Download or read book Research Ethics Committees Data Protection and Medical Research in Europe key Issues written by Deryck Beyleveld and published by Ashgate Publishing Company. This book was released on 2006 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Research Ethics Committees Data Protection and Medical Research in European Countries written by D. Townend and published by Routledge. This book was released on 2017-05-15 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Big Data Ethics in Research written by Nicolae Sfetcu and published by MultiMedia Publishing. This book was released on with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Implementation of the Data Protection Directive in Relation to Medical Research in Europe written by D. Townend and published by Routledge. This book was released on 2017-11-28 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book ePub Ethics Protocols and Research Ethics Committees written by Dan Remenyi and published by Academic Conferences Limited. This book was released on 2011-01-01 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book draws on the work of the authors who have had direct experience with Ethics Committees and helping students comply with the requirements.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book The Data Protection Directive and Medical Research Across Europe written by D. Townend and published by Routledge. This book was released on 2017-07-05 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book GDPR Requirements for Biobanking Activities Across Europe written by Valentina Colcelli and published by Springer Nature. This book was released on 2024-01-27 with total page 627 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.
Download or read book Manual for Research Ethics Committees written by Sue Eckstein and published by Cambridge University Press. This book was released on 2003-02-20 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Acceptable Risk in Biomedical Research written by Sigmund Simonsen and published by Springer Science & Business Media. This book was released on 2012-01-04 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.
Download or read book Ethics Law and Governance of Biobanking written by Deborah Mascalzoni and published by Springer. This book was released on 2015-01-22 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Privacy Confidentiality and Health Research written by William W. Lowrance and published by Cambridge University Press. This book was released on 2012-06-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: The potential of the e-health revolution, increased data sharing, database linking, biobanks and new techniques such as geolocation and genomics to advance human health is immense. For the full potential to be realized, though, privacy and confidentiality will have to be dealt with carefully. Problematically, many conventional approaches to such pivotal matters as consent, identifiability, and safeguarding and security are inadequate. In many places, research is impeded by an overgrown thicket of laws, regulations, guidance and governance. The challenges are being heightened by the increasing use of biospecimens, and by the globalization of research in a world that has not globalized privacy protection. Drawing on examples from many developed countries and legal jurisdictions, the book critiques the issues, summarizes various ethics, policy, and legal positions (and revisions underway), describes innovative solutions, provides extensive references and suggests ways forward.
Download or read book Ethics of Research Involving Minors written by Dirk Lanzerath and published by LIT Verlag Münster. This book was released on 2018 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research involving minors is an area of controversy within medical ethics and medical law. Minors represent a vulnerable group, for whom particular protective measures are required and who should be excluded from research that does not offer the prospect of direct benefit. However, the exclusion of minors from research into disorders of relevance to their age group precludes the potential for beneficial medical advances. Furthermore, effective prevention strategies for common medical conditions with an origin in childhood and adolescence, such as mental disorders, require the delineation of those who are at increased risk. This volume considers the ethical challenges of research with minors for the researchers, but also for the involved research ethics committees. In particular, it reflects how minors can be more involved in the decision-making-processes and reports about the experiences in conducting the European multicentric research project IMAGEMEND.
Download or read book Ethics in Medical Research written by Trevor Smith and published by Cambridge University Press. This book was released on 1999-08-12 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive guide for researchers to the ethical issues raised by different kinds of biomedical research.
Download or read book Biomedical Research written by Council of Europe and published by Council of Europe. This book was released on 2004-01-01 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication, the fifth in the Ethical Eye series, contains contributions from a multidisciplinary group of authors from different countries in Europe which examine a range of ethical issues arising from the use of biomedical research. Topics discussed include: the problems of obtaining consent, standards for the selection and recruitment of participants for research, the use of placebos, clinical trials of new medicines or experimental treatments for cancer sufferers, industry-sponsored clinical trials, the internationalisation of medical research, and gender aspects. The publication looks at various international and European standards governing this field including the Helsinki Declaration of the World Medical Association, EU DIrective 2001/20 on pharmaceutical research, and the Council of Europe's Convention on Human Rights and Biomedicine.
Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Download or read book Data Privacy in European Medical Research written by Christian Dierks and published by . This book was released on 2021 with total page 1 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
