Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency

Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.     

城市治理结构中抽象系统信任建设与法治*--以书面文化认同为线索

城市治理结构优化有赖于抽象系统信任的进化与法治的发展。抽象系统信任在城市社会中承担着特殊的社会信任重建功能，并推动着法律信任、法治发展和城市治理改善。从各国的城市治理基本规律和经验教训来看，让抽象系统信任和法治在城市治理结构中处于重要维度既是各国城市治理建设的基本经验之一，也是衡量一国城市治理现代化水平的重要标志。而书面文化认同既是抽象系统信任本身和城市化的产物，同时又参与到了抽象系统信任建设和城市治理完善之中。     

社会资本视角下地方政府行政潜规则与信任危机刍议

行政规则的规范和信任资本的积累是地方政府治理的重要基础,行政规则的运作会影响信任资本的发展,而信任资本的状况也会影响行政规则的效力。行政潜规则的存在会弱化显规则的效力,削弱地方政府的公信力。因此,必须完善行政规则体系,提升信任资本,通过行政规则和信任资本的良性互动循环增进地方合作治理的绩效。     

Trust in the Police in Rural China: a Comparison Between Villagers and Local Officials

Although the past decade has witnessed the rise of studies on Chinese evaluations of the police, rural villagers’ assessments of the police remain under-researched. Drawing upon performance theory and survey data from China’s countryside, this study tested whether variations in satisfaction with government performance and life are linked to villagers’ and officials’ trust in county and local/town police. We found that villagers displayed lower levels of trust in the police than local officials. Higher satisfaction with government performance and integrity were associated with greater trust in county police among both villagers and officials. Villagers’ greater satisfaction with crime control and safety led to their stronger trust in both county and town police, but such satisfaction was not significantly related to officials’ trust in both levels of police forces. Rural residents’ generalized trust and particularized trust were associated with a greater likelihood of viewing the police as trustworthy. Meanwhile, female respondents, both villagers and officials, and higher-income officials were more likely to view the police as trustworthy. Directions for future research and policy are discussed.

     

The R&D performance of the South African manufacturing sector, 1970–1993

In this article we undertake a detailed exploration of the research and development activities in one particular middle-income country. We explore what the data from R&D surveys can tell us about the levels, the determinants and the effectiveness of R&D in the manufacturing sector. We point to some of the broader factors that may have influenced South Africa’s drive to improve the technological capacity of its manufacturing sector, but we mostly focus on those issues associated directly with R&D. We show that the degree of interaction between the different domains of R&D activity, business, government and the tertiary sector has been weak, and that the possibility of positive spill-overs between these domains has not been fully exploited. In addition, little or no policy intervention designed to stimulate R&D activity by industry has been deployed in South Africa. We find that South African R&D activity has mainly been reactive in character and suggest that this lies at the heart of South Africa’s mixed R&D performance in relation to other developing countries.     

Child Discipline Practices in Kosovo: Attitudes and Sociodemographic Correlates

Journal of Family Violence - Empirical evidence on the use of disciplinary practices across low- and middle-income countries remains limited and impedes the development of prevention practices....     

Organizational Trust and the Limits of Management‐Based Regulation

This article examines the relationship between management‐based regulation and occupational health and safety through two case studies. The first describes how corporate occupational health and safety systems and standards were interpreted and implemented differently at different mine sites within the same company and examines the particular role of trust between workers and management in explaining variations in occupational health and safety performance. The second explores the difficulties of moving from a highly devolved system of responsibility to a more centralized approach, and the incapacity of externally mandated management‐based regulation to change behavior at site level in the absence of a supportive workplace culture. The article argues that notwithstanding the heavy emphasis currently being placed on both internal (company‐driven) and external (government‐driven) management‐based regulation, a commitment at corporate level does not necessarily percolate down to individual facilities where ritualistic responses or resistant subcultures may thwart effective change. The findings have important implications for the effectiveness of management‐based regulation and meta‐regulation more broadly.     

The Importance of Establishing Reliability and Validity of Assessment Instruments for Mental Health Problems: an Example from Somali Children and Adolescents Living in Three Refugee Camps in Ethiopia

Assessing mental health problems cross-culturally for children exposed to war and violence presents a number of unique challenges. One of the most important issues is the lack of validated symptom measures to assess these problems. The present study sought to evaluate the psychometric properties of two measures to assess mental health problems: the Achenbach Youth Self-Report and the Child Posttraumatic Stress Disorder Symptom Scale. We conducted a validity study in three refugee camps in Eastern Ethiopia in the outskirts of Jijiga, the capital of the Somali region. A total of 147 child and caregiver pairs were assessed, and scores obtained were submitted to rigorous psychometric evaluation. Excellent internal consistency reliability was obtained for symptom measures for children and their caregivers. Validation of study instruments based on local case definitions was obtained for the caregivers but not consistently for the children. Sensitivity and specificity of study measures were generally low, indicating that these scales would not perform adequately as screening instruments. Combined test–retest and inter-rater reliability was low for all scales. This study illustrates the need for validation and testing of existing measures cross-culturally. Methodological implications for future cross-cultural research studies in low- and middle-income countries are discussed.     

公共治理困境与公法学的理性回应

公共治理是公共行政领域一种方兴未艾的模式,但公共治理不是万能的,也存在治理"失灵",存在政府"空心化",公共行政"能力赤字"、问责过程的复杂化、成本—收益计算模糊化、公众对政府的信任度降低等困境。公共治理不仅是一个政治学术语,也是重要的法学范畴,主要表现为公共治理以依法治理为前提,是公民参与、协商合作的持续互动,是追求平等、权利、尊严的过程。所以,面对公共治理的困境,法学策略显得尤为重要,应当彰显公共利益,树立有限政府理念,增强政府核心能力;厘清责任链,建立责任政府,加强非政府组织的责任承担能力;引入成本—收益核算机制,提高公共治理的效率;减少宪法规定的社会权种类,加强国家对民生的保障力度。     

信托法与物权法定原则的冲突及其解决

信托法起源于英美法,而英美法在法律概念、体系构造和思维方式上与大陆法存在很大差别,所以在大陆法国家移植信托法的过程中,必然要遇到如何协调和解决外来的信托制度与本土法律制度冲突的问题,其中,物权法定原则与信托制度之间的冲突尤值关注。结合信托诸种制度的特性进行具体分析,可以看出我国新近通过的《物权法》所确立的物权法定原则与信托法之间存在着尖锐的理念冲突。在新《物权法》背景下,如果在理论和实务上因应得宜,则我国的信托制度不仅不会被物权法定原则所窒息,甚至可以此为契机改变信托法在我国法律体系中的边缘地位。     

The WHO European program of health legislation and the Health for All policy

The purpose of this paper is to provide a comprehensive review of the work of the World Health Organization (WHO), begun a decade ago in Europe, in the field of health legislation. This program is the result of the interaction between two important factors: the trends in national health policy and legislation at the country level, and the implementation of the Health for All policy, which has been collectively adopted by the European Member States in various WHO fora. Health legislation has proved to be a valuable tool in supporting National Health Policies in European countries and a key element in international health activities. The paper will be presented in three main parts. The first examines the legislative implications of the Health for All policy and strategy. The second gives an overview of developments in health legislation in Europe, focusing on national achievements in three areas in which change is necessary to achieve Health for All: health care systems, the environment, and lifestyles. The third part gives an account of activities carried out by the Regional Office for Europe of WHO in the health legislation field, recalls the organization of the first WHO medium-term program in this field, and summarizes its four current subprograms on health policy, health situation, exchange of information, and training. The conclusion briefly outlines the prospects for further developments in Europe.     

发达国家政府绩效评估经验对我国的启示

随着我国政治体制改革的不断深化,政府绩效评估作为行政管理制度的有效工具,必须以公务员绩效考核制度为基础。本文结合西方发达国家政府绩效评估的实践及其经验,分析了目前我国政府绩效评估的不足及其成因。认为,公务员是创造政府绩效的重要载体,公务员考核制度的完善是政府绩效评估得以顺利开展的前提。因此,提高公务员队伍整体素质是我国政府绩效评估工作中一个亟待解决的问题。     

E‐government and developing countries: an overview

E‐governance is more than just a government website on the Internet. The strategic objective of e‐governance is to support and simplify governance for all parties; government, citizens and businesses. The use of ICTs can connect all three parties and support processes and activities. In other words, in e‐governance electronic means support and stimulate good governance. Therefore, the objectives of e‐governance are similar to the objectives of good governance. Good governance can be seen as an exercise of economic, political, and administrative authority to better manage affairs of a country at all levels. It is not difficult for people in developed countries to imagine a situation in which all interaction with government can be done through one counter 24 hours a day, 7 days a week, without waiting in lines. However to achieve this same level of efficiency and flexibility for developing countries is going to be difficult. The experience in developed countries shows that this is possible if governments are willing to decentralize responsibilities and processes, and if they start to use electronic means. This paper is going to examine the legal and infrastructure issues related to e‐governance from the perspective of developing countries. Particularly it will examine how far the developing countries have been successful in providing a legal framework.     

论我国政府购买公共服务主体制度

主体制度是政府购买公共服务的重要制度,从"二元主体"发展到"三元主体"是其基本的演进路径,但在不同国家的不同历史时期,由于受市场机制在国家治理中的影响程度不同,其范围及权利义务迥异。在我国这样市场机制发展不充分的国度,完善政府购买公共服务主体制度是迫切而又棘手的课题。基本解决之道在于紧扣国家改革推进政策,紧密结合国情,科学界定主体的范围及各主体的权利义务,在此基础上采取完善立法、事业单位改革以及公众参与等多种措施来构建有中国特色的主体制度。     

Hospitals, finance, and health system reform in Britain and the United States, c. 1910-1950: historical revisionism and cross-national comparison

Comparative histories of health system development have been variously influenced by the theoretical approaches of historical institutionalism, political pluralism, and labor mobilization. Britain and the United States have figured significantly in this literature because of their very different trajectories. This article explores the implications of recent research on hospital history in the two countries for existing historiographies, particularly the coming of the National Health Service in Britain. It argues that the two hospital systems initially developed in broadly similar ways, despite the very different outcomes in the 1940s. Thus, applying the conceptual tools used to explain the U.S. trajectory can deepen appreciation of events in Britain. Attention focuses particularly on working-class hospital contributory schemes and their implications for finance, governance, and participation; these are then compared with Blue Cross and U.S. hospital prepayment. While acknowledging the importance of path dependence in shaping attitudes of British bureaucrats toward these schemes, analysis emphasizes their failure in pressure group politics, in contrast to the United States. In both countries labor was also crucial, in the United States sustaining employment-based prepayment and in Britain broadly supporting system reform.     

小城镇污染集中治理市场化中法律制度的调整

为了解决小城镇严重的环境污染问题,应当加快小城镇环境污染集中治理步伐,并实现污染集中治理市场化目标。在市场化过程中,原来的政府和排污企业单一的双方法律关系转变为政府、污染集中治理设施与排污企业三方的多重法律关系,面对法律关系主体和法律关系内容发生转变,现行的与环境污染防治相关的法律制度应当做出适当的调整。本文针对小城镇的环境污染问题,对现行的排污收费制度、许可证制度、三同时制度、限期治理制度存在的问题和调整内容进行了探讨。     

村社认同如何影响政治信任? ——公民参与和个人传统性的作用

【问题】政治信任是支撑政治系统运行的重要心理基础,对推进政民良性互动、提升公众的政府支持具有重要意义。村、社区是公众的社会生活共同体和国家治理的基本单元,人们对村社的认同如何转化为对政治系统的信任以及此过程受到何种条件的影响,这将是本研究尝试探究的问题。【方法】论文基于95个行政村和城镇社区的5040份有效数据,将村社认同作为高层级变量,运用多水平结构方程模型和贝叶斯可信区间估计,对所提出的跨层级的“有调节的中介模型”进行检验。【发现】村社认同对个体的政治信任水平具有显著的正向预测作用,且公民参与在二者关系中具有部分中介作用。同时,个人传统性不仅在村社认同和公民参与关系中具有显著的负向影响,也能进一步调节村社认同与政治信任的间接关系。具体来看,在不同水平的个人传统性下,村社认同差异通过公民参与对政治信任影响的间接效应表现出来。【贡献】论文从政治心理学的视角出发,揭示了“村社认同→公民参与→政治信任”这一中介作用路径,并进一步分析了个体传统性变量对上述影响机制作用发挥的边界效应,为理解和分析本土情境下公众的政治信任发生机制提供了可鉴路径,对激发公民参与、提升政治信任和推动基层治理转型的治理实践具有启示。     

Explaining health care system change: problem pressure and the emergence of "hybrid" health care systems

In this article, we will further the explanation of the state's changing role in health care systems belonging to the Organisation for Economic Cooperation and Development (OECD). We build on our analysis of twenty-three OECD countries, which reveals broad trends regarding governments' role in financing, service provision, and regulation. In particular, we identified increasing similarities between the three system types we delineate as National Health Service (NHS), social health insurance, and private health insurance systems. We argue that the specific health care system type is an essential contributor to these changes. We highlight that health care systems tend to feature specific, type-related deficiencies, which cannot be solved by routine mechanisms. As a consequence, non-system-specific elements and innovative policies are implemented, which leads to the emergence of "hybrid" systems and indicates a trend toward convergence, or increasing similarities. We elaborate this hypothesis in two steps. First, we describe system-specific deficits of each health care system type and provide an overview of major adaptive responses to these deficits. The adaptive responses can be considered as non-system-specific interventions that broaden the portfolio of regulatory policies. Second, we examine diagnosis-related groups (DRGs) as a common approach for financing hospitals efficiently, which are nevertheless shaped by type-specific deficiencies and reform requirements. In the United States' private insurance system, DRGs are mainly used as a means of hierarchical cost control, while their implementation in the English NHS system is to increase productivity of hospital services. In the German social health insurance system, DRGs support competition as a means to control self-regulated providers. Thus, DRGs contribute to the hybridization of health care systems because they tend to strengthen coordination mechanisms that were less developed in the existing health care systems.     

A Proposal for a Framework Convention on Global Health

This article searches for solutions to the most perplexing problemsin global health—problems so important that they affectthe fate of millions of people, with economic, political, andsecurity ramifications for the world's population. No State,acting alone, can insulate itself from major health hazards.It is for this reason that safeguarding the world's populationrequires cooperation and global governance. What is truly needed,and what richer countries instinctively do for their own citizens,is to meet what I call ‘basic survival needs.’ Byfocusing on the major determinants of health, the internationalcommunity could dramatically improve prospects for good health.A vehicle such as a Framework Convention on Global Health (FCGH)could powerfully improve global health governance. Such a FrameworkConvention would commit States to a set of targets, both economicand logistic, and dismantle barriers to constructive engagementby the private and charitable sectors. It would stimulate creativepublic/private partnerships and actively engage civil societystakeholders. A FCGH could set achievable goals for global healthspending; define areas of cost effective investment to meetbasic survival needs; build sustainable health systems; andcreate incentives for scientific innovation for affordable vaccinesand essential medicines.