Conducting Biosocial Surveys

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Conducting Biosocial Surveys

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys
Conducting Biosocial Surveys Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys
Publisher : National Academies Press
Page : 125 pages
File Size : 47,7 Mb
Release : 2010-09-02
Category : Computers
ISBN : 9780309161374

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Conducting Biosocial Surveys by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys Pdf

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.

Conducting Biosocial Surveys

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys
Conducting Biosocial Surveys Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys
Publisher : National Academies Press
Page : 124 pages
File Size : 54,8 Mb
Release : 2010-10-02
Category : Computers
ISBN : 9780309157063

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Conducting Biosocial Surveys by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on National Statistics,Panel on Collecting, Storing, Accessing, and Protecting Biological Specimens and Biodata in Social Surveys Pdf

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.

Biosocial Surveys

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys
Biosocial Surveys Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys
Publisher : National Academies Press
Page : 429 pages
File Size : 47,9 Mb
Release : 2008-01-06
Category : Social Science
ISBN : 9780309108676

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Biosocial Surveys by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys Pdf

Biosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewerâ€"respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.

Biosocial Surveys

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys
Biosocial Surveys Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys
Publisher : Unknown
Page : 428 pages
File Size : 44,8 Mb
Release : 2007-12-06
Category : Electronic
ISBN : 0309385962

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Biosocial Surveys by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys Pdf

Biosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewerâ "respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.

Research Integrity and Responsible Conduct of Research

Ann Nichols-Casebolt
Research Integrity and Responsible Conduct of Research Book PDF

Author : Ann Nichols-Casebolt
Publisher : Oxford University Press
Page : 170 pages
File Size : 55,9 Mb
Release : 2012-01-25
Category : Social Science
ISBN : 9780199703128

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Research Integrity and Responsible Conduct of Research by Ann Nichols-Casebolt Pdf

As the social work profession increasingly emphasizes scholarship and research, the education and training of faculty and students in the responsible conduct of research (RCR) becomes imperative. Research Integrity and Responsible Conduct of Research provides specific guidelines regarding the practical considerations, recommendations, and tools in the ethical and responsible practice of social work research. Using core instructional areas identified by the U.S. Office of Research Integrity, this essential guide covers data acquisition, management, sharing and ownership; conflict of interest and commitment; subjects' protection; research misconduct; publication practices and responsible authorship; mentor and mentee responsibilities; peer review; and collaborative science. For each core area, the book identifies specific issues that are relevant for social work researchers. For example, the chapter on collaborative science discusses issues related to community-based research, and the chapter on subjects' protection covers common institutional review board issues with social behavioral protocols, such as doing research "on" students. Case studies designed to enhance critical thinking about ethical dilemmas confronted by social scientists in the practice of research are also included. Drawing on research, curriculum models, and identified best practices that have been primarily developed for biomedical researchers, the book presents practical strategies for educating and promoting RCR among social scientists. With useful case studies, sample protocols, and take-home points, this is a succinct yet valuable guide to the ethical practice of research for social work students, faculty, and agency-based staff.

The Ashgate Research Companion to Biosocial Theories of Crime

Anthony Walsh
The Ashgate Research Companion to Biosocial Theories of Crime Book PDF

Author : Anthony Walsh
Publisher : Routledge
Page : 542 pages
File Size : 54,9 Mb
Release : 2016-04-01
Category : Social Science
ISBN : 9781317044048

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The Ashgate Research Companion to Biosocial Theories of Crime by Anthony Walsh Pdf

In response to exciting developments in genetics, neuroscience and evolutionary psychology, a number of criminologists have embraced the position that criminal behaviour is the product of biological, psychological, and sociological factors operating together in complex ways. They have come to realize that if they are to capture the dynamic nature of criminal behaviour then they must span multiple levels of analysis and thus multiple disciplines. The explosion of interest in this field of biosocial criminology over the past ten years means that the time is ripe for this research companion aimed at graduate students and scholars, giving them an essential overview of the current state of research in the field. The authors are experts in a variety of disciplines (sociology, psychology, biology, criminal justice, and neuroscience), but they all have in common a strong interest in criminal behaviour. This unique book is essential and accessible reading for all students and scholars in the field.

Privacy, Confidentiality, and Health Research

William W. Lowrance
Privacy Confidentiality and Health Research Book PDF

Author : William W. Lowrance
Publisher : Cambridge University Press
Page : 128 pages
File Size : 51,5 Mb
Release : 2012-06-21
Category : Law
ISBN : 9781139510820

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Privacy, Confidentiality, and Health Research by William W. Lowrance Pdf

The potential of the e-health revolution, increased data sharing, database linking, biobanks and new techniques such as geolocation and genomics to advance human health is immense. For the full potential to be realized, though, privacy and confidentiality will have to be dealt with carefully. Problematically, many conventional approaches to such pivotal matters as consent, identifiability, and safeguarding and security are inadequate. In many places, research is impeded by an overgrown thicket of laws, regulations, guidance and governance. The challenges are being heightened by the increasing use of biospecimens, and by the globalization of research in a world that has not globalized privacy protection. Drawing on examples from many developed countries and legal jurisdictions, the book critiques the issues, summarizes various ethics, policy, and legal positions (and revisions underway), describes innovative solutions, provides extensive references and suggests ways forward.

Improving Surveys with Paradata

Frauke Kreuter
Improving Surveys with Paradata Book PDF

Author : Frauke Kreuter
Publisher : John Wiley & Sons
Page : 327 pages
File Size : 49,9 Mb
Release : 2013-04-25
Category : Education
ISBN : 9781118591635

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Improving Surveys with Paradata by Frauke Kreuter Pdf

Explore the practices and cutting-edge research on the new and exciting topic of paradata Paradata are measurements related to the process of collecting survey data. Improving Surveys with Paradata: Analytic Uses of Process Information is the most accessible and comprehensive contribution to this up-and-coming area in survey methodology. Featuring contributions from leading experts in the field, Improving Surveys with Paradata: Analytic Uses of Process Information introduces and reviews issues involved in the collection and analysis of paradata. The book presents readers with an overview of the indispensable techniques and new, innovative research on improving survey quality and total survey error. Along with several case studies, topics include: Using paradata to monitor fieldwork activity in face-to-face, telephone, and web surveys Guiding intervention decisions during data collection Analysis of measurement, nonresponse, and coverage error via paradata Providing a practical, encompassing guide to the subject of paradata, the book is aimed at both producers and users of survey data. Improving Surveys with Paradata: Analytic Uses of Process The book also serves as an excellent resource for courses on data collection, survey methodology, and nonresponse and measurement error.

Sociality, Hierarchy, Health

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population
Sociality Hierarchy Health Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population
Publisher : National Academies Press
Page : 400 pages
File Size : 51,8 Mb
Release : 2014-09-16
Category : Social Science
ISBN : 9780309306645

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Sociality, Hierarchy, Health by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population Pdf

Sociality, Hierarchy, Health: Comparative Biodemography is a collection of papers that examine cross-species comparisons of social environments with a focus on social behaviors along with social hierarchies and connections, to examine their effects on health, longevity, and life histories. This report covers a broad spectrum of nonhuman animals, exploring a variety of measures of position in social hierarchies and social networks, drawing links among these factors to health outcomes and trajectories, and comparing them to those in humans. Sociality, Hierarchy, Health revisits both the theoretical underpinnings of biodemography and the empirical findings that have emerged over the past two decades.

Handbook of Theories of Aging

Dr. Vern L. Bengtson, PhD,Dr. Richard Settersten, Jr, PhD
Handbook of Theories of Aging Book PDF

Author : Dr. Vern L. Bengtson, PhD,Dr. Richard Settersten, Jr, PhD
Publisher : Springer Publishing Company
Page : 752 pages
File Size : 54,6 Mb
Release : 2016-05-28
Category : Social Science
ISBN : 9780826129437

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Handbook of Theories of Aging by Dr. Vern L. Bengtson, PhD,Dr. Richard Settersten, Jr, PhD Pdf

This state-of-the-art handbook will keep researchers and practitioners in gerontology abreast of the newest theories and models of aging. With virtually all new contributors and content, this edition contains 35 chapters by the most highly respected luminaries in the field. It addresses theories and concepts built on cumulative knowledge in four disciplinary areas- biology, psychology, social sciences, and policy and practice- as well as landmark advances in trans-disciplinary science. With its explicit focus on theory, the handbook is unique in providing essential knowledge about primary explanations for aging, spanning from cells to societies. The chapters in the third edition place a strong emphasis on the future of theory development, assessing the current state of theories and providing a roadmap for how theory can shape research, and vice versa, in years to come. Many chapters also address connections between theories and policy or practice. Each set of authors has been asked to consider how theories in their area address matters of diversity and inequalities in aging, and how theories might be revised or tested with these matters in mind. The third edition also contains a new section, "Standing on the Shoulders of Giants," which includes personal essays by senior gerontologists who share their perspectives on the history of ideas in their fields, and on their experiences with the process and prospects of developing good theory. Hallmarks of the Third Edition: Highlights important gains in trans-disciplinary theories of aging Emphasizes the future of theory development Provides insights on theory development from living legends in gerontology Examines what human diversity and inequality mean for aging theories Emphasizes interconnections between theory, research, intervention, and policy Underscores international issues with greater representation of international authors Includes section introductions by the editors and associate editors that summarize theoretical developments Key Features: Highlights variability and diversity in aging processes, from the cellular level of biological aging to the societal level of public policy Provides insights on theory development from living legends in gerontology Offers intergenerational, interdisciplinary, and international perspectives Disseminates a forward-thinking, future-oriented focus in theory development

Cells and Surveys

National Research Council,Commission on Behavioral and Social Sciences and Education,Committee on Population
Cells and Surveys Book PDF

Author : National Research Council,Commission on Behavioral and Social Sciences and Education,Committee on Population
Publisher : National Academies Press
Page : 388 pages
File Size : 45,6 Mb
Release : 2001-01-19
Category : Social Science
ISBN : 9780309171434

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Cells and Surveys by National Research Council,Commission on Behavioral and Social Sciences and Education,Committee on Population Pdf

What can social science, and demography in particular, reasonably expect to learn from biological information? There is increasing pressure for multipurpose household surveys to collect biological data along with the more familiar interviewer-respondent information. Given that recent technical developments have made it more feasible to collect biological information in non-clinical settings, those who fund, design, and analyze survey data need to think through the rationale and potential consequences. This is a concern that transcends national boundaries. Cells and Surveys addresses issues such as which biologic/genetic data should be collected in order to be most useful to a range of social scientists and whether amassing biological data has unintended side effects. The book also takes a look at the various ethical and legal concerns that such data collection entails.

Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genome Research Using Population-Based Banked Specimens
Issues in Returning Individual Results from Genome Research Using Population Based Banked Specimens with a Focus on the National Health and Nutrition Examination Survey Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genome Research Using Population-Based Banked Specimens
Publisher : National Academies Press
Page : 110 pages
File Size : 50,6 Mb
Release : 2014-09-08
Category : Social Science
ISBN : 9780309307079

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Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Steering Committee for the Workshop on Guidelines for Returning Individual Results from Genome Research Using Population-Based Banked Specimens Pdf

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.

Principles and Practices for a Federal Statistical Agency

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics
Principles and Practices for a Federal Statistical Agency Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics
Publisher : National Academies Press
Page : 179 pages
File Size : 42,9 Mb
Release : 2013-06-22
Category : Social Science
ISBN : 9780309284332

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Principles and Practices for a Federal Statistical Agency by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics Pdf

Publicly available statistics from government agencies that are credible, relevant, accurate, and timely are essential for policy makers, individuals, households, businesses, academic institutions, and other organizations to make informed decisions. Even more, the effective operation of a democratic system of government depends on the unhindered flow of statistical information to its citizens. In the United States, federal statistical agencies in cabinet departments and independent agencies are the governmental units whose principal function is to compile, analyze, and disseminate information for such statistical purposes as describing population characteristics and trends, planning and monitoring programs, and conducting research and evaluation. The work of these agencies is coordinated by the U.S. Office of Management and Budget. Statistical agencies may acquire information not only from surveys or censuses of people and organizations, but also from such sources as government administrative records, private-sector datasets, and Internet sources that are judged of suitable quality and relevance for statistical use. They may conduct analyses, but they do not advocate policies or take partisan positions. Statistical purposes for which they provide information relate to descriptions of groups and exclude any interest in or identification of an individual person, institution, or economic unit. Four principles are fundamental for a federal statistical agency: relevance to policy issues, credibility among data users, trust among data providers, and independence from political and other undue external influence. Principles and Practices for a Federal Statistical Agency: Fifth Edition explains these four principles in detail.

Principles and Practices for a Federal Statistical Agency

National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on National Statistics
Principles and Practices for a Federal Statistical Agency Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on National Statistics
Publisher : National Academies Press
Page : 219 pages
File Size : 47,8 Mb
Release : 2017-08-27
Category : Social Science
ISBN : 9780309461672

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Principles and Practices for a Federal Statistical Agency by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on National Statistics Pdf

Publicly available statistics from government agencies that are credible, relevant, accurate, and timely are essential for policy makers, individuals, households, businesses, academic institutions, and other organizations to make informed decisions. Even more, the effective operation of a democratic system of government depends on the unhindered flow of statistical information to its citizens. In the United States, federal statistical agencies in cabinet departments and independent agencies are the governmental units whose principal function is to compile, analyze, and disseminate information for such statistical purposes as describing population characteristics and trends, planning and monitoring programs, and conducting research and evaluation. The work of these agencies is coordinated by the U.S. Office of Management and Budget. Statistical agencies may acquire information not only from surveys or censuses of people and organizations, but also from such sources as government administrative records, private-sector datasets, and Internet sources that are judged of suitable quality and relevance for statistical use. They may conduct analyses, but they do not advocate policies or take partisan positions. Statistical purposes for which they provide information relate to descriptions of groups and exclude any interest in or identification of an individual person, institution, or economic unit. Four principles are fundamental for a federal statistical agency: relevance to policy issues, credibility among data users, trust among data providers, and independence from political and other undue external influence. Principles and Practices for a Federal Statistical Agency: Sixth Edition presents and comments on these principles as they've been impacted by changes in laws, regulations, and other aspects of the environment of federal statistical agencies over the past 4 years.

Proposed Revisions to the Common Rule

National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
Proposed Revisions to the Common Rule Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
Publisher : National Academies Press
Page : 110 pages
File Size : 46,8 Mb
Release : 2013-08-26
Category : Social Science
ISBN : 9780309288262

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Proposed Revisions to the Common Rule by National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences Pdf

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas: 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.