Research Ethics Committees Data Protection And Medical Research In Europe Key Issues

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 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 book draws on the work of the authors who have had direct experience with Ethics Committees and helping students comply with the requirements.

The main problems faced by scientists in working with Big Data sets, highlighting the main ethical issues, taking into account the legislation of the European Union. After a brief Introduction to Big Data, the Technology section presents specific research applications. There is an approach to the main philosophical issues in Philosophical Aspects, and Legal Aspects with specific ethical issues in the EU Regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive - General Data Protection Regulation, "GDPR"). The Ethics Issues section details the specific aspects of Big Data. After a brief section of Big Data Research, I finalize my work with the presentation of Conclusions on research ethics in working with Big Data. CONTENTS: Abstract 1. Introduction - 1.1 Definitions - 1.2 Big Data dimensions 2. Technology - 2.1 Applications - - 2.1.1 In research 3. Philosophical aspects 4. Legal aspects - 4.1 GDPR - - Stages of processing of personal data - - Principles of data processing - - Privacy policy and transparency - - Purposes of data processing - - Design and implicit confidentiality - - The (legal) paradox of Big Data 5. Ethical issues - Ethics in research - Awareness - Consent - Control - Transparency - Trust - Ownership - Surveillance and security - Digital identity - Tailored reality - De-identification - Digital inequality - Privacy 6. Big Data research Conclusions Bibliography DOI: 10.13140/RG.2.2.11054.46401

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 sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn’t only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.