浅谈《侵权责任法》中医疗知情同意书的成功与不足

知情同意书贯穿于整个临床医疗过程.知情同意书是督促医务人员履行告知说明的义务、保证患者知情同意权实现,同时规定了患者在紧急特殊情况的处置.但对患者对知情同意权无法取舍选择、社会公共利益考量,口头知情同意权,及知情同意与生命健康权的关系等方面还有待进一步健全完善,对减少和处置医疗纠纷,构建和谐社会具有重要现实意义.     

与妇产科手术患者知情同意后进行针对性交流沟通的意义

妇产科患者手术知情同意的影响因素主要为年龄、文化程度、职业以及手术费用等,相关医护人员应根据患者的具体情况对患者进行有针对性的交流沟通,并且进行相应的知识教育。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。     

关于医院全面落实患者知情同意权的思考

知情同意是法律赋予患者的权力，认真履行告知义务是对医务人员的要求。在临床上，虽然患者知情同意权的落实情况有了很大改观，但由于受诸多因素影响，落实知情同意仍有许多工作要做，并成为医院当前加强医疗管理、降低医疗纠纷的关键之一。     

浅谈手术签字与知情同意权

知情同意制度是医院一项十分重要的医疗工作制度．尤其目前“举证责任倒置原则”的环境下．各医院更应该重视知情同意制度的执行。知情同意分为口头、书面两种告知形式．在医疗活动中，手术前谈话是十分重要的知情过程．也是外科手术病人病历中不可缺少的重要内容。同时更重要的是用书面形式征求、体现、维护病人的知情同意权，保护医患双方的利益。     

恶性肿瘤患者知情同意中存在的问题及对策

为减少和避免知情同意在护理实践中的矛盾,笔者分析了知情同意在护理实践过程中出现的问题:知情同意与医疗保护的矛盾;与医患双方医疗知识不平等的矛盾;与正常医疗护理行为不一致的矛盾;告知患者知情权时医与医、医与护不一致。并针对问题提出相应对策:增强法律知识学习;处理好知情权与医疗保护;与患者沟通的过程中用简洁明了、浅显易懂的语言描述问题;尊重患者的自主权;维护患者知情权中的医护一致性。     

关于医疗行为中知情权告知方式研究

在中国式医患沟通中,医务人员常常向病人家属解释、说明医疗信息并争取病人家属同意实施必要的诊疗措施。这种做法是与我国现行法律的立法精神相背离的,同时也侵犯了病人对自身生命、健康的自主决定权。本文意在明晰知情同意权的主体,更好的保护病人的知情同意权。     

尊重患者知情同意权,防范医疗纠纷的发生

知情同意权是患者的基本权利,是现代医学模式转变的要求,尊重患者的知情同意权,有助于防范医疗纠纷的发生,改善医患关系。医务人员应及时调整行医模式,充分尊重患者知情同意权利。     

对药物临床试验伦理审查中的知情同意的概述

1知情同意的定义所谓知情同意,是指人体试验受试者享有知情同意权,研究者必须取得受试者知情同意才可开展试验,即试验者必须真实充分地向受试者说明有关人体试验的情况,如果受试者本人不能行使知情同意权,则必须取得与受试者没有利益     

临床护理工作中知情同意存在的问题及对策

随着社会在不断地发展,我们的生活、文化水平也在不断的提高,因此患者在就医过程中对自己就医权利的法律意识增强,对医疗护理的质量,医疗护理安全的要求也不断提高。此外,长期以来护士的护理传统理念没有改变,使护士习惯于对患者采取主导地位,而对患者知情同意权未予重视或具体操作不规范引发了医疗纠纷。所以护理人员必须提高法律意识,使护理安全隐患消失在萌芽状态。现就护理工作中患者的知情同意存在的问题进行探讨研究及对策。     

《民法典》出台对医院病案管理的影响分析及病案管理对策探讨

《民法典》的出台给医疗领域带来了很多影响,该文通过对比《民法典》与《侵权责任法》中医疗相关条款的新变化,提出了对病案管理的新要求,包括增强对患者知情同意权的保护、强调病案资料的完好保存、更加注重患者个人信息的保护.同时结合当前病案管理中电子病案的重要性日益突出、病案的经济价值越来越大、病案的保管方式从传统的院内保管到外...     

药物临床试验伦理审查质量风险的管理研究

目的:为提高我国药物临床试验伦理审查质量、保障受试者权益提供参考。方法:以风险管理理论为指导,运用文献研究法、专家意见法和层次分析法对药物临床试验伦理审查流程进行梳理,提取并确定影响伦理审查质量的风险因素及其权重,并对我国药物临床试验伦理审查工作提出改进建议。结果与结论:构建的药物临床试验伦理审查风险指标体系包括5个方面共31个影响因素,其中影响药物临床试验伦理审查质量的5个方面的重要性(权重)排序依次为医学伦理委员会的自身建设(0.2635)、审查会议的管理(0.2514)、跟踪审查(0.1945)、审查申请的受理与处理(0.1892)、文件档案的管理(0.1014);权重较高的影响因素包括"讨论投票过程利益冲突人员回避(0.0787)""对方案修改、知情同意修改、严重不良事件等情形及时审查或召开会议讨论(0.0705)""明确伦理审查工作流程及时间并对外公示(0.0598)""统一、规范的审查标准与批准标准(0.0521)"等。建议可通过讨论投票环节利益冲突人员予以回避,对方案修改、知情同意修改、严重不良事件等情形及时审查或召开伦理会议讨论,明确伦理审查工作流程及时间,建立统一、规范的审查标准和批准标准等方式提高药物临床试验伦理审查的质量。     

浅谈受试者在药物临床试验中知情同意权的法律保护

目的:为我国药物临床试验相关立法的完善以及受试者人权的保护提供参考。方法:介绍药物临床试验中知情同意权保护的现状,对知情同意权的构成要素进行阐释,并对我国知情同意权保护实践中存在的问题及原因进行分析。结果与结论:我国尚须进一步完善药物临床试验的立法,加强对研究人员的法制教育,加强对违法侵权行为的法律监督。     

我国药物临床试验中伦理审查存在的问题与对策

目的 促进伦理审查程序规范化.方法 通过对相关文献的总结与归纳,指出目前我国药物临床试验中伦理审查存在的问题,有针对性的提出了一些对策与措施.结果 与欧美等发达国家相比,我国的药物临床试验伦理审查起步较晚,存在一些问题,比如研究方案不够科学、知情同意不够规范、相关培训不充分、对受试者的经济补偿不到位等.结论 应建立和完善药物临床试验机构的管理制度,加强各级伦理委员会的监督和管理;科学设计药物临床试验方案;完善知情同意;制定合理的补偿措施;并开展伦理委员会的专项培训.     

Effectiveness of consenting in Otorhinolaryngology

Informed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.     

真实世界药物评价的伦理价值与伦理问题

近年来,真实世界研究越来越受到广泛关注,其在药物评价等领域的应用彰显了伦理价值,同时也带来了许多伦理问题。其重要的伦理价值在于遵循了伦理学的实践品格,印证了医药道德的广泛适用性的基本特征,更好地实现了个人利益与公共利益相统一。该文分析了真实世界药物评价在知情同意、隐私权和知识产权保护、评价的真实性及伦理审查等方面存在的问题,并提出了相应的解决对策。     

Ethical considerations in human experimentation.

An accepted practice in medical research has been the subordination of individual rights to the benefit of mankind. The Nazi experiments, and other recent abuses, have focused increased attention on the dignity and rights of human research subjects and have led to new regulations to control human experimentation. Central to establishing what constitutes permissible human experimentation are the issues of risk-benefit ratio and informed consent. Evaluating the risk-benefit ratio requires consideration of the nature of the experiment, the likelihood of its success, and the type of subjects to be utilized. Participation in a study requires voluntary "educated" informed consent. Certain categories of subjects, such as children and the mentally handicapped, require special protection in this regard. Finally, formal education in medical ethics and prohibiting publication of unethical studies are likely to prove more effective in curbing unethical experimentation than increasing government regulation.     

An open future? The principle of autonomy within medical ‘codes of conduct’ versus the heteronomy effects of predictive medicine

Traditionally, the average code of conduct within Western health care starts from the autonomy of the patient. In addition, medicine today is ‘evidence based’ and the patient is an ‘informed consent’. Yet, the individual autonomy of the patient in health care is not simply enhancing today. Quite a few fundamental changes have and are currently at work within health care, which I will summarize here with the paradigm of predictive medicine. One of the characteristics of this paradigm is the increase of medical consults which are not autonomously chosen by an individual. For reasons of public health and diminishing of health risks or for reasons of prevention, on one hand we are dealing with ethical codes centered around the autonomy of patients and the face-to-face relations with health care workers, on the other, we are dealing with a society that takes an increasingly greater medical initiatives. Therefore, the question arises if predictive medicine confronts us with the limits of an ethical code as we know it today. Is there not an urgent need for a political code of conduct in health care?     

The need for evidence-based research ethics: a review of the substance abuse literature

Participants in substance abuse research may be vulnerable for multiple reasons. International research ethics guidelines and policy statements require that researchers provide extra protections when conducting research with vulnerable subjects, but it is uncertain which measures best protect vulnerable individuals. Concerns about vulnerability have been translated into only the vaguest regulatory requirements, and very little empirical data exist to guide researchers and ethics review committee members who want to protect participants. This article reviews two bodies of substance abuse research ethics literature. First, "normative" articles, that is, articles that discuss ethical issues that may arise in substance abuse research, are discussed. The resulting taxonomy of ethical issues then guides a review of empirical studies on issues like the informed consent process and the use of financial incentives in substance abuse research. While the ethical issues in substance abuse research are numerous and well-documented, the evidentiary base for addressing these issues is inadequate. If any one major theme emerged from the existing studies, it is that many well-intentioned, protectionist concerns--about recruitment incentives, consent comprehension, and drug administration studies--are not supported by empirical data. While these findings are at best tentative, they suggest how research on research ethics might ultimately benefit participants.     

Exploring pharmacy ethics in developing countries: a scoping review

Background Healthcare ethics have been profoundly influenced by principles of bioethics that emerged post-World War II in the Declaration of Geneva 1948. ‘Beneficence’ (to do good), ‘Non-Maleficence’ (to do no harm), ‘Justice’ (fairness and justice in access) and ‘Respect for Autonomy’ (respect for patient individuality, including decision making, privacy, and right to refuse), have become foundational principles of contemporary medical codes of ethics. These principles are well reflected in most professional pharmacy code of ethics globally. This domain remains relatively unexplored in most developing countries and the majority of what has been published in this area relates to western cultures. There have been no attempts to pool findings from a similar scope of research emanating in developing countries. Aim of the review This study aims to explore the scope of pharmacy ethics in the literature pertaining to developing countries. Methods An extensive search of three relevant (Scopus, CINAHL, IPA) databases was conducted from Jan 2000 to Feb 2020, in order to identify relevant studies conducted in or focussed on ethics in pharmacy in developing countries. A separate Google Scholar search was carried out in an effort to locate supplementary articles, hand-searched articles were also included to achieve an exhaustive investigation of all current relevant studies. Results The full text of 20 relevant articles that met inclusion criteria were critically analysed and qualitatively categorised into three emerging themes; Ethical challenges in pharmacy practice, Approaches used in teaching pharmacy ethics, and Code of ethics analysis and implementation. Conclusions: Findings of this literature review illuminated a gap in pharmacy ethics literacy in developing countries and variances in pharmacists’ ethical attitudes in handling ethical dilemmas, as well as a lack of familiarity with ethical principles and codes of ethics. Pharmacists’ lack of respect for patients’ autonomy and pharmacists being prone to financial pressure were found to have a significant impact on pharmacy practice in most of developing countries. However, attempts are being made to rectify this gap by efforts to incorporate ethical and professional education in undergraduate curricula, and by studies in which new codes of ethics are being implemented.