Research with Human Participants in the European Union

2021 ◽  
Author(s):  
David Shaw ◽  
David Townend
Keyword(s):  
European Union ◽  
Cultural Values ◽  
Single Market ◽  
The European Union ◽  
Member States ◽  
General Data Protection Regulation ◽  
Eu Legislation ◽  
General Data ◽  
Human Participants ◽  
The Eu

This chapter examines research with human participants in the European Union. In the EU, the driving force for legislation is the creation of the single market. Research with human participants is both a response to the urgent demand to advance the health of EU citizens through the efficiencies of the single market, and to the commitment of the EU to act in accordance with the shared social and cultural values of the Member States. One might expect, therefore, that EU legislation on research with human participants would be clear, creating a harmonized framework within the single market both for internal consistency and to enhance external competitiveness. However, each of the 27 Member States of the EU operates with a large amount of independence in relation to the governance of research with human participants. The chapter then describes the EU legislation on clinical trials and considers the protection of privacy through the General Data Protection Regulation.

scholarly journals Whistleblowing systems: A systematic literature review on the design specifications and the consideration of the risk for organizational insiders to blow the whistle

2021 ◽  
Vol 18 (2) ◽  
pp. 60-73
Author(s):  
Sandra Scherbarth ◽  
Stefan Behringer
Keyword(s):  
European Union ◽  
Literature Review ◽  
Systematic Literature Review ◽  
The European Union ◽  
Member States ◽  
Eu Legislation ◽  
Design Specifications ◽  
Comprehensive Database ◽  
Data Basis ◽  
The Eu

Whistleblowing systems as internal company instruments for prevention and detection of compliance violations are increasingly recommended both in academic and practical literature. In the European Union, the discussion is currently activated by the EU legislation for better protection of whistleblowers, which needs to be transferred in national law by the member states end of 2021. This literature review examines the literature for the design specifications developed for whistleblowing systems under consideration of the risk for organizational insiders to blow the whistle. The purpose is to review the design specifications developed in scientific studies, the data basis on which they are built whether and, if so, how the risk for organizational insiders to blow the whistle is taken into account. A comprehensive database of literature has been examined. The result is systematic categorization of the specifications for the design of whistleblowing systems. Moreover, we conclude, that there is a lack of data basis for clear specifications. The research shows that in the design of whistleblowing-systems there is a lack of discussion of the risks for whistleblowers to suffer social and professional disadvantages

scholarly journals Is European Data Protection Toxic for Innovative AI? An Estonian Perspective

2021 ◽  
Vol 30 ◽  
pp. 99-110
Author(s):  
Paloma Krõõt Tupay ◽  
Martin Ebers ◽  
Jakob Juksaar ◽  
Kea Kohv
Keyword(s):  
European Union ◽  
Data Protection ◽  
Fundamental Rights ◽  
The European Union ◽  
Public Authorities ◽  
General Data Protection Regulation ◽  
Seven Principles ◽  
Socioeconomic Changes ◽  
General Data ◽  
The Eu

The General Data Protection Regulation (GDPR) is, together with its seven principles, designed to function as the cornerstone of data protection in the European Union. Although the GDPR was meant to keep up with technological and socioeconomic changes while guaranteeing fundamental rights, its unclear wording with regard to the use of artificial intelligence (AI) systems has led to uncertainty. Therefore, the development and application of ever new AI systems raises various, as yet unresolved questions. Moreover, the complexity of legal requirements poses the risk of inhibiting AI innovation in the European Union. On the other hand, the GDPR gives Member States certain leeway to regulate data processing by public authorities. Therefore, data protection requirements for AI systems in public administration must be assessed under both the GDPR and national law. Against this backdrop, the article aims to guide the reader through the relevant data-protection rules applicable to AI systems in both the EU and in Estonia.

scholarly journals Challenges ahead for the European Union

Competitio ◽  
2005 ◽  
Vol 4 (2) ◽  
pp. 7-12 ◽  
Author(s):  
Alexandre Lamfalussy
Keyword(s):  
European Union ◽  
Monetary Policy ◽  
Euro Area ◽  
Single Market ◽  
Free Movement ◽  
The European Union ◽  
Member States ◽  
The Uk ◽  
Heads Of Government ◽  
The Eu

It is a mild understatement that nowadays the EU is navigating in rough waters. Close to half of the member countries of the Euro area are in breach of their fiscal stability commitment – and some of them very substantially. Quite a few heads of government publicly criticise the ECB’s monetary policy. Germany and France are determined to water down the Bolkenstein directive on the implementation of a genuine single market for services (which amount to about two-thirds of the EU’s GDP), to which, incidentally, no major objections had been raised by the governments of the member states during the drafting stage. There is no agreement on the longer term EU budget. Only Ireland, the UK and Sweden accept the free movement of the residents of the ten countries which became members of the EU in May last year.

scholarly journals Data Protection in the EU and its Implications on Software Development outside the EU

2019 ◽  
Vol 24 (1) ◽  
pp. 1-5
Author(s):  
Ralf Kneuper
Keyword(s):  
European Union ◽  
Software Development ◽  
Data Protection ◽  
Personal Data ◽  
Software Requirements ◽  
The European Union ◽  
General Data Protection Regulation ◽  
It Systems ◽  
General Data ◽  
The Eu

In May 2018, the General Data Protection Regulation (GDPR 2016) came into effect in the European Union (EU), defining requirements on how to handle personal data of EU citizens. This report discusses the effects of this regulation on software development organisations outside the EU, and summaries the software requirements that result from GDPR and therefore apply to most information technology (IT) systems that will handle data of individuals based in the EU.

scholarly journals THE REFORM OF TRADE MARS PROTECTION IN THE EUROPEAN UNION AND IT’S IMPACT ON LEGISLATION OF UKRAINE

2016 ◽  
Vol 1 (127) ◽  
pp. 80-86
Author(s):  
Y. Kapitsa
Keyword(s):  
European Union ◽  
Trade Mark ◽  
The European Union ◽  
Industrial Property ◽  
Member States ◽  
Eu Legislation ◽  
License Agreements ◽  
Scope Of Protection ◽  
Collective Marks ◽  
The Eu

The adoption of the EU in 2015 the Directive 2015/2436 and Regulation 2015/2424 resulted in significant changes for the protection of trade marks at the level of the Member States and the EU trade mark. These changes are the result of the policy of the entire approximation of Member States laws in all issues of trademarks, which differs from the harmonization of «minimum rights» and the EU approach to harmonization of legislation on other industrial property objects. Comparison of changes to EU legislation and legislation of Ukraine demonstrates the necessity of making a number of amendments to national legislation regarding registration of scent and other non- traditional marks; clarify the scope of protection of rights; grounds for refusal of registration; concluding license agreements, protection of collective marks etc. It is essential to provide the clarification of the procedure for registration of trademarks in Ukraine to ensure compliance with the registration procedure, established by the Directive 2015/2436.

scholarly journals Data protection impact assessment in the European Union: developing a template for a report from the assessment process

2020 ◽  
Author(s):  
Dariusz Kloza ◽  
Alessandra Calvi ◽  
Simone Casiraghi ◽  
Sergi Vazquez Maymir ◽  
Nikolaos Ioannidis ◽  
...  
Keyword(s):  
European Union ◽  
Impact Assessment ◽  
Data Protection ◽  
Fundamental Rights ◽  
Assessment Process ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Use Of Resources ◽  
General Data ◽  
The Eu

This Policy Brief proposes a template for a report from a process of data protection impact assessment (DPIA) in the European Union (EU). Grounded in the previously elaborated framework (cf. Policy Brief No. 1/2017) and method for impact assessment (cf. Policy Brief No. 1/2019), the proposed template conforms to the requirements of Articles 35–36 of the General Data Protection Regulation (GDPR) and reflects best practices for impact assessment, offering at the same time five novel aspects. First, it aims at comprehensiveness to arrive at the most robust advice for decision making. Second, it aims at efficiency, that is, to produce effects with the least use of resources. Third, it aims at exploring and accommodating the perspectives of various stakeholders, although the perspective of individuals dominates; it, therefore, fosters fundamental rights thinking by, for example, requiring justification for each choice, hence going beyond a mere ‘tick-box’ exercise. Fourth, it aims at adhering to the legal design approach to guide the assessors in a practical, easy and intuitive manner throughout the 11-step assessment process, providing necessary explanations for each step, while being structured in expandable and modifiable tables and fields to fill in. Fifth, it assumes its lack of finality as it will need to be revised as experience with its use grows. The template is addressed predominantly to assessors entrusted by data controllers to perform the assessment process, yet it may also assist data protection authorities (DPA) in the EU to develop (tailored down) templates for DPIA for their own jurisdictions.

scholarly journals Case Study on the Interaction Between the General Data Protection Regulation and Artificial Intelligence Technologies

Pro Futuro ◽  
2021 ◽  
Vol 10 (4) ◽  
Author(s):  
Gizem Gültekin Várkonyi
Keyword(s):  
Artificial Intelligence ◽  
Data Protection ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Eu Legislation ◽  
Legal Questions ◽  
Rules And Principles ◽  
General Data ◽  
The Eu

This paper presents a general overview of the problems regarding the regulation of artificial intelligence (AI) raised in the official published works of the European Union (EU) and interprets these problems from the perspective of the Hungarian experts as a case study. Even though a new regulation on AI has already been proposed at the EU level, the paper evaluates specific rules and principles regarding data protection since data is the lifeblood of AI systems and the protection of such data is a fundamental right enshrined in the EU legislation via the General Data Protection Regulation (GDPR). The result of the study shows that the application of the GDPR on AI systems in an efficient and uniform way might be at stake since different outputs were generated by the experts to the same legal questions deriving from a scenario presented.

Political aspects of security of the European Union Member States

2020 ◽  
pp. 97-105
Author(s):  
Aleksandra Kusztykiewicz-Fedurek
Keyword(s):  
European Union ◽  
Negative Impact ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Political Security ◽  
New Institutions ◽  
The Stability ◽  
Key Aspects ◽  
The Eu

Political security is very often considered through the prism of individual states. In the scholar literature in-depth analyses of this kind of security are rarely encountered in the context of international entities that these countries integrate. The purpose of this article is to draw attention to key aspects of political security in the European Union (EU) Member States. The EU as a supranational organisation, gathering Member States first, ensures the stability of the EU as a whole, and secondly, it ensures that Member States respect common values and principles. Additionally, the EU institutions focus on ensuring the proper functioning of the Eurozone (also called officially “euro area” in EU regulations). Actions that may have a negative impact on the level of the EU’s political security include the boycott of establishing new institutions conducive to the peaceful coexistence and development of states. These threats seem to have a significant impact on the situation in the EU in the face of the proposed (and not accepted by Member States not belonging to the Eurogroup) Eurozone reforms concerning, inter alia, appointment of the Minister of Economy and Finance and the creation of a new institution - the European Monetary Fund.

Review by Constitutional Courts of the Obligation of National Courts of Last Instance to Refer a Preliminary Question to the Court of Justice of the EU

2015 ◽  
Vol 16 (6) ◽  
pp. 1663-1700 ◽  
Author(s):  
Clelia Lacchi
Keyword(s):  
European Union ◽  
Eu Law ◽  
The European Union ◽  
Constitutional Courts ◽  
Member States ◽  
Constitutional Review ◽  
National Courts ◽  
Court Of Justice ◽  
Judicial Remedy ◽  
The Eu

The Constitutional Courts of a number of Member States exert a constitutional review on the obligation of national courts of last instance to make a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU).Pursuant to Article 267(3) TFEU, national courts of last instance, namely courts or tribunals against whose decisions there is no judicial remedy under national law, are required to refer to the CJEU for a preliminary question related to the interpretation of the Treaties or the validity and interpretation of acts of European Union (EU) institutions. The CJEU specified the exceptions to this obligation inCILFIT. Indeed, national courts of last instance have a crucial role according to the devolution to national judges of the task of ensuring, in collaboration with the CJEU, the full application of EU law in all Member States and the judicial protection of individuals’ rights under EU law. With preliminary references as the keystone of the EU judicial system, the cooperation of national judges with the CJEU forms part of the EU constitutional structure in accordance with Article 19(1) TEU.

Core of State Sovereignty and Boundaries of European Union's Identity in the Lissabon – Urteil

2010 ◽  
Vol 11 (4) ◽  
pp. 399-418
Author(s):  
Elisabetta Lanza
Keyword(s):  
European Union ◽  
State Sovereignty ◽  
Constitutional Court ◽  
The European Union ◽  
Member States ◽  
Treaty Of Lisbon ◽  
Federal Constitutional ◽  
German Federal Constitutional Court ◽  
German Federal Constitutional ◽  
The Eu

In the 2009 judgment dealing with the Treaty of Lisbon, the German Federal Constitutional Court urges to modify a domestic statute in order to guarantee the rights of the internal rule-making power and also provides a reasoning on the role of the European Union (EU) as an international organization, the principle of sovereignty and the relations between European Institutions and Bodies and the EU Member States. According to the German Court the Treaty of Lisbon does not transform the European Union into a Federal State (Staatsverband), but into a Confederation of States (Staatenverbund). In spite of the 1993 landmark judgment, the so-called “Maastricht Urteil”, the Court steps forward and focuses also the subject-matters that necessarily have to pertain to the Member States jurisdiction, the so-called “domain reserve”. The German Federal Constitutional Court decision on the Lisbon Treaty arouses the reflection on the core of State sovereignty and on the boundaries of the EU legal system and focuses on the force of the right to vote of every citizen, the basis of democracy.Furthermore, the decision of the German Federal Constitutional Court highlights the well-known issue of the EU's identity and the balancing between EU democracy and Member State sovereignty. In the light of the German Constitutional Court statements, the present work aims to understand which could be actually the EU's identity and how could be approached “democratic deficit” of the EU.

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