Download or read book Secondary Findings in Genomic Research written by and published by Academic Press. This book was released on 2020-02-29 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Secondary Findings in Genomic Research offers a single, highly accessible resource on interpreting, managing and disclosing secondary findings in genomic research. With chapters written by experts in the field, this book is the first to concisely explain the ethical and practical issues raised by secondary genomics findings for a multi and interdisciplinary audience of genomic researchers, translational scientists, clinicians, medical students, genetic counselors, ethicists, legal experts and law students, public policy specialists and regulators. Contributors from Europe, North America, and Asia effectively synthesize perspectives from a spectrum of different scientific, societal, and global contexts, and offer pragmatic approaches to a range of topics, including oversight, governance and policy surrounding secondary genomic results, criteria for identifying results for return, communication and consent, stakeholders’ attitudes and perspectives, disclosing results, and clinical, patient-centered protocols. Thoroughly addresses the scientific, ethical, practical and clinical issues raised by secondary findings resulting from genomic research, including active debate and challenges in the field Provides researchers, clinicians, regulators, and stakeholders with a holistic, interdisciplinary approach to interpreting, managing and disclosing secondary findings Brings together expert analysis from scholars across Europe, North America, and Asia representing a wide variety of scientific and societal contexts
Download or read book Secondary Findings in Genomic Research written by and published by Academic Press. This book was released on 2020-03-18 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Secondary Findings in Genomic Research offers a single, highly accessible resource on interpreting, managing and disclosing secondary findings in genomic research. With chapters written by experts in the field, this book is the first to concisely explain the ethical and practical issues raised by secondary genomics findings for a multi and interdisciplinary audience of genomic researchers, translational scientists, clinicians, medical students, genetic counselors, ethicists, legal experts and law students, public policy specialists and regulators. Contributors from Europe, North America, and Asia effectively synthesize perspectives from a spectrum of different scientific, societal, and global contexts, and offer pragmatic approaches to a range of topics, including oversight, governance and policy surrounding secondary genomic results, criteria for identifying results for return, communication and consent, stakeholders' attitudes and perspectives, disclosing results, and clinical, patient-centered protocols. Thoroughly addresses the scientific, ethical, practical and clinical issues raised by secondary findings resulting from genomic research, including active debate and challenges in the field Provides researchers, clinicians, regulators, and stakeholders with a holistic, interdisciplinary approach to interpreting, managing and disclosing secondary findings Brings together expert analysis from scholars across Europe, North America, and Asia representing a wide variety of scientific and societal contexts
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.
Download or read book Issues in Returning Individual Results from Genome Research Using Population Based Banked Specimens with a Focus on the National Health and Nutrition Examination Survey written by National Research Council and published by National Academies Press. This book was released on 2014-09-08 with total page 149 pages. Available in PDF, EPUB and Kindle. Book excerpt: Population surveys traditionally collect information from respondents about their circumstances, behaviors, attitudes, and other characteristics. In recent years, many surveys have been collecting not only questionnaire answers, but also biologic specimens such as blood samples, saliva, and buccal swabs, from which a respondent's DNA can be ascertained along with other biomarkers (e.g., the level of a certain protein in the blood). The National Health and Nutrition Examination Survey (NHANES), sponsored by the National Center for Health Statistics (NCHS), has been collecting and storing genetic specimens since 1991, and other surveys, such as the Health and Retirement Study (HRS) funded by the National Institute on Aging, have followed suit. In order to give their informed consent to participate in a survey, respondents need to know the disposition and use of their data. Will their data be used for one research project and then destroyed, or will they be archived for secondary use? Sponsors of repeated cross-sectional surveys, such as NHANES, and of longitudinal surveys that follow panels of individuals over time, such as HRS, generally want to retain data for a wide range of secondary uses, many of which are not explicitly foreseen at the time of data collection. They typically inform respondents that their data will be stored in a secure manner and may be provided to researchers with suitable protections against individual identification. The addition of biologic specimens to a survey adds complications for storing, protecting, and providing access to such data and measurements made from them. There are also questions of whether, when, and for which biologic measurements the results should be reported back to individual respondents. Recently, the cost of full genomic sequencing has plummeted, and research findings are beginning to accumulate that bear up under replication and that potentially have clinical implications for a respondent. For example, knowing that one possesses a certain gene or gene sequence might suggest that one should seek a certain kind of treatment or genetic counseling or inform one's blood relatives. Biomedical research studies, in which participants are asked to donate tissues for genetic studies and are usually told that they will not be contacted with any results, are increasingly confronting the issue of when and which DNA results to return to participants. Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey is the summary of a workshop convened in February 2013 by the Committee on National Statistics in the Division of Behavioral and Social Sciences and Education of the National Research Council. This report considers how population surveys, in particular NHANES, should implement the reporting of results from genomic research using stored specimens and address informed consent for future data collection as well as for the use of banked specimens covered by prior informed consent agreements. The report will be of interest to survey organizations that include or contemplate including the collection of biologic specimens in population surveys for storing for genetic research. The issues involved are important for advancing social, behavioral, and biomedical knowledge while appropriately respecting and protecting individual survey respondents.
Download or read book Clinical Genome Sequencing written by Aad Tibben and published by Academic Press. This book was released on 2019-04-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Genome Sequencing: Psychological Aspects thoroughly details key psychological factors to consider while implementing genome sequencing in clinical practice, taking into account the subtleties of genetic risk assessment, patient consent and best practices for sharing genomic findings. Chapter contributions from leading international researchers and practitioners cover topics ranging from the current state of genomic testing, to patient consent, patient responses to sequencing data, common uncertainties, direct-to-consumer genomics, the role of genome sequencing in precision medicine, genetic counseling and genome sequencing, genome sequencing in pediatrics, genome sequencing in prenatal testing, and ethical issues in genome sequencing. Applied clinical case studies support concept illustration, making this an invaluable, practical reference for this important and multifaceted topic area within genomic medicine.
Download or read book Assessing Genomic Sequencing Information for Health Care Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 2014-08-19 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid advances in technology have lowered the cost of sequencing an individual's genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic information in medicine. Because of the lack of evidence available for assessing variants, evaluation bodies have made only a few recommendations for the use of genetic tests in health care. For example, organizations, such as the Evaluation of Genomic Applications in Practice and Prevention working group, have sought to set standards for the kinds of evaluations needed to make population-level health decisions. However, due to insufficient evidence, it has been challenging to recommend the use of a genetic test. An additional challenge to using large-scale sequencing in the clinic is that it may uncover "secondary," or "incidental," findings - genetic variants that have been associated with a disease but that are not necessarily related to the conditions that led to the decision to use genomic testing. Furthermore, as more genetic variants are associated with diseases, new information becomes available about genomic tests performed previously, which raises issues about how and whether to return this information to physicians and patients and also about who is responsible for the information. To help develop a better understanding of how genomic information is used for healthcare decision making, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine held a workshop in Washington,DC in February 2014. Stakeholders, including clinicians, researchers, patients, and government officials, discussed the issues related to the use of genomic information in medical practice. Assessing Genomic Sequencing Information for Health Care Decision Making is the summary of that workshop. This report compares and contrasts evidence evaluation processes for different clinical indications and discusses key challenges in the evidence evaluation process.
Download or read book American Jewish Year Book 2012 written by Arnold Dashefsky and published by Springer Science & Business Media. This book was released on 2012-12-09 with total page 609 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2012 American Jewish Year Book, “The Annual Record of American Jewish Civilization,” contains major chapters on Jewish secularism (Barry Kosmin and Ariela Keysar), Canadian Jewry (Morton Weinfeld, David Koffman, and Randal Schnoor), national affairs (Ethan Felson), Jewish communal affairs (Lawrence Grossman), Jewish population in the United States (Ira Sheskin and Arnold Dashefsky), and World Jewish population (Sergio DellaPergola). These chapters provide insight into major trends in the North American and world Jewish community. The volume also acts as a resource for the American Jewish community and for academics studying that community by supplying obituaries and lists of Jewish Federations, Jewish Community Centers, national Jewish organizations, Jewish overnight camps, Jewish museums, Holocaust museums, local and national Jewish periodicals, Jewish honorees, major recent events in the American Jewish community, and academic journals, articles, websites, and books. The volume should prove useful to social scientists and historians of the American Jewish community, Jewish communal workers, the press, and others interested in American and Canadian Jews.
Download or read book Genomics in Drug Discovery and Development written by Dimitri Semizarov and published by John Wiley & Sons. This book was released on 2008-11-03 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.
Download or read book Anticipate and Communicate written by Presidential Commission for the Study of Bioethical Issues and published by CreateSpace. This book was released on 2015-03-11 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anticipate and Communicate is the Bioethics Commission's sixth major report. In this report the Bioethics Commission offers specific recommendations for the management of incidental and secondary findings in clinical, research and direct-to-consumer settings. Emerging medical technologies, changing cost structures, and evolving medical practice make the likelihood of discovering incidental and secondary findings across contexts a growing certainty. Such findings can be lifesaving, but also can lead to uncertainty and distress if they are unexpected or identify conditions for which no effective treatment is available.
Download or read book Reaping the Benefits of Genomic and Proteomic Research written by National Research Council and published by National Academies Press. This book was released on 2006-03-09 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
Download or read book Genetic Screening written by and published by National Academies. This book was released on 1975-01-01 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book New Directions in the Sociology of Aging written by Panel on New Directions in Social Demography, Social Epidemiology, and the Sociology of Aging and published by National Academies Press. This book was released on 2014-01-09 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aging of the population of the United States is occurring at a time of major economic and social changes. These economic changes include consideration of increases in the age of eligibility for Social Security and Medicare and possible changes in benefit levels. Furthermore, changes in the social context in which older individuals and families function may well affect the nature of key social relationships and institutions that define the environment for older persons. Sociology offers a knowledge base, a number of useful analytic approaches and tools, and unique theoretical perspectives that can facilitate understanding of these demographic, economic, and social changes and, to the extent possible, their causes, consequences and implications. The Future of the Sociology of Aging: An Agenda for Action evaluates the recent contributions of social demography, social epidemiology and sociology to the study of aging and identifies promising new research directions in these sub-fields. Included in this study are nine papers prepared by experts in sociology, demography, social genomics, public health, and other fields, that highlight the broad array of tools and perspectives that can provide the basis for further advancing the understanding of aging processes in ways that can inform policy. This report discusses the role of sociology in what is a wide-ranging and diverse field of study; a proposed three-dimensional conceptual model for studying social processes in aging over the life cycle; a review of existing databases, data needs and opportunities, primarily in the area of measurement of interhousehold and intergenerational transmission of resources, biomarkers and biosocial interactions; and a summary of roadblocks and bridges to transdisciplinary research that will affect the future directions of the field of sociology of aging.
Download or read book Research Involving Human Biological Materials written by United States. National Bioethics Advisory Commission and published by . This book was released on 1999 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Using Discrete Choice Experiments to Value Health and Health Care written by Mandy Ryan and published by Springer Science & Business Media. This book was released on 2007-10-23 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work takes a fresh and contemporary look at the growing interest in the development and application of discrete choice experiments (DCEs) within the field of health economics. The book comprises chapters by highly regarded academics with experience of applying DCEs in the area of health. Thus the book is relevant to post-graduate students and applied researchers with an interest in the use of DCEs for valuing health and health care and has international appeal.
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.
Download or read book Implementing and Evaluating Genomic Screening Programs in Health Care Systems written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-05-16 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of these genomics-based programs may be to identify individuals with clinically actionable variants as a way of preventing disease, providing diagnoses for patients with rare diseases, and advancing research on genetic contributions to health and disease. Of particular interest are genomics- based screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions. On November 1, 2017, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to explore the challenges and opportunities associated with integrating genomics-based screening programs into health care systems. This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access. This publication summarizes the presentations and discussions from the workshop.
Download or read book Modern Medical Genetics and Genomics written by Israel Gomy and published by BoD – Books on Demand. This book was released on 2019-12-18 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of medical genetics and genomics has been constantly revolutionized by new breakthroughs, which bring more knowledge into the etiology and help improve the health care of individuals with either rare or common diseases. Nevertheless, as technologies evolve, novel challenges emerge, both technically and ethically, so they must be prudentially addressed. Among the myriad applications of genomics in medicine, this book depicts a glimpse of the advances achieved that have been leading us to the personalized/precision medicine era.
