Abstract: Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75–224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. ; Peer reviewed
The article is devoted to the analysis of the globalization values, namely tolerance as a necessary condition for the progressive progress of mankind in the XXI century. The research methodology is based on the complex use of general scientific and specific scientific methods: analytical, historical, and conceptual. Based on the work of S. Fedyunina, the manifestations of tolerance in the global space are described: integration of life opportunities, cultural integration; political integration. M. Walzer's scientific experience allowed to substantiate five "regimes of tolerance" in accordance with the social and state system. The difference between this phenomenon in the conditions of a multinational empire, nation state and immigrant society is shown. The notion of tolerance is distinguished from the notions of reconcilability. The study shows the difficulties in implementing absolute tolerance, which does not require any standards at all, because part of the political system is recognized as any cultural community or tradition. The necessity of overcoming psychological stereotypes that hinder tolerant attitude towards others is shown. The need for interaction of collective and personal aspects of formation of socio-cultural context of tolerance in international relations is substantiated. To do this, more attention should be paid to conceptualizing not only theoretical but also practical models of improving international policy, which will take into account both national and international processes of integration and disintegration, will take into account the history of a country, its peoples and various social groups. ; Статья посвящена анализу ценностных принципов глобализации, а именно: толерантности как необходимого условия прогрессивного развития человечества в XXI в. Методология исследования основывается на комплексном использовании общенаучных и научных методов: аналитическом, историческом, концептуальном. Основываясь на наследии С. Федюниной, описаны ипостаси терпимости в глобальном пространстве: интеграция жизненных возможностей, культурная интеграция; политическая интеграция. Научный опыт М. Уолцера позволил обосновать пять режимов толерантности в соответствии с общественно-государственного устройства. Показано различие этого парадокса в условиях многонациональной империи, государственного страны и общества иммигрантов. Разграничено понятие толерантности с понятиями терпимости. В результате исследования показаны трудности в реализации абсолютной толерантности, не предполагающей вообще никаких стандартов, ведь частью политической системы признается любое культурное сообщество или традиция. Показана необходимость преодоления психологических стереотипов мешающих толерантному отношению к другому. Обоснована потребность взаимодействия коллективного и личностного аспектов формирования социокультурного контекста толерантности в международных отношениях. Для этого нужно больше внимания уделять концептуализации не только теоретических, но и практических моделей усовершенствования международной политики, которые будут учитывать как национальные, так и межнациональные процессы интеграции и дезинтеграции, будут принимать во внимание историю конкретной страны, ее народов и различных социальных групп. ; Стаття присвячена аналізу ціннісних засад глобалізації, а саме толерантності як необхідної умови прогресивного поступу людства у ХХІ столітті. Методологія дослідження ґрунтується на комплексному використанні загальнонаукових та конкретно наукових методів: аналітичний, історичний, концептуальний. Базуючись на доробку С. Федюніної, описано іпостасі толерантності у глобальному просторі: інтеграція життєвих можливостей, культурна інтеграція; політична інтеграція. Науковий досвід М. Уолцера дозволив обґрунтувати п'ять «режимів толерантності» відповідно до суспільно-державного устрою. Показано відмінність цього феномену в умовах багатонаціональної імперії, національної держави та суспільства іммігрантів. Розмежовано поняття толерантності з поняттями терпимості. В результаті дослідження показано труднощі в реалізації абсолютної толерантності, яка не передбачає взагалі жодних стандартів, адже частиною політичної системи визнається будь-яке культурне співтовариство або традиція. Показано необхідність подолання психологічних стереотипів які заважають толерантному ставленню до іншого. Обґрунтовано потребу взаємодії колективного і особистісного аспектів формування соціокультурного контексту толерантності у міжнародних відносинах. Для провадження цього потрібно більше уваги приділяти концептуалізації не лише теоретичних, але й практичних моделей удосконалення міжнародної політики, які враховуватимуть як національні, так і міжнаціональні процеси інтеграції та дезінтеграції, будуть брати до уваги історію конкретної країни, її народів та різних соціальних груп.
"Dieser Beitrag analysiert institutionelle Wechselwirkung zwischen regionaler und globaler Integration in der internationalen Handelspolitik, indem er den kausalen Einfluss untersucht, den Nordamerikanisches Freihandelsabkommen (NAFTA) und Welthandelsorganisation (WTO) aufeinander ausüben. Konkret wird der Frage nachgegangen, wie und warum die beiden Institutionen interagieren und welche Folgen sich daraus für deren normative Entwicklung und Steuerungswirksamkeit ergeben. Zunächst wird auf Basis von Colemans 'Makro-Mikro-Makro-Modell' ein theoretischer Ansatz zur Analyse institutioneller Wechselwirkung mit Hilfe von Kausalmechanismen entwickelt Der empirische Teil analysiert vier empirische Fälle institutioneller Wechselwirkung zwischen NAFTA und WTO. Hierbei wird zweierlei ersichtlich: Erstens beruht der inter-institutionelle Einfluss zwischen NAFTA und WTO auf den Einflusslogiken Wechselwirkung durch institutionelle Bindung und Wechselwirkung durch Verhalten. Zweitens treten in Abhängigkeit von der Richtung des kausalen Einflusses zwei unterschiedliche Effekte auf: Die WTO als globale Institution erhöht die Steuerungsfähigkeit der NAFTA als regionale Institution, während die NAFTA die Steuerungsfähigkeit der WTO unterminiert." (Autorenreferat)
Der Klimawandel birgt zahlreiche Risiken für die Stabilität des Finanzsystems und für die Übertragung der Geldpolitik. Für die Europäische Zentralbank existieren ausreichende wirtschaftliche und rechtliche Gründe, um Klimarisiken und den Übergang zur Klimaneutralität stärker in die Geldpolitik zu integrieren. Die geldpolitischen Instrumente von Zentralbanken wurden nicht zur Bekämpfung des Klimawandels konzipiert, können aber so kalibriert werden, dass sie eine Umstellung der Wirtschaft auf Klimaneutralität fördern. Das mächtigste geldpolitische Instrument, die Ankäufe von Vermögenswerten, breiter einzusetzen, kann problematisch sein, da es schwierig ist, ein spezifisches Klimaziel in einen begrenzten geldpolitischen Rahmen einzupassen. Das klimapolitische Engagement könnte die Unabhängigkeit der EZB beeinträchtigen. Gleichzeitig kann es sich auch positiv auf ihre Position im globalen Finanzsystem und auf die internationale Rolle des Euro auswirken, unter anderem durch die Aktivitäten der EZB und der nationalen Zentralbanken des Eurosystems im Network for Greening the Financial System. Geldpolitisches Engagement kann in der Klimapolitik allenfalls unterstützend wirken; wichtig sind hier vor allem das Handeln der Staaten, die Bewusstseinsbildung in der Bevölkerung sowie neue Konsum- und Produktionsstandards. (Autorenreferat)
Contents of a research. To achieve the uniform and efficient application and treatment of international jurisdiction rules enshrined in the New Lugano Convention. In order to disclose these rules and evaluate whether it is ensured the efficient hearing of civil cases between Lithuania and Norway, a state member of the EFTA, investigate legal acts which are in force nowadays and research ECJ case law and national case law of Lithuania and Norway. Aim of a research. Identify the international jurisdiction rules enshrined in the New Lugano Convention and investigate whether it is ensured the efficient hearing of civil cases between Lithuania and Norway, a state member of the EFTA. Results of a research. The aim and objectives, determined at the beginning of a research, achieved: defined the concept of international jurisdiction and assessed its relation with national jurisdiction; disclosed the legal acts regulating international jurisdiction in civil cases and determined their applicability order; identified the need of adoption of the New Lugano Convention and evaluated its place between other legal acts regulating international jurisdiction in civil cases; disclosed international jurisdiction rules enshrined in the New Lugano Convention and evaluated whether there is ensured parallel acting of the provisions of this legal act and of the Brussels I bis regulation; and assessed whether the hearing of civil cases between Lithuania and Norway, a state member of the EFTA, is efficiently ensured. After the evaluation of research results, provided possible suggestions for legislation improvement (amendmens of some articles of the New Lugano Convention) and other solution for ensurement of the efficient hearing of civil cases on regulation of international jurisdiction in the New Lugano Convention.
Contents of a research. To achieve the uniform and efficient application and treatment of international jurisdiction rules enshrined in the New Lugano Convention. In order to disclose these rules and evaluate whether it is ensured the efficient hearing of civil cases between Lithuania and Norway, a state member of the EFTA, investigate legal acts which are in force nowadays and research ECJ case law and national case law of Lithuania and Norway. Aim of a research. Identify the international jurisdiction rules enshrined in the New Lugano Convention and investigate whether it is ensured the efficient hearing of civil cases between Lithuania and Norway, a state member of the EFTA. Results of a research. The aim and objectives, determined at the beginning of a research, achieved: defined the concept of international jurisdiction and assessed its relation with national jurisdiction; disclosed the legal acts regulating international jurisdiction in civil cases and determined their applicability order; identified the need of adoption of the New Lugano Convention and evaluated its place between other legal acts regulating international jurisdiction in civil cases; disclosed international jurisdiction rules enshrined in the New Lugano Convention and evaluated whether there is ensured parallel acting of the provisions of this legal act and of the Brussels I bis regulation; and assessed whether the hearing of civil cases between Lithuania and Norway, a state member of the EFTA, is efficiently ensured. After the evaluation of research results, provided possible suggestions for legislation improvement (amendmens of some articles of the New Lugano Convention) and other solution for ensurement of the efficient hearing of civil cases on regulation of international jurisdiction in the New Lugano Convention.
This booklet contains the conclusions and recommendations elaborated during the plenary sessions of the conference and the two opening adresses. The meeting was opened by an address on "Human Rights and Democracy - New Tasks in German-African Development Partnership" by the Federal Minister for Economic Cooperation and Development, Carl-Dieter Spranger. Nigerian Nobel Laureate for Literature, Wole Soyinka, followed Minister Spranger's address by delivering a keynote speech entitled "Democracy and the Cultural Apologia". (DÜI-Hff)
