bluuebunny/crossref_metadata_2025_split huggingface dataset:
4 Ethics of Pandemic Research
Authors: Smith Maxwell J. 
Published: August 2024

Abstract
Research conducted during infectious disease outbreaks or pandemics can be crucial to control or ameliorate their consequences, but scientists are confronted with significant ethical questions about how to conduct research in such contexts. This chapter examines foundational ethical questions and considerations undergirding the research enterprise in pandemic contexts, including whether pandemics necessitate deviations from ethical and scientific standards for research, how research priorities are and ought to be set during pandemics, the ethics of conducting research alongside pandemic response efforts, and how pandemic research ought to be governed and coordinated. Scientists may have only a brief interval to understand the disease and develop medical countermeasures, and social pressures to produce fast results may seem overwhelming. Despite these challenges, this does not justify relaxing fundamental ethical or scientific standards, although there is scope for accelerating procedural requirements. Even during a pandemic, provision of most biomedical research funding by high-resource countries can influence the directions and results of research, leading to interventions that are more applicable in resource-rich than in resource-poor countries. The World Health Organization and other institutions are trying to correct or at least reduce these discrepancies. Biomedical research and health care response to a pandemic need not be rivals for funding support. The 2014 Ebola and 2019 COVID-19 experiences have demonstrated that the two can work synergistically. Both medical care and research responses are integral to our defenses against emerging or re-emerging infectious disease. Finally, the COVID-19 pandemic has made clear the need for changes in global architecture for pandemic response. The scientific and organizational adaptations required must be guided by ethical principles, such as the need to reduce the glaring inequities between high-income and low-income settings across the world as well as within countries. Preparing for the next pandemic will require a blueprint to accelerate the organization, coordination, and conduct of critical research and development.
27 A Global Framework for Research Preparedness and Response
Authors: Lurie Nicole , Keusch Gerald T. 
Published: August 2024

Abstract
The world has faced many infectious disease emergencies during this century and is certain to see more in the decades ahead. Urgent research to study new pathogens and how to control and counter them is now increasingly being integrated into global response to infectious diseases to chronicle their clinical presentation, identify treatment alternatives, and develop approaches to prevention or control—and to do so with the urgency befitting a pandemic with many lives at stake. The recent Ebola outbreaks in Africa and the coronavirus disease 2019 (COVID-19) pandemic have spurred more coordination on response among global stakeholders. However, they also revealed many shortcomings and spurred movement toward a global framework providing more consistent resources, coordination, and governance. A well thought-out, realistic framework is needed not only for more effective scientific research including clinical trials, but to better account for popular perceptions of and reactions to events, and to ensure that the products of emergency research are equitably distributed among the world’s population. The key elements of the research ecosystem must be in place before a new infectious disease appears.
30.1 In Focus: Research and Medical Humanitarian NGOs
Authors: Grais Rebecca F. , Baron Emmanuel 
Published: August 2024

Abstract
It is a commonplace belief that medical humanitarian organizations, of which Médecins Sans Frontières (MSF), or Doctors without Borders, have a mission very different from that of research scientists investigating medical interventions against disease. While this may be so to an extent, MSF has also been a leader not only in effective humanitarian action but also in incorporating needed research into its response to infectious disease emergencies. Epicentre is a research organization within MSF that can work with MSF humanitarian staff to facilitate potentially useful research in an emergency, especially as the possibility of generating data for medical countermeasure approval during an emergency has become more realistic in recent years. Epicentre promotes research that is most useful to the disadvantaged populations it often serves, in part because it does not depend on pharmaceutical company or government funding. Moreover, Epicentre is committed to making its colleagues from developing countries full partners in research as in medical care, thus contributing to medical research capacity building—an area that often gets more lip service than investment.
31 Operational Recommendations for Streamlining Emergency Research Responses to Pandemics
Authors: Larson Gregg , Harrigan Rachel , McNay Laura A. 
Published: August 2024

Abstract
This chapter describes clinical research operations and some of the obstacles to accelerated research response during Ebola outbreaks since 2014 and the coronavirus disease 2019 (COVID-19) pandemic. It makes recommendations for streamlining operational requirements in order to accelerate research response without comprising ethical and scientific rigor. The Ebola outbreaks provided invaluable experience in emergency research operations in resource-poor settings for hundreds of research staff and served as a proving ground for rapid implementation of clinical research. They helped broaden acceptance of expedited clinical research as an integral part of emergency response to an infectious disease outbreak with pandemic potential. The COVID-19 outbreak offered further lessons for assessment of future vaccines, therapeutics, and diagnostics (VTDs) in time to mitigate morbidity and mortality during the course of the pandemic. Illustrative research programs include the Randomised Evaluation of COVID-19 Therapy (RECOVERY) study in the UK and the US-based Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) studies. Learning from these and other response research programs can guide swift, coherent, and flexible research response to new public health emergencies if sufficient funding is available for preparedness and response.
32.2 In Focus: Clinical Trial Insurance and Indemnification
Authors: Larson Gregg 
Published: August 2024

Abstract
For clinical trials to proceed, an agreement on how to meet costs from possible injuries or deaths associated with a clinical study is needed. Health risks to clinical trial participants can result from administration of investigative vaccines, pharmaceuticals, or treatments during clinical research in emergency response settings, or from other injuries that occur at trial sites. Various risk management strategies are available in the form of insurance and indemnification. International examples relate to both commercial insurance and sponsor funding of injury and death claims from the 2014–2015 West Africa Ebola pandemic. The related subject of in-country back-up medical care and medical evacuation insurance for local and international medical and research personnel is also covered.
33.1 In Practice: Ethical Review During Emergencies: The Liberian Experience
Authors: Bolay Fatorma , Sorenson Robert A. 
Published: August 2024

Abstract
Ethical review for human subject research is challenging during an infectious disease emergency, all the more so in a lower-income country where there has been little previous clinical research. The Ebola experience in Liberia demonstrated that it is possible to advance and empower a local ethical review board even while launching an urgent, ambitious research program. The strengthened institution(s) can serve the country and biomedical research well in the follow-through and in subsequent emergencies.
33.2 In Practice: Independent Monitoring of Emergency Response Clinical Trials
Authors: Vogel Susan , Pierson Jerome F. 
Published: August 2024

Abstract
Independent monitoring of clinical trial studies safeguards the rights, safety, and welfare of patients who have agreed to participate in clinical trials of experimental medical countermeasures. Monitoring is especially important and may be more difficult to implement, in countries with limited medical care and medical research infrastructure and personnel, a shortfall often exacerbated by poverty, poor transport and communications, and uncertain security. The randomized controlled trial of Ebola virus disease therapeutics implemented in the northeastern Democratic Republic of the Congo (DRC) during the 2018–2020 Ebola outbreak there demonstrates that it is possible to monitor the adequacy of trial sites and resources, qualifications and proper training of investigators, protocol implementation, and study task assignments even during an emerging outbreak in an insecure environment. Independent monitoring buttresses continuous quality improvement by and for all research stakeholders. It requires flexibility and efficient communications and can help build local capacity for research when that is a goal of the program.
34 Information and Communications Technology to Support Research in Low-Resource Settings
Authors: Galcik Mike , Parrish David 
Published: August 2024

Abstract
Any emergency research response requires continual communication and collaboration between people, organizations, and systems to meet dynamically evolving circumstances. This chapter will lay out the essentials for providing communications and information and communications technology (ICT) to a research response in a low-resource area. ICT needs are similar everywhere, but procurement, configuration, and operations are especially demanding tasks where ICT infrastructure is lacking and skilled personnel scarce. The key questions are how, when, and what technologies and tools to introduce, and how to balance overhead and running costs with operational efficiencies. Changes in program activities and in the roster of partner organizations can complicate matters in what may be a high-mortality outbreak with a steep learning curve. Response activities will at first depend largely on existing local infrastructure, supplemented by equipment the incoming team can bring. The team will also initially depend on the operational infrastructure of its primary local partner, which will influence the research program’s communications and decision-making style. As the response becomes more established, and centralized ICT support solidifies, the ICT infrastructure must be adapted as appropriate to the evolving needs of the collective research organization.
39 Cold Chain and Electrical Power for Emergency Research Response
Authors: Littlefield Daniel J. 
Published: August 2024

Abstract
Many pharmaceutical products, and particularly investigational products, must be kept at specified temperatures during manufacturing, shipment, and storage before they are administered to patients or clinical trial participants. That is simply stated but not simply accomplished, especially when the products must be shipped long distances and arrive unharmed at remote clinical trial sites where there is little infrastructure or experience with such requirements. We describe many considerations involved in ensuring that this essential element of clinical trials and patient treatment can be met as required where capacity is wanting and review some principles and practices of physics and electrical supply to help research program planners and logisticians carry out their mission successfully.
4.2 In Practice: Research Ethics Committee Review in Public Health Emergencies
Authors: Koneti Rao V. 
Published: August 2024

Abstract
In order to conduct clinical research early in an epidemic of a new or poorly understood infectious disease, preparatory requirements include scientific deliberations, essential health care infrastructure, and assessment of readiness for rapid research response, including expedited ethical review. Essential ethical safeguards must be met as for all clinical trials, but review of ethics should not become an impediment and delay clinical trials in an emergency. As with all research involving human participants, emergency response research protocols must be approved prospectively by a research ethics committee (REC) to ensure that study participant safety and welfare are protected. Upholding ethical and scientific standards in medical research cannot be left to the discretion of individual investigators, as was understood at least as far back as the Nuremburg Medical Trial of 1947. The structure of today’s medical research review mechanisms evolved gradually over the decades after World War II, culminating in a deliberative process that is effective at preventing most abuses. In more recent years, there have been concerns that established procedures for funding, reviewing, and implementing clinical research can be too slow and tardy in an outbreak one hopes to contain expeditiously, especially an outbreak of a high-mortality disease or a pandemic with widespread mortality (Ebola and coronavirus disease 2019 [COVID-19]). Since outbreaks are likely to arise in developing countries with little capacity for rapid research response, it is especially important to increase their review and oversight capacity along with their broader research capacity to facilitate rigorous clinical research studies that can provide global benefits.
40 Selecting and Opening a Clinical Research Site in a Low-Resource Setting
Authors: Mbaya Olivier Tshiani , Njoh Wissedi , Barrett Kevin , Smolskis Mary , Miranda Alejandra , Gettinger Nikki 
Published: August 2024

Abstract
Conducting clinical research in a public health emergency response not only involves the collective efforts of the scientific community to establish relevant protocols designed to provide answers to the most pressing questions regarding the infectious disease threat, but also requires an infrastructure where research can take place. This chapter identifies factors to consider regarding the who, what, where, when, and how of establishing a clinical research site in a setting where infrastructure may be lacking and few or no clinical trials have been conducted in the past. The chapter also provides a roadmap that describes site selection criteria, checklists for site activation, and considerations for flowcharts to ensure that protocols can be implemented at the site. The chapter concludes with the important reminder that, while every emergency is different from the previous one and lessons learned may not be directly applicable, the experience provides a framework within which to creatively address the next challenge.
6 Meeting Regulatory Criteria and Seeking Licensure: Medicines Development Before and During Public Health Emergencies
Authors: Cavaleri Marco , Gruber Marion , Gaspar Rogerio , Darko Mimi 
Published: August 2024

Abstract
The Ebola outbreak of 2014 and the COVID-19 pandemic have underscored the importance of expedited preclinical and clinical product development to assure access to life-saving therapies during public health emergencies. Advances in manufacturing methods and the availability of platform technologies provide opportunities for streamlined product development by leveraging data derived from other products based on the same platform. Use of adaptive and seamless clinical trial designs, especially during the COVID-19 pandemic, led to more rapid progress through phases of clinical development and resulted in earlier availability of therapeutics and vaccines to billions of people.
Regulatory agencies played a critical role in this process as they were tasked with an expedited assessment of preclinical, clinical, and manufacturing protocols and data to ensure product safety and effectiveness. At the same time, regulators had to balance benefits and risks in a rapidly evolving scenario, thus emphasizing the importance of transparent communication. Close collaboration between the global regulatory community, manufacturers, the scientific community, and global public health authorities was essential in this process. Lessons learned from these public health emergencies demonstrate that use of novel preclinical and clinical testing strategies, continued improvements in efficiency of product assessment, and further strengthening of global regulatory collaboration, using more convergence in standards and reliance in procedural aspects, are necessary to ensure an effective and timely response to future pandemics.
7 Research, Sample, and Data Sharing During Outbreaks, Pandemics, and Beyond
Authors: Terry Robert Fraser , Littler Katherine 
Published: August 2024

Abstract
The agreement at the time the human genome was first sequenced to release the data to the public domain set an example that encouraged other scientists doing other types of research to share their data freely to empower scientific discovery and minimize the burden of disease. There are still many barriers to data sharing, including how to ensure patient privacy, manage intellectual property, and reduce inequity in data reuse, with a one-way flow of raw data from less developed countries to wealthy countries and corporations that produce medical countermeasures that may first go to the highest bidder. In an era of increasing infectious disease outbreaks, ensuring the efficient exchange of research data is essential to expeditious response to emerging pathogens, especially in the urgent case of a potential or actual pandemic. This chapter will review principles of open access to research highlighted by the coronavirus disease 2019 (COVID-19) pandemic and current challenges to establishment of a global data-sharing system meeting the needs and interests of all the stakeholders, that is, every living human being.
Introduction: Germany and Korea as Partners in International Development and Green Transitions
Authors: Klingebiel Stephan , Kalinowski Thomas , Keijzer Niels 
Published: August 2024

AbstractThis chapter introduces the book and its three parts, which explore the alignment of global sustainable development priorities between Germany and the Republic of Korea. Notably, both nations share a common commitment to development policy and international climate action, an alignment that holds immense potential for enhanced cooperation in today’s evolving global landscape. Germany's historical role as a founding member of the international development cooperation system juxtaposes with Korea's more recent entry into the Organisation for Economic Co-operation and Development (OECD) and its Development Assistance Committee (DAC) in 2010. Korea has transformed from a significant development assistance recipient to an active provider, a transition mirrored in its engagement in international climate finance.
Germany and Korea: Comparing Systems, Policies and Cooperation Patterns
Authors: Keijzer Niels , Klingebiel Stephan , Oh Min Jee 
Published: August 2024

AbstractAlthough geographically distant, there is considerable convergence in the development policy priorities of Germany and the Republic of Korea (hereafter referred to as Korea)—and indeed scope for cooperation between them. Whereas Germany was a founding member of the Organisation for Economic Co-operation and Development (OECD) and its Development Assistance Committee (DAC), Korea joined the DAC more recently in 2010 as an important former recipient as well as a current provider of development cooperation. Both countries maintain a centralized political responsibility for development policy—in Germany’s case with a dedicated ministry, whereas in Korea, two ministries share the responsibility for development cooperation. With various line ministries and organizations with implementing mandates involved in both countries’ development cooperation systems, fragmentation is a challenge and raises questions about issues that include results reporting, the introduction and use of standard indicators, independent evaluations, consistent official development assistance (ODA) reporting and ensuring effective cooperation.
Conclusion and Implications for the Russia-Ukraine War and Other Conflicts in Ukraine
Authors: Katchanovski Ivan 
Published: August 2024

AbstractThe final chapter summaries the main findings of the comprehensive evidence-based and theoretically based analysis of the Maidan massacre in Ukraine. The analysis of various evidence, such as synchronized videos, audio recordings, testimonies of the absolute majority of wounded Maidan protesters, and some 500 other witnesses, shows beyond any reasonable doubt that the Maidan protesters and the police were massacred by Maidan snipers located in Maidan-controlled buildings in a rationally organized operation with involvement of far-right and oligarchic elements of the Maidan opposition.
Exit, Voice, and Networks. Die Digitalisierung als Katalysator für Widerspruch und Netzwerkbildung in Organisationen
Authors: Baumgart Lene 
Published: August 2024

ZusammenfassungDie Verfügbarmachung digitaler Plattformen in Organisationen beeinflusst, wie deren Mitglieder miteinander kommunizieren und sich vernetzen. Entlang eines empirischen Beispiels wird in dem Beitrag gezeigt, dass Kommunikationsplattformen nicht nur genutzt werden, um die Arbeit in der Organisation zu strukturieren, sondern auch, um Unzufriedenheit und Widerspruch zu äußern. Statt Unterstützung von institutionalisierten Interessenvertretungen einzuholen, greifen Organisationsmitglieder auf digitale Plattformen zurück, vernetzen sich über diese informal und gründen alternative Repräsentationsgruppen. Damit wird die Digitalisierung zum Katalysator für Widerspruchskommunikation und für eine Vernetzung jenseits der Formalstruktur. Für Organisationen stellen solche Widerspruchsnetzwerke eine potenzielle Gefahr dar. Sie reagieren daher mit Kooptation, das heißt, sie integrieren die Netzwerke in ihre Formalstruktur, unterstützen sie so bei deren Arbeit und wenden das Problem produktiv für die beteiligten Akteure.
Algorithmisches Management jenseits der Plattformökonomie. Digitale Assistenzsysteme in Industrie und Logistik
Authors: de Paiva Lareiro Patricia 
Published: August 2024

ZusammenfassungDigitale Technologien durchziehen immer stärker unseren privaten und beruflichen Alltag. Im beruflichen Alltag können sie Arbeits- und Lernprozesse unterstützen und strukturieren, der Qualitätskontrolle dienen oder zur Überwachung und Kontrolle von Arbeitsprozessen eingesetzt werden. Unter dem Begriff des algorithmischen Managements wurde der Einsatz digitaler Technologien zur Ausübung und Ausweitung von Kontrolle im Arbeitsprozess in den Bereichen der plattformbasierten Gig- und Crowdwork vielfach kritisch diskutiert. Dieser Beitrag befasst sich mit der Frage, wie sich algorithmisches Management jenseits der Plattformökonomie gestaltet. Anhand einer Metaanalyse aktueller Forschungsergebnisse zum Einsatz digitaler Assistenzsysteme in Industrie und Logistik wird dargestellt, welche Bedeutung algorithmisches Management in stärker regulierten innerbetrieblichen Kontexten im Rahmen der Kontrolle und Steuerung von Arbeit einnimmt.