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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.
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.
Population surveys collect information from participants by asking questions. Today, many surveys also collect biologic specimens that can be used to analyze a respondents DNA and other biomarkers. The National Health and Nutrition Examination Survey (NHANES) is a population survey that also administers a physical examination, collects biospecimens, and reports some test results (e.g., cholesterol levels) to the participant. While visiting communities large and small throughout the country, NHANES collects health and nutrition data from a representative sample of individuals through in-person interviews and health examinations that take place at special mobile examination centers. The examination component consists of medical, dental, and physiological examinations, as well as laboratory tests. On December 2, 7, and 8, 2022, a workshop was convened to focus on anticipated future collections of genomic data by NHANES. The 2022 workshop explored ethical considerations and current practices for returning genomic information from active research and population surveys. This Proceedings of a Workshop summarizes the presentations and discussions at the workshop.
In March 2008, the Committee on National Statistics of the National Academies held a workshop to assist the Bureau of Economic Analysis (BEA) with next steps as it develops plans to produce a satellite health care account. This account, designed to improve its measurement of economic activity in the medical care sector, will benefit health care policy. The purpose of the workshop, summarized in this volume, was to elicit expert guidance on strategies to implement the objectives of the BEA program. The ultimate objectives of the program are to: compile medical care spending information by type of disease-a system more directly useful for measuring health care inputs, outputs, and productivity than current estimates of spending by type of provider; produce a comprehensive set of accounts for health care-sector income, expenditure, and product; develop medical care price and real output measures that will help analysts to break out changes in the delivery of health care from changes in the prices of that care; and coordinate BEA and Centers for Medicare and Medicaid Services (CMS) health expenditure statistics.
Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
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.
This book assesses the scientific value and merit of research on human genetic differencesâ€"including a collection of DNA samples that represents the whole of human genetic diversityâ€"and the ethical, organizational, and policy issues surrounding such research. Evaluating Human Genetic Diversity discusses the potential uses of such collection, such as providing insight into human evolution and origins and serving as a springboard for important medical research. It also addresses issues of confidentiality and individual privacy for participants in genetic diversity research studies.
The first book devoted exclusively to the principles and practice of genetic counseling—now in a new edition First published in 1998, A Guide to Genetic Counseling quickly became a bestselling and widely recognized text, used nationally and internationally in genetic counseling training programs. Now in its eagerly anticipated Second Edition, it provides a thoroughly revised and comprehensive overview of genetic counseling, focusing on the components, theoretical framework, and unique approach to patient care that are the basis of this profession. The book defines the core competencies and covers the genetic counseling process from case initiation to completion—in addition to addressing global professional issues—with an emphasis on describing fundamental principles and practices. Chapters are written by leaders in the field of genetic counseling and are organized to facilitate academic instruction and skill attainment. They provide the most up-to-date coverage of: The history and practice of genetic counseling Family history Interviewing Case preparation and management Psychosocial counseling Patient education Risk communication and decision-making Medical genetics evaluation Understanding genetic testing Medical documentation Multicultural counseling Ethical and legal issues Student supervision Genetic counseling research Professional development Genetics education and outreach Evolving roles and expanding opportunities Case examples A Guide to Genetic Counseling, Second Edition belongs on the syllabi of all medical and human genetics and genetic counseling training programs. It is an indispensable reference for both students and healthcare professionals working with patients who have or are at risk for genetic conditions.