Academic literature on the topic 'CRO (Contract Research Organization)'

The article deals with the current theoretical and practical issues relating to the development of competition among contract research organizations (CRO), and the role of the State in the development of institutions and mechanisms that ensure the development science on a competitive basis. Concludes that the need for further improving the legal and institutional framework to successfully meet the challenges of scientific and technological development through the contract paradigm.

With the ever increasing Research and Development cost for the pharmaceutical industries, the cost of bringing a drug to market was increasing drastically. The funds for drug development was drying up and thus to maintain a healthy profit margin , the pharmaceutical companies have adopted to frame out research and development (R&D) to Contract Research Organizations (CRO’s). The CRO’s have become an important partner to biotechnological and pharmaceutical companies, in the development of new compounds and at the same time in drug registration also it has extended its hands. Out of 20, 19 pharmaceutical companies have invested in emerging markets like China, India, Russia and Latin America since clinical research is accessible to these markets due to adoption of ICH and GCPs guidelines. The traditional nature of CRO’s have changed and they will develop into a formidable industry in near future.

This study aims to explore the uniqueness of the psychological contract in the Faith-Based Organization (FBO). Psychological contracts, as part of the bond between individuals and organizations, are constantly evolving research. In line with the Conservation of Organizational Resources (COR) theory, organizations strive to defend their resources. Faith-Based Organization (FBO) is an organization with minimal written formal contracts. The bond with the members is a bond with the same values ​​and goals. This research examines the psychological contract of FBO, from the aspects of formation, contribution, and violation. The formation of shared values ​​which becomes the affective commitment of FBO members is specifically discussed because of the uniqueness of the organization with its ideological and religiosity sides. Using the lens of the COR theory, this study sees the psychological contract of the two elements of the FBO, namely members and organizations. This study is a literature review using traditional narrative methods. The results show that there have not been many in-depth studies of the psychological contract on religious organizations (FBO) with religious aspects that characterize the psychology of individuals in it. This study creates new gaps in research related to psychological contracts.

Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.

Abstract Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process.

19 Background: With the increased clinical activity that we are seeing with combination IO therapies, more sponsors are searching for contract research organizations (CROs) that have experience managing combination IO clinical trials which are often large, complex, multi-national, resource-intensive, competitive and highly specialized. Pharmaceutical Product Development (PPD), a contract research organization (CRO) has worked with sponsors in managing combination IO clinical trials. This includes early and late phase trials with many different classes of agents in multiple tumor types. We sought to review PPDs experience in combination immunotherapy trials and highlight key challenges, efficiencies, innovative modern trial designs, endpoints and enrollment strategies in a competitive market. Methods: We reviewed IO trials managed by PPD over the past 5 years, information from PPDs Immuno-Oncology Center of Excellence (IOCOE) and Immuno-Oncology Working Group (IOWG) and the current pace of development of IO therapies. Results: PPD has collaborated with multiple sponsors to manage innovative, complex IO trials that push the boundaries of clinical development. Comprehensive planning and risk management strategies steeped in a deep understanding of the trial environment are essential for successful IO protocols. Protocol and trial optimization have been useful to make trials more efficient and less expensive. Conclusions: IO approvals are increasing at a rapid pace and both sponsors and CROs will need to work together to continue to develop innovative trial designs, biomarkers and endpoints that will determine efficacy and tolerability of combination IO therapies. PPDs innovative tools, technology and resources have been useful to help sponsors with enrollment strategies to prevent increasing study timelines and delays in study results. The IO space is pushing the limitations of scientific, technological and operational advances, and we are happy to continue to share our learnings in this ever-evolving landscape.

This article provides an update on new development of China Bioanalysis Forum (CBF). CBF became a member association of Chinese Pharmaceutical Association (CPA) at the end of 2019. The official ceremony and first scientific symposium were held in Shanghai on 18 September 2020. The president of Chinese Pharmaceutical Association and representatives from industry, Contract Research Organization (CRO), hospitals and academic institutes attended the ceremony. Seven experts in the field gave presentations on various topics including Drug Metabolism and Pharmacokinetics (DMPK) and bioanalytical support in drug discovery and development as well as experience in Traditional Chinese Medicine research. With the continuous growth of research and development in China, it is well acknowledged that bioanalysis provides critical support for new innovative medicines and generic drug development in the region.

The approach undertaken to deliver a Good Laboratory Practice (GLP) validation of whole slide images (WSIs) and the associated workflow for the digital primary evaluation and peer review of a GLP-compliant rodent inhalation toxicity study is described. The contract research organization (CRO) undertook validation of the slide scanner, scanner software, and associated database software. This provided a GLP validated environment within the database software for the primary histopathologic evaluation using WSI and viewed with the database software web viewer. The CRO also validated a cloud-based digital pathology platform that supported the upload and transfer of WSI and metadata to a cache within the sponsor's local area network. The sponsor undertook a separate GLP validation of the same cloud-based digital pathology platform to cover the download and review of the WSI. The establishment of a fit-for-purpose GLP-compliant workflow for WSI and successful deployment for the digital primary evaluation and peer review of a large GLP toxicology study enabled flexibility in accelerated global working and potential future reuse of digitized data for advanced artificial intelligence and machine learning image analysis.

Mestrado em Biomedicina Farmacêutica
O presente documento relata a experiência de trabalho desenvolvida durante 10 meses de estágio na Unidade de Estudos Clínicos da Keypoint CRO, a empresa que me acolheu ao longo deste período, e o seu impacto na aquisição de ferramentas e competências pessoais e profissionais. Esta experiência profissional permitiu-me consolidar e reavivar todos os conceitos e conhecimentos teóricos adquiridos ao longo de 5 anos de formação académica, e em especial o programa curricular que constitui o Mestrado em Biomedicina Farmacêutica, da Universidade de Aveiro, facilitando a minha integração em todas as actividades da empresa que me foram sendo propostas. Todas estas actividades realizadas durante o estágio estão descritas ao longo deste documento, seguindo-se depois uma parte de discussão/reflexão que pretende fazer um balanço de toda a aprendizagem, destacando os seus pontos fortes e pontos fracos. Com este relatório, pretendo assim dar a conhecer a minha adaptação ao meio laboral, após aquela que foi a minha primeira experiência profissional na área em que me formei. Uma experiência repleta de verdadeiros desafios e obstáculos mas também de sucessos que só a plena sintonia entre o estudante, a empresa acolhedora e a instituição de ensino permitiram alcançar.
This document reports the professional experience developed over 10 months of internship in the Clinical Operations Unit of Keypoint CRO, the company which took me throughout this time, and its impact in the acquisition of tools and personal and professional skills. This professional experience allowed me to consolidate and revive all the concepts and theoretical knowledge gained over 5 years of academic training at University of Aveiro, making facilitated my inclusion into all activities of the company that have been proposed for me. All of these activities performed during the internship are described throughout this document, followed by a later part of discussion/reflection which aims to make a balance of all learning, highlighting their strengths and weaknesses. With this report, I want to let known my adaptation to the labor field, after my first professional experience in the field where I have been graduated. A true experience not only full of challenges and obstacles but also full of successes which only the full understanding between the student, the company and the educational institution allowed to achieve.

Mestrado em Biomedicina Farmacêutica
This report describes my experience as a trainee at W4Research, a national Contract Research Organization (CRO). This internship intended to put into practice the skills acquired during the curricular year of the Master in Pharmaceutical Biomedicine. This professional context experience has allowed me to perform activities especially in the implementation of a quality management system and also in medical writing. I was also involved in the design of two observational studies and one socioepidemiological study, and in a clinical trial site feasibility.
Este relatório descreve a minha experiência enquanto estagiária na W4Research, uma Contract Research Organization (CRO) nacional. Este estágio pretendeu pôr em prática os conhecimentos adquiridos durante a parte curricular do Mestrado em Biomedicina Farmacêutica. Esta experiência de contexto profissional permitiu-me desempenhar atividades sobretudo no âmbito da implementação de um sistema de gestão da qualidade e também de medical writing. Estive também envolvida na conceção de dois estudos observacionais e um sócio epidemiológico, e para além disso, participei na fase de feasibility de um ensaio clínico.

Mestrado em Biomedicina Farmacêutica
O presente relatório destina-se a descrever as atividades desenvolvidas no âmbito do estágio curricular que teve lugar na W4Research, uma Contract Research Organization (CRO). O estágio teve a duração de 8 meses durante os quais o estagiário desempenhou funções de CRA sendo o principal foco a monitorização de estudos observacionais. Para além da principal atividade, foram ainda desenvolvidas funções em áreas adjacentes à investigação clínica, tais como, o Medical Writing e a gestão da qualidade. Este trabalho pretende mostrar a visão obtida e os pontos de vista do estagiário enquanto monitor de estudos observacionais.
This report intends to describe the activities carried out under the traineeship which took place in W4Research, a Contract Research Organization (CRO). The internship had the duration of 8 months during which the trainee worked as a CRA, being the main focus the monitoring of observational studies. Besides the main activity, the trainee also had the opportunity to perform adjacent functions to the clinical research, such as Medical Writing and quality management areas. This document intends to show the obtained vision and the points of view of the trainee while monitoring observational studies.

Thesis (M.A.)--Boston University
With the increased costs of drug development, pharmaceutical companies outsource most of drug development to contract research organizations (CROs) and academic research organizations (AROs). Given the importance of the relationship between the contracting organization and pharmaceutical companies, project management has become the hallmark in conducting clinical trials. The purpose of this project was to identify whether there are differences in the project management practices of CROs and AROs who conduct clinical trials. An electronic survey and follow up interview were administered to 134 CROs and 15 AROs who provide clinical trial services to pharmaceutical and biotechnology companies. The survey collected information on the characteristics of project managers, the organization demographics, and project management within the organization. The survey demonstrated significant differences between the services provided (p less than .001), (p=0.001), availability of project management standard operating procedures (SOPs), training of project managers (p less than 0.05), and salary of project managers (p=0.003). The overall response rate of the survey was 36%; thus, the full variance of project management practices may not have been obtained in this survey. These findings highlight some differences between AROs and CROs, and provide a foundation to learn more about project management at these organizations.

碩士
國立臺灣師範大學
高階經理人企業管理碩士在職專班(EMBA)
105
Based on the concept of job embeddedness, this study aims to discuss the high CRA staff turnover of Contract Research Organization (CRO) in the pharmaceutical biotechnology services industry. Starting from the concept of retention, this study further explores the factors of staff dependency on the organization,and how organizations can improve some negative factors to reduce the intentions and behavior of staff turnover. This study is expected to use the framework of job embeddedness to develop talent strategies, concerning both the advantages of organizations and the preferences for employees. The study adapts a case study method to conduct in-depth interviews with the case company’s former and current CRA staff and supervisors. In addition to interviewing former employees to understand their main reasons for leaving their organization, we also interview current employees to find out the reasons why they choose to stay and the reasons why they remain staying in their organization even if they want to leave. We also interview supervisors about the ideal organizational practices that could improve the job stability of CRA personnel. The results reveal that because junior staff view working in foreign companies as their job priority, factors in job embeddedness such as “fit, links and sacrifice” wouldn’t be suitable incentives for them to stay in their current companies. However, “link” and “fit” can be best explained for the senior staff to stay, and “sacrifice” has no significant effect. The main discovery of the study is that when we adapt the idea of job embeddedness to CRA staff, we can justify that their turnover intention is resulted from industries they belonged to and their job characteristics as well. Therefore, the organization should rather think about employment strategies than look for retaining strategies. In terms of employment strategies, we suggest that senior staff lead junior staff, and companies moderately incorporate foreign employees through the provision of work permits and bonuses for long-term work. By providing the double incentive, we hope to obtain stable sources of manpower. After all, the salary structure of an individual corporation can’t fit the demand for the whole industry; therefore, it must remain close to the market. Furthermore, companies should provide a promising future of itself to attract excellent talents and to be unafraid of foreign companies’ headhunting actions. The conclusion of this study is that the main cause of high CRA staff turnover is lacking in biotechnological talents. If the government, schools and industry could reinforce the collaboration between industries and schools, emphasize on the cultivation of talents and reduce the gap between schools and industry, the quality and quantity of human resource could be improved simultaneously. Hopefully, the lack of talents in the biotechnology industry can be resolved.

碩士
銘傳大學
管理研究所碩士在職專班
94
The twenty-first century is a knowledgeable and economic era that is full of explosive knowledge. In order to increase inner strength and cope with the changeable environment, enterprises must have the capability to absorb new information and transform it into useful knowledge. However, how can an organization learn quickly and effectively? It must depend on its organizational learning capability. An organization with strong organizational learning capability will apply the knowledge effectively and be very helpful to increase its whole performance. Therefore, organizational learning capability and learning performance become one of the most important issues for all enterprises today. The research objects of this study are the relative personnel of pharmacy contract research organization (CRO) in Taiwan. The purpose of the study is to investigate the influences of the knowledge attributes and organizational learning capability on learning performance. Meanwhile, the knowledge attributes are used to be a modulator in this case to find out its influence between organizational learning capabilities and learning performance. According to the analytic results from 268 effective questionnaires, the following consequences are presented. First of all, the tacitness in the knowledge attributes has negative influences on learning performance, and both cumulativeness and complexity have positive influence. Besides, all of the three factors in organizational learning capability variables, which are integrating absorption, learning intention and diffusing communication, have positive effects on learning performance. Diffusing communication has the most influence on the learning growth factor of learning performance variable, and integration absorbing has the most influence on the market performance factor of learning performance variable. Nevertheless, the influences of knowledge attributes between organizational learning capability and learning performance are not significant. This study not only builds the measure ways and relations of knowledge attributes, organizational learning capability and learning performance in the pharmacy contract research organization or industries in Taiwan, but also offers the suggestions to the industries on how to use organizational learning capability to improve their learning performance.

碩士
國立政治大學
科技管理研究所
100
In the Bio-service Industry, clinical trial service is the most profitable and valuable item. In 2009, the revenue of clinical trial service accounted for about half of the revenue of CRO Industry. Recently, since all the countries in the world are speeding up developing Pharmaceutical Industry and pharmaceutical companies are gradually raising the proportion of clinical trial outsourcing, the demand of clinical trial service are grately increasing. From 1997, Taiwan local companies have been working so hard in the clinical trial service area. Till now, Taiwan local companies have accumulated lots of successful experience. But when facing the oligopoly market of CRO Industry and competition of Asia new CRO companies, Taiwan CRO companies still have big stress on operation. However, since Taiwan CRO companies have had great competence in clinical trial service, we believe that if Taiwan CRO companies can tidy up, analyze and expand their own core competence, the competitive strength of Taiwan CRO companies will get improved to face the global competition. Besides, intellectual capital of CRO companies which are knowledge intensive business services (KIBS) shows real value of the CRO companies. Hence, this study is trying to investigate the core competence of clinical trial service companies from intellectual capital aspect, and also trying to compare the differences of the core competence in the different timing. We hope this study can on the one hand provide CRO companies a way to analyze their core competence, and on the other hand can provide the successful core competence information of the study cases for CRO companies as a reference. There are several conclusions from this study: 1. Using relationship capital-business collaboration is an important way for the clinical trial service companies to improve their service ability, broaden their service area, and develop their core competence. 2. The clear values and culture of clinical trial service companies can help the development and operation of the companies, and create the characteristic of the companies. 3. A mature clinical trial service company has accumulated plentiful core competence in human capital, organizational capital and customer capital, and it’s hard for the company to deepen and broaden its core competence. Relatively, it’s easier for a young clinical trial service company to develop its core competence. 4. The intellectual capital of “Education” and “Brands” of clinical trial service companies can upgrade other intellectual capital of the companies. 5. Taiwan local clinical trial service companies emphasize the core competence with differenciation while foreign clinical trial service companies in Taiwan emphasize good executive ability of the employee. Keywords: Clinical trial services, CRO, Core competence, Intellectual capital

碩士
國立中山大學
高階經營碩士班
95
Abstract Bio-technology has been viewed as the “star” industry in the 21st century. To entrepreneurs around the world bio-technology has offered an enormous opportunity for development. Recently partly because of the encouragement of government incentive programme a large number of bio-tech related firms have been established. In Taiwan these firms are associated with several characteristics: small but innovative; high growth; highly active; technology-intensive; high R& D spending; low on manufacturing; lacking attention to intangible asset and so on. By synthesizing the literature review and intensive case studying, this study has concluded that the bio-tech firms in Taiwan have faced a number of key barriers including lacking of capital and capital trapping, lacking confidence and infrastructure, lacking attention to R&D. This study has adopted, in conjunction with those developed by Chen (year) and Tan (year), the Michael Porter’s diamond model to develop its research framework (Porter, year). This study has also utilised the SWOT and the five force model analysis method in its framework. This study has analysed two firms from each of the following industrial sectors: The research framework was proposed in light of intensive literature review. The research framework was examined by the data collected from both primary and secondary research. The main data collection methods employed were personal interviews with experts specialised in bio-technology and some secondary information. The key findings of this study include: (1) Though some traditional bio-tech industrial sectors are already saturated, some bio-technology related sectors are still emerging and developing. (2) It is found that the most important factors influencing CMO is the transaction cost, followed by resource dependence. (3) Transaction cost is negatively related to CMO while resource dependence is positively associated with CMO. The degree of satisfaction of CMO is also positively related to the degree of CMO. (4) Consistent with existing literature.The research concerning CMO needs to be explored from three aspects: economic costing, operational strategy and social costing. (5) Strategic alliance is widely evidenced in the management, for example, in the areas of research and development and marketing. In the future bio-technology firms are suggested to well utilise the capabilities of major research centres in order to overcome the barriers caused by the inadequacy of institutional laws and lacking of research funds. Key word:Biotech, Biotechnolog, Biotechnolog industry, CMO, CRO, SWOT Analysis。

碩士
國立清華大學
科技法律研究所
103
Since the Contract Research Organization, CRO) industry has gradually booming trend in the Asian region, Taiwan has the advantage to development it. It is because the intellectual property rights protection and health care systems that increases the CRO industry companies and the CRO have more opportunities to work together with the sponsors. Therefore, the legal relationship between the sponsors and the CRO becomes more important. However, most papers mostly focused to discuss the legal relationship between the sponsors and experimental subject or the CRO and experimental subject. The legal relationship between the sponsors and the CRO lacks academic discussion, but the practice starts appearing the civil disputes about them. Therefore, this article tries to set the CRO as the discussion center in drug discovery research process, and try to clarify the relationship between civil law and torts responsibility of the CRO. There are six chapters in this thesis. It is summarized in the following paragraphs. The first chapter focuses on the background and status of the CRO industry, described research motivation, research methods and research scope and limitations. The second chapter includes making case analysis about the two cases of the United States and the two domestic cases. In order to realize the civil liability of the CRO, try to discuss contractual liability and tort liability about the CRO. The third chapter will discuss the contract relationship between the sponsors and the CRO. The first section will introduce the rules of the U.S. contracts. The second section will introduce the civil laws about contracts. In the section III, try to make a comparative study of law against US law and domestic civil law about the contractual responsibility of the CRO. The fourth chapter will discuss the tort relationship about the CRO. The first section will introduce the tort law of the U.S. The second section will introduce the civil laws about tort of Taiwan. In the section III, try to make a comparative study of law against US law and domestic civil law about the tort responsibility of the CRO. The fifth chapter will solve the concurrent relationship between the contract and tort. Try to discuss respectively the solution of the U.S. and Taiwan courts. The last chapter will make a conclusion about the civil liability of the CRO.

Managers are regularly confronted with unsolved problems. If a manager knows who can solve a problem, they can assign the problem to the correct person to have it solved under an ex ante contract or other form of agreement/commitment, inside or outside the organization. If they do not know who can solve it, they can crowdsource it, broadcasting the problem to an undefined set of people (the crowd) to self-select and solve it with no ex ante contract or other commitment. Although the practice of crowdsourcing goes back to at least the Longitude Prize of 1714, research on the phenomenon has only recently flourished, thanks, in part, to advances in information technology, globalization, and other macro-environmental factors. This chapter presents a crowdsourcing primer and framework with the goal of providing management scholars with some of the fundamentals needed to pursue their research interests in this compelling phenomenon.

Drawing upon social exchange theory and the norm of reciprocity, we review the employee–organization relationship (EOR). A number of EOR frameworks share common theoretical ground yet have developed independently: psychological contracts, perceived organizational support, employment relationship, social and economic exchange, and idiosyncratic deals. We examine the empirical evidence linking each of the frameworks to employees’ organizational citizenship behavior (OCB). Relationships based on minimal investment (quasi-spot contracts and transactional psychological contracts) and psychological contract breach are negatively related to OCB. Economic exchange is unrelated to OCB. Relationships that demonstrate investment, support, fulfillment of obligations, and granting of idiosyncratic deals are positively related to OCB because they signal a trusting and benefit conferring relationship. We outline challenges and future research directions that address the “value addedness” of the EOR frameworks.

The continuous changes that characterize the world of work and labor relations today change in various ways the perceptions, expectations and beliefs of workers and employers regarding the content and fulfillment of their commercial relations. Thus, these perceptions, expectations and beliefs configure psychological contracts which define the framework of the interactions between individuals and organizational agents and influence their attitudes, behaviors and decisions as well. That’s why the psychological contract constitutes a fundamental element for understanding the psychosocial processes involved in labor relations. This book aims to offer an overview of the diversity that characterizes the conceptual reflection and research on the psychological contract carried out from various countries in the Americas. Researchers from Colombia, Puerto Rico, Mexico, Brazil, Canada and Spain present a set of theoretical and empirical works that seek to deepen the understanding of employee-organization relations in the multiple labor contexts of their countries. Summarizing, this book offers for the first time a broad, though not exhaustive, overview of psychological contract research in a selection of Spanish, English, and Portuguese-speaking American countries in the south, center, and north of the continent, also represents a valuable contribution to research in organizational and work psychology in those contexts.

Nationalism: Past as Prologue began as a single volume being compiled by Ad Akande, a scholar from South Africa, who proposed it to me as co-author about two years ago. The original idea was to examine how the damaging roots of nationalism have been corroding political systems around the world, and creating dangerous obstacles for necessary international cooperation. Since I (Bruce E. Johansen) has written profusely about climate change (global warming, a.k.a. infrared forcing), I suggested a concerted effort in that direction. This is a worldwide existential threat that affects every living thing on Earth. It often compounds upon itself, so delays in reducing emissions of fossil fuels are shortening the amount of time remaining to eliminate the use of fossil fuels to preserve a livable planet. Nationalism often impedes solutions to this problem (among many others), as nations place their singular needs above the common good. Our initial proposal got around, and abstracts on many subjects arrived. Within a few weeks, we had enough good material for a 100,000-word book. The book then fattened to two moderate volumes and then to four two very hefty tomes. We tried several different titles as good submissions swelled. We also discovered that our best contributors were experts in their fields, which ranged the world. We settled on three stand-alone books:” 1/ nationalism and racial justice. Our first volume grew as the growth of Black Lives Matter following the brutal killing of George Floyd ignited protests over police brutality and other issues during 2020, following the police assassination of Floyd in Minneapolis. It is estimated that more people took part in protests of police brutality during the summer of 2020 than any other series of marches in United States history. This includes upheavals during the 1960s over racial issues and against the war in Southeast Asia (notably Vietnam). We choose a volume on racism because it is one of nationalism’s main motive forces. This volume provides a worldwide array of work on nationalism’s growth in various countries, usually by authors residing in them, or in the United States with ethnic ties to the nation being examined, often recent immigrants to the United States from them. Our roster of contributors comprises a small United Nations of insightful, well-written research and commentary from Indonesia, New Zealand, Australia, China, India, South Africa, France, Portugal, Estonia, Hungary, Russia, Poland, Kazakhstan, Georgia, and the United States. Volume 2 (this one) describes and analyzes nationalism, by country, around the world, except for the United States; and 3/material directly related to President Donald Trump, and the United States. The first volume is under consideration at the Texas A & M University Press. The other two are under contract to Nova Science Publishers (which includes social sciences). These three volumes may be used individually or as a set. Environmental material is taken up in appropriate places in each of the three books. * * * * * What became the United States of America has been strongly nationalist since the English of present-day Massachusetts and Jamestown first hit North America’s eastern shores. The country propelled itself across North America with the self-serving ideology of “manifest destiny” for four centuries before Donald Trump came along. Anyone who believes that a Trumpian affection for deportation of “illegals” is a new thing ought to take a look at immigration and deportation statistics in Adam Goodman’s The Deportation Machine: America’s Long History of Deporting Immigrants (Princeton University Press, 2020). Between 1920 and 2018, the United States deported 56.3 million people, compared with 51.7 million who were granted legal immigration status during the same dates. Nearly nine of ten deportees were Mexican (Nolan, 2020, 83). This kind of nationalism, has become an assassin of democracy as well as an impediment to solving global problems. Paul Krugman wrote in the New York Times (2019:A-25): that “In their 2018 book, How Democracies Die, the political scientists Steven Levitsky and Daniel Ziblatt documented how this process has played out in many countries, from Vladimir Putin’s Russia, to Recep Erdogan’s Turkey, to Viktor Orban’s Hungary. Add to these India’s Narendra Modi, China’s Xi Jinping, and the United States’ Donald Trump, among others. Bit by bit, the guardrails of democracy have been torn down, as institutions meant to serve the public became tools of ruling parties and self-serving ideologies, weaponized to punish and intimidate opposition parties’ opponents. On paper, these countries are still democracies; in practice, they have become one-party regimes….And it’s happening here [the United States] as we speak. If you are not worried about the future of American democracy, you aren’t paying attention” (Krugmam, 2019, A-25). We are reminded continuously that the late Carl Sagan, one of our most insightful scientific public intellectuals, had an interesting theory about highly developed civilizations. Given the number of stars and planets that must exist in the vast reaches of the universe, he said, there must be other highly developed and organized forms of life. Distance may keep us from making physical contact, but Sagan said that another reason we may never be on speaking terms with another intelligent race is (judging from our own example) could be their penchant for destroying themselves in relatively short order after reaching technological complexity. This book’s chapters, introduction, and conclusion examine the worldwide rise of partisan nationalism and the damage it has wrought on the worldwide pursuit of solutions for issues requiring worldwide scope, such scientific co-operation public health and others, mixing analysis of both. We use both historical description and analysis. This analysis concludes with a description of why we must avoid the isolating nature of nationalism that isolates people and encourages separation if we are to deal with issues of world-wide concern, and to maintain a sustainable, survivable Earth, placing the dominant political movement of our time against the Earth’s existential crises. Our contributors, all experts in their fields, each have assumed responsibility for a country, or two if they are related. This work entwines themes of worldwide concern with the political growth of nationalism because leaders with such a worldview are disinclined to co-operate internationally at a time when nations must find ways to solve common problems, such as the climate crisis. Inability to cooperate at this stage may doom everyone, eventually, to an overheated, stormy future plagued by droughts and deluges portending shortages of food and other essential commodities, meanwhile destroying large coastal urban areas because of rising sea levels. Future historians may look back at our time and wonder why as well as how our world succumbed to isolating nationalism at a time when time was so short for cooperative intervention which is crucial for survival of a sustainable earth. Pride in language and culture is salubrious to individuals’ sense of history and identity. Excess nationalism that prevents international co-operation on harmful worldwide maladies is quite another. As Pope Francis has pointed out: For all of our connectivity due to expansion of social media, ability to communicate can breed contempt as well as mutual trust. “For all our hyper-connectivity,” said Francis, “We witnessed a fragmentation that made it more difficult to resolve problems that affect us all” (Horowitz, 2020, A-12). The pope’s encyclical, titled “Brothers All,” also said: “The forces of myopic, extremist, resentful, and aggressive nationalism are on the rise.” The pope’s document also advocates support for migrants, as well as resistance to nationalist and tribal populism. Francis broadened his critique to the role of market capitalism, as well as nationalism has failed the peoples of the world when they need co-operation and solidarity in the face of the world-wide corona virus pandemic. Humankind needs to unite into “a new sense of the human family [Fratelli Tutti, “Brothers All”], that rejects war at all costs” (Pope, 2020, 6-A). Our journey takes us first to Russia, with the able eye and honed expertise of Richard D. Anderson, Jr. who teaches as UCLA and publishes on the subject of his chapter: “Putin, Russian identity, and Russia’s conduct at home and abroad.” Readers should find Dr. Anderson’s analysis fascinating because Vladimir Putin, the singular leader of Russian foreign and domestic policy these days (and perhaps for the rest of his life, given how malleable Russia’s Constitution has become) may be a short man physically, but has high ambitions. One of these involves restoring the old Russian (and Soviet) empire, which would involve re-subjugating a number of nations that broke off as the old order dissolved about 30 years ago. President (shall we say czar?) Putin also has international ambitions, notably by destabilizing the United States, where election meddling has become a specialty. The sight of Putin and U.S. president Donald Trump, two very rich men (Putin $70-$200 billion; Trump $2.5 billion), nuzzling in friendship would probably set Thomas Jefferson and Vladimir Lenin spinning in their graves. The road of history can take some unanticipated twists and turns. Consider Poland, from which we have an expert native analysis in chapter 2, Bartosz Hlebowicz, who is a Polish anthropologist and journalist. His piece is titled “Lawless and Unjust: How to Quickly Make Your Own Country a Puppet State Run by a Group of Hoodlums – the Hopeless Case of Poland (2015–2020).” When I visited Poland to teach and lecture twice between 2006 and 2008, most people seemed to be walking on air induced by freedom to conduct their own affairs to an unusual degree for a state usually squeezed between nationalists in Germany and Russia. What did the Poles then do in a couple of decades? Read Hlebowicz’ chapter and decide. It certainly isn’t soft-bellied liberalism. In Chapter 3, with Bruce E. Johansen, we visit China’s western provinces, the lands of Tibet as well as the Uighurs and other Muslims in the Xinjiang region, who would most assuredly resent being characterized as being possessed by the Chinese of the Han to the east. As a student of Native American history, I had never before thought of the Tibetans and Uighurs as Native peoples struggling against the Independence-minded peoples of a land that is called an adjunct of China on most of our maps. The random act of sitting next to a young woman on an Air India flight out of Hyderabad, bound for New Delhi taught me that the Tibetans had something to share with the Lakota, the Iroquois, and hundreds of other Native American states and nations in North America. Active resistance to Chinese rule lasted into the mid-nineteenth century, and continues today in a subversive manner, even in song, as I learned in 2018 when I acted as a foreign adjudicator on a Ph.D. dissertation by a Tibetan student at the University of Madras (in what is now in a city called Chennai), in southwestern India on resistance in song during Tibet’s recent history. Tibet is one of very few places on Earth where a young dissident can get shot to death for singing a song that troubles China’s Quest for Lebensraum. The situation in Xinjiang region, where close to a million Muslims have been interned in “reeducation” camps surrounded with brick walls and barbed wire. They sing, too. Come with us and hear the music. Back to Europe now, in Chapter 4, to Portugal and Spain, we find a break in the general pattern of nationalism. Portugal has been more progressive governmentally than most. Spain varies from a liberal majority to military coups, a pattern which has been exported to Latin America. A situation such as this can make use of the term “populism” problematic, because general usage in our time usually ties the word into a right-wing connotative straightjacket. “Populism” can be used to describe progressive (left-wing) insurgencies as well. José Pinto, who is native to Portugal and also researches and writes in Spanish as well as English, in “Populism in Portugal and Spain: a Real Neighbourhood?” provides insight into these historical paradoxes. Hungary shares some historical inclinations with Poland (above). Both emerged from Soviet dominance in an air of developing freedom and multicultural diversity after the Berlin Wall fell and the Soviet Union collapsed. Then, gradually at first, right wing-forces began to tighten up, stripping structures supporting popular freedom, from the courts, mass media, and other institutions. In Chapter 5, Bernard Tamas, in “From Youth Movement to Right-Liberal Wing Authoritarianism: The Rise of Fidesz and the Decline of Hungarian Democracy” puts the renewed growth of political and social repression into a context of worldwide nationalism. Tamas, an associate professor of political science at Valdosta State University, has been a postdoctoral fellow at Harvard University and a Fulbright scholar at the Central European University in Budapest, Hungary. His books include From Dissident to Party Politics: The Struggle for Democracy in Post-Communist Hungary (2007). Bear in mind that not everyone shares Orbán’s vision of what will make this nation great, again. On graffiti-covered walls in Budapest, Runes (traditional Hungarian script) has been found that read “Orbán is a motherfucker” (Mikanowski, 2019, 58). Also in Europe, in Chapter 6, Professor Ronan Le Coadic, of the University of Rennes, Rennes, France, in “Is There a Revival of French Nationalism?” Stating this title in the form of a question is quite appropriate because France’s nationalistic shift has built and ebbed several times during the last few decades. For a time after 2000, it came close to assuming the role of a substantial minority, only to ebb after that. In 2017, the candidate of the National Front reached the second round of the French presidential election. This was the second time this nationalist party reached the second round of the presidential election in the history of the Fifth Republic. In 2002, however, Jean-Marie Le Pen had only obtained 17.79% of the votes, while fifteen years later his daughter, Marine Le Pen, almost doubled her father's record, reaching 33.90% of the votes cast. Moreover, in the 2019 European elections, re-named Rassemblement National obtained the largest number of votes of all French political formations and can therefore boast of being "the leading party in France.” The brutality of oppressive nationalism may be expressed in personal relationships, such as child abuse. While Indonesia and Aotearoa [the Maoris’ name for New Zealand] hold very different ranks in the United Nations Human Development Programme assessments, where Indonesia is classified as a medium development country and Aotearoa New Zealand as a very high development country. In Chapter 7, “Domestic Violence Against Women in Indonesia and Aotearoa New Zealand: Making Sense of Differences and Similarities” co-authors, in Chapter 8, Mandy Morgan and Dr. Elli N. Hayati, from New Zealand and Indonesia respectively, found that despite their socio-economic differences, one in three women in each country experience physical or sexual intimate partner violence over their lifetime. In this chapter ther authors aim to deepen understandings of domestic violence through discussion of the socio-economic and demographic characteristics of theit countries to address domestic violence alongside studies of women’s attitudes to gender norms and experiences of intimate partner violence. One of the most surprising and upsetting scholarly journeys that a North American student may take involves Adolf Hitler’s comments on oppression of American Indians and Blacks as he imagined the construction of the Nazi state, a genesis of nationalism that is all but unknown in the United States of America, traced in this volume (Chapter 8) by co-editor Johansen. Beginning in Mein Kampf, during the 1920s, Hitler explicitly used the westward expansion of the United States across North America as a model and justification for Nazi conquest and anticipated colonization by Germans of what the Nazis called the “wild East” – the Slavic nations of Poland, the Baltic states, Ukraine, and Russia, most of which were under control of the Soviet Union. The Volga River (in Russia) was styled by Hitler as the Germans’ Mississippi, and covered wagons were readied for the German “manifest destiny” of imprisoning, eradicating, and replacing peoples the Nazis deemed inferior, all with direct references to events in North America during the previous century. At the same time, with no sense of contradiction, the Nazis partook of a long-standing German romanticism of Native Americans. One of Goebbels’ less propitious schemes was to confer honorary Aryan status on Native American tribes, in the hope that they would rise up against their oppressors. U.S. racial attitudes were “evidence [to the Nazis] that America was evolving in the right direction, despite its specious rhetoric about equality.” Ming Xie, originally from Beijing, in the People’s Republic of China, in Chapter 9, “News Coverage and Public Perceptions of the Social Credit System in China,” writes that The State Council of China in 2014 announced “that a nationwide social credit system would be established” in China. “Under this system, individuals, private companies, social organizations, and governmental agencies are assigned a score which will be calculated based on their trustworthiness and daily actions such as transaction history, professional conduct, obedience to law, corruption, tax evasion, and academic plagiarism.” The “nationalism” in this case is that of the state over the individual. China has 1.4 billion people; this system takes their measure for the purpose of state control. Once fully operational, control will be more subtle. People who are subject to it, through modern technology (most often smart phones) will prompt many people to self-censor. Orwell, modernized, might write: “Your smart phone is watching you.” Ming Xie holds two Ph.Ds, one in Public Administration from University of Nebraska at Omaha and another in Cultural Anthropology from the Chinese Academy of Social Sciences, Beijing, where she also worked for more than 10 years at a national think tank in the same institution. While there she summarized news from non-Chinese sources for senior members of the Chinese Communist Party. Ming is presently an assistant professor at the Department of Political Science and Criminal Justice, West Texas A&M University. In Chapter 10, analyzing native peoples and nationhood, Barbara Alice Mann, Professor of Honours at the University of Toledo, in “Divide, et Impera: The Self-Genocide Game” details ways in which European-American invaders deprive the conquered of their sense of nationhood as part of a subjugation system that amounts to genocide, rubbing out their languages and cultures -- and ultimately forcing the native peoples to assimilate on their own, for survival in a culture that is foreign to them. Mann is one of Native American Studies’ most acute critics of conquests’ contradictions, and an author who retrieves Native history with a powerful sense of voice and purpose, having authored roughly a dozen books and numerous book chapters, among many other works, who has traveled around the world lecturing and publishing on many subjects. Nalanda Roy and S. Mae Pedron in Chapter 11, “Understanding the Face of Humanity: The Rohingya Genocide.” describe one of the largest forced migrations in the history of the human race, the removal of 700,000 to 800,000 Muslims from Buddhist Myanmar to Bangladesh, which itself is already one of the most crowded and impoverished nations on Earth. With about 150 million people packed into an area the size of Nebraska and Iowa (population less than a tenth that of Bangladesh, a country that is losing land steadily to rising sea levels and erosion of the Ganges river delta. The Rohingyas’ refugee camp has been squeezed onto a gigantic, eroding, muddy slope that contains nearly no vegetation. However, Bangladesh is majority Muslim, so while the Rohingya may starve, they won’t be shot to death by marauding armies. Both authors of this exquisite (and excruciating) account teach at Georgia Southern University in Savannah, Georgia, Roy as an associate professor of International Studies and Asian politics, and Pedron as a graduate student; Roy originally hails from very eastern India, close to both Myanmar and Bangladesh, so he has special insight into the context of one of the most brutal genocides of our time, or any other. This is our case describing the problems that nationalism has and will pose for the sustainability of the Earth as our little blue-and-green orb becomes more crowded over time. The old ways, in which national arguments often end in devastating wars, are obsolete, given that the Earth and all the people, plants, and other animals that it sustains are faced with the existential threat of a climate crisis that within two centuries, more or less, will flood large parts of coastal cities, and endanger many species of plants and animals. To survive, we must listen to the Earth, and observe her travails, because they are increasingly our own.

It is assumed that employees display favorable attitudes (e.g., high organizational commitment) and behaviors (e.g., high work effort) when identified as organizational talent. If they did not, the idea that talent management creates value by making disproportionate investments into organizational talent would need to be reconsidered. We reviewed the literature to explore whether the assumed favorable reactions among talent are valid and the results are not straightforward. Many studies found evidence for the assumption; however, several studies revealed that talent designation bears considerable risks: Being identified as talent creates (overly optimistic) expectations of receiving rewards and benefits from the organization and it increases the felt pressure to meet high performance standards. We discuss the findings in the light of social exchange theory, psychological contract theory, and others commonly used in talent-management research, highlighting key issues regarding talent designation and identifying avenues for future research.

This book presents a radically new approach to how societies can get corruption under control. Since the late 1990s, the detrimental effects of corruption on human wellbeing have become well established in research. This has resulted in a stark increase in anti-corruption programs launched by international and national development organizations. Despite these efforts, evaluations of the effects of these anti-corruption programs have been disappointing. As it can be measured, it is difficult to find substantial effects from such anti-corruption programs. The argument in this book is that this huge policy failure can be explained by three factors. Firstly, that the corruption problem has been poorly conceptualized since what should count as the opposite to corruption—the quality of government—has been left out. Secondly, that the problem has been located in the wrong social spaces. It is neither a cultural nor a legal problem. Instead, it is for the most part located in what organization theory defines as the “standard operating procedures” in social organizations. Thirdly, that the general theory that has dominated anti-corruption efforts—the principal-agent theory—is based on serious misspecification of the basic nature of the problem. The book presents a reconceptualization of corruption and a new theory—drawing on the tradition of the social contract—to explain it and motivate policies of how to get corruption under control. Several empirical cases serve to underpin this new theory ranging from the historical organization of religious practices to specific social policies, universal education, gender equality, and auditing.

Project Management has had an increasingly important role in industrial organization, new product development and innovation theories over the last few decades. The majority of the current project management research and literature are focused on the post contract award phase as well as the skills and know-how of the project manager. Empirical research shows that, despite strict adherence to the best management norms and best practices, many projects still fail to achieve their objectives while others are aborted before they are completed. The authors argue that this project failute is due to the lack of an analytical and systematic process of designing the project prior to its award and that this phase of Project Design plays a major role in predetermining the project’s outcome. The following paper is a research proposal for presenting the literature review, theoretical basis and empirical evidence of the need for a theoretical framework for designing projects. This framework will encompass a dynamic model for the interactions between the various project success factors across different project categories.

This paper addresses the analytical methods used to determine the response of a dry storage spent fuel cask to hypothetical loading. Because of the sensitive nature of the topic under discussion, the response of the cask is described in qualitative terms, and the paper is intentionally vague on the parameters and results. This research was sponsored by the U.S. Nuclear Regulatory Commission (NRC) Spent Fuel Project Office. The work was performed under contract from the Sandia National Laboratory (SNL), Transportation Risk and Packing organization. The analytical effort was performed at the Oak Ridge National Laboratory (ORNL) facilities with loading specified by SNL.

In Japan, from the point of view of energy saving and environmental protection, a 300kW Ceramic Gas Turbine (CGT) Research and Development program started in 1988 and is still continuing as a part of “the New Sunshine Project” promoted by the Ministry of International Trade and Industry (MITT). The final target of the program is to achieve 42% thermal efficiency at 1350°C of turbine inlet temperature (TIT) and to keep NOx emissions below present national regulations. Under contract to the New Energy and Industrial Technology Development Organization (NEDO), Kawasaki Heavy Industries, Ltd. (KHI) has been developing the CGT302 with Kyocera Corporation and Sumitomo Precision Products Co., Ltd. By the end of the fiscal year 1996, the CGT302 achieved 37.0% thermal efficiency at 1280°C of TIT. In 1997, TIT reached 1350°C and a durability operation for 20 hours at 1350°C was conducted successfully. Also fairly low NOx was proved at 1300°C of TIT. In January 1998, the CGT302 has achieved 37.4% thermal efficiency at 1250°C TIT. In this paper, we will describe our approaches to the target performance of the CGT302 and current status.

Based on the successful result of the Japanese national project for 300 kW class ceramic gas turbine development (this project was finished in March 1999), the New Energy and Industrial Technology Development Organization (NEDO) contract project “Research and Development on Practical Industrial Co-generation Technology”, funded by the Ministry of Economy, Trade and Industry (METI), started in August 1999. This project is a five-year plan until the end of the 2003 fiscal year. The objective of this project is to encourage prompt industrial applications of co-generation technology that employs a hybrid gas turbine (HGT; using both metal and ceramic parts in its high-temperature section) by confirming its soundness and reliability. The development activities are performed through ceramic material evaluation test and long-term operation test for the HGT of the medium size (8,000-kW class). It is expected that the development can realize low pollution and reducing the emission of CO2 with highly efficient use of energy. To grasp the material characteristic of the ceramic, the tensile creep rupture test, cyclic fatigue test, sub-critical crack growth test, and exposure test had been carried out. Sub element tests, such as Sector Model Text and Pre-test were carried out prior to the operation study. The operation study was started in the 2002 fiscal year. The operation tests to 5/8-load (about 5,000-kW) had been carried out as of February 2003. This paper gives the progress of the developments of the HGT.