医院伦理委员会建设探讨

鉴于目前国内外对临床研究的伦理重视程度日益提高,结合医院伦理工作实际,从伦理委员会的工作模式、标准化流程（SOP）、档案管理和队伍建设等有关方面,探讨医院伦理委员会的建设及应当注意的问题,认为医院伦理委员会工作应形成书面规范文件,以提高伦理委员会运行的规范性,需建立健全伦理审查制度,以体现伦理委员会运作的程序性。     

刍议伦理审查委员会的信息公开与公众参与

近年来随着伦理审查委员会的建立及活动开展,其运作监管体系的建设日益受到了相关部门官员及学者的重视.然而建立较为完备的伦理审查委员会运作监管体系有待时日,因此,强化伦理审查委员会自身工作能力则是一种切合实际的途径.加强伦理审查委员会的工作能力有如下途径：加强伦理审查委员会对自身的教育培训与研究交流，以提高其伦理审查能力；     

山西省地市级医院伦理委员会建设实证研究

通过调研伦理委员会建设和运行现状,进而分析影响山西省地市级医院伦理审查工作的主要因素,为完善伦理委员会工作提出建议。采用问卷调查和访谈的方式调查山西省地市级24所医院伦理委员会人员组成、制度和标准操作规程、人员培训情况及审查项目方式、时限情况等。分析结果发现,地市级三级医院伦理委员会设置及制度基本合理,能够积极发挥伦理委员会的职能。目前大部分医院对伦理委员会工作不够重视,缺乏专职人员及系统化的培训,伦理审查能力不足。二级医院伦理委员会建设流于形式,未开展实质性工作。建议通过加强上级部门的监管,加大伦理委员和研究者培训力度,完善伦理委员会信息化管理,进一步提高伦理审查能力和效率。     

医院伦理委员会的制度化建设

该院成立伦理委员会以来，在制度化建设方面的体会是：医院领导的重视程度对医院伦理委员会的建立和发展起重要作用；普及医学伦理学教育可为伦理审查工作奠定工作基础；只要强调生物医学研究课题申报与伦理审查工作协调一致才能保证伦理审查工作不流于形式，认为建立健全的医院伦理委员会相关制度是更好和更有效地开展医院伦理委员会工作的基本保证。     

公立医院开展干细胞临床研究中的伦理审查实践探讨

为配合医院开展干细胞临床研究机构及项目备案,武汉市中心医院伦理委员会对干细胞临床研究伦理审查工作做了相关的准备,并按照国家省市文件要求开展干细胞临床研究伦理审查工作。但在伦理委员会实际伦理审查工作运行中,存在干细胞供者知情同意告知、受试者风险告知不充分,伦理委员干细胞研究专业背景不够等问题。因此,在开展干细胞临床研究伦理审查过程中,应当调整伦理委员会组织架构,加强知情同意审查,落实跟踪审查责任,完善培训机制,以促进干细胞临床研究的开展。     

机构审查委员会再析

鉴于目前国内对各种伦理委员会（医院伦理委员会、机构审查委员会和医学伦理委员会）认识的混乱现状，作者试图对其中一种——机构审查委员会的发展背景、定义、组成、功能、意义等方面进行重新分析。     

中医院伦理委员会运行管理及审查质量持续改进措施分析

伦理委员会在临床研究全过程中对保护受试者的权益起着重要的作用。在医疗卫生机构临床研究项目申报和立项逐渐增多的实际情况下，中医院伦理委员会需要明确自身职责，通过完善管理制度，按照国际国内的相关法律法规，不断修订完善标准操作规程，使伦理委员会的运行管理各方面有章可循。高质量伦理审查是提高伦理审查效率的前提。伦理委员会通过定期的自我质量评估，提出持续质量改进计划，并切实监督执行。伦理委员会通过接受上级部门的监督检查或独立的第三方评估，可以对自身的运行管理和项目的审查质量等进行全方位的综合评价。伦理委员会运行管理及审查质量的持续改进，还需要得到医疗卫生机构在人员配置、资金支持、存档空间、软件系统等多方面的支持。同时，伦理办公室在日常工作中，需要与项目实施者及药物临床试验机构（GCP）办公室、科研处科研项目的行政管理部门进行有效的沟通交流，不断提高伦理跟踪审查的力度和执行力。     

医院伦理委员会的职能与建设探讨

文章论述了国内外伦理委员会发展及现状、工作模式及存在问题,如缺少标准化的操作规程和专门的监管机构。针对问题提出要加强国内医院伦理委员会组织和制度建设、人员构成及培训、严格按照标准执行审查、加快与国际接轨,并引进SIDCER认证操作平台对伦理委员会操作规程进行规范,科学合理指导医院伦理委员会正确行使职责,有力保护受试者和患者的安全和权益。借鉴国外伦理委员会审查职能,在涉及患者伦理方面的病例讨论,术前讨论等各种临床诊疗过程中发挥伦理审查作用进行了探索,提出建设符合本国的伦理委员会论证体系,以便更好的保护受试者的医疗安全、质量和权益。     

某医院伦理委员会在临床试验开展中的职能、存在的问题与对策研究

某医院伦理委员会在项目审查中常发现以下问题：试验方案撰写不规范,知情同意书格式不规范、要素不全、语言描述过于专业化,申请伦理审查的时机滞后。对此,提出相应对策：加强研究者的医学伦理学教育、强化研究者对伦理审查的认识,加强伦理委员会内部的培训和继续教育,加强伦理委员会建设、制定和不断完善伦理委员会的标准操作规程和工作制度。     

医学伦理审查工作在我院的规范运行

针对我国医学伦理审查的现状及存在的问题,结合温州医学院附属第二医院自2001年成立伦理委员会以来所开展的对临床试验、医疗技术和医学科研进行伦理审查的一些经验和体会,对医学伦理审查工作的系统化和规范化进行了实践探索.     

医院伦理委员会建设若干问题的探讨

通过介绍上海几家有代表性医院的伦理委员会建设成就,阐明了我国的医院伦理委员会建设应具有自己的特点。对人才培养成为医院伦理委员会建设的瓶颈、缺乏针对伦理委员会委员的系统化培训、缺乏可操作性强的操作指南、伦理委员会的建设发展不平衡、伦理委员会的工作缺乏较高的独立性和透明度、缺乏利益冲突的管理机制等医院伦理委员会建设中存在的问题进行了探讨,提出了加快医学伦理学的人才培养、探索实行伦理委员会注册和伦理委员资格认定、尝试建立联合伦理委员会、广泛开展保护受试者和患者安全和权益的社会宣传、明确利益冲突的防范和管理原则等对策。     

Research on human subjects: Australian ethics committees take tentative steps.

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported.     

Hospital ethics committees in Israel: structure,function and heterogeneity in the setting of statutory ethics committees

OBJECTIVES: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons. SETTING: Israel five years after the passage of the Patients' Rights Act. Main measurements: Patients' rights and informal ethics committee structure and function. RESULTS: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction. CONCLUSIONS: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement.     

江苏省三甲医院医务人员伦理认知状况调查

目的：了解江苏省医务人员对医学伦理的认知情况,为医院医学伦理组织的建设提供参考。方法：采用问卷调查的方法对江苏省26家三甲医院的医务人员进行问卷调查。结果：312名医务人员中54人（17．3％）表示在继续教育中接受过医学伦理教育;227人（72．8％）知道所在医院已经设立伦理组织,但其中70％的人不知道所在医院设置伦理组织的种类或数量,18％认为伦理审查有利于患者而不利于科研;多数医务人员听说过伦理相关制度规范,但不了解详细内容,部分人员不知道所列举规范的名称及内容。结论：江苏省三甲医院医学伦理组织建设已经取得一定成效,但仍存在一些问题。需要加强医学伦理知识培训,促进医院伦理组织常态化运行,规范服务行为,健全卫生法律法规等。     

Hospital ethics committees. Administrative aspects

Two physicians with experience in setting up hospital ethics committees (HECs) review some of the administrative and legal aspects of the committees' formation and operation. They identify HECs as having an advisory function rather than a regulatory or decision making role, and explore the rationale for these committees and their relationship to institutional review boards. Advice is offered to hospitals planning to establish ethics committees on defining their goals, selecting members, deciding about patient and family participation, opening meetings to all interested persons, and keeping records. Fost and Cranford also discuss the questions of access to committees, their jurisdiction, whether consultation should be optional or mandatory, and the effect of committee consultations on legal liability. They conclude that, if properly formed and administered, hospital ethics committees can help promote ethically defensible decisions about life-sustaining care.     

Ethics-committee authorization in Germany.

On 9 August 1994 the German legislature revised the German Drug Law (AMG). Included in the revision is a passage requiring, for the first time, that the sponsors and investigators of clinical studies involving human subjects first obtain the approval of an ethics committee before carrying out such studies. According to the legislation, which takes effect on 17 August 1995, approval is to come from 'an independent ethics committee, set up and administered according to state law [emphasis added]' (1). Although it is clear according to the text that the 16 federal states have been empowered to establish ethics committees within their jurisdictions, this does not mean that the state governments are free to transfer exclusive authority in the matter to their respective medical associations, a step that would effectively abolish Germany's private ethics committees. First, the legislation does not rule out the authorization of private ethics committees. Second, as legal scholars attest, the exclusive control of ethics committees by the medical associations would constitute an illegal monopoly. Third, it is arguable that medical-association ethics committees fail to meet the one prior federal requirement, that of independence. There is a great deal of confusion in Germany today about which kinds of ethics committees (public and/or private) the states will sanction before 17 August 1995. In an attempt to sort things out we present a brief explanation of how ther came to be two kinds of ethics committees in Germany, review the legal battle between the two over the issue of authorization, point out how the German legislature, in passing the recent bill, has missed an opportunity to clarify the issue and, finally suggest why the administration of ethics committees by the medical associations may be incompatible with the requirement that ethics committees be independent.     

Hospital policy on advance directives. Do institutions ask patients about living wills?

Surveys have shown that a substantial proportion of the population has prepared an advance directive. The purpose of this exploratory study was to assess the existence and nature of hospital policy regarding these documents. A survey questionnaire was sent to 394 randomly selected hospitals in the United States. Of the 219 responding hospitals, 146 (67%) reported having a formal policy regarding advance directives. The large majority of those with a policy require the patient to notify the hospital of an advance directive, while only 4% of the respondents actively inquire about these documents. Hospitals in states with legislation that sanctions advance directives were significantly more likely to have a formal policy regarding these documents than hospitals in states without such legislation. Forty-six percent of the respondents reported having an ethics committee; however, the presence of an ethics committee was not significantly associated with the presence of a formal policy. Of the 69 hospitals that had both a formal policy and an ethics committee, only 30 (43%) reported that the policy had been reviewed by the ethics committee. Ethical and legal issues regarding hospital policy on advance directives are discussed. Hospitals should adopt formal policies to ask all adult patients at the time of admission whether they have prepared a living will, durable power of attorney, or similar document; and ethics committees should play a more active role in policy development.     

Education of ethics committee members: experiences from Croatia

OBJECTIVES: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. DESIGN: Before/after cross-sectional study using a self administered questionnaire. SETTING: Educational workshop for members of hospital ethics committees, Zagreb, 2003. Main outcome measurements: Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. RESULTS: The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. CONCLUSIONS: The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.     

Evaluation of research ethics committees in Turkey

In Turkey, there was no legal regulation of research on human beings until 1993. In that year "the amendment relating to drug researches" was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control. There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees (RECs) play a central educational role by helping physicians to be aware of moral problems and by contributing to the training of research teams.     

论医学伦理委员会的意义和发展

介绍了促使医学伦理委员会产生的具体历史事件,论述医学伦理委员会的意义,认为,发展中国家的医学伦理委员会具有特殊的重要意义.就促进我国伦理委员会的发展提出了五点建议:消除顾虑,加快建设医学伦理委员会的步伐;挖掘传统文化中优秀的伦理精神,建立符合中国国情的生命伦理原则和理念;紧密结合医疗和社会的进步,勇于创新;加强对生命伦理学专业人材的培养;推动医学伦理委员会之间的交流.