The design and use of the Bioethics Consultation Form

The emergence of the ethics consultation as a means to resolve moral crises in clinical medicine has revealed the need for a worksheet that would facilitate intake and analysis. The author developed the Bioethics Consultation Form as an attempt to remedy this need. The form is arranged in an outline format and is a useful asset to ethics committee discussions and record keeping. The first section covers basic intake data concerning the patient's medical and personal information, advance directives, and values, as well as the values of the physician and family. After the intake section is completed with the above data, the ethics consultant then turns to the analysis section. This second section allows for (1) the discussion of conflicting values, (2) the identification of priorities, and (3) the elucidation of ethical norms relevant to the case.The Bioethics Consultation Form was adopted by the Patient Care Advisory committee of the Franklin Square Hospital Center in Baltimore, Maryland in 1986. The methodology in the use of the form will be discussed. Further, the potential spectrum of consultative cases that can be analyzed using the form will be highlighted.     

临床研究结果发布的伦理审查辨析

《涉及人的生命科学和医学研究伦理审查办法》对于临床研究结果的发布提出了伦理审查和知情同意告知的要求。探讨临床研究的结果发布可以最大程度实现临床研究的价值,包括有利于实现临床研究的透明性,有利于增强公众的信赖,有利于落实研究参与者的知情权,并分析了研究结果发布在隐私保护、发布形式、发布时间、科研诚信和学术不端方面带来的潜在伦理问题。建议伦理委员会从隐私风险最小化、发布形式规范化、发布时间合理化三方面进行伦理审查,同时给出了加强多部门协作和跟踪审查以及参与学术不端治理的伦理审查策略建议。

     

基层医院伦理委员会建设存在问题及对策

基层医院以承担本地区人民群众的健康保障工作为首要任务,以临床工作为主,科研工作开展相对较少,伦理委员会的建设存在较大问题。针对基层医院伦理委员会在建设过程中存在认识和重视程度不足、独立性欠缺、规章制度不完善、人员组成及审查不规范以及缺乏有效指导和监管等问题,结合基层医院的特点和功能定位,在完善工作制度和流程、组建全面合理代表性强的伦理委员会以及加强培训提高认识等方面提出比较科学可行的对策,为基层医院伦理委员会的规范化建设提供参考。     

临床试验受试者补偿存在的问题及改进措施探讨

通过对补偿等相关概念界定,对临床试验受试者补偿的范围界定不明确、补偿金额缺乏具体核算标准及报销手续繁琐与兑现时间长、补偿方式单一,未体现不同受试者多样化需求、受试者维权能力与维权意识薄弱、伦理委员会履职能力也影响受试者权益维护等问题进行了分析,针对问题探讨其改进措施,如明确补偿的具体内容与范围,制定具体补偿标准及提高补偿兑现效率,采取合理的多样化补偿和激励方式,充分向受试者告知补偿权益,提高受试者的维权意识,提高伦理委员的审查能力等,为制定受试者补偿相关指导意见及保护受试者权益提供一定的理论参考。     

人体生物医学研究中受试者权益保护对策

在人体生物医学研究日益发达的今天,受试者权益保护问题逐渐浮出水面。目前我国对受试者的保护主要依赖于知情同意书和伦理委员会,关于受试者权益保护的规范性文件存在层级低、不系统和不完整等问题。建立专门的受试者保护法,完善受试者权益保护相关制度迫在眉睫。研究认为,制定专门的人体生物医学研究受试者权益保护法律,完善伦理委员会制度,推行强制保险以及救济金制度,建立严格的责任体系、开展积极的社会教育是受试者权益保护的基本对策。     

欧美生命伦理委员会的机构建设与咨询服务

在当今国际世界,生命伦理学已经发展成一种国际性的“社会运动”,成为学术界和公众关注的热点领域。在欧美国家健全和完善现代医疗保健制度过程中,“生命伦理委员会”起到至关重要的作用,它不仅促使人们从伦理学角度探索“我/我们应当如何决定和行为”的问题,也推动社会从制度建构和文化塑造层面回答“政府应当如何行为”、“如何增进公民的生命伦理意识”等问题,并从哲学领域深入探索如何应对生命伦理学理论与实践中的复杂问题与困境,论证相关伦理选择及其实践的合理性。20世纪60年代以来,欧美社会生命伦理学在机构建设、咨询服务和思维方式等方面的经验可以为中国生命伦理学学科发展及生命伦理委员会建设提供有益的参考。     

ICU临终患者治疗抉择的伦理问题

医生面对ICU临终患者很难抉择是应该积极治疗到底还是提供舒适的保守治疗,目前相关的伦理及法律问题仍尚需完善,伦理指导是一项解决纠纷、政善沟通有效的工具,成立伦理委员会对医生进行合理的建议和指导是非常必要的。     

Getting Beyond Form Filling: The Role of Institutional Governance in Human Research Ethics

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus on modifying research behaviour through a combination of education and sanctions. The assessment of whether a researcher is ‘ethical’ is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research.     

加强医学伦理学教育指导医疗实践

通过对五所医院医务人员和两所医科大学的学生从医学伦理学教育和伦理培训等四方面进行现场调查和分析,提出目前在医科大学,医学伦理学已经逐步被认识和接受;医学伦理在临床实践和医疗科研中已有较大的影响;医学伦理委员会的工作需要进一步加强;医学伦理教育任重道远.     

医疗机构伦理审查委员会独立性评价指标体系构建

伦理审查委员会独立性是保障伦理审查过程及决策的科学性与伦理合理性的重要措施,也是保护受试者安全与权益的基本要求。通过文献检索、法规解读、专家小组讨论、德尔菲专家函询法进行筛选指标,确定医疗机构伦理审查委员会独立性评价指标体系及各指标权重,最终形成的指标体系共3项一级指标,11项二级指标,37项三级指标。该指标体系从伦理审查委员会设置、运行、内涵建设三个维度,建立了以独立性为框架的科学全面的独立性评价指标体系,为建设与评价伦理审查委员会独立性提供参考。