Download or read book Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research written by Maimuna Mendy and published by . This book was released on 2017 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking has developed at a rapid pace in recent years, initiated by the drive for personalized medicine, the need for high-quality biological resources and associated data for scientific research, and technological advancement of analytical platforms for molecular and genetic research. This book includes guidelines and recommendations for biobanks not only in high-income countries but also in low- and middle-income countries (LMICs). The recommendations are based on validated and/or evidence-based guidelines. The book also includes sections on sample sharing, ethical, legal, and social issues (ELSI), and harmonization guidelines important to support collaborative research efforts that make use of biological materials. In particular, the section on open access deals with the principles of sharing and provides recommendations for biobanks in relation to sample and data sharing, which is key to establishing research collaboration. The section on governance provides guidelines on governance structures and standard templates for biobanks for a transparent and effective running of the facilities. This book also benefits from the experience and knowledge gained by IARC from coordinating the LMICs Biobank and Cohort Building Network (BCNet) and managing an international biobank, which contains diverse collections of specimens and data drawn from studies across the world, including the EPIC (European Prospective Investigation into Cancer and Nutrition) collection.
Download or read book Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research written by International Agency for Research on Cancer and published by IARC Technical Reports. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanking has developed at a rapid pace in recent years, initiated by the drive for personalized medicine and the need for high-quality biological resources, associated data for scientific research, and technological advancement of analytical platforms for molecular and genetic research. This book includes guidelines and recommendations for biobanks not only in high-income countries but also in low- and middle-income countries (LMICs). The recommendations are based on validated and/or evidence-based guidelines. The book also includes sections on sample sharing, ethical, legal, and social issues (ELSI) and harmonization guidelines that are important in supporting the collaborative research efforts that make use of biological materials. In particular, the section on open access deals with the principles of sharing and provides recommendations for biobanks in relation to sample and data sharing, which is key to establishing research collaboration. The section on governance provides guidelines on governance structures and standard templates for biobanks for transparent and effective running of the facilities. This book also benefits from the experience and knowledge gained by IARC from coordinating the LMICs Biobank and Cohort Building Network (BCNet) and managing an international biobank, which contains diverse collections of specimens and data drawn from studies across the world, including the EPIC (European Prospective Investigation into Cancer and Nutrition) collection.
Download or read book Common Minimum Technical Standards and Protocols for Biological Resource Centres Dedicated to Cancer Research written by Elodie Caboux and published by . This book was released on 2007 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this document is limited to tissue collections not needed for diagnosis or transplantation. The present document focusses on developing recommendations towards common minimum technical standards in order to stimulate the creation, development and networking of BRCs at the international level, and, through their use, enhance and improve cancer research worldwide.
Download or read book International Network of Biological Resource Centres for Cancer Research Recommendations on Minimum Technical Standards written by Elodie Caboux and published by . This book was released on 2007-09-04 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological Resource Centres (BRCs) as defined by the Organization for Economic Co-operation and Development (OECD) are service providers and repositories of living cells as well as genomes of organisms of archived cells and tissues and of information relating to these materials (Organisation for Economic Cooperation and Development and Directorate for Science 2001). Collection annotation and use of human biospecimens are essential activities of cancer research. These processes are becoming critical in allowing patient access to molecular-based diagnosis and prognosis. BRCs need to comply with strict ethical and technical requirements and may be subject to regulation and/or legislation at various levels (institutional local or national governmental international). The aim of this document is not to replace such regulations. It is limited to tissue collections not needed for diagnosis or transplantation. The present document focuses on developing recommandations towards common minimum technical standards in order to stimulate the creation development and networking of BRCs at the international level and through their use enhance and improve cancer research worldwide. Ethical legal and regulatory standards and recommandations will be addressed in a separate document with the objective of promoting common standards while taking into account cultural and social differences among countries and states.
Download or read book OECD Best Practice Guidelines for Biological Resource Centres written by OECD and published by OECD Publishing. This book was released on 2007-03-28 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: These best practice guidelines are intended to serve as a target for the quality management of biological resource center collections. They are the result of discussions held by OECD member countries together with a number of key partner countries ...
Download or read book Molecular Epidemiology written by Paul A. Schulte and published by Academic Press. This book was released on 2012-12-02 with total page 609 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Colposcopy and Treatment of Cervical Precancer OP written by Department of Obstetrics and Gynaecology Walter Prendiville and published by . This book was released on 2017-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This colposcopy manual was developed in the context of the cervical cancer screening research studies of the International Agency for Research on Cancer (IARC) and the related technical support provided to national programs. It is thus a highly comprehensive manual, both for the training of new colposcopists and for the continuing education and reorientation of those who are more experienced. This manual offers a valuable learning resource, incorporating recent developments in the understanding of the etiology and pathogenesis of cervical intraepithelial neoplasia (CIN), as well as in colposcopy and cervical pathology. Expertise in performing satisfactory, safe, and accurate colposcopic examinations requires high competence in the technical, interpretive, and cognitive aspects, and the capability to develop pragmatic and effective management plans and treatment. This comprehensive and concise manual covers all these aspects and serves as a useful handbook for acquiring the necessary skills for the visual recognition and interpretation of colposcopic findings and for developing the personal and professional attributes required for competence in colposcopy.
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.
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 2018-08-23 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.
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.
Download or read book Biobanking of Human Biospecimens written by Pierre Hainaut and published by Springer. This book was released on 2017-06-06 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
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. .
Download or read book Biobanking written by William H. Yong and published by Humana Press. This book was released on 2018-12-14 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
