Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.     

Balancing Ethical Principles in Emergency Medicine Research

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

医疗界与法律界的关系问题——中国医疗秩序重构中的重要课题

医疗秩序是指各医疗要素的合理配置、医疗关系中各主体的有规则的有序互动所形成的整齐规则状态。当今中国医疗失序的本质是医疗正义的缺失。医疗秩序重构和恢复的实质在于医疗正义的彰显。在彰显医疗正义的过程中,需要研究解决的重要课题之一是如何处理作为医疗实践者的医疗界与作为正义实践者的法律界之间的关系。     

医疗事故纠纷的本质及法律责任

医疗事故纠纷及处理的道德本质和司法原则在于对病人权利的维护。强化医务人员对病人生命与健康的医德责任感和病人权利意识,并使之成为自律、自觉的行为是预防和减少医疗事故纠纷发生的第一要素;而提高医务人员的法律意识,完善法律的制约机制,对医疗事故的防范是同样重要的。     

安乐死对象的界定

目前关于安乐死对象的界定,突出了医学要件,忽略了权利要件。为安乐死立法,必须对安乐死对象作出法律界定,应该满足两个条件：一是自然条件,即存在死亡痛苦;二是权利条件,即公民享得并行使安乐死的权利。不规定和具备权利条件,仅存在死亡痛苦,在法律上不能列为安乐死对象。     

急诊医学中的人文关怀

人文关怀是对人、人类社会的生存和发展、命运和前途的关心,是对人性和人权的尊重和保护,是对人独立思想和人格的容许与提倡。随着医学模式的转变和急诊医学的发展和完善,越来越需要重视对病人的人文关怀,也就是对病人人权和人格的重视。在急诊医学教学当中,不但要传授相关的专业知识,而且需要将人文关怀的理念贯穿于教学始终,培养医学生人文关怀的素养,教师同时要重视医学生自身对人文关怀的需求。     

急诊医疗中的知情同意问题

急诊医疗中的知情同意似乎与通常的临床情形不同,它不需要完全的知情同意,甚至可以被免除。这一特点可能给人以一种印象,即在急诊情况下对知情同意的考量,或可与其他情形有所不同。其实急诊情形下之所以出现知情同意的例外或免除,并非知情同意原则在急诊情况下不适用,或者是知情同意原则做出了让步。真正的原因是,知情同意在急诊治疗中往往以特殊或不同的形式表现出来。     

The Context of Satisficing in Vignette Research

Abstract

Although at the time of this article's publication, many anecdotes and cross-sectional studies had reported that law students experience significant distress during their 1st year, few researchers had controlled for prelaw school status (e.g., M. Garrison, B. Tomko, & I. Yip, 1996; L. Guinier, M. Fine, J. Balin, A. Bartow, & D. L. Stachel, 1994), and only a single group of researchers had explored a psychosocial factor that predicted these changes. The present authors tested 3 sets of potential predictors of adjustment: sources of stress, coping strategies, and relationship factors. The present data replicated declines in students' psychological health, physical health, and attitudes toward law over the 1st year of school. That result supports the generalizability and currency of previous studies. In contrast to other researchers, the present authors found few gender differences. Less relationship happiness, less emotional support, and use of less active coping tactics at the beginning of the year predicted poorer outcomes at the end of the year. Strain from academic pressures, lack of personal time, and social isolation were correlated with poorer outcomes.     

中医学认识规律研究论纲——破译中医特殊性的认识论原因

中医学是特殊的认识成果,在其认识发生发展的过程中,必然存在特殊的认识论原因,也一定存在可循的规律。从认识对象、实践活动、主体认识结构和认识建构过程对中医学特殊认识进行了比较系统的分析和论述,力图揭示出中医学的认识论原因和规律。     

透析器复用的医学、经济与法制思考

回顾透析器复用的历史并分析其复用现状,医学原因和经济学原因是透析器复用的基础,复用存在的医学和法律相矛盾问题,并分析透析器复用的标准和效果评价.从医学、法律、社会三个方面分析透析嚣复用的前景,认为透析器复用有利于患者和减轻社会压力,但是存在医疗风险,透析器的"单用比复用好,而复用比不用好".     

Review of Research on Age Discrimination in the Employment Interview

This paper reviews the research literature on age discrimination in the employment interview and related contexts. Twenty one studies were identified which explored whether age discrimination occurs within the context of the employment interview since the Age Discrimination in Employment Act was put into law. Sixteen studies were conducted in laboratory settings. It was concluded that evidence of age discrimination in the employment interview is commonly observed in laboratory studies which do not assess the influence of other job-relevant characteristics. Laboratory studies may create too much artificiality, where the impact of qualifications is artificially minimized and the impact of irrelevant factors like age are maximized. Only 5 of the 21 studies were conducted in the field, but they found far less consequential age discrimination in the employment interview.     

The MMPI-2: A Contemporary Normative Study of Midwestern Family Medicine Outpatients

For more than 60 years it has been known that profiles from the Minnesota Multiphasic Personality Inventory (MMPI), obtained from medical patients, are elevated when scores are plotted using general population norms. These elevations have been most apparent on the neurotic triad (NTd), the first 3 clinical scales on the MMPI profile. More than 45 years have passed since a nonreferred, normative sample of MMPIs was established from 50,000 consecutive medical outpatients. We present comparable but contemporary normative data for the revised MMPI (MMPI-2) based on a nonreferred sample of 1,243 family medicine outpatients (590 women; 653 men). As true for the original MMPI, contemporary medical outpatients have profiles that are significantly different, clinically and statistically, from the general population norms for the MMPI-2. This is particularly evident in elevations on the NTd. New normative tables of uniform medical T (UMT) scores were developed following the procedures used to create the uniform T scores for the MMPI-2. Measures of internal consistency are reported; test-retest reliability was established over a mean of 3.7 weeks, and results characterizing the stability of the validity and clinical scales are presented.     

The effects of priming legal concepts on perceived trust and competitiveness, self-interested attitudes, and competitive behavior

Socio-legal scholars have suggested that, as a ubiquitous social system, law shapes social reality and provides interpretive frameworks for social relations. Across five studies, we tested the idea that the law shapes social reality by fostering the assumptions that people are self-interested, untrustworthy, and competitive. In Studies 1 and 2, we found that people implicitly associated legal concepts with competitiveness. Studies 3-5 showed that these associations had implications for social perceptions, self-interested attitudes, and competitive behavior. After being primed with constructs related to the law, participants perceived social actors as less trustworthy and the situation as more competitive (Study 3), became more against a political issue when it conflicted with their normative self-interest (Study 4), and made more competitive choices during a prisoner’s dilemma game when they believed that social relations were basically zero-sum in nature (Study 5). The implications and applications of these results are discussed.     

急诊医学医患共同决策中的博弈分析

通过急诊医学的实践,借助博弈论方法分析了急诊医学中实施医患共同决策（shared decision making,SDM）的现状,为急诊医学中实施SDM提供参考意见。分析发现,在急诊医疗决策中存在“公地悲剧”“蜈蚣博弈”“博傻理论”等博弈现象。急诊医学中的信息技术滞后、医患对SDM的认知不足、医患信任等因素是影响SDM在急诊医学中实施的重要博弈因素。通过推动急诊医学的信息化建设、SDM理念的普及和技能培训,借助博弈论的方法和相关法律制度的完善,提升互联网作为健康宣传和健康教育的工具作用,有利于SDM在急诊医学的应用推广,从而促进急诊医学和谐医患关系的构建。

     

以急诊医学为依托的全科医学培养模式探讨

全科医生是一类重要的复合型医学人才。但目前在我国,合格的全科医生十分匮乏,其中一个重要的原因是我国尚未建立起科学有效的全科医师培养模式。因此,探索适合我国国情且行之有效的全科医生培养模式迫在眉睫。由于全科医学与急诊医学学科特点上有诸多相似性,以急诊医学为依托进行全科医生培养是全科医学发展初始阶段的有益探索,以实现由急诊医生培养全科医生逐步过渡到全科医生培养全科医生。以急诊医学为依托的全科医学培养模式符合全科医学的内在要求,为探索符合我国现阶段实际的全科医学模式提供了新的思路。     

关于牙齿再生研究的述评

牙齿再生医学是目前口腔医学中面临的最为重要的科学问题,成为口腔医学研究领域的热点。无论从牙发育生物学到牙生物信息学到牙组织工程技术,由此而得到了很大程度的发展。但是,这个领域目前面临许多问题。就有关研究的现状、困惑、面临的问题进行探讨,对于牙再生医学研究的模式,从方法论的角度提出探讨。引发相关研究领域研究人员思考,以早日实现牙齿组织再生,满足人们需要。     

关于牙齿再生研究的述评

牙齿再生医学是目前口腔医学中面临的最为重要的科学问题,成为口腔医学研究领域的热点.无论从牙发育生物学到牙生物信息学到牙组织工程技术,由此而得到了很大程度的发展.但是,这个领域目前面临许多问题.就有关研究的现状、困惑、面临的问题进行探讨,对于牙再生医学研究的模式,从方法论的角度提出探讨.引发相关研究领域研究人员思考,以早日实现牙齿组织再生,满足人们需要.     

Prioritizing Rights in the Social Justice Curriculum

The biggest problem facing schools having social justice curricula, beyond implementation of a programme, I claim, is the problem of justification: what grounds what in social justice and how do we make this manifest to ourselves and to the curricula? If we cannot address this, then social justice curricula are doomed to begging the question. I claim that a ranking of human rights is not only necessary to adjudicate competing claims for social justice and at the same time, thwart interference with already agreed-upon human rights: it is necessary for any curriculum of social justice for schools. That is to say, curricular programs of social justice cannot justify social practices that interfere with human rights, nor can they teach otherwise than this. Due attention to the violation of human rights is necessary, I shall argue, and must be central in the discussion of education for social justice.