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.     

关于学习环模式的研究综述

学习环模式是一种有效的科学学习与教学模式。西方科学教育工作者对此做了大量研究,取得了丰硕成果。本文综述了学习环模式的理论基础、基本结构与发展。这一模式对于我国当前中小学科学课程设计和探究性学习的开展有一定的借鉴意义。     

欺负行为测量:问题及解决

近20年来,各国心理学家就欺负问题做了大量的研究工作。本文主要分析了欺负行为研究中对欺负行为的评价和测量上存在的局限以及相应的改进策略。目前欺负行为评价中的问题主要有：对欺负定义的理解和界定不一致;对欺负的评价角度不一致;测量工具在适用年龄上缺乏连续性;测量方法存在单一性;测量时间取样不明确等。针对上述问题,本研究提出了操作性定义的界定基础、研究工具的开发方向、测量方法的选取技巧和数据分组的原则等来提高对校园欺负行为研究的科学性。     

Promoting social competence in school-aged children: The effects of the open circle program

One hundred fifty-four fourth graders took part in an investigation of the Open Circle Program (OCP), an intervention model that encourages students, teachers and administrators to learn and practice communication, self-control and social problem-solving skills. Eight classrooms, two in each of four schools, were sampled. Two of these schools were located in middle to upper-middle class suburban areas and two served more diverse populations. Half the classrooms were headed by teachers well versed in OCP curriculum. The other half was not implementing a social competence program. Participants completed the student version of the Social Skills Rating System (SSRS) once in the fall and again in the spring. Teachers also rated the social competence of students at these same two points in the school year. Doubly-repeated measures mixed-design MANOVA analyses revealed that across the school year, OCP participants showed significantly greater teacher-reported improvements in both social skills and problem behaviors than did control group members. Although the largest gains were made by OCP children in urban areas, significant positive effects of program participation were shown by all students, regardless of school setting.     

Defining and Measuring Mechanisms of Change in Psychological Therapies: The Path Not Taken

Metcalf and Dimidjian (this issue) have provided an important review of the current evidence base for mindfulness‐based cognitive therapy (MBCT) and presented a helpful summary of the proposed mechanisms of change. It is necessary to engage in a continuous dialogue regarding the evidence base for change mechanisms, and the article by Metcalf and Dimidjian highlights an important barrier of concern to the field of treatment outcome research. The present commentary aims to expand the discussion regarding the definition, measurement, and evaluation of “mechanisms of change.” Using MBCT as an example, this commentary addresses the ambiguity surrounding the definition and operationalisation of these mechanisms in research on psychological therapies and how the method of measurement may impact the results obtained in clinical trials. It is argued that a potentially fruitful avenue of future research would involve investigation of techniques, important client‐therapeutic processes, and mechanisms in a single study in order to comprehensively evaluate how change occurs.     

护理学专业学位硕士研究生临床实践体验研究

采用质性研究中的现象学研究方法,对来自全国各地10所院校的12名护理学专业学位研究生进行半结构式深度访谈。通过对录音访谈内容进行三级编码,逐步归纳提炼出三个主题,每个主题下涵盖不同的副主题：（1）临床实践获益感方面：提升核心能力、体现自身价值;（2）心理体验：归属感、失落感;（3）影响临床实践效果的瓶颈因素：缺乏明确的临床能力考评标准、临床带教师资队伍薄弱。因此,教育者和管理者应重视专业学位硕士研究生,晦床核心能力培养,构建一个充满人文关怀的临床实习环境,消除瓶颈因素,以提高其临床实践效果。     

本科实习护生人文关怀能力及影响因素的质性研究

采用质性研究的方法,分析实习期拳科护生对人文关怀的理解、将其运用到临床实践的能力及影响关怀能力的因素。结果显示,本科护生对护理人文关怀的作用有比较明确的认知,但人文关怀能力不足,护理人文关怀行为主要来自模仿带教老师,其关怀能力主要受到自身素质、带教老师、科室管理、人文氛围等因素的影响。因此,医院应注意加强医护人员人文关怀教育,提高带教老师人文素养,树立角色榜样,改善临床人文环境,促进护生提升人文关怀能力,真正将人文关怀运用到临床护理实践中。     

The meaning of the h-index

The h-index originates from the assumption that the number of citations received by a scientist is a better indicator of the relevance of his or her work than the number of papers he or she publishes or the journals where they are published. It takes into account the number of papers published and the citations to those papers in a balanced way, and thus is useful to make comparisons between scientists. The present paper addresses the most frequent questions about the h-index. Specifically, it explains its origin, its advantages compared to other indices, the factors that can influence it (e.g. age, field of knowledge, topic of research and language of publication), its variants, and the injustices it may lead to. In short, this paper provides a clear exposition of the hoped-for role of the h-index in the evaluation of scientists: that it serves as a useful complement to other indicators that are more subjective, and that it contributes to the progress of science by aiding decision-making on allocation of research resources in a more effective way, and on rewarding researchers who contribute to scientific progress in a more fair way.     

Using a Two-Tier Test to Examine Taiwanese Graduate Students’ Misunderstanding of Responsible Conduct of Research

The present study investigates Taiwanese graduate students’ general understanding and misunderstanding of Responsible Conduct of Research (RCR). A total of 580 graduate students responded to the self-developed Responsible Conduct of Research Reasoning Test. The results reveal that, first, students did not have sufficient knowledge to reason why a particular instance of research (mis)conduct was doable or not. Second, the statistical results show that female students, students majoring in the humanities or the social sciences, doctoral-level students, and students with RCR-related training outperformed others. In addition, the misbehaviors that students judged relatively uncritically comprise the following nine categories: (a) seeing authorship as a property or power, (b) misinterpreting research coauthors’ responsibilities, (c) inaccurately conducting the informed-consent process, (d) fabricating and falsifying research data, (e) misinterpreting the correct citation of research sources, (f) holding vague concepts of self-plagiarism, (g) misinterpreting the Taiwan Copyright Act, (h) accepting duplicate-publication practices, and (i) accepting piecemeal publication practices. The present study discusses participative students’ major misunderstandings of actual RCR-related practices. The study also presents further implications and suggestions based on the findings.