Institutional Review Board

Author : Robert J. Amdur,Elizabeth A. Bankert
Publisher : Jones & Bartlett Publishers
Page : 224 pages
File Size : 46,5 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9781449609924

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Institutional Review Board Member Handbook by Robert J. Amdur,Elizabeth A. Bankert Pdf

The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.

Author : Kerm Henriksen
Publisher : Unknown
Page : 526 pages
File Size : 47,6 Mb
Release : 2005
Category : Medical
ISBN : CHI:70548902

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Advances in Patient Safety by Kerm Henriksen Pdf

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Author : Carl E. Schneider
Publisher : MIT Press
Page : 293 pages
File Size : 49,6 Mb
Release : 2015-04-10
Category : Law
ISBN : 9780262028912

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The Censor's Hand by Carl E. Schneider Pdf

An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good. Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called “institutional review boards” (IRBs). Do—can—these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience—the law's learning about regulation—and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging—universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.

Author : Public Responsibility in Medicine & Research (PRIM&R),,Elizabeth A. Bankert,Bruce G. Gordon,Elisa A. Hurley
Publisher : Jones & Bartlett Learning
Page : 1113 pages
File Size : 42,5 Mb
Release : 2021-03-01
Category : Medical
ISBN : 9781284181159

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Institutional Review Board: Management and Function by Public Responsibility in Medicine & Research (PRIM&R),,Elizabeth A. Bankert,Bruce G. Gordon,Elisa A. Hurley Pdf

Institutional Review Board (IRB) members and oversight personnel face challenges with research involving new technology, management of big data, globalization of research, and more complex federal regulations. Institutional Review Board: Management and Function, Third Edition provides everything IRBs and administrators need to know about efficiently managing and effectively operating a modern and compliant system of protecting human research subjects. This trusted reference manual has been extensively updated to reflect the 2018 revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). An essential resource for both seasoned and novice IRB administrators and members, Institutional Review Board: Management and Function provides comprehensive and understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical step-by-step guidance for effectively implementing regulatory oversight.

Author : Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection
Publisher : National Academies Press
Page : 208 pages
File Size : 47,9 Mb
Release : 2001-01-13
Category : Computers
ISBN : 9780309071871

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Protecting Data Privacy in Health Services Research by Institute of Medicine,Division of Health Care Services,Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection Pdf

The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.

Author : Sarah Babb
Publisher : Unknown
Page : 208 pages
File Size : 40,8 Mb
Release : 2020
Category : Business & Economics
ISBN : 1503611221

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Regulating Human Research by Sarah Babb Pdf

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.

Author : Elizabeth A. Bankert,Robert J. Amdur
Publisher : Jones & Bartlett Learning
Page : 568 pages
File Size : 42,6 Mb
Release : 2006
Category : Institutional review boards (Medicine)
ISBN : 0763730491

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Institutional Review Board by Elizabeth A. Bankert,Robert J. Amdur Pdf

This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. The updated Second Edition includes seven new chapters: IRB Closure of Study Files, Internet Research, Research in Public Schools, Phase I Clinical Trials in Healthy Volunteers, Vulnerability in Research, Balancing the Risks and Potential Benefits,and HIPAA.

Author : Mariana Kruger,Paul Ndebele,Lyn Horn
Publisher : AFRICAN SUN MeDIA
Page : 224 pages
File Size : 50,5 Mb
Release : 2014-06-01
Category : Science
ISBN : 9781920689308

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Research Ethics in Africa by Mariana Kruger,Paul Ndebele,Lyn Horn Pdf

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 .

Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 84 pages
File Size : 52,6 Mb
Release : 1984
Category : Electronic
ISBN : MINN:319510029207547

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IRB Information Sheet by United States. Food and Drug Administration Pdf

Author : Laura Stark
Publisher : University of Chicago Press
Page : 242 pages
File Size : 54,5 Mb
Release : 2012-02
Category : History
ISBN : 9780226770864

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Behind Closed Doors by Laura Stark Pdf

Drwaing on extensive archival sources, Laura Stark reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working - and 'warring' - on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects.

Author : Zachary M. Schrag
Publisher : JHU Press
Page : 263 pages
File Size : 42,5 Mb
Release : 2010-09-01
Category : History
ISBN : 9780801899140

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Ethical Imperialism by Zachary M. Schrag Pdf

A powerful indictment of the IRB regime. University researchers in the United States seeking to observe, survey, or interview people are required first to complete ethical training courses and to submit their proposals to an institutional review board (IRB). Under current rules, IRBs have the power to deny funding, degrees, or promotion if their recommended modifications to scholars’ proposals are not followed. This volume explains how this system of regulation arose and discusses its chilling effects on research in the social sciences and humanities. Zachary M. Schrag draws on original research and interviews with the key shapers of the institutional review board regime to raise important points about the effect of the IRB process on scholarship. He explores the origins and the application of these regulations and analyzes how the rules—initially crafted to protect the health and privacy of the human subjects of medical experiments—can limit even casual scholarly interactions such as a humanist interviewing a poet about his or her writing. In assessing the issue, Schrag argues that biomedical researchers and bioethicists repeatedly excluded social scientists from rule making and ignored the existing ethical traditions in nonmedical fields. Ultimately, he contends, IRBs not only threaten to polarize medical and social scientists, they also create an atmosphere wherein certain types of academics can impede and even silence others. The first work to document the troubled emergence of today's system of regulating scholarly research, Ethical Imperialism illuminates the problems caused by simple, universal rule making in academic and professional research. This short, smart analysis will engage scholars across academia.

Author : Frank E. Ritter,Jong W. Kim,Jonathan H. Morgan,Richard A. Carlson
Publisher : SAGE
Page : 209 pages
File Size : 41,9 Mb
Release : 2013
Category : Psychology
ISBN : 9781452217420

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Running Behavioral Studies With Human Participants by Frank E. Ritter,Jong W. Kim,Jonathan H. Morgan,Richard A. Carlson Pdf

A practical, concrete road map to running research studies with human subjects. Covering both conceptual and practical issues critical to implementing a study with human participants, this book is organized to follow the standard process in experiment-based research, covering such issues as potential ethical problems, risks to validity, experimental setup, running a study, and concluding a study. The detailed guidance on each step of a study is ideal for anyone who has had little or no previous practical training in research methodology. The book's examples and sample forms are drawn from areas such as cognitive psychology, human factors, human-computer interaction, and human-robotic interaction. Key Features A coherent view of how to implement the experimental process, including detailed discussions of the setup and running of behavioral studies, gives you a practical guide for implementing your own experiments. Concrete examples speak to the diverse needs of the HCl, human factors, cognitive science, and related communities. Practical coverage of risks and problems that can be anticipated and avoided helps you recognize the ethical challenges you might encounter during the course of designing, running, or concluding a study. Three running example scenarios drawn from industrial and academic settings help you understand the major themes of each chapter. Example forms provide you with models you can use as you create your own experimental documents (such as IRB applications, experimental scripts, consent forms, and room layouts) to meet your particular research needs. Practical advice and examples of challenges associated with experimental setup and execution (such as how to set up experimental rooms, manage late or missing participants, and devise an effective experimental script) humanize key points in a memorable way, helping you recall the major points of the book. Built-in learning aids include further readings, an appendix on running studies online, questions at the end of each chapter, and publication paths and types that encourage you to take ownership of the research process and engage in research in a directed and methodical way. Book jacket.

Author : Robin Levin Penslar
Publisher : U.S. Government Printing Office
Page : 486 pages
File Size : 49,7 Mb
Release : 1993
Category : Body, Human
ISBN : PURD:32754063100964

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Protecting Human Research Subjects by Robin Levin Penslar Pdf

2d edition. Issued in looseleaf form with index dividers and a spinelabel. Prepared under contract by Robin Levin Penslar, at IndianaUniversity, Poynter Center for the Study of Ethics and AmericanInstitutions. Includes sections on: institutional administration (ofthe Institutional Review Board, the IRB); regulations and policies;biomedical and behavioral research, an overview; special classes ofsubjects (such as fetuses, women, children, prisoners, comatosepatients, and volunteers); bibliography; glossary; texts ofinternational human rights documents (Nuremburg, Helsinki, andBelmont); lists of contacts; Federal regulations; and otherinformation.

Author : J. C. Barnes,David R. Forde
Publisher : John Wiley & Sons
Page : 967 pages
File Size : 48,7 Mb
Release : 2021-09-08
Category : Social Science
ISBN : 9781119110729

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The Encyclopedia of Research Methods in Criminology and Criminal Justice, 2 Volume Set by J. C. Barnes,David R. Forde Pdf

The Encyclopedia of RESEARCH METHODS IN CRIMINOLOGY & CRIMINAL JUSTICE The most comprehensive reference work on research designs and methods in criminology and criminal justice This Encyclopedia of Research Methods in Criminology and Criminal Justice offers a comprehensive survey of research methodologies and statistical techniques that are popular in criminology and criminal justice systems across the globe. With contributions from leading scholars and practitioners in the field, it offers a clear insight into the techniques that are currently in use to answer the pressing questions in criminology and criminal justice. The Encyclopedia contains essential information from a diverse pool of authors about research designs grounded in both qualitative and quantitative approaches. It includes information on popular datasets and leading resources of government statistics. In addition, the contributors cover a wide range of topics such as: the most current research on the link between guns and crime, rational choice theory, and the use of technology like geospatial mapping as a crime reduction tool. This invaluable reference work: Offers a comprehensive survey of international research designs, methods, and statistical techniques Includes contributions from leading figures in the field Contains data on criminology and criminal justice from Cambridge to Chicago Presents information on capital punishment, domestic violence, crime science, and much more Helps us to better understand, explain, and prevent crime Written for undergraduate students, graduate students, and researchers, The Encyclopedia of Research Methods in Criminology and Criminal Justice is the first reference work of its kind to offer a comprehensive review of this important topic.

Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller
Publisher : OUP USA
Page : 848 pages
File Size : 40,5 Mb
Release : 2011-02
Category : Medical
ISBN : 9780199768639

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The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Pdf

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.