No-fault compensation for medical injuries: the prospect for error prevention.

Leading patient safety proposals promote the design and implementation of error prevention strategies that target systems used to deliver care and eschew individual blame. They also call for candor among practitioners about the causes and consequences of medical injury. Both goals collide with fundamental tenets of the medical malpractice system. Thus, the challenge of addressing error in medicine demands a thorough reconsideration of the legal mechanisms currently used to deal with harms in health care. In this article, we describe an alternative to litigation that does not predicate compensation on proof of practitioner fault, suggest how it might be operationalized, and argue that there is a pressing need to test its promise. We tackle traditional criticisms of "no-fault" compensation systems for medical injury-specifically, concerns about their cost and the presumption that eliminating liability will dilute incentives to deliver high-quality care. Our recent empirical work suggests that a model designed around avoidable or preventable injuries, as opposed to negligent ones, would not exceed the costs of current malpractice systems in the United States. Implementation of such a model promises to promote quality by harmonizing injury compensation with patient safety objectives, especially if it is linked to reforms that make institutions, rather than individuals, primarily answerable for injuries.     

美国医疗损害赔偿研究述评

在美国,医疗损害赔偿是社会热点、难点问题,其相关研究从上世纪80年代至今就一直方兴未艾.虽然,医疗损害赔偿相关研究所得结论各异,甚至有些结果截然相反,但其研究角度、思路和方法值得借鉴.归纳、分析这些相关研究发现,其研究角度和思路是在医疗、保险、法律、互动的框架下,着眼于研究相关制度的赔偿功能、预防功能、实施成本的研究;而研究方法则以实证为主,尤其注重法律经济分析;研究的前提及理念是尊重和保障各相关利益主体的自由和权利.     

“不属于医疗事故不承担赔偿责任”之违法性分析

《医疗事故处理条例》第49条第二款规定：“不属于医疗事故的，医疗机构不承担赔偿责任。”这一规定从法理上来看，违反了上位法优于下位法规则及法制统一原则；从实践中来看，极为不利于维护患者的合法权益，亟需修改与完善。     

Individual risk and community benefit in international research

It is widely agreed that medical researchers who conduct studies in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community, not only the subjects. The justification for this moral requirement has not been adequately examined. Most attempts to justify this requirement focus on researchers' interaction with the community as a whole, not on their relationship with their subjects. This paper argues that in some cases, research must benefit the broader host community for researchers to treat subjects and prospective subjects ethically. If research presents substantial net risks to subjects, researchers can ethically ask LMIC citizens to participate only if people in LMICs, normally including people in the host community, stand to benefit.     

Aftercare for participants in clinical research: ethical considerations in an asthma drug trial.

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to compensate and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound.     

Consent and the mentally handicapped

A 1987 legal case, In re T, has pointed up the lack in British law of a provision for third party consent to medical procedures on mentally handicapped adults. T, a severely retarded 19-year-old, was found to be 11 weeks pregnant. Application was made to a Family Division court to sanction an abortion and a sterilization. Britain's 1983 Mental Health Act allows for third party consent only to psychiatric treatment, so the judge relied on a court rule to authorize the procedures in the best health interests of the young woman. Physicians with mentally handicapped patients are uncertain where they stand legally in the wake of the decision, particularly where abortion or sterilization is concerned. Two major medical defense associations recommend that their members seek legal advice before performing these procedures on an adult patient unable to consent on his or her own.     

浅谈“过度医疗”加入《侵权责任法》

《侵权责任法》将"过度医疗"加入侵权责任条款,其目的是保护患者的合法权益。从现实医疗诊断过程中反映出来的"过度医疗"表现,说明其上升到法律层面是顺应社会发展潮流和变化的。在明确"过度医疗"应承担赔偿责任的基础上,提出规避的措施和办法。     

合理解决医疗事故中赔偿问题的对策

医疗事故一经确定后,经济赔偿问题常常成为医疗事故处理的核心问题.由于医患双方所站角度不同,医院坚持实行一次性经济补偿,患者要求全额赔偿.本文认为这一问题处理的公正与否直接关系到医疗事业的发展及患者合法权益的保护,指出了解决医疗事故赔偿问题的合理途径.     

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.     

公立医院补偿机制演变的研究

公立医院补偿机制是对医疗服务过程中卫生资源的耗费进行弥补、充实的方式和途径,也就是对医院经济活动的耗费有补偿作用的各种要素的有机结合。笔者从我国公立医院服务过程中的财政补助、医疗服务收费和药费加成三种补偿途径分别阐述了传统机制下、改革初期、改革探索中的补偿机制。     

Ethics in a scientific approach: the importance of the biostatistician in research ethics committees

In medical practice and research it is necessary to consider the rights of the researcher or physician and of the subject or patient, to conform to scientific standards and to examine the appropriateness with respect to laws and moral values. Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research on human subjects. Research of no scientific value is also against ethical principles. To obtain valid and reliable results from biomedical research, it is a scientific and ethical obligation to make use of the science of statistics. Therefore, for research to be evaluated using biostatistics intensively from ethical and scientific points of view, a biostatistics expert is necessary on research ethics committees. Developments in Turkey are used as examples.     

Decisions at the end of life: an empirical study on the involvement, legal understanding and ethical views of preregistration house officers

OBJECTIVES: To collect information on the involvement, legal understanding and ethical views of preregistration house officers (PRHO) regarding end-of-life decision making in clinical practice. DESIGN: Structured telephone interviews. PARTICIPANTS: 104 PRHO who responded. MAIN OUTCOME MEASURES: Information on the frequency and quality of involvement of PRHO in end-of-life decision making, their legal understanding and ethical views on do-not-resuscitate (DNR) order and withdrawal of treatment. RESULTS: Most PRHO participated in team discussions on the withdrawal of treatment (n = 95, 91.3%) or a DNR order (n = 99, 95.2%). Of them, 46 (44.2%) participants had themselves discussed the DNR order with patients. In all, it was agreed by 84 (80.8%) respondents that it would be unethical to make a DNR order on any patient who is competent without consulting her or him. With one exception, it was indicated by the participants that patients who are competent may refuse tube feeding (n = 103, 99.0%) and 101 (97.1%) participants thought that patients may refuse intravenous nutrition. The withdrawal of artificial ventilation in incompetent patients with serious and permanent brain damage was considered to be morally appropriate by 95 (91.3%) and 97 (93.3%) thought so about the withdrawal of antibiotics. The withdrawal of intravenous hydration was considered by 67 (64.4%) to be morally appropriate in this case. CONCLUSIONS: PRHO are often involved with end-of-life decision making. The results on ethical and legal understanding about the limitations of treatment may be interpreted as a positive outcome of the extensive undergraduate teaching on this subject. Future empirical studies, by a qualitative method, may provide valuable information about the arguments underlying the ethical views of doctors on the limitations of different types of medical treatment.     

Brief report on the experience of using proxy consent for incapacitated adults

The Medicines for Human Use (Clinical Trials) Regulations 2004, which came into force in the UK in May 2004, cover the conduct of clinical trials on medicinal products. They allow a legal representative (a person not connected with the conduct of the trial) to consent to the participation of incompetent adults in medical research. Currently, very little is known about how such representatives will make their decisions.We have experience with proxy consent for older adults in a large, national trial. From 2445 potentially eligible but incapacitated patients, proxy, relative assent resulted in trial participation of only 87 (3.6%) patients. The reasons for this were that a large number of incapacitated patients had no relative available for assent (2286), but also a high proportion of relatives approached refused to provide assent (72/159, 45.3%). In comparison, 17.7% of patients declined participation in the trial.Proxy consent allowed only a small increase in trial recruitment of incapacitated patients. The fact that a greater proportion of relatives than patients refused to provide assent implies that they were more cautious than the patients themselves, or perhaps used different criteria, when making their decision.In future research involving incapacitated older patients there is likely to be heavy reliance on proxy consent provision by legal representatives. Our findings imply that consent decisions of legal representatives will not necessarily reflect those of patients themselves.     

“举证责任倒置”与病案管理的法律意义

目的:本文试图揭示病案管理在医疗侵权诉讼中的法律意义,使医务人员从思想上提高认识,加强自我保护意识,不断培养法律观念,在医务工作中立于不败之地。方法:通过对《医疗事故处理条例》中提出的“举证责任倒置”的分析和揭示当前病案管理存在的一些现状,论证病案管理法律意义的重要性。结果:保证病案管理客观、真实、完整,一靠法律,二靠自律。结论:提高医务人员的法律观念和病案管理的法制化是医疗机构乃至医学界的重要议题。     

加强医疗纠纷课程教育 促进社会和谐

改革开放以来,医疗纠纷、医患矛盾日益增多、日益激化。医疗纠纷以及医患矛盾已经成为当今社会一个不可忽视的重要的热点社会问题,严重威胁到社会的和谐稳定。其中,医方的法律意识淡薄以及医德医风沦丧是造成医疗纠纷的众多原因之一。我国医学院校对医学生的教育,仍然未能顺应＂生物——心理——社会＂医学模式的发展要求,过分强调医学知识与...     

Participation in biomedical research is an imperfect moral duty: a response to John Harris

In his paper "Scientific research is a moral duty", John Harris argues that individuals have a moral duty to participate in biomedical research by volunteering as research subjects. He supports his claim with reference to what he calls the principle of beneficence as embodied in the "rule of rescue" (the moral obligation to prevent serious harm), and the principle of fairness embodied in the prohibition on "free riding" (we are obliged to share the sacrifices that make possible social practices from which we benefit). His view that biomedical research is an important social good is agreed upon, but it is argued that Harris succeeds only in showing that such participation and support is a moral good, among many other moral goods, while failing to show that there is a moral duty to participate in biomedical research in particular. The flaws in Harris's arguments are detailed here, and it is shown that the principles of beneficence and fairness yield only a weaker discretionary or imperfect obligation to help others in need and to reciprocate for sacrifices that others have made for the public good. This obligation is discretionary in the sense that the individuals are free to choose when, where, and how to help others in need and reciprocate for earlier sacrifices. That Harris has not succeeded in claiming a special status for biomedical research among all other social goods is shown here.     

论《侵权责任法》与《医疗事故处理条例》的关系

<医疗事故处理条例>在处理医疗事故纠纷及其民事赔偿上起到了很大的作用,但随着<侵权责任法>的实施,关于医疗事故损害案件的纠纷处理就在客观上面临着两种规范路径,即<侵权责任法>和<医疗事故处理条例>.因此,二者之间的法律适用关系就颇具探讨的必要.事实上,二者并非简单地存废关系,而是存在着继承、创新、补充和矛盾四种具体关系...     

The place of medicine in the American prison: ethical issues in the treatment of offenders.

In Britain doctors and others concerned with the treatment of offenders in prison may consult the Butler Report (see Focus, pp 157) and specialist journals, but these sources are concerned with the system in Britain only. In America the situation is different, both in organization and in certain attitudes. Dr Peter L Sissons has therefore provided a companion article to that of Dr Paul Bowden (page 163) describing the various medical issues in prisons. The main difference between the treatment of offenders in prisons in America and in Britain lies in the nature of the federal system which means that each state may operate a different system in a variety of prisons and prison medical services are as various. Nationally, the prison systems are 'structured to treat and cure the offender'. Therefore it follows that the prison medical officer is only one of the professionals concerned with this 'cure' of the offender. This principle also applies to any form of research: medical research in prisons is part of a programme which covers a wide field of social and judicial research. The prison medical officer (where there is one) has of course to look after sick prisoners, and the American idea of 'cure' is also expressed in the need for more corrective surgery where, for example, it is necessary to remove physical impediments to social rehabilitation. But a doctor is only found on the staff of those institutions which are large: in the smaller prisons there may be only first-aid facilities, and no specially appointed doctor in the community. Moreover medicines are often dispensed by medical auxiliaries who are sometimes prisoners themselves. Finally, in America prisoners are regularly invited to volunteer as subjects for medical and social research for which they are paid. In short, although it is hoped to 'cure' a prisoner he is a criminal first and a patient second.     

基于定性比较分析方法的薪酬满意度影响因素研究

目的:从宏观视角下分析医务人员薪酬满意度影响因素的联合效应。方法:分层抽取黑龙江省和河北省共32所公立医院的351名员工进行问卷调查,运用模糊集定性比较方法分析医务人员薪酬满意度的影响因素组合。结果:薪酬满意度的产生存在3种条件组合:"工作环境导向型"反映制度、岗位环境等环境要素与薪酬满意度之间的关系;"社会环境导向型"突出了医务人员作为职业群体的特殊性,不能简单用"经济人"的概念考量;"额外收入补偿型"中额外收入的存在弥补了对薪酬制度的满意度,反映的是微观的薪酬制度中成本效益不匹配现象。结论:医务人员薪酬满意度是多要素共同作用的结果;薪酬满意度的改善不是医疗系统一方可以做到的,它建立在良好的薪酬制度体系基础上。