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Author | : Laura Stark |
Publisher | : University of Chicago Press |
Total Pages | : 242 |
Release | : 2012-02 |
Genre | : History |
ISBN | : 0226770869 |
Download Behind Closed Doors Book in PDF, ePub and Kindle
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 | : Robert J. Amdur |
Publisher | : Jones & Bartlett Publishers |
Total Pages | : 224 |
Release | : 2010-10-22 |
Genre | : Medical |
ISBN | : 1449609929 |
Download Institutional Review Board Member Handbook Book in PDF, ePub and Kindle
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 | : |
Total Pages | : 526 |
Release | : 2005 |
Genre | : Medical |
ISBN | : |
Download Advances in Patient Safety Book in PDF, ePub and Kindle
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author | : Sarah Babb |
Publisher | : |
Total Pages | : 208 |
Release | : 2020 |
Genre | : Business & Economics |
ISBN | : 9781503610149 |
Download Regulating Human Research Book in PDF, ePub and Kindle
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 | : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Publisher | : |
Total Pages | : 614 |
Release | : 1978 |
Genre | : Ethics, Medical |
ISBN | : |
Download The Belmont Report Book in PDF, ePub and Kindle
Author | : Elizabeth A. Bankert |
Publisher | : Jones & Bartlett Learning |
Total Pages | : 568 |
Release | : 2006 |
Genre | : Institutional review boards (Medicine) |
ISBN | : 9780763730499 |
Download Institutional Review Board Book in PDF, ePub and Kindle
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 | : Carl E. Schneider |
Publisher | : MIT Press |
Total Pages | : 293 |
Release | : 2015-04-10 |
Genre | : Law |
ISBN | : 0262028913 |
Download The Censor's Hand Book in PDF, ePub and Kindle
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 | : Robert Klitzman |
Publisher | : Oxford University Press, USA |
Total Pages | : 433 |
Release | : 2015 |
Genre | : Medical |
ISBN | : 0199364605 |
Download The Ethics Police? Book in PDF, ePub and Kindle
Studies on humans have saved countless lives, but sometimes harm participants. Research ethics committees currently monitor scientists, but have been increasingly criticized for blocking important research. How these committees work, however, is largely unknown. This book uniquely illuminates this hidden world that ultimately affects us all.
Author | : Owen McGee |
Publisher | : |
Total Pages | : 400 |
Release | : 2005 |
Genre | : Biography & Autobiography |
ISBN | : |
Download The IRB Book in PDF, ePub and Kindle
This book analyzes the ideology and organizational traditions of the Irish Republican Brotherhood (IRB), its role in Irish politics and its place in Irish history. While the IRB has long been associated with the insurrections of 1867 and 1916, Owen McGee argues that it was never primarily an insurrectionary conspiracy; rather it was a popular fraternal organization and propagandistic body, committed to bringing about popular politicization in Ireland along republican lines. Focusing primarily on the new departures in Irish politics between the land war of 1879-81 and the outbreak of the First World War, this study identifies this period as being a critical phase in the evolution of modern Irish republicanism, as well as being the pivotal stage in the history of the IRB itself. It throws fresh light on the social and political origins of the Irish revolution of 1912-23, as well as the IRB's intended political role during that eventful epoch. Prominent members included: Michael Collins, James Stephens, Arthur Griffith, Bulkmer Hobson, Eamonn Ceannt and Edward Daly (the latter two fought in 1916 and were executed as a result of their involvement).
Author | : Dennis J. Mazur |
Publisher | : Johns Hopkins University Press |
Total Pages | : 0 |
Release | : 2007-02-05 |
Genre | : Medical |
ISBN | : 9780801885020 |
Download Evaluating the Science and Ethics of Research on Humans Book in PDF, ePub and Kindle
Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research—institutional review boards, or IRBs—is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas—drugs, medical devices, and genetic information—Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.