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.     

知情同意在护理实践中存在的问题及实施技巧

阐述知情同意的概念,分析知情同意在护理实践中存在的问题,提出医护人员在履行知情同意过程中的注意事项以及临床护理活动中知情同意实施的方法和技巧等.     

知情同意引发医疗纠纷的探讨

综述了知情同意引发医疗纠纷的问题,主要包括知情同意引发医疗纠纷的原因、完善知情同意的建议。认为研究患者的知情同意权问题,严格执行知情同意,有助于保障患者的合法权益,缓解医患矛盾,减少医疗纠纷的发生,进而推进医学事业的发展。     

医疗知情同意书有了书写参考

<正>中国医院协会近日发出通知,在其会员单位中推行"医疗知情同意书参考指南",以规范医务人员的告知行为与告知内容,维护患者的知情同意权。近日在广西南宁召开的中国医院协会医疗法制专业委员会学术年会暨全国百姓放心医院创建中期推动会上,有关专家介绍了"医疗知情同意书参考指南"的内容。据了解,该指南分为3个部分:手术知情同意书、特殊检查知情同意书、特殊治疗知情同意书的3个模块,     

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。     

医患双方对医疗知情同意书意见的调查

目的探讨医患双方对医疗知情同意书的意见,以期为修改医疗知情同意书提供参考依据。方法收集不同等级医院的医疗知情同意书进行分析。采用自制的调查问卷对某医院100名医生和100名患者进行医疗知情同意书意见的调查。结果医患双方在医疗知情同意书的性质、过程、签署及改进方面的差异均有统计学意义(均P<0.05)。结论临床现行医疗知情同意书仍有许多方面不能达到医生及患者的要求,且绝大部分的医生及患者均认同知情同意书应采取全国统一格式。     

医学伦理学(二)(辅导材料)

2.3 如何才能做到知情同意知情同意有四个要素,也就是实行知情同意的四个必要条件:     

消化道肿瘤病人的知情程度对生活质量及满意度的影响

[目的]探讨消化道肿瘤病人的知情程度对生活质量以及满意度的影响。[方法]将2014年8月—2016年10月收治的120例接受化疗的消化道肿瘤病人依据知情程度分为完全知情组、部分知情组和不知情组3组,每组40例,按照知情程度的不同给予不同的护理措施,分别对其接受化疗3个月后生活质量状况以及住院满意度进行调查。[结果]化疗3个月后,与不知情组比较,部分知情组和完全知情组病人具有较好的生活质量以及满意度,差异有统计学意义(P0.05);完全知情组和部分知情组生活质量以及满意度比较,差异有统计学意义(P0.05)。[结论]消化道肿瘤病人对病情完全知情有利于更好地对其进行护理,提高病人生活质量以及对医疗工作的满意度。     

《上颌窦穿刺冲洗知情同意书》的设计与应用

总结设计并应用《上颌窦穿刺冲洗知情同意书》的体会.根据对上颌窦穿刺患者知情告知需求的调查结果,编写了《上颌窦穿刺冲洗知情同意书》并应用于临床实践.《上颌窦穿刺冲洗知情同意书》的应用不仅促进了医患沟通,而且有助于提高医疗服务满意度,得到了患者的赞同,既体现了重视患者的知情同意权,同时也有助于维护护理工作者的合法权益.     

知情同意在护理工作中的应用

患者在就医诊疗过程中应享有知情同意权。不管是从医德伦理,还是法律上,护士无疑与医生同样负有责任。实践中人们认识不一,做法也各不相同。本文在参阅大量相关资料的基础上,重点从什么是知情同意、知情同意在国内外进展状况、知情同意与护理工作的关系、知情同意在临床护理中存在的问题以及知情同意在实践中应注意的问题和技巧等方面进行了综述,认为不断提高法律意识和自身修养,明确职责范围和法律责任,对提高医护质量,减少医护纠纷有着重要的意义。     

The nurse's role in the informed consent process

OBJECTIVES: To review the informed consent process in relation to oncology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies. DATA SOURCES: Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.     

Barriers to informed consent

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.     

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。     

Applying the principles of informed consent to patient care. Legal and ethical considerations for physical therapy

This paper presents legal and ethical considerations regarding informed consent for the evaluation and treatment of patients in physical therapy practice. Therapists traditionally think of informed consent in relation to clinical research, but as the trend toward independent practice and private practice increases in physical therapy, the physical therapist must understand the process of informed consent in relation to patient care. Legal concepts of battery, self-determination, and the fiduciary relationship create a legal foundation for informed consent. The patient's moral right to self-determination and the corresponding duty of health professionals to "do no harm" create a strong moral basis for gaining a patient's informed consent. Practical suggestions are offered to physical therapists to help them assess their need for obtaining informed consent.     

知情同意在护理实践中存在的问题与对策

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；告知病人知情权时医与医、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；尊重病人的自主权；维护病人知情权中的医护一致性。     

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。     

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.     

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals.The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process.Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study.Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.     

Teaching the informed consent process to residents

We believe the focus and emphasis of this committee on informed consent is unique, and that the development of an informed consent teaching process for residents will focus on the moral and ethical issues regarding informed consent. Even more important, we believe we will emphasize the patient care aspects of informed consent and also teach residents their responsibilities for long-term patient care with regard to patients' satisfaction and understanding of their disease process.