国际重要伦理学文献简介(二)

赫尔辛基宣言——Declaration of Helsinki 1964年6月在芬兰赫尔辛基召开的第18届世界医学大会通过了关干涉及人的医学研究的伦理准则的《赫尔辛基宣言》。1964年,世界医学协会颁布了《赫尔辛基宣言》,它是生物医学研究伦理学领域中的基本国际性文件,影响着国际、地区、国家的立法和行为准则的制订。《宣言》曾修订多次(世界医学大会分别于1975年第29届、1983年第35届、1989年第41届、1996年第48届和2000年第52届世界医学大会对该宣言进行了五次修改,最近一次是在2000年)。     

改善医患关系必须重视知情工作

知情是医疗行为过程中的重要环节 ,是患者同意、医生采取进一步医疗措施的前提。医生给患者诊断治疗疾病 ,首先需要的是对患者身体不适情况的了解 ,这是知情 ;患者在接受诊断和治疗中 ,需要对医生采取的医疗措施了解与认可 ,由此与医生配合 ,接受诊断和治疗 ,这也是知情。因此知情是医患双方双向沟通的过程 ,是双方的共同需要。在医疗活动中 ,医患矛盾由于多种因素而难以避免 ,其中知情环节的缺陷 ,尤其医生一方对患者知情重要性认识的缺陷是一个重要的原因。1　知情是患者正当的权利世界医学会 1986年召开第 38届年会时 ,通过的《医师专业…     

联合国教科文组织国际生命伦理委员会关于知情同意的报告（摘译）

1．知情同意原则是现代医学伦理学的一项基本原则,它也是基于个人自主权的现代医学伦理学诞生的标志。《纽伦堡宣言》强调,生物医学研究必须坚持知情同意原则。二战后所发生的种种违背人道的科学研究行为也再次强调了知情同意原则的重要性。从临床实践看,知情同意原则是病人权利运动的产物,也是新兴的生物医学技术发展要求由病人自己对复杂的卫生保健选择做出决定的必然结果。知情同意原则的实践应用,改变了传统的家长式卫生保健医患关系。     

患者知情同意原则的法律应用分析

患者知情同意原则是现代医疗法律的基本原则之一。《侵权责任法》首次在基本民事法律层面规定了患者知情同意原则,弥补了以往的法律缺失,具有极为重要的意义。针对《侵权责任法》第55条在适用中存在的问题,本文提出,在实践中应将患者知情同意原则区分为患者知情权和患者同意权两个权利,同时应给予患者的知情范围一个大致明确的界定和确定医疗机构履行告知义务的标准,最终还应明确医疗机构的免责条件。     

医术——体现人性与仁术之美

我们都熟悉希腊希波克拉底誓言和1948年在此基础上世界医学会（WMA）制定的《日内瓦宣言》,从这两个誓言我们可以看出时代的烙印。因此,在那之后,1988年美国医学伦理学家整理细化为“一个医生所承诺的促进病人利益的义务”,被很多西方国家用来作为医学生毕业时背诵的“后希波克拉底誓言”。     

化疗患者护理中的知情同意

知情同意原则提出于20世纪60年代，起源于美国，是一项利于达到医疗目标的措施，体现了对患者人格的尊重和生命权利的尊重。1996年，国内学者也提出了“患者的权利”，其中提出了一项重要权利是“知情同意权”，所以，在治疗护理活动中，怎样让患者接受和理解各种与其所患疾病相关的医疗信息和护理措施，以便对医务人员制定的诊疗护理计划自行决定取舍，护士有告知义务，既是尊重患者权利的需要，也是保证护理安全、减少医疗纠纷和护士进行自我保护的需要。     

积极干预可使一半人免于卒中

鉴于卒中已肆虐全球,卒中的预防、治疗和康复现状亟待改进,唤醒专业人士和公众对卒中的警觉已迫在眉睫。日前,在温哥华举行的第五届世界卒中大会宣布,将每年的6月24日设立为世界卒中日。来自美、法、中等国的100多位专家共同起草了《世界卒中日宣言》。《宣言》说,卒中是可以预     

从知情同意的发展史正确认识知情同意权

1知情同意权的诞生“知情同意”(inform edconsent)是英美法系的产物。在英语语言文献中,涉及知情同意的首次记载可追溯至1767年的英国slater案[95Eng.Rep860(K.B.1767)]。在该案中,法院认为,在实施手术前取得患者的同意是“外科医生之惯例和法则”。美国早年的知情同意案子关注的是在医疗行为实施中患者“同意”的缺失。1905年的Pratt案[118111.App.161(1905)]和1914年的Schloendorff案[105N.E.92(1914)]皆是患者因对手术缺乏同意而引发的案子。在前一案中,B rown法官认为,“自由公民第一位的和最大的权利”是“其自身不可侵犯的权利”…     

医院在实施病人知情同意权中的存在问题及思考

知情同意权的提出始于二战后的纽伦堡审判，1957年，美国加尼福尼亚州的法院首次将知情同意引入医疗纠纷的领域。在我国，实施数十年的手术同意书制度已经充分反应了病人知情同意的重要性。随着人民群众法律意识的加强，国家法制的健全，医院在医疗行为过程中实施病人知情同意的必要性显得更为突出。事实正是如此，近年来医疗纠纷逐年上升.     

患者知情同意权利的构成及其涵义

从我国在病人知情同意的历史发展中,论述病人知情同意的形成和确立.提出病人知情同意权利的实现有赖于医师告知义务制度的建立.     

Ethical concerns regarding guidelines for the conduct of clinical research on children

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration of Helsinki, and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health (formerly the British Paediatric Association), and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration.     

The three official language versions of the Declaration of Helsinki: what's lost in translation?

BACKGROUND: The Declaration of Helsinki, the World Medical Association's (WMA's) statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish. METHODS: A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document. RESULTS: There were many minor linguistic differences between the three versions. However, in paragraphs 1, 6, 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance. INTERPRETATION: Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA.     

从2013年版《赫尔辛基宣言》的变化生命伦理学研究的新进展

通过对2013年版《赫尔辛基宣言》和旧版本进行比较,分析生命伦理学发展的新进展：一是对受试者的保护工作进一步加强,表现在从研究设计的源头管控保障受试者利益和从知情同意的过程管控维护受试者权利两方面.二是对研究医生的管理进一步规范,涉及研究医生的定义问题、资质问题、职责问题.三是对伦理委员会的定位进一步明确.此外,新版宣言更加重视对生态环境的保护.     

医疗同意权主体合理性探究

医疗同意权是患者充分了解自己病情诊断以及可供选择的治疗方案信息后,作出接受治疗与否以及选择何种治疗方案的人格权利。患者医疗同意权作为患者的一项重要权利越来越受到关注。在借鉴、吸收学术界研究成果的基础上,对如何更好地维护患者的医疗同意权作了初步探讨。     

The Declaration of Helsinki and research in vulnerable populations

Mooted changes to the Declaration on the agenda of the World Medical Association have sparked a vigorous debate on international research issues. The medical, research and ethics communities in Australia need to participate more broadly in this debate.     

The standard of care debate: the Declaration of Helsinki versus the international consensus opinion

The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.     

The myth of informed consent: in daily practice and in clinical trials.

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests.     

Medical oaths, declarations, and codes

In the second of a series of articles on philosophical medical ethics, Gillon briefly describes the World Medical Association's declarations on medical ethics, including the Declaration of Geneva, the international code of medical ethics adopted in London in 1949, and the Declarations of Helsinki, Lisbon, Sydney, Oslo, Tokyo, Hawaii, and Venice. Raising the question whether British physicians should be bound by these declarations, rather than by the code of ethics of the General Medical Council which has legal jurisdiction over them, he contends that law is too fluid to serve as a foundation for ethics. He plans to discuss the fundamental underpinnings of medical ethics in subsequent articles.     

通过独立的伦理委员会保护受试者权益

首先介绍了我国临床药理基地(Baced of clinical Tical)的设置、职能、任务和现行的临床试验分期,概述了我国临床试验管理规范中关于维护和尊重受试者权益的基本要求.重点介绍了通过设置独立的伦理委员会,按照赫尔辛基宣言等国际公认的法规和准则,从保障受试者权益的角度,对临床药理试验全面进行伦理学评审和把关的途径和方法.最后还简要介绍了作者所主持的学校医学伦理学委员会坚持工作的独立性,坚持正确的评审原则,坚持会审会签制度等有效方法,并对可能出现的问题作了讨论.