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Author: Bartha Knoppers
Publisher:
ISBN:
Category :
Languages : en
Pages : 8
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Book Description
Genetic research gained a new momentum with the completion of the Human Genome Project in 2003. Formerly entered on the investigation of single-genes research, genetics now targets the whole genome, its environment and the impact on genomic variation. Indeed, increasing our understanding of common disease risk and human health, population genomics draws on basic data on genomic variation and on lifestyle behaviours and environmental factors. But, the study of normal genomic variation across whole populations requires the collection of data and biological samples from individuals on a longitudinal scale. Consequently, in Canada and the rest of the world, large-scale biobanking initiatives have emerged. As for the participants in these population biobanks, they provide DNA and personal information with no individual benefit and are followed up over time through recontact and access to administrative health record systems. The benefits are systemic: better disease/health research, targeted drug delivery and improved health care programs based on an understanding of the role of the environment in the expression of genetic risk factors. However, achieving these goals requires statistical power and, in order to do so, sharing data across studies and countries is crucial. This chapter will first examine, from an international perspective, how the importance of access is reflected in different national legislation and international guidelines. Secondly, taking the example of CARTaGENE, a Quebec population biobank, we will demonstrate how the novel and complex nature of population longitudinal studies is interacting with the ethics governance surrounding access and how this uneasy, but nonetheless mandatory, relationship can sometimes risk defeating the very purpose of a resource, facilitating good science.
Author: Bartha Knoppers
Publisher:
ISBN:
Category :
Languages : en
Pages : 8
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Book Description
Genetic research gained a new momentum with the completion of the Human Genome Project in 2003. Formerly entered on the investigation of single-genes research, genetics now targets the whole genome, its environment and the impact on genomic variation. Indeed, increasing our understanding of common disease risk and human health, population genomics draws on basic data on genomic variation and on lifestyle behaviours and environmental factors. But, the study of normal genomic variation across whole populations requires the collection of data and biological samples from individuals on a longitudinal scale. Consequently, in Canada and the rest of the world, large-scale biobanking initiatives have emerged. As for the participants in these population biobanks, they provide DNA and personal information with no individual benefit and are followed up over time through recontact and access to administrative health record systems. The benefits are systemic: better disease/health research, targeted drug delivery and improved health care programs based on an understanding of the role of the environment in the expression of genetic risk factors. However, achieving these goals requires statistical power and, in order to do so, sharing data across studies and countries is crucial. This chapter will first examine, from an international perspective, how the importance of access is reflected in different national legislation and international guidelines. Secondly, taking the example of CARTaGENE, a Quebec population biobank, we will demonstrate how the novel and complex nature of population longitudinal studies is interacting with the ethics governance surrounding access and how this uneasy, but nonetheless mandatory, relationship can sometimes risk defeating the very purpose of a resource, facilitating good science.
Author: Zhengming Chen
Publisher: Springer Nature
ISBN: 9811576661
Category : Medical
Languages : en
Pages : 212
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Book Description
This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management. Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity. The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.
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. .
Author: Ma'n H. Zawati
Publisher: Academic Press
ISBN: 0323913482
Category : Medical
Languages : en
Pages : 204
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Book Description
Reciprocity in Population Biobanks: Relational Autonomy and the Duty to Inform in the Genomic Era begins by discussing how current judicial interpretation keeps standard of disclosure at the core of genomic research. The book then outlines multiple limitations individualistic autonomy faces in the context of gene and population biobanks, including an analysis of the complexities of benefit considerations in the research setting. Second, the book explores how individualistic autonomy fails to acknowledge the multilateral relationships implicated in genomic research, including those that affect the broader research community, research participants' families, and the general public. In carrying out this analysis, this book pays special attention to alternative approaches and ways researchers, public health officials, and judicial bodies might interact in years to come. In other words, implementing an understanding of relational autonomy that acknowledges and sustains the multilateral relationships found in genomic research without compromising the rights of participants. In short, this book proposes a reconceived duty to inform for researchers and a new standard of disclosure that is more meaningful and impactful for research participants and researchers. - Examines the limitations individualistic autonomy faces in the context of gene and population biobanks - Proposes a reconceived duty to inform for researchers and a new standard of disclosure more meaningful to genomic research participants - Suggests ways researchers, public health officials, and judicial bodies might interact to drive genomic research while still protecting research participants
Author: Mark Stranger
Publisher: Routledge
ISBN: 1317075889
Category : Social Science
Languages : en
Pages : 317
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Book Description
Rapid technological advances, the establishment of large-scale biobanks, and the exchange of data across international boundaries raise a variety of questions for regulators struggling with the problem of how to govern such stores of information and the processes connected with them. Engaging with the pressing issues of privacy, consent, access to data, and benefit sharing, Principles and Practice in Biobank Governance draws together the latest empirical research from the UK, Europe, America, Australia and Asia to focus on these challenges. Current models of governance are critiqued, principles and policies are debated, and new models and theoretical frameworks are presented through this intellectually stimulating, informative volume. This truly international volume offers new insights from a range of disciplinary perspectives and will be essential reading for policy makers and scholars across a range of social sciences, including sociology, bioethics, law and social policy.
Author: Ma'n H. Zawati
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Samples and data from population studies are stored for long periods of time, and can be accessed by national and international researchers to further their own studies and contribute to their understanding of the impact of a number of factors (e.g., environment, lifestyle) on common diseases and their progression. Part 2 of this Chapter discusses the nature of the researcher's duty to inform, which is the result of an individualistic conception of autonomy. Parts 3 and 4 review the restrictive conception of autonomy, and concludes that it is rooted in a unilateral approach that is incongruous with the nature of biobank genomic research. Finally, part 5 proposes that autonomy be complemented by the principle of reciprocity, which would not only create a fair and balanced relationship between researchers and participants, but would also recognize the public as a key contributor to genomic research.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309161371
Category : Computers
Languages : en
Pages : 125
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Book Description
Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.
Author: Manfred Dietel
Publisher: Springer
ISBN: 3319139576
Category : Medical
Languages : en
Pages : 134
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Book Description
This book presents an overview of the most important current developments in the pre-analytical handling of tissue. It addresses in particular potential ways to improve the situation whereby methods employed in the pre-analytical phase – the period from surgical removal of tissue to the start of pathological processing – have remained essentially unchanged for decades with only modest standardization. It is examined how the pre-analytical period can be optimized, resulting not only in an increase in diagnostic quality but also in a reduction in processing time and costs. Among the key topics examined are the so-called cold ischemia time between tissue removal and fixation, the potential superiority of vacuum-based preservation over immediate formalin fixation, two-temperature fixation, molecular analysis methods, and the pre-analytics of specimens from particular tissues. Readers will find this book to be an important update that reveals the full importance of the pre-analytical phase for quality of pathological work-up.
Author: Bartha Knoppers
Publisher:
ISBN:
Category :
Languages : en
Pages : 6
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Book Description
Nearly a decade since their creation, population biobanks have been credited for making possible large-scale human population genetics research studies looking to investigate and comprehend diseases by analyzing genetic variations and gene-environment interactions. The increase in number of both these population biobanks and the participants included therein has led to the need to harmonize where appropriate, both the approaches and the tools used, so as to be able to achieve statistical significance. In that respect, the international Public Population Project in Genomics (P3G) enables this collaborative process. Indeed, only the passage of time will determine whether the bodies put in place to direct, oversee, set conditions for access, and also report to the public (who both participates and pays for the creation of such infrastructures) actually serve as ethical safeguards or instead impede the use of biobanks for research. Examining in turn, then, the issues of governance, consent, confidentiality, and access followed by the emerging literature on return of results, recontact, reconsent, and commercialization, we will conclude with a critical examination of the future of population biobanks after a decade of their development.
Author: William H. Yong
Publisher: Humana Press
ISBN: 9781493989331
Category : Medical
Languages : en
Pages : 470
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Book Description
This volume not only discusses various common biobanking topics, it also delves into less-discussed subjects such as what is needed to start a biobank, training of new biobanking personnel, and ethnic representation in biospecimen research. Other chapters in this book span practical topics including: disaster prevention and recovery; information technology; flora and fauna preservation including zoological fluid specimen photography; surgical and autopsy biobanking; biobanking of bodily fluids; biosafety; cutting frozen sections; immunohistochemistry; nucleic acid extraction; and biospecimen shipping. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Unique and comprehensive, Biobanking: Methods and Protocols is a valuable resource for novice and practicing biobankers, and for end-user researchers. This book aims to bring new insight into the field and expand on current biomedical biobanking studies.
