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Behind Closed Doors

Behind Closed Doors
Author: Laura Stark
Publisher: University of Chicago Press
Total Pages: 242
Release: 2012-02
Genre: History
ISBN: 0226770869

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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.


Institutional Review Board Member Handbook

Institutional Review Board Member Handbook
Author: Robert J. Amdur
Publisher: Jones & Bartlett Publishers
Total Pages: 224
Release: 2010-10-22
Genre: Medical
ISBN: 1449609929

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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.


Advances in Patient Safety

Advances in Patient Safety
Author: Kerm Henriksen
Publisher:
Total Pages: 526
Release: 2005
Genre: Medical
ISBN:

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


The Belmont Report

The Belmont Report
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
Total Pages: 614
Release: 1978
Genre: Human experimentation in medicine
ISBN:

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Protecting Data Privacy in Health Services Research

Protecting Data Privacy in Health Services Research
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 208
Release: 2001-01-13
Genre: Computers
ISBN: 0309071879

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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.


The Ethics Police?

The Ethics Police?
Author: Robert Klitzman
Publisher: Oxford University Press, USA
Total Pages: 433
Release: 2015
Genre: Medical
ISBN: 0199364605

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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.


The IRB

The IRB
Author: Owen McGee
Publisher:
Total Pages: 400
Release: 2005
Genre: Biography & Autobiography
ISBN:

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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).


Evaluating the Science and Ethics of Research on Humans

Evaluating the Science and Ethics of Research on Humans
Author: Dennis J. Mazur
Publisher: Johns Hopkins University Press
Total Pages: 0
Release: 2007-02-05
Genre: Medical
ISBN: 9780801885020

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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.


Ethical Imperialism

Ethical Imperialism
Author: Zachary M. Schrag
Publisher: JHU Press
Total Pages: 263
Release: 2010-09-01
Genre: History
ISBN: 0801899141

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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.


Institutional Review Board

Institutional Review Board
Author: Elizabeth A. Bankert
Publisher: Jones & Bartlett Learning
Total Pages: 568
Release: 2006
Genre: Institutional review boards (Medicine)
ISBN: 9780763730499

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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.