NIH readings on the protection of human subjects in behavioral and social science research

conference proceedings and background papers
Author: Joan E. Sieber,National Institutes of Health (U.S.). Office for Protection from Research Risks,University of Texas at Dallas
Publisher: Univ Pubns of Amer
ISBN: N.A
Category: Law
Page: 203
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Ethical Imperialism

Institutional Review Boards and the Social Sciences, 1965–2009
Author: Zachary M. Schrag
Publisher: JHU Press
ISBN: 9780801899140
Category: History
Page: 264
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This short, smart analysis will engage scholars across academia.

Advances in Experimental Social Psychology


Author: Mark P. Zanna
Publisher: Elsevier
ISBN: 0120152258
Category: Psychology
Page: 397
View: 1021
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This volume offers essays on advances in the field of experimental social psychology. Among the topics discussed are universals in the structure and content in values and the social psychology of Stanley Milgram.

The Censor's Hand

The Misregulation of Human-Subject Research
Author: Carl Schneider
Publisher: MIT Press
ISBN: 0262028913
Category: Law
Page: 296
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An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good.

Chimpanzees in Biomedical and Behavioral Research:

Assessing the Necessity
Author: Committee on the Use of Chimpanzees in Biomedical and Behavioral Research,Board on Health Sciences Policy,Board on Life Sciences,Division on Earth and Life Studies,Institute of Medicine,National Research Council
Publisher: National Academies Press
ISBN: 0309220394
Category: Science
Page: 200
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For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.

Beyond the HIPAA Privacy Rule:

Enhancing Privacy, Improving Health Through Research
Author: Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule,Board on Health Sciences Policy,Board on Health Care Services,Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category: Computers
Page: 334
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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.

Expanding Underrepresented Minority Participation:

America's Science and Technology Talent at the Crossroads
Author: Committee on Underrepresented Groups and the Expansion of the Science and Engineering Workforce Pipeline,Committee on Science, Engineering, and Public Policy,Policy and Global Affairs,National Academy of Sciences,National Academy of Engineering,Institute of Medicine
Publisher: National Academies Press
ISBN: 0309159687
Category: Education
Page: 286
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In order for the United States to maintain the global leadership and competitiveness in science and technology that are critical to achieving national goals, we must invest in research, encourage innovation, and grow a strong and talented science and technology workforce. Expanding Underrepresented Minority Participation explores the role of diversity in the science, technology, engineering and mathematics (STEM) workforce and its value in keeping America innovative and competitive. According to the book, the U.S. labor market is projected to grow faster in science and engineering than in any other sector in the coming years, making minority participation in STEM education at all levels a national priority. Expanding Underrepresented Minority Participation analyzes the rate of change and the challenges the nation currently faces in developing a strong and diverse workforce. Although minorities are the fastest growing segment of the population, they are underrepresented in the fields of science and engineering. Historically, there has been a strong connection between increasing educational attainment in the United States and the growth in and global leadership of the economy. Expanding Underrepresented Minority Participation suggests that the federal government, industry, and post-secondary institutions work collaboratively with K-12 schools and school systems to increase minority access to and demand for post-secondary STEM education and technical training. The book also identifies best practices and offers a comprehensive road map for increasing involvement of underrepresented minorities and improving the quality of their education. It offers recommendations that focus on academic and social support, institutional roles, teacher preparation, affordability and program development.

Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences


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
ISBN: 0309298091
Category: Social Science
Page: 182
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Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, this consensus report aims to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report aims to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible. The ethics of human subjects research has captured scientific and regulatory attention for half a century. To keep abreast of the universe of changes that factor into the ethical conduct of research today, the Department of Health and Human Services published an Advance Notice of Proposed Rulemaking (ANPRM) in July 2011. Recognizing that widespread technological and societal transformations have occurred in the contexts for and conduct of human research since the passage of the National Research Act of 1974, the ANPRM revisits the regulations mandated by the Act in a correspondingly comprehensive manner. Its proposals aim to modernize the Common Rule and to improve the efficiency of the work conducted under its auspices. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences identifies issues raised in the ANPRM that are critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences. For each identified issue, this report provides guidance for IRBs on techniques to address it, with specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.

Institutional Review Board: Management and Function


Author: Elizabeth A. Bankert,Robert J. Amdur
Publisher: Jones & Bartlett Learning
ISBN: 9780763730499
Category: Medical
Page: 530
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This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

And the Band Played On

Politics, People, and the AIDS Epidemic, 20th-Anniversary Edition
Author: Randy Shilts
Publisher: St. Martin's Griffin
ISBN: 9781429930390
Category: History
Page: 656
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Upon it's first publication twenty years ago, And The Band Played on was quickly recognized as a masterpiece of investigative reporting. An international bestseller, a nominee for the National Book Critics Circle Award, and made into a critically acclaimed movie, Shilts' expose revealed why AIDS was allowed to spread unchecked during the early 80's while the most trusted institutions ignored or denied the threat. One of the few true modern classics, it changed and framed how AIDS was discussed in the following years. Now republished in a special 20th Anniversary edition, And the Band Played On remains one of the essential books of our time.

Laboratory Life

The Construction of Scientific Facts
Author: Bruno Latour,Steve Woolgar
Publisher: Princeton University Press
ISBN: 1400820413
Category: Social Science
Page: 296
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This highly original work presents laboratory science in a deliberately skeptical way: as an anthropological approach to the culture of the scientist. Drawing on recent work in literary criticism, the authors study how the social world of the laboratory produces papers and other "texts,"' and how the scientific vision of reality becomes that set of statements considered, for the time being, too expensive to change. The book is based on field work done by Bruno Latour in Roger Guillemin's laboratory at the Salk Institute and provides an important link between the sociology of modern sciences and laboratory studies in the history of science.

Research Ethics in Africa

A Resource for Research Ethics Committees
Author: Mariana Kruger,Paul Ndebele,Lyn Horn
Publisher: AFRICAN SUN MeDIA
ISBN: 1920689303
Category: Science
Page: 224
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The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .

Parenting Matters

Supporting Parents of Children Ages 0-8
Author: National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Supporting the Parents of Young Children
Publisher: National Academies Press
ISBN: 0309388570
Category: Social Science
Page: 524
View: 618
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Decades of research have demonstrated that the parent-child dyad and the environment of the familyâ€"which includes all primary caregiversâ€"are at the foundation of children’s well- being and healthy development. From birth, children are learning and rely on parents and the other caregivers in their lives to protect and care for them. The impact of parents may never be greater than during the earliest years of life, when a child’s brain is rapidly developing and when nearly all of her or his experiences are created and shaped by parents and the family environment. Parents help children build and refine their knowledge and skills, charting a trajectory for their health and well-being during childhood and beyond. The experience of parenting also impacts parents themselves. For instance, parenting can enrich and give focus to parents’ lives; generate stress or calm; and create any number of emotions, including feelings of happiness, sadness, fulfillment, and anger. Parenting of young children today takes place in the context of significant ongoing developments. These include: a rapidly growing body of science on early childhood, increases in funding for programs and services for families, changing demographics of the U.S. population, and greater diversity of family structure. Additionally, parenting is increasingly being shaped by technology and increased access to information about parenting. Parenting Matters identifies parenting knowledge, attitudes, and practices associated with positive developmental outcomes in children ages 0-8; universal/preventive and targeted strategies used in a variety of settings that have been effective with parents of young children and that support the identified knowledge, attitudes, and practices; and barriers to and facilitators for parents’ use of practices that lead to healthy child outcomes as well as their participation in effective programs and services. This report makes recommendations directed at an array of stakeholders, for promoting the wide-scale adoption of effective programs and services for parents and on areas that warrant further research to inform policy and practice. It is meant to serve as a roadmap for the future of parenting policy, research, and practice in the United States.

Physical Activity and Health

A Report of the Surgeon General
Author: Audrey F. Manley
Publisher: DIANE Publishing
ISBN: 0788134965
Category:
Page: 278
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A landmark review of the research on physical activity & health -- the most comprehensive ever. Covers: historical background, terminology, evolution of recommendations & measurement; physiologic responses & long-term adaptations to exercise; the effects of physical activity on health & disease (cardiovascular disease, cancer, diabetes, osteoarthritis, osteoporosis, obesity, mental health, quality of life, adverse effects of physical activity, occurrence of adverse effects); patterns & trends in physical activity; & understanding & promoting physical activity. Charts & tables.

Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee
Publisher: National Academies Press
ISBN: 030929665X
Category: Medical
Page: 134
View: 2454
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Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.

Social experimentation


Author: Donald Thomas Campbell,M. Jean Russo
Publisher: Sage Publications, Inc
ISBN: 9780761904045
Category: Computers
Page: 407
View: 1452
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This book provides researchers, evaluators, and graduate students with a user-friendly presentation of Donald T. Campbell's essential work (including his thoughts on some of his classic works) in social experimentation. The book includes Campbell's exploration of the experimenting society and how experimentation can be used to improve society; the compatibility of quantitative and qualitative methods for validity seeking; threats to the validity of social experiments and how they can be controlled; the degree to which the social sciences can achieve scientific status; and the degree to which the operations, products, and consequences of science have a social impact. By including introductions for each part and detailed overviews to each article, Social Experimentation provides social scientists with useful insights into Campbell's papers in a format accessible to advanced undergraduate and graduate students.

Responsible Conduct of Research


Author: Adil E. Shamoo,David B. Resnik
Publisher: Oxford University Press
ISBN: 0199376042
Category: Medical
Page: 440
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Since the early 2000s, the field of Responsible Conduct of Research has become widely recognized as essential to scientific education, investigation, and training. At present, research institutions with public funding are expected to have some minimal training and education in RCR for their graduate students, fellows and trainees. These institutions also are expected to have a system in place for investigating and reporting misconduct in research or violations of regulations in research with human subjects, or in their applications to federal agencies for funding. Public scrutiny of the conduct of scientific researchers remains high. Media reports of misconduct scandals, biased research, violations of human research ethics rules, and moral controversies in research occur on a weekly basis. Since the 2009 publication of the 2nd edition of Shamoo and Resnik's Responsible Conduct of Research, there has been a vast expansion in the information, knowledge, methods, and diagnosis of problems related to RCR and the multitude of ethical issues of human subject protections. With the climate surrounding research conduct always shifting, developments in the field make an updated edition a necessity. All chapters have been revised and reflect the most current RCR landscape. New or further-developed topics include social responsibility and misconduct in social sciences, climate-change research, authorship, and peer review. Updates include new information on research involving human subjects or "vulnerable" biological subjects, as well as genetic research. Just like in previous editions, all chapters contain recent case studies and legal examples of various subjects.

The Quest for Artificial Intelligence


Author: Nils J. Nilsson
Publisher: Cambridge University Press
ISBN: 1139642820
Category: Computers
Page: N.A
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Artificial intelligence (AI) is a field within computer science that is attempting to build enhanced intelligence into computer systems. This book traces the history of the subject, from the early dreams of eighteenth-century (and earlier) pioneers to the more successful work of today's AI engineers. AI is becoming more and more a part of everyone's life. The technology is already embedded in face-recognizing cameras, speech-recognition software, Internet search engines, and health-care robots, among other applications. The book's many diagrams and easy-to-understand descriptions of AI programs will help the casual reader gain an understanding of how these and other AI systems actually work. Its thorough (but unobtrusive) end-of-chapter notes containing citations to important source materials will be of great use to AI scholars and researchers. This book promises to be the definitive history of a field that has captivated the imaginations of scientists, philosophers, and writers for centuries.

Scientific Research in Education


Author: National Research Council,Division of Behavioral and Social Sciences and Education,Center for Education,Committee on Scientific Principles for Education Research
Publisher: National Academies Press
ISBN: 9780309133098
Category: Education
Page: 204
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Researchers, historians, and philosophers of science have debated the nature of scientific research in education for more than 100 years. Recent enthusiasm for "evidence-based" policy and practice in educationâ€"now codified in the federal law that authorizes the bulk of elementary and secondary education programsâ€"have brought a new sense of urgency to understanding the ways in which the basic tenets of science manifest in the study of teaching, learning, and schooling. Scientific Research in Education describes the similarities and differences between scientific inquiry in education and scientific inquiry in other fields and disciplines and provides a number of examples to illustrate these ideas. Its main argument is that all scientific endeavors share a common set of principles, and that each fieldâ€"including education researchâ€"develops a specialization that accounts for the particulars of what is being studied. The book also provides suggestions for how the federal government can best support high-quality scientific research in education.

Guide for the Care and Use of Laboratory Animals:

Eighth Edition
Author: Committee for the Update of the Guide for the Care and Use of Laboratory Animals,Institute for Laboratory Animal Research,Division on Earth and Life Studies,National Research Council
Publisher: National Academies Press
ISBN: 0309154006
Category: Science
Page: 248
View: 8642
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A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.