“知情同意权利”驳正

“知情同意权利”一词，是个公法上的概念，并非临床诊疗业务过程特有。《纽伦堡法典》等文献中的“知情同意权利”系指“生物医学研究（实验）过程”。以上的“知情同意权利”概念均不应被简单地照搬到“临床诊疗业务过程”。而“临床诊疗业务过程中的知情同意权利”，必须受制于本领域特有的自然规律和伦理规范，实行保护性医疗制度和赋予患者家属独特的权利主体地位是其最明显的特点，也是国际临床医学界通例。     

临床医学科研中的知情同意之我见

结合临床医学科研伦理管理中的经验,对知情同意的要素、知情同意的方式、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、知情同意书的保存等方面进行了探讨,提出了一些见解、体会和经验,供广大医学科学研究工作者和医学科研管理人员参考.     

上海市部分公立医院涉及人体医学研究项目知情同意过程分析

建议进一步加强医院伦理委员会的作用,规范知情同意的操作,加强公众宣传、改善医患关系,以改善公立医院涉及人体研究项目的知情同意工作。     

我国开展角膜移植手术过程中存在的伦理争论探讨及对策

目的探讨我国开展角膜移植手术过程中存在伦理争论及其解决措施。方法从供体、受体、医生三者关系出发,探讨生命伦理问题,剖析其产生根源,并对如何规避生命科技发展中的伦理风险提出建议。结果目前伦理争论主要包括:供体面临的伦理问题是自愿捐赠原则受到批评与置疑;供体家属希望获得相应受体的资料。受体面临的伦理问题是异种移植使受体人格同一性问题更加复杂化。医生面临的伦理问题是如何把握合理死亡标准;捐献者及其亲属是否知情同意;供体与受体双方利益如何统一。结论根据目前存在的伦理争论,提出相应解决措施:建立合理的伦理规范原则;建立器官供体激励机制;规范和建设眼库;建立和加强对器官移植工作的监督机制。     

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。     

伦理审查视角下临床研究知情同意书质量分析

目的从伦理审查的视角调查医院临床研究中知情同意书质量,分析申办者和研究者发起的临床研究中知情同意书存在的主要问题,对其要点进行评价归纳并提出建议。方法收集整理上海市某三级甲等医院伦理委员会2013年1月—2020年12月接受伦理审查的临床研究项目知情同意书共计678项,根据《药物临床试验质量管理规范》要求对知情同意书的内容和语言等要素进行统计分析。结果完全符合规范的知情同意书311份(占45.9%),存在要素和/或语言问题的知情同意书367份(占54.1%),问题主要体现在研究过程(占23.7%)、可能的风险(占15.5%)、受损害后的赔偿补偿(占15.0%)和研究相关费用的告知(占14.2%)等方面;申办者发起的临床研究的知情同意书合格率高于研究者发起的临床研究。结论合格的知情同意书文本应保证内容完整和语言规范,以达到信息完整、理解无误、自愿同意的效果,确保受试者做出符合其真实意愿的选择。对于知情同意书质量的保障,需要包括申办者、研究者和伦理委员会在内的临床研究各相关方的共同努力。     

医患沟通中疾病认知模式的伦理审视

医患沟通中双方时疾病的认知存在较大差异,分别可得到相应的伦理辩护,却存在着知情同意与屏蔽、怀疑共存,医疗保密与伪装、公开兼容,尊重生命与低估、忽视相伴等方面的伦理冲突.在医学行善总原则下.通过求同存异中的医患互动,多方参与下的医患谈判,以病人为中心的医患决策的伦理抉择,可以实现疾病认知差异下的良性沟通.     

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。     

医学期刊对涉及人的研究论文进行伦理审查的原则及实践路径

【目的】提高国内医学期刊的伦理规范意识,促进医学期刊发挥正确的伦理学导向作用。【方法】采用文献分析法,通过分析医学期刊对涉及人的研究论文进行伦理审查的意义,探讨其伦理审查的原则及实践路径。【结果】医学期刊作为坚守科研道德阵地的最后防线,对涉及人的研究论文进行伦理审查具有重要的时代意义,应坚持维护受试者利益、科学性、知情同意等原则,并通过完善投稿须知或稿约、把好审稿关等相关路径予以实现。【结论】医学期刊对涉及人的研究论文进行伦理审查具有重要意义,应坚持有关原则进行审查,并通过相关实践路径实现规范有序的伦理审查。     

论预防接种的知情原则

预防接种作为医疗卫生服务内容之一,与其他医疗服务过程中贯彻"知情同意"原则一样,必须尊重和落实接种者和受种者双方的"知情权".知情是同意的前提,同意或选择是知情的目的.@@1知情原则的内涵与主体@@预防接种的实施必须在接种者和受种者的共同配合下才能完成,接种是否成功不仅取决于疫苗产品的质量和接种的质量,还与受种者的个体状况密切相关.     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

Simulated Patient Studies: An Ethical Analysis

Context: In connection with health care reform, the U.S. Department of Health and Human Services commissioned a “mystery shopper,” or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over “government spying” on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods: We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings: Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy‐relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions: As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy‐relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge.     

Ethics of clinical trials in family medicine

In this paper several issues are examined that arise from conducting randomized clinical trials in a family practice setting. The distinctive research tradition in family practice involves a patient's primary care physician performing an experimental investigation that usually, though not invariably, is focused on common health problems. Representative clinical trials are presented as examples that illustrate two ethical difficulties evoked by such research: a potential violation of the primary care physician's therapeutic imperative to provide the best possible treatment for his or her patient, and the likelihood that the type of physician-patient relationship fostered in family practice significantly diminishes the capacity of the patient to give true informed consent. In an attempt to resolve these ethical difficulties, a model of moral reasoning is presented that is based on easily understood ethical principles and is applicable to actual clinical decision making. Using that model, a tentative set of rules or guidelines is offered for implementing clinical trials in family medicine.     

医院实施知情同意调查

知情同意作为医疗实践的一个基本原则越来越为人们所接受和认可,但是目前医院在实施知情同意的过程中还存在种种制约因素？本文通过调查某三甲医院医师94人及住院患者105人对知情同意的理解和看法,探讨当前在医院实施知情同意中存在的不足和问题,提出了建议与对策     

Ethical problems of recording physician-patient interactions in family practice settings

Recordings of actual physician-patient interactions are an important tool for family medicine education and research. Their use, however, poses two sets of ethical problems: one dealing with privacy and confidentiality, and another related to limitations upon informed consent in the context of ordinary medical care. Experience with audiotaping and videotaping led to engaging in a "principle-based" method of ethical reasoning in which problems generated by difficult cases were examined in light of both current rules or guidelines and four fundamental ethical principles. Through this approach specific policies were developed for voluntary, informed consent and for protection of privacy, while recognizing that each case must be judged in the light of the physician's obligation to do the best for each patient.     

供精治疗的管理

辅助生殖技术应用产生的伦理问题很多,所引起的争论是前所未有的。人类辅助生殖技术伦理原则包括有利于患者、知情同意、保护后代、社会公益、保密、严防商业化及伦理监督7个方面。而供精人工授精存在的伦理观念的冲突更加明显。如果不对其进行规范化的管理,就会导致涉及社会、伦理等重大后果。沈阳东方医疗集团菁华医院通过近5年的临床实践,在供精管理方面进行了许多有益的尝试,在知情同意、随访、冷冻精液等方面形成了系列的管理体系,取得一些实效。     

The informed consent procedure in epidemiological research

After a brief introduction on the beginning and subsequent developments of informed consent (IC), this paper analyses its ethical, legal, medical and scientific implications and its specific applications to epidemiological research. The aim is to highlight how IC principles should be fulfilled through different procedures responding to the ethical and scientific requirements of epidemiological research. At least two improper applications, in fact, can deprive IC of its meaning: referring to ethical principles without discernment, or following IC guidelines without critical evaluation. Attempts to improve IC procedures adapting them to specific needs and scientific developments should be evaluated carefully and without preconceptions.     

Analysis of Master theses in nursing under the spotlight of bioethics

The goal of this study is to investigate the application of ethical principles in research with people in the master's thesis of students of the Nursery Master's Course at the Federal University of Ceará (UFC). The theoretical reference were the principles of Bioethics of benevolence/maleficence, autonomy and justice, the 196/96 resolution and Coren's Resolution 240/2000. It was concluded that students have always followed some basic ethical principles; researcher's conduct has not changed after the adoption of Resolution 196/96; in spite of obligatoriness of sending research projects to Ethics and Research Council (CEP); most of the researchers did not fulfill that requirement; the principle most approached in Bioethics was autonomy with emphasis on informed consent and secrecy.     

供精治疗的管理

辅助生殖技术应用产生的伦理问题很多,所引起的争论是前所未有的。人类辅助生殖技术伦理原则包括有利于患者、知情同意、保护后代、社会公益、保密、严防商业化及伦理监督7个方面。而供精人工授精存在的伦理观念的冲突更加明显。如果不对其进行规范化的管理,就会导致涉及社会、伦理等重大后果。沈阳东方医疗集团菁华医院通过近5年的临床实践,在供精管理方面进行了许多有益的尝试,在知情同意、随访、冷冻精液等方面形成了系列的管理体系,取得一些实效。