初探如何加强医疗器械临床试验的伦理审查

通过对医疗器械临床试验的伦理审查内容、流程进行分析和评述,探讨其审查过程中需要重点关注的几个方面、以及执行过程中可能存在的问题及其解决方案,为医疗机构提高医疗器械临床试验伦理审查的质量和水平提供参考。     

医学研究知情同意过程及信息告知的伦理审查要点

提高伦理委员会审查质量与严格执行知情同意是保障受试者权益的主要措施。伦理委员会应依据国际、国内公认的法规,把握充分告知、特殊告知及获取知情同意过程等审查要点,对知情同意的过程及知情同意书告知信息进行审查,达到维护受试者权益和安全的目的。     

FDA医疗器械设备问题术语集的应用研究

美国食品药品监督管理局（FDA）于2009年7月开始实施新的设备问题术语集。通过阐述FDA设备问题术语集的实施概况及其术语集结构,基于美国MAUDE数据库论证了该设备问题术语集对医疗器械风险评价的实际意义,分析了FDA设备问题术语集对于我国监测实情的应用难度,并结合监测现状提出了借鉴FDA设备问题术语集的实施建议,以期对我国设备故障术语集的建立提供有益思路。     

Physical therapists’ perception of workplace ethics in an evolving health-care delivery environment: a cross-sectional survey

Physical therapists are trained and obligated to deliver optimal health care and put patients first above all else. In the changing health-care environment, health-care organizations are grappling with controlling cost and increasing revenues. Moral distress may be created when physical therapists’ desire to provide optimal care conflicts with their organization’s goals to remain financially viable or profitable. Moral distress has been associated with low perception of ethical environment, professional burnout, and high turnover in organizations. This study identified groups who may be vulnerable to low perception of organizational ethical environment and identified self-reported strategies to remedy these perceptions. An ethics environment questionnaire was mailed to a random sample of 1200 physical therapists in Georgia. Respondents (n = 340) were analyzed by age, workplace setting, and position in organization. Therapists working in skilled nursing/assisted living environments scored the lowest on the questionnaire and voiced concerns regarding their ethical work environments. Owners and executives perceived their organizations to be more ethical than front-line clinicians. Respondent concerns included high productivity standards, aggressive coding/billing policies, decreased reimbursement, and increased insurance regulation. Possible solutions included more frequent communication between management and clinicians about ethics, greater professional autonomy, and increased training in business ethics and finance.     

肿瘤专科医院新护士伦理气氛认知与工作绩效的相关性研究

目的探讨肿瘤专科医院新护士伦理气氛认知与工作绩效的相关性。方法2017年3月-2018年7月采用一般资料调查表、医院伦理气氛认知量表和工作绩效量表对110名新护士进行调查。结果新护士的伦理气氛认知总均分为(3.55±0.47)分;工作绩效总均分为(3.91±0.48)分,新护士伦理气氛认知总分及各维度得分与工作绩效总分成正相关(r=0.219~0.575,P<0.05);多元线性回归分析显示伦理气氛认知可解释工作绩效38.9%的变异。结论医院管理者可通过营造良好的医院伦理氛围,提高新护士的伦理气氛认知水平,进而提高工作绩效水平。     

生物医学前沿中的伦理问题

本文在讨论科学技术与伦理学关系、生命伦理学基本原则以及道德与伦理学之间的异同后,探讨了人的克隆和干细胞研究、基因治疗、生殖遗传学、异种移植、生物医学和临床研究中的伦理问题。     

新版《药物临床试验质量管理规范》下安全性报告伦理审查述要

新版《药物临床试验质量管理规范》在2020年颁布并实施,以充分贯彻落实中央《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》的精神,并适应人用药物注册技术要求国际协调会的规则。新版《药物临床试验质量管理规范》涉及伦理审查的重要更新之一在于,强调了申办者需要及时向伦理委员会提交可疑且非预期严重不良反应报告、其他潜在的严重安全性风险信息报告、研发期间安全性更新报告等安全性报告,对机构伦理审查能力提出了新的要求和挑战。作者结合欧盟、美国、英国等人用药物注册技术要求国际协调会成员国对安全性报告的伦理审查要求,探讨了我国在新形势下以注册为目的的药物临床试验安全性报告伦理审查的要点。     

62,406 and Counting

What will we remember, as scholars, practitioners, policy-makers, educators, and citizens, about this acute phase of the catastrophe in the United States? The shocking federal failure concerning testing? That the first shortage was not of ventilators but protective gear? How infection rates and deaths in communities of color, immigrant neighborhoods, and nursing homes mercilessly exposed the relationship between social inequalities and health inequities? I hope we will remember that the field of bioethics did good work under pressure, learned that public health ethics and global health ethics are about securing the conditions for decent lives and decent work as well as saving lives, and committed ourselves to progress on the problem of inequality.