癌症病人知情同意的现状与对策

综述了知情同意对癌症病人的心理影响,不同人群对癌症知情同意的态度以及癌症告知策略。     

癌症病人知情同意的现状与对策

综述了知情同意对癌症病人的心理影响。不同人群对癌症知情同意的态度以度癌症告知策略。     

临床医学科研中知情同意现状及对策

结合在临床医学科学研究中有关知情同意中发生的案例,就涉及研究样本的知情同意、知情同意的主体、知情告知的主要内容、知情告知的过程、知情同意书的签署等方面存在的问题和解决方法进行分析,为医学科研及管理人员在临床科学研究知情同意原则的执行提出一些见解.     

护理过程中影响“知情同意”落实的原因及对策

目的 本文就目前病人知情同意权在护理环节落实中存在的问题及产生根源进行了分析，并提出对策建议，供护理人员借鉴。方法 分析目前病人知情同意在护理环节落实中存在的问题；分析病人知情同意在护理环节中落实不力的原因。结果 提出护理环节过程中落实“知情同意”的对策和建议：重视护理环节过程中落实“知情同意”，重视告知义务与病人知情内容。结论 转变观念，加强知情权和同意权是病人生命权的重要保证，这种权利不单指书面形式的签字同意，还包括其他方式的知情同意，护士有责任弄清楚病人是否真的理解治疗与护理的目的、方法和其它相关问题，护理人员必须认真告知和记录病人的一切相关内容。     

患者知情同意义务的履行探讨

让患者知情同意是医师在医疗活动中必须注意履行的义务.它一方面要求医师必须履行医疗告知,另一方面需要患者针对医疗告知做出是否同意的决定.让患者医疗知情,医师就必须履行对患者的医疗告知义务,因此,患者知情同意义务的履行核心是医疗告知.现就医疗告知的相关问题探讨如下.     

知情同意

正知情同意(informed consent)是科学研究中的伦理原则之一,要求研究者在告知被研究者有关研究的可能益处和风险以后,被研究者自愿同意参加该项研究。通常"知情同意"由知情信与同意表格组成。在知情信里,要告知被研究者该次研究的目的、过程、益处和潜在风险,保护被研究者隐私的承诺,自愿原则,以及被研究者有权在任何情况下不需任何理由可退出研究而     

护理过程中影响"知情同意"落实的原因及对策

目的本文就目前病人知情同意权在护理环节落实中存在的问题及产生根源进行了分析,并提出对策建议,供护理人员借鉴.方法分析目前病人知情同意在护理环节落实中存在的问题;分析病人知情同意在护理环节中落实不力的原因.结果提出护理环节过程中落实"知情同意"的对策和建议:重视护理环节过程中落实"知情同意";重视告知义务与病人知情内容.结论转变观念,加强知情权和同意权是病人生命权的重要保证,这种权利不单指书面形式的签字同意,还包括其他方式的知情同意,护士有责任弄清楚病人是否真的理解治疗与护理的目的、方法和其它相关问题,护理人员必须认真告知和记录病人的一切相关内容.     

知情同意的例外在急诊护理工作中的解读

知情同意的例外是指医生在没有获得病人同意的情况下,对病人实施他所认为的有利于病人的治疗和抢救,通常在紧急情况下实施。其实质是说明知情同意的程序在某些急诊情况下可以简化或省略,而不是知情同意原则本身可以免除。急诊护理工作是急救医疗的重要组成部分,即使在紧急救治病人的状况下,告知病人或其家属仍然是急诊护士必须承担的法律义务,也是义不容辞的责任。本文就知情同意的例外在护理工作中的告知的主体、内容、时间、程序、技巧等诸要素的变化做一简要解读。     

履行病人知情同意权的实践与体会

护士在为病人提供护理服务时,告知医疗护理措施实施的原因及方法、医院环境与制度、医疗风险、病人的病情及自我护理方法并征得病人的同意,减少了医疗纠纷的发生,保护了护患双方的合法权益;培养护士的法律意识,建立良好的护患关系,建立护理告知监督制度是履行告知义务、病人知情同意的基本素质。     

儿童药物临床试验研究知情同意的伦理审查

由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求。文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查。     

生物样本库知情同意书规范化设计

知情同意书的签署是生物样本库伦理建设的核心, 其结构包括"知情告知"和"自主同意"两部分主体内容。本文依据现阶段生物样本库的特点, 提出生物样本库知情同意书的规范化设计, 具体描述从"生物样本库完备告知"到"捐赠者充分知情"两部分核心内容和要求, 以供生物样本库实践者参考和借鉴。     

Improving informed consent in clinical trials: a duty to experiment

Practitioners of clinical trials have a responsibility to ensure that patients' participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. We should test innovations in informed consent in realistic contexts (i.e., in clinical trials) and with randomization, when it is appropriate, at the first opportunity. In this study, we develop a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. We discuss the conceptual, ethical, organizational, and technical bases for such an effort.     

The meaning of autonomy in Chinese culture: obtaining informed consent for operation

The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.     

Evaluating the quality of information about alternatives to research participation in oncology consent forms

A careful consideration of the alternatives to research participation is an essential element of making an informed choice to enroll in a biomedical research study. While there is general agreement on the importance of informing prospective subjects about alternatives to research participation, little is known about how investigators communicate this information. The purpose of this study was to attempt to assess the quality of information about alternatives contained in informed consent documents in oncology randomized controlled trials. Our study indicates that there is room for improvement concerning the discussion of alternatives to research participation in informed consent documents in oncology randomized controlled trials. Though most of the documents in our study met the minimal disclosure standard found in the U.S. federal regulations, less than a third met the reasonable person standard, a widely accepted principle endorsed by the common law and various ethics guidelines and documents. There was a statistically significant difference between the alternative discussions in local and model forms (P < 0.0014). The alternatives discussions in local informed consent documents were more likely to receive higher scores than those in model consent documents, with an odds-ratio of 3.5 to 1.     

Consent in clinical trials: What do patients know?

ObjectiveTo assess participants' knowledge of key aspects about the clinical trials in which they are enrolled, describe the consent process, and assess the importance that investigators give to various aspects of trial information when verbally informing candidates.DesignProspective study based on a structured questionnaire interview of participants within 3 months after trial enrollment and an anonymous questionnaire sent to clinical trial investigators.SubjectsA total of 140 participants included in 40 clinical trials were interviewed, and 51 investigators answered the questionnaire.ResultsThe formal steps to obtain informed consent were usually carried out. Participants were aware of the purpose of the trial and the right to discontinue participation, but only 23% knew that treatment was randomly allocated, 57% knew they might receive a placebo, and 42% was aware that adverse effects could occur. Patients who had read the information sheet had better knowledge of most aspects, except for the risk of adverse effects. The investigators considered that compensation, insurance coverage, possibility of receiving a placebo, and treatment allocation were the least important aspects of the trial when informing candidates for participation.ConclusionsAlthough the formal steps for obtaining informed consent were usually carried out, a relevant percentage of patients included in clinical trials were unaware of important aspects of their participation. Patients showed more limited knowledge about the same points that investigators considered less important when informing potential participants. Deferring signature on the consent form and encouraging reading of the information sheet may improve participants' knowledge about clinical trials.     

What Emergency Physicians Should Know About Informed Consent: Legal Scenarios,Cases, and Caveats

The basic concept of obtaining informed consent is familiar to emergency physicians, and many consider themselves well versed on the topic; however, lack of obtaining proper informed consent is a frequent source of lawsuits. The legal definitions and nuances of informed consent might surprise even the most experienced physician. This article will detail the historical legal evolution of the concept of informed consent. It will also report defining and recent court cases that illustrate the current medical–legal status of informed consent. Special scenarios, caveats, and documentation recommendations are discussed. After reading this article the emergency physician will know how to practice and document the appropriate aspects of informed consent in emergency medicine, as well as understand available legal defenses if a lawsuit should arise.     

尊重患者自主性原则及其实践方式知情同意的临床伦理分析

法律及伦理层面对医疗知情同意的要求日益严格,本文从伦理学角度剖析尊重患者自主性和医疗知情同意原则,以期为临床实践和临床伦理学相关研究和教学提供参考。首先分析尊重患者自主性的伦理学概念,在此基础上论述知情同意是落实尊重患者自主性原则的实践应用,梳理国内外关于医疗知情同意原则的确立历史和目前公认的知情同意实施过程,并由此得出如下结论:临床医疗知情同意存在共识尚待完善、培训不足、规范形成落后于新技术应用等挑战,未来应加强培训、开展相关研究并形成指南/共识,以帮助医务工作者在临床诊疗中更好地实施知情同意。     

尊重患者自主性原则及其实践方式知情同意的临床伦理分析

法律及伦理层面对医疗知情同意的要求日益严格,本文从伦理学角度剖析尊重患者自主性和医疗知情同意原则,以期为临床实践和临床伦理学相关研究和教学提供参考。首先分析尊重患者自主性的伦理学概念,在此基础上论述知情同意是落实尊重患者自主性原则的实践应用,梳理国内外关于医疗知情同意原则的确立历史和目前公认的知情同意实施过程,并由此得出如下结论:临床医疗知情同意存在共识尚待完善、培训不足、规范形成落后于新技术应用等挑战,未来应加强培训、开展相关研究并形成指南/共识,以帮助医务工作者在临床诊疗中更好地实施知情同意。     

Informing parents about newborn screening

OBJECTIVE: To evaluate current rules and regulations for educating parents about newborn screening. DESIGN: Cross-sectional survey. SAMPLE: Newborn screening program coordinators in all 50 states and the District of Columbia. MEASUREMENTS: Answers to a standardized semi-structured telephone survey in January 2004. RESULTS: Fifty programs provide standardized information about screening, and 32 of these have information available in multiple languages. Most programs (n=36) believe that parents should be informed about newborn screening as a part of prenatal care; however, none has rules or regulations requiring this. Five require documented informed consent; only one provides the consent form in a language other than English. Hospitals and birthing centers are required by many programs to educate families, including providing information (n=12), obtaining informed consent (n=5), informing parents of the right to refuse screening (n=13), and documenting refusal on institutionally developed forms (n=9). We found considerable variation in policy language across the newborn screening programs. CONCLUSIONS: The complexity of current newborn screening programs and the likelihood of expansion in the number of conditions on newborn screening panels present a unique opportunity and challenge for public health nurses to ensure that these programs are effective and that care is integrated.     

Informed consent in physical medicine and rehabilitation. The physician/patient relationship--the doctor as a fiduciary

This article reviews the principle of informed consent and the ethical and legal bases upon which it rests. The process of obtaining an appropriate informed consent is explored, and the elements that make a consent valid are delineated. The principles of substitute decision-making and the special rules applied to circumstances such as emergency, therapeutic privilege, refusal of consent, and medical necessity are discussed. The concept of the relationship between physician and patient as a fiduciary relationship is explored as the fundamental basis for the modern doctrine of informed consent.