疗纠纷案件占据很大的比例,从这些纠纷的情况看,主要存在以下几个问题:1.1强调病人家属的知情同意,轻视病人本身的知情同意权将病人家属或单位作为知情同意的主要主体,而将病人作为知情同意的次要主体。在医疗实践中一直将病人作为治疗的服从对象看待,遇到需对患者进行手术、特殊检查、特殊治疗、试验性临床医疗时,首先印入思维的是向病人家属交代,由患者近亲属签署同意书,而对病人本人却“保密”,执行所谓的医疗保护制度…     

我是病人我有“权”－－剖析患者的“知情同意权”

２００１年７月２６日，中国消费者协会与中国消费者报社在北京联合召开了“如何落实患者知情同意权”座谈会，会议围绕患者的知情同意权应包含的内容、患者行使知情同意权的法律依据、患者行使知情同意权的障碍、医院落实知情同意权的困难等问题进行了交流。然而，在广大的读者心目中，对于自己这个权利不仅知之甚少，而且还有很多读者对之是闻所未闻。     

从《侵权责任法》到《民法典》审视知情同意权

知情同意权是患方的一项重要权利,医疗实践中常会出现因患方未行使此权利,阻碍医方的医疗行为,从而影响对患者的救治,导致知情同意权存在的意义受到质疑。从2010年实施的《侵权责任法》到2021年实施的《民法典》,逐步强化了知情同意权作为公民基本权利的地位和作用。医疗机构应当遵循立法者的本意,正确而深刻地认识知情同意权的内涵和要求,切实保障患方知情同意权的行使。     

知情同意权在医疗实践中的应用

随着医疗纠纷的日益增多,在医疗实践中充分运用知情同意权显得十分重要。通过阐述知情同意权的法定原则．分析运用知情同意权存在的问题,提出在医疗实践中正确行使知情同意权的方法、知情同意在医疗特殊情况下的告知以及行使知情同意告知的几点注意。     

知情同意权视角下的预先医疗指示制度

预先医疗指示是患者行使知情同意权的有效途径。患者在具有同意能力的情形下,可以就将来自己失去同意能力时的医疗照护方案做出预先指示,这将有助于保护患者的知情同意权和个人尊严,有利于医患关系的改善。我国应根据实际情况的迫切需要,借鉴国外相关立法经验,适时构建预先医疗指示制度。     

急危重患者抢救制度要点分析及建议

基于典型案例分析,阐述了急危重患者抢救制度在实践中的4种常见问题,分别是急危重患者抢救不及时、抢救记录补记不及时、未取得患者近亲属意见时未及时施救、多学科救治归属问题。指出,急危重患者抢救制度执行,重点在于提高医务人员发现和抢救急危重患者的能力,持续提升抢救记录书写质量,重视患方知情同意权,强化急危重患者多学科救治。     

论孕妇李丽云母子双亡案件的法律对策

孕妇李丽云母子双亡案件暴露了患者紧急救治权和知情同意权在特定情况下的冲突.该权利冲突使医师紧急救治面临法律困境.基于急危患者得不到及时救治会严重损害其生命健康权的事实,立法应明确急危患者救治中患者的紧急救治权优先于知情同意权,即医师在没有得到急危患者或者其亲属同意治疗的情况下,有权报请所在医疗机构负责人同意后实施紧急救治,同时立法也应明确紧急救治医疗费用政府保障制度以及紧急救治医师责任豁免制度以有效保障患者紧急救活权的优先实现.     

《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.     

转化医学中利益冲突及其影响

医学、法律和伦理是相互伴生的科学.近年来,转化医学的提出及其开展,促进基础研究成果的快速的临床转化和应用,促使研究成果尽快形成市场化的产品,提高医疗诊断水平和促进健康.同时面临一些新的挑战,产生新的伦理问题,并使一些现有伦理问题更为凸显.开展转化医学具有潜在的风险和问题,利益冲突,及其对受试者权益保护和知情同意的潜在影响还没有受到应有的重视,需要伦理委员会加强审核.     

The Role of Research Ethics Committees in Making Decisions About Risk

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role.     

Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study

Seeking informed consent from patients in the acute phase of acute myocardial infarction (AMI) poses an ethical challenge due to the fact that these patients are under stress and require urgent medical attention. The very procedure of informed consent, which is supposed to protect eligible patients, may in fact cause harm due to a potential delay in the provision of therapy. Whether or not informed consent can and should be obtained under these particular circumstances is far from evident. Patients participating in various large-scale AMI trials have been enrolled with, as well as without, informed consent in recent years. Little is known, however, about how patients experience the informed consent process in the emergency situation of an AMI. This paper reports the results from qualitative interviews with 32 patients, who had to decide whether or not to participate in a large multi-centre clinical trial in Denmark. We analyse to what extent patients found the informed consent process acceptable as well as how various factors influenced their experience of the consent process. We argue that it is morally sound to involve those patients in a brief and concise informed consent process and that consent should be sought in such trials. Finally, we discuss how future AMI trials may nonetheless be improved by accommodating some of the concerns of the patients.     

A qualitative study of subject recruitment for familial cancer research

PURPOSE: Familial epidemiological studies of cancer raise familiar ethical issues relating to informed consent and recruitment of participants. When the family is the unit of study, however, additional complexity arises. Educating and recruiting participants must be tailored to the relatives', as well as the proband's needs. An understanding of the prospective participants' concerns will aid the development of strategies for recruitment and will facilitate informed and voluntary consent. In the present study, qualitative methods were used to investigate these issues. METHODS: Focus groups with cancer patients, relatives of cancer patients, and individuals from the general population were separately conducted to identify issues that concern people who are asked to participate in family studies. RESULTS: Many of the issues which arose in the course of the focus group discussions were similar to those in any study. Yet, some of the themes emerging from the discussions were specific to familial research. In particular, participants expressed that the study should be endorsed by a trusted and familiar source; group discussions might facilitate the consent process; the benefit of the research should be clear and personal, as well as benefit the participants' family members; risks of participation should be explicit (e.g., insurance discrimination); and education about the disease and its familial nature would maintain commitment to the study. Finally, participants expressed concerns about being approached by programs to facilitate the identification and recruitment of other family members for research on family health issues. CONCLUSIONS: Findings from this study will aid future familial studies in developing a protocol that both adequately informs potential participants of the nature of familial research and maximize participation.     

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。     

Autonomy and informed consent: A mistaken association?

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill’s conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill’s conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.