Legislation and Ethics of Clinical Trials in Portugal and Spain

Legislation and Ethics of Clinical Trials in Portugal and Spain PDF Author: Brigitte E. S. Jansen
Publisher: Dr Brigitte Jansen
ISBN: 3869240016
Category : Clinical trials
Languages : en
Pages : 185

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Book Description

Legislation and Ethics of Clinical Trials in Portugal and Spain

Legislation and Ethics of Clinical Trials in Portugal and Spain PDF Author: Brigitte E. S. Jansen
Publisher: Dr Brigitte Jansen
ISBN: 3869240016
Category : Clinical trials
Languages : en
Pages : 185

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Book Description


International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans PDF Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0

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Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

CIHR Best Practices for Protecting Privacy in Health Research

CIHR Best Practices for Protecting Privacy in Health Research PDF Author:
Publisher:
ISBN: 9786624105642
Category :
Languages : en
Pages :

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Book Description


GDPR and Biobanking

GDPR and Biobanking PDF Author: Jane Reichel
Publisher: Springer Nature
ISBN: 3030493881
Category : Biobanks
Languages : en
Pages : 432

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Book Description
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. .

The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe

The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe PDF Author: Nils Hoppe
Publisher: Universitätsverlag Göttingen
ISBN: 3863950313
Category : Medical
Languages : en
Pages : 183

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Book Description
"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ('Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union--an Evidence-Based Impact Analysis') to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results"--Publisher's description

International Ethical Guidelines for Biomedical Research Involving Human Subjects

International Ethical Guidelines for Biomedical Research Involving Human Subjects PDF Author: Council for International Organizations of Medical Sciences
Publisher: World Health Organization
ISBN:
Category : Law
Languages : en
Pages : 116

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Book Description
The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.

The Law and Ethics of Medical Research

The Law and Ethics of Medical Research PDF Author: Aurora Plomer
Publisher: Routledge
ISBN: 1135338337
Category : Law
Languages : en
Pages : 177

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Book Description
This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the changes in form and content of international instruments for regulating the conduct of biomedical research.

Children’s Competence to Consent

Children’s Competence to Consent PDF Author: Gary B. Melton
Publisher: Springer Science & Business Media
ISBN: 1468442899
Category : Psychology
Languages : en
Pages : 364

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Book Description


Research Handbook on EU Health Law and Policy

Research Handbook on EU Health Law and Policy PDF Author: Tamara K. Hervey
Publisher: Edward Elgar Publishing
ISBN: 1785364723
Category : Law
Languages : en
Pages : 640

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Book Description
The steady expansion of the European Union’s involvement in health over the past 20 years has been accelerated by recent events. This handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agenda(s) for the future.

Personalism and Medical Ethics

Personalism and Medical Ethics PDF Author: Paul Schotsmans
Publisher: Gompel&Svacina
ISBN: 9463714308
Category : Medical
Languages : en
Pages : 102

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Book Description
Church-ethical statements in the context of contemporary medicine often give rise to a lot of controversy and commotion. Just think of the debates about medically assisted reproduction, genetics, prenatal diagnosis, stem cell research, organ donation, palliative sedation or euthanasia. Paul Schotsmans notes that many of these statements are inspired by a well-defined ethical model, specifically the act-deontological model. He argues that a more dynamic ethical model (personalism based on Western-European value-systems) creates space for a humane integration of the new medical possibilities. With this book, he seeks to indicate how Christian faith can be an inspiration for an open-minded, humane and dynamic health care.