Reciprocity in Population Biobanks


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




Biobanking of Human Biospecimens


Book Description

This volume is the first comprehensive text on human biobanking, authored by scientists and regulatory officers who have led the field over the past 10 years. It covers biobanking issues and its importance in advancing the field of research in cancer, cardiovascular, metabolic, and other diseases. Biobanks of human specimens have become the cornerstone for research on human health that harnesses the power of “omics” technologies to identify biomarkers for disease susceptibility. Biobanks are an essential component of the development of personalized medicine, which relies on the molecular analysis of biospecimens that are truly representative of individuals and of diseases. Over the past decade, biobanking has been the focus of major investments and developments aimed at developing appropriate infrastructure, methods, networking practice and evidence-based pre-analytical procedures. This volume explores topics including specimen storage, protocol design, specimen collection, pre-analytical processing and preservation, long-term storage, retrieval and separation, and distribution to analytical laboratory platforms. These activities are extremely complex and are essential for biomedical and biotechnological developments and this text provides critical information about biobanking for the development of future forms of medicine.​




GDPR and Biobanking


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. .




Promoting the “Human” in Law, Policy, and Medicine


Book Description

Professor Bartha Maria Knoppers stepped down from the Canada Research Chair in Law and Medicine at McGill University in April 2024, a post she held for more than 20 years. Professor Knoppers consistently prioritized “humanity” in her academic work and in policymaking. As such, she forged a strong intellectual legacy, notably through her work on the human right to science, genomic and health-related data sharing, genome editing, human reproductive technologies, stem cell research, the rights of children, and population health. This collection of essays honours her extraordinary academic contributions to law, policy, and medicine.




Benefit Sharing


Book Description

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries.




Human Genetic Biobanks in Asia


Book Description

This volume investigates human genetic biobanking and its regulation in various countries in Asia, including Japan, the People’s Republic of China, the Republic of China, Hong Kong, India and Indonesia.




Returning Individual Research Results to Participants


Book Description

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.




Incidental Radiological Findings


Book Description

This book covers incidental radiological findings (IFs) from different perspectives, provides interesting ethical background information, highlights the differences between IFs in clinical routine and during research studies, explains the management of IFs with reference to practices in different countries. The prevalence of IFs is increasing due to the wider use of modern imaging modalities in routine clinical practice and large population-based cohort studies. The reporting of these findings may lead to further diagnostic investigations and treatment and must therefore be handled with knowledge and care. The management of IFs in clinical routine is regulated by the guidelines of the different academic societies, while management in the setting of research studies depends on a variety of factors. In general, IFs must be disclosed to the imaged subject if they are potentially clinically relevant, but subjects must also be protected from the consequences of false positive findings. This book, written by distinguished experts in their fields, discusses all these issues and will be of interest to radiologists, other clinicians, and radiographers/technicians.




The Immortal Life of Henrietta Lacks


Book Description

#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.




Molecular Epidemiology


Book Description

This book will serve as a primer for both laboratory and field scientists who are shaping the emerging field of molecular epidemiology. Molecular epidemiology utilizes the same paradigm as traditional epidemiology but uses biological markers to identify exposure, disease or susceptibility. Schulte and Perera present the epidemiologic methods pertinent to biological markers. The book is also designed to enumerate the considerations necessary for valid field research and provide a resource on the salient and subtle features of biological indicators.