Implementation Of The Data Protection Directive In Relation To Medical Research In Europe

The Data Protection and Medical Research in Europe: PRIVIREAL series focuses on the 'Privacy in Research Ethics and Law' EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the first stage of this project concerning the implementation of the Data Protection Directive, in particular in the area of medical research. It contains reports from 26 European countries on the implementation of the Directive, or the data protection regime, all with a specific focus on issues and questions relating to medical research. Presenting a unique resource for all those involved in data protection, medical research and their implications for each other, this title provides a valuable insight into the actual workings across Europe, including both the New Member States and the Newly Associated Member States.

The Data Protection and Medical Research in Europe: PRIVIREAL series focuses on the 'Privacy in Research Ethics and Law' EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the first stage of the project regarding the implementation of the Data Protection Directive, in particular in the area of medical research. It contains an introduction and overview of this topic, keynote papers addressing specific questions on the subject, and a report on both the general implementation of the Directive and the implementation in relation to medical research in 26 European countries. The book will be invaluable for those people with an interest in data protection, medical research and their implications for each other. It lays open the actual situation across Europe, including both New Member States and Newly Associated Member States.

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of this EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the second stage of this project and is concerned with the setting up and role of research ethics committees. It assesses their legal responsibilities, especially with regard to data protection matters and contains reports from more than 20 European countries on these issues. Focusing on the theoretical role and practical operation of research ethics committees and the impact of relevant international and national instruments, this volume will be an essential resource for all those concerned with data protection issues in medical research.

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of the EC-funded project, examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the second stage of this project, and is concerned with the role of research ethics committees across Europe in ensuring that participants in medical research gain the protection of the Directive. The work examines the specific provision of each Member State. It provides an overview of the European position through a comparative analysis of the domestic positions, and through a series of papers addressing key issues in the area. This book presents a valuable guide to the role and operation of research ethics committees and will be essential reading for all those involved with data protection issues in medical research.

The Data Protection and Medical Research in Europe: PRIVIREAL series focuses on the 'Privacy in Research Ethics and Law' EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the first stage of the project regarding the implementation of the Data Protection Directive, in particular in the area of medical research. It contains an introduction and overview of this topic, keynote papers addressing specific questions on the subject, and a report on both the general implementation of the Directive and the implementation in relation to medical research in 26 European countries. The book will be invaluable for those people with an interest in data protection, medical research and their implications for each other. It lays open the actual situation across Europe, including both New Member States and Newly Associated Member States.

Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.

The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects. The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data. A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design.