涉及人的生物医学研究知情同意初探

从知情同意的哲学、法学以及伦理学渊源入手,探讨知情同意的必要性与行使原则,并对未成年人和精神障碍者等特殊受试者的知情同意过程提出建议。     

Myth of mental health nursing and the challenge of recovery

Although the concept of 'mental health nursing' has grown in popularity over the past 35 years, it remains a myth. People believe that they know what it is and value it highly, but cannot describe or define it other than in vague terms. This paper briefly charts the rise of 'mental health nursing', emphasizing its political implications, and in particular, the drive towards an embrace of a person-centred, recovery-focused approach to care. If nurses are to realize such ambitions, they must resolve their historical association with psychiatric nursing. The concept of the 'mental health nurse' might signal the emergence of a new vision for human services, but might also signal the need for 'mental health nurses' to negotiate a formal separation from the traditional 'psychiatric' family.     

医疗机构中医疗器械临床试验的伦理审查

医疗器械临床试验是对医疗器械的安全性和有效性按照规定进行试用或验证的过程,该过程需由具有医疗器械临床试验资格的医疗机构审核．经其医学伦理委员会评审通过后,方可进行。对医疗机构中医疗器械临床试验伦理审查的内容,流程和批准标准分别进行了分析和评述．为医疗机构保证临床试验的安全有效提供依据。     

Addressing the ethical grey zone in surgery: a framework for identification and safe introduction of novel surgical techniques and procedures

While the introduction of new surgical techniques can radically improve patient care, they may equally expose patients to unforeseen harms associated with untested procedures. The enthusiastic uptake of laparoscopic cholecystectomy in the early 1990s saw a dramatic increase in the rate of common bile duct injuries, and was described by Alfred Cuschieri as ‘the biggest unaudited free‐for‐all in the history of surgery’ due to ‘a lack of effective centralised control’. Whether a new surgical intervention is considered an acceptable ‘minor’ variation of an established procedure, or is sufficiently ‘novel’ to constitute experimentation on human subjects is often unclear. Furthermore, once a new technique is identified as experimental, there is no agreed protocol for safety evaluation in a first‐in‐human setting. In phase I (first‐in‐human) pharmacological trials only small, single arm cohorts of highly selected patients are enrolled in order to establish the safety profile of a new drug. This exposes only a small number of patients to the unknown or unforeseen risks that may be associated with a new agent, in a highly regulated and scientifically rigorous manner. There is no equivalent study design for the introduction of new and experimental surgical procedures. This article proposes a practical stepwise approach to the safe introduction of new surgical procedures that surgeons and surgical departments can adopt. It includes criteria for new surgical techniques which require formal prospective ethical evaluation, and a novel study design for conducting a safety evaluation at the ‘first in human’ stage.     

Impact of written information consent on the number of intravenous contrast--enhanced CT and MR studies

RATIONALE AND OBJECTIVES: The purpose of this study was to evaluate the impact of written informed consent on the number of intravenous contrast-enhanced CT and MR imaging studies. MATERIALS AND METHODS: On December 2002, the Conference of Physicians and Medical Directors in our institution decided that all referring physicians must obtain written informed consent in each case before intravenous injection of contrast material for CT and MR imaging studies. The numbers and proportions of contrast-enhanced CT and MR imaging studies before introduction of the written informed consent requirement (January 2002-December 2002) were compared with those after (January 2003-December 2003). RESULTS: The number of contrast-enhanced CT studies decreased from 5930 (50.6% of all CT studies) to 5539 (49.0% of all CT studies) (odd ratio [OR]: 0.94, 95% confidence interval [CI]: 0.89-0.99). The number of contrast-enhanced MR studies also decreased from 1895 (46.5% of all MR studies) to 1712 (43.4% of all MR studies) (OR: 0.88, 95% CI: 0.81-0.96). CONCLUSION: Findings suggest that the written informed consent requirement reduces the number of intravenous contrast-enhanced CT and MR imaging studies.     

Ethical advocacy based on caring: a model for neonatal and paediatric nurses

Advocacy has been identified as an ideal in nursing practice. National codes (Australian Nursing and Midwifery Council) and professional standards (Australian College of Neonatal Nurses) state that nurses are to respect their patients' autonomous choices and act as their advocates. This responsibility includes acting as advocates for the needs and welfare of patients, for the profession of nursing and for the interests of colleagues in nursing. However, ambiguous interpretations of the concept of patient advocacy continue to pose a number of problems for nurses in practice and in particular neonatal practice. Neonatal nurses often perceive themselves primarily as advocates for the rights of helpless and vulnerable infants in their care. Advocacy is underpinned by caring, which is a significant feature in the delivery of quality care for each baby and child. This advocacy may be expressed at the bedside, in committee meetings, in agency discussions or in the public arena.     

审美意识引领生命科学技术发展--审美轴心说初探

审美意识是超知识、超功利、超道德的人类精神最高境界,它不仅是指对美的“愉悦”．更是指对万物一体的感悟,对崇高诗意境界的追求。审美轴心说揭示．审美意识决定道德追求和科技发展的目标．引导科技伦理的进步．指引科学技术发展的方向。对于生命科学技术的发展,审美意识指向的伦理准则是：人性原则。明辨义利原则和公平、公正与效益合理性原则;审美意识指向的审美原则是：天人合一、人为中心原则．和谐原则,生态中心转向,“庖丁解牛”的高远艺术境界。     

上海市“互联网+护理服务”试点中存在的问题及对策

分析了上海市"互联网+护理服务"试点工作中存在的问题,如群众需要与实际提供之间存在认知的不完全一致,相关管理制度和服务规范需要进一步细化规范,护士安全保护与患者隐私保护之间的平衡,突发医学护理活动事件护士的伦理决策,护士的人文关怀精神培养和树立等问题,并提出相应的建议,以促进"互联网+护理服务"的发展。