上海市医院伦理委员会伦理审核工作现状分析

对上海市33所公立医院进行了涉及人体生物医学研究的伦理审核状况的调查，结果显示，绝大多数医院伦理委员会均设有初始审核、快速审核与不良事件审核的相应操作规程和要求，但跟踪审核和不良事件审核需进一步加强，上海市医院伦理委员会的伦理审核程序需进一步统一。     

上海市医院各类人员对伦理委员会功能与管理状况的综合评价

根据对上海市医院伦理委员会委员、医院管理者与一般医务人员的调查，发现上海市医院伦理委员会工作状况受到良好评价；建议应加强医院伦理委员会管理与工作绩效的研究，应建立医院伦理委员会的认证体系。     

上海市医院伦理委员会机构建设与功能定位的现状分析

通过对上海市33所公立医院机构与医务人员的问卷调查，分析了解了医院伦理委员会机构建设与功能定位的现状。调查显示上海市医院伦理委员会组织与功能框架基本形成，但对于临床医疗服务项目的伦理审核和咨询以及对医务人员生命伦理的教育与培训功能需加强。     

上海市医院伦理委员会日常运行管理现状分析

对上海市设有医院伦理委员会的33所公立医院伦理委员会开展的包括伦理审核的申请、日常会议的召开、利益冲突的控制、文档资料的管理、委员会日常经费的来源、伦理培训以及伦理服务的收费情况等日常运行和管理现况的调查内容进行分析，并对上海市医院伦理委员会建设提出建议。     

药物临床试验中医学伦理委员会运作模式的探讨

鉴于当前国际和我国对临床研究的伦理重视程度日益提高,各级医疗机构相应成立了医学伦理委员会。本文结合医院伦理工作实际,试从伦理委员会的组成、职责、任务及工作模式等有关内容,探讨伦理委员会在当前药物临床试验中的运作模式,从而更好地发挥其在临床试验中的重要地位作用。     

上海市医院伦理委员会功能与管理状况研究概述

介绍上海市医院伦理委员会功能与管理状况研究的背景、内容与方法以及研究的基本结论与建议，为上海市及全国加强医院伦理委员会的规范化建设提供决策信息。     

上海市医院伦理建设的实践探索与未来挑战

本文根据上海市医院伦理建设的工作情况,结合2011年上海市医院伦理委员会对部分医院伦理委员会的督导情况,对我市医疗机构伦理建设的实践进行总结分析,并对未来工作的挑战进行前瞻思考,提出上海市医院伦理建设工作的政策建议.     

从发表科技论文中分析探索医院科研项目伦理审查

目的 通过调查三级甲等医院科研项目伦理审查现状,分析其存在的问题,为完善医院伦理委员会科研项目伦理审查工作提供依据与建议.方法 对福建省3家具有代表性的三级甲等综合性医院近4年来发表论文的伦理审查情况及各伦理委员会相关资料进行回顾性调查.结果 近4年来3家医院共发表论文5 120篇,其中涉及伦理的论文有2 877篇,占论文总数的56.19％;在涉及伦理的论文中只有627篇通过伦理审查,仅占涉及伦理论文总数的21.79％,而有伦理审批的论文主要为基金论文,自选课题伦理审查几乎缺失;涉及动物伦理审查均无开展;伦理审查的形式以快速审查为主,会议审查、紧急会议审查为辅.结论 医院伦理委员会应进一步健全的管理制度,加强对临床科研项目的管理,尤其是自选课题的管理,这对促进临床研究管理与国际接轨、保障患者或受试者的安全与权益起到重要作用.     

单位制下伦理委员会审查能力建设

受单位制社会意识的影响,伦理委员会的工作也带有许多单位制的明显特征,制约了伦理审查质量的提高.分析机构伦理委员会建设现状,提出垂直管理机制、资质准入、项目交叉审查、统一标准作业程序、技术性与伦理性审查相对分开等建议.     

美国医院伦理委员会产生的原因探析

医院伦理委员会在促进现代医院管理、推进现代医疗卫生事业的发展和现代医学科学的发展以及现代社会的发展进步中发挥着特别重要的作用.美国是世界上医院伦理委员会产生最早的国家.文章就美国医院伦理委员会产生的原因进行了客观深入的探析,透视了美国医院伦理委员会产生的背景,这对推进我国医院伦理委员会的建设与发展必将有重要的启发.     

The Functioning of Hospital Ethics Committees: A Multiple-Case Study of Four Canadian Committees

A multiple-case study of four hospital ethics committees in Canada was conducted and data collected included interviews with key informants, observation of committee meetings and ethics-related hospital documents, such as policies and committee minutes. We compared the hospital committees in terms of their structure, functioning and perceptions of key informants and found variation in the dimensions of empowerment, organizational culture of ethics, breadth of ethics mandate, achievements, dynamism, and expertise.     

Situation and role of local structures of hospital ethics: s survey of Hospital Public Care in Paris

This article presents the main results of a survey carried out among the local structures for hospital ethics of the Public Assistance sector of the Hospitals of Paris. The results show that the situation of these structures has completely transformed itself since the law of 1988 on human research. Only four ethics committees subsist out of the 16 university-hospital committees that existed in 1991. Seven new structures have been created since 1994, which are open to all categories of personnel and within which doctors are a minority. The four ethics committees provide almost no decision making opinions anymore and are, like the new groups, fora for discussion, reflection, or even information on issues of hospital ethics. Almost none of these structures has an official mission. This situation presents the question of the role that a local ethics structure can hold within a hospital.     

The Presence of Ethics Programs in Critical Access Hospitals

The purpose of this study was to assess the presence of ethics committees in rural critical access hospitals across the United States. Several studies have investigated the presence of ethics committees in rural health care facilities. The limitation of these studies is in the definition of ‘rural hospital’ and a regional or state focus. These limitations have created large variations in the study findings. In this nation-wide study we used the criteria of a critical access hospital (CAH), as defined by the Medicare Rural Hospital Flexibility Program (Flex Program, 2007), to bring consistency and clarity to the assessment of the presence of ethics committees in rural hospitals. The Flex Monitoring Team conducted a national telephone survey of 381 CAH administrators throughout the United States. The survey covered a wide variety of questions concerning hospitals’ community benefit, impact activities, and whether the hospital had a formally established an ethics committee. About 230 (60%) of the respondents indicated they had a formally established ethics committee or ethics consultation program at their CAH. The prevalence of ethics committees declined as the CAH location became increasingly rural along a rural–urban continuum. Unlike CAHs, all rural Department of Veterans Affairs Medical Centers have ethics committees. The results of this study provide an understanding of the limited presence of ethics committee in rural America and the need to consider new approaches for providing ethics assistance. A virtual ethics committee network may be the most efficient and effective way of providing rural hospitals access to a knowledgeable ethics committee or consultant.     

A survey of New Jersey hospital ethics committees

A mail survey in 1988 of all 108 hospitals in New Jersey, and telephone follow-up in 1990, investigated the extent and structure of ethics committees with attention to the distinctions between prognosis, infant care review committees (ICRC) and general ethics committees (HECs). It disclosed that as of August, 1990, 74 hospitals had prognosis committees, 16 had ICRCs, and 64 had HECs. All types of committees tend to cluster in teaching hospitals and in hospitals with 200-500 beds. HECs average 13 members which include 4-5 physicians, 2-3 nurses, administrators and clergy (1-2 each), and fewer than one each for any other single profession. The primary purpose of HECS is to develop hospital ethics policy (96%), followed by educating hospital staff (80%), and providing counsel and support to physicians (67%). Case review with recommendation is provided by 54% of the HECs and 21% are involved in confirmation of prognosis.     

Ethics Committees in Croatia in the Healthcare Institutions: The First Study about their Structure and Functions, and some Reflections on the Major Issues and Problems

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees. SETTING: Croatia six years after the implementation of the Law on the Health Protection. MAIN MEASUREMENTS: Structure and function of ethic committees in the healthcare institutions. RESULTS: 46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work. CONCLUSIONS: Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.     

Do Organizational and Clinical Ethics in a Hospital Setting Need Different Venues?

The structure of ethics work in a hospital is complex. Professional ethics, research ethics and clinical ethics committees (CECs) are important parts of this structure, in addition to laws and national and institutional codes of ethics. In Norway all hospital trusts have a CEC, most of these discuss cases by means of a method which seeks to include relevant guidelines and laws into the discussion. In recent years many committees have received more cases which have concerned questions of principle. According to Ellen Fox and co-authors the traditional CEC model suffers from a number of weaknesses. Therefore, in their organization a separate body deals with organizational matters. In this paper, we discuss what is gained and what is lost by creating two separate bodies doing ethics consultation. We do this through an analysis of detailed minutes of CEC discussions in one CEC during a 6-year period. 30 % of all referrals concerned matters of principle. Some of these discussions originated in a dilemma related to a particular patient. Most of the discussions had some consequences within the hospital organization, for clinical practice, for adjustment of guidelines, or may have influenced national policy. We conclude that a multiprofessional CEC with law and ethics competency and patient representation may be well suited also for discussion of general ethical principles. A CEC is a forum which can help bridge the gap between clinicians and management by increasing understanding for each others’ perspectives.     

When there's a heartbeat: miscarriage management in Catholic-owned hospitals

As Catholic-owned hospitals merge with or take over other facilities, they impose restrictions on reproductive health services, including abortion and contraceptive services. Our interviews with US obstetrician-gynecologists working in Catholic-owned hospitals revealed that they are also restricted in managing miscarriages. Catholic-owned hospital ethics committees denied approval of uterine evacuation while fetal heart tones were still present, forcing physicians to delay care or transport miscarrying patients to non-Catholic-owned facilities. Some physicians intentionally violated protocol because they felt patient safety was compromised. Although Catholic doctrine officially deems abortion permissible to preserve the life of the woman, Catholic-owned hospital ethics committees differ in their interpretation of how much health risk constitutes a threat to a woman's life and therefore how much risk must be present before they approve the intervention.     

Today's ethics committees face varied issues. A CHA survey reveals committees' functions, authority, and structure

In a survey of Catholic Health Association member hospitals, 92 percent indicated they have formal ethics committees at their institutions. Sixty-two percent said their ethics committees were formed between 1983 and 1989. The survey found that current ethics committees are still committed to their traditional roles--education, policy development, and case review--but the education is directed to more diverse audiences than in the past. Support for medical and nursing staffs may be emerging as another possible function of ethics committees. The issues that precipitated the formation of institutional ethics committees have become more complex. In particular, questions involving the appropriate use of technology, the renewed awareness of patients' rights, changing relationships among healthcare providers, and conflicting social values have continued to require the intervention of ethics committees. However, the frequency with which respondents said their committees provide case consultations seems lower than it should be if committees were used to their full advantage. The institutional ethics committee can play a part in enlarging the current healthcare reform debate and promoting moral values. It can address such important questions as, Should the well-being of individuals take precedence over the well-being of communities?