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

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Author :
Publisher : Universitätsverlag Göttingen
ISBN 13 : 3863950313
Total Pages : 183 pages
Book Rating : 4.8/5 (639 download)

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Book Synopsis The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe by : Nils Hoppe

Download or read book The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe written by Nils Hoppe and published by Universitätsverlag Göttingen. This book was released on 2011 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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

Biobanks and Tissue Research

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 9400716737
Total Pages : 240 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Biobanks and Tissue Research by : Christian Lenk

Download or read book Biobanks and Tissue Research written by Christian Lenk and published by Springer Science & Business Media. This book was released on 2011-07-30 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.

Human Tissue Research

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Publisher : Oxford University Press, USA
ISBN 13 : 0199587558
Total Pages : 217 pages
Book Rating : 4.1/5 (995 download)

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Book Synopsis Human Tissue Research by : Christian Lenk

Download or read book Human Tissue Research written by Christian Lenk and published by Oxford University Press, USA. This book was released on 2011-01-27 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of human tissue for medical research and scientific progress raises many ethical and legal challenges. This multi-authored interdisciplinary text provides a fascinating insight into interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe.

GDPR and Biobanking

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Publisher : Springer Nature
ISBN 13 : 3030493881
Total Pages : 432 pages
Book Rating : 4.0/5 (34 download)

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Book Synopsis GDPR and Biobanking by : Jane Reichel

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. .

The Ethics of Research Biobanking

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Publisher : Springer Science & Business Media
ISBN 13 : 0387938729
Total Pages : 361 pages
Book Rating : 4.3/5 (879 download)

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Book Synopsis The Ethics of Research Biobanking by : Jan Helge Solbakk

Download or read book The Ethics of Research Biobanking written by Jan Helge Solbakk and published by Springer Science & Business Media. This book was released on 2009-07-31 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking, i.e. storage of biological samples or data emerging from such samples for diagnostic, therapeutic or research purposes, has been going on for decades. However, it is only since the mid 1990s that these activities have become the subject of considerable public attention, concern and debate. This shift in climate is due to several factors. The purpose of this book is to investigate some of the ethical, legal and social challenges raised by research biobanking in its different modern forms and formats. The issues raised by research biobanking in its modern form can be divided into four main clusters: how biological materials are entered into the bank; research biobanks as institutions; under what conditions researchers can access materials in the bank, and problems concerning ownership of biological materials and of intellectual property arising from such materials; and how the information is collected and stored, e.g. access-rights, disclosure, confidentiality, data security and data protection.

Biobanks and Tissue Research

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Publisher : Springer
ISBN 13 : 9789400716728
Total Pages : 238 pages
Book Rating : 4.7/5 (167 download)

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Book Synopsis Biobanks and Tissue Research by : Christian Lenk

Download or read book Biobanks and Tissue Research written by Christian Lenk and published by Springer. This book was released on 2011-07-30 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.

Human Medical Research

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Publisher : Springer Science & Business Media
ISBN 13 : 3034803893
Total Pages : 192 pages
Book Rating : 4.0/5 (348 download)

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Book Synopsis Human Medical Research by : Jan Schildmann

Download or read book Human Medical Research written by Jan Schildmann and published by Springer Science & Business Media. This book was released on 2012-03-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.

Trust in Biobanking

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Publisher : Springer Science & Business Media
ISBN 13 : 354078845X
Total Pages : 266 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Trust in Biobanking by : Peter Dabrock

Download or read book Trust in Biobanking written by Peter Dabrock and published by Springer Science & Business Media. This book was released on 2012-02-22 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanks are promising instruments of biomedical research and of transnational medicine in particular. Ethical, legal and social issues associated with biobanking, however, have recently led to a more critical view on this concept. All efforts addressing these concerns have been grounded on well-established standards of biomedical ethics such as informed consent procedures, protection of individual autonomy, benefit sharing etc. By additionally highlighting the widely neglected aspect of trust, this book aims at broadening the horizon of the ELSI-debate and thus filling a gap in current research on biobanking. The contributions of leading experts and junior researchers cover a wide field of disciplines relevant for biobanking including law, ethics, medicine, public health, social sciences, philosophy and theology.

Amniotic Membrane

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Publisher : Springer
ISBN 13 : 940179975X
Total Pages : 254 pages
Book Rating : 4.4/5 (17 download)

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Book Synopsis Amniotic Membrane by : Ana Catarina Mamede

Download or read book Amniotic Membrane written by Ana Catarina Mamede and published by Springer. This book was released on 2015-07-14 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the human amniotic membrane from its origin, characterization and medical applications, summarizing all the latest developments and findings related to this tissue with contributions from some of the leading researchers in the field. The book addresses issues for its preservation, separation and identification of amniotic membrane-derived cells, as well as the potential ethical issues involved in their use. The topic of this book is particularly pertinent for clinicians and researchers involved in the research and use of this tissue.

The Immortal Life of Henrietta Lacks

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Publisher : Crown
ISBN 13 : 0307589382
Total Pages : 386 pages
Book Rating : 4.3/5 (75 download)

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Book Synopsis The Immortal Life of Henrietta Lacks by : Rebecca Skloot

Download or read book The Immortal Life of Henrietta Lacks written by Rebecca Skloot and published by Crown. This book was released on 2010-02-02 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.

The Ethics of Medical Data Donation

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Publisher :
ISBN 13 : 9781013273506
Total Pages : 198 pages
Book Rating : 4.2/5 (735 download)

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Book Synopsis The Ethics of Medical Data Donation by : Luciano Floridi

Download or read book The Ethics of Medical Data Donation written by Luciano Floridi and published by . This book was released on 2020-10-08 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one's own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.

The Science of Citizen Science

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Publisher : Springer Nature
ISBN 13 : 3030582787
Total Pages : 520 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis The Science of Citizen Science by : Katrin Vohland

Download or read book The Science of Citizen Science written by Katrin Vohland and published by Springer Nature. This book was released on 2021 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book discusses how the involvement of citizens into scientific endeavors is expected to contribute to solve the big challenges of our time, such as climate change and the loss of biodiversity, growing inequalities within and between societies, and the sustainability turn. The field of citizen science has been growing in recent decades. Many different stakeholders from scientists to citizens and from policy makers to environmental organisations have been involved in its practice. In addition, many scientists also study citizen science as a research approach and as a way for science and society to interact and collaborate. This book provides a representation of the practices as well as scientific and societal outcomes in different disciplines. It reflects the contribution of citizen science to societal development, education, or innovation and provides and overview of the field of actors as well as on tools and guidelines. It serves as an introduction for anyone who wants to get involved in and learn more about the science of citizen science.

Returning Individual Research Results to Participants

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Publisher : National Academies Press
ISBN 13 : 0309475171
Total Pages : 399 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Returning Individual Research Results to Participants by : National Academies of Sciences, Engineering, and Medicine

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-09-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

International Ethical Guidelines for Health-Related Research Involving Humans

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Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.

The UNESCO Universal Declaration on Bioethics and Human Rights

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Publisher : UNESCO
ISBN 13 : 923104088X
Total Pages : 371 pages
Book Rating : 4.2/5 (31 download)

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Book Synopsis The UNESCO Universal Declaration on Bioethics and Human Rights by : H. ten Have

Download or read book The UNESCO Universal Declaration on Bioethics and Human Rights written by H. ten Have and published by UNESCO. This book was released on 2009-01-01 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: In October 2005, UNESCO Member States adopted by acclamation the Universal Declaration on Bioethics and Human Rights. For the first time in the history of bioethics, some 190 countries committed themselves and the international community to respect and apply fundamental ethical principles related to medicine, the life sciences and associated technologies. This publication provides a new impetus to the dissemination of the Declaration, and is part of the organisation's continuous effort to contribute to the understanding of its principles worldwide. The authors, who were almost all involved in the elaboration of the text of the Declaration, were asked to respond on each article: Why was it included? What does it mean? How can it be applied? Their responses shed light on the historical background of the text and its evolution throughout the drafting process. They also provide a reflection on its relevance to previous declarations and bioethical literature, and its potential interpretation and application in challenging and complex bioethical debates.

Eye Banking

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Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805591241
Total Pages : 150 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Eye Banking by : T. Bredehorn

Download or read book Eye Banking written by T. Bredehorn and published by Karger Medical and Scientific Publishers. This book was released on 2009-01-01 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Corneal transplantation has been performed with increasing success for more than 100 years. In the last 20 years, standards, outcomes and developments in the field of corneal transplantation and eye banking have been discussed at the annual meetings of the European Eye Bank Association (EEBA) to share and promote good practice and guarantee a high level of safety for the recipients. The EEBA standards for donor selection and eye banking provide professional advice and guidance to eye banks and corneal surgeons.This book highlights the history and development of eye banking and all significant steps including the donation, processing and distribution of corneas for transplantation. Additional contributions on the sclera, amnion and retinal pigment epithelium provide further insights into ocular surgery and the future potential for transplantation. This book contributes the essentials in eye banking activities for ophthalmologists and eye bankers as well as for regulatory and legislative authorities.

GDPR Requirements for Biobanking Activities Across Europe

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Author :
Publisher : Springer Nature
ISBN 13 : 3031429443
Total Pages : 627 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis GDPR Requirements for Biobanking Activities Across Europe by : Valentina Colcelli

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.