Regulating Biobanks in Humans: The Use of Adult and Children Biomaterials for Clinical and Research Purposes

Elena Salvaterra (Editor)
Scientific Institute “E.Medea”, Associazione La Nostra Famiglia, Bosisio Parini, Lecco, Italy

Series: Biomaterials – Properties, Production and Devices
BISAC: MED050000

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Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick

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Human biobanks are a revolution in the field of medical sciences and technologies. As organized bioresources of samples and data providing high quality services for clinical and research applications, human biobanks are contributing to the shape of the modern realm of translational research globally. In relation to this facet, human biorepositories are raising a number of ethical, legal and social issues surrounding the use of biomaterials and related information for therapeutic or research purposes.

This book seeks to draw up the main issues related to the established and emerging human biobanks focusing on the issues of ownership, commercialization, informed consent, privacy protection and return of results. To provide a comprehensive analysis of these elements, this book proposes a reading of known as well as emerging ethical and regulatory issues related to biorepositiories, comprised of both adult and pediatric biobanks. This book includes an edition of papers addressing ethical, legal and social aspects of biobanks and news contributions related to this field. (Imprint: Novinka )

Introduction

Chapter 1 - Cord Blood Banks: Ethical, Legal and Social Aspects (pp. 1-14)
Elena Salvaterra (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Chapter 2 - Umbilical Cord Clamping Timing and Cord Blood Banking: Scientific Aspects and Ethical Issues (pp. 15-28)
Elena. Salvaterra (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Chapter 3 - Research Biobanks in Pediatrics: Ethical, Legal and Social Issues under the Lens of Health Professionals (pp. 29-46)
E. Salvaterra, R. Giorda, M. T. Bassi, R. Borgatti, L. Knudsen, A. Martinuzzi, M. Nobile, U. Pozzoli, G. P. Ramelli, G. L. Reni, D. Rivolta, M. A. Stazi, S. Strazzer, C. Thijs, V. Toccaceli, A. Trabacca, A. C. Turconi, S. Zanini, C. Zucca, N. Bresolin and L. Lenzi (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Chapter 4 - Research Biobanks: A Unified Model of Informed Consent to Collect, Store, Distribute and Use Human Biological Materials and Data from Adults (pp. 47-62)
Elena Salvaterra, Lucilla Lecchi, Silvia Giovanelli, Barbara Butti, Maria Teresa Bardella, Pier Alberto Bertazzi, Silvano Bosari, Guido Coggi, Domenico A. Coviello, Faustina Lalatta, Maurizio Moggio, Mario Nosotti, Alberto Zanella and Paolo Rebulla (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Chapter 5 - Stem Cell Banks for Research: Regulatory Trends in Europe and USA (pp. 63-78)
Elena Salvaterra (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Chapter 6 - Emerging Bio Resources: A Preliminary Analysis of Ethical and Policy Issues Related to Neonatal Bloodspot Biobanks (pp. 79-84)
Elena Salvaterra (Scientific Institute IRCCS “E. Medea”, Associazione La Nostra Famiglia, Parini, Italy)

Index

"Salvaterra et al provide an educational foundation on Ethical and legal and social (ELSI) and other regulatory issues in cord blood, stem cell, neonatal biobanking. Aggregated teachings from key collaborators in the field contribute historical perspective, detailed insight and analyses into ELSI issues germane to adult and pediatric biospecimen and clinical research." READ MORE... - Lisa B Miranda, President and Chief Executive Officer, Biobusiness Consulting Incorporated

This book could be of interest for a number of people working in the field of biobanks and including clinicians (mainly, pathologists, geneticists, biologists, biomedical engineers), medical researchers, bioethicists, lawyers, policy makers, regulatory affair specialists working in PHARMA, Ethical Commissions, Patient Advocacy Groups and Associations, Scientific associations involved in the field of basic and translational research.

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