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Institutional Review Board Member Handbook

2010-10-22 Medical
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Release : 2010-10-22
Genre : Medical
Kind : eBook
Book Rating : 929/5 ( reviews)

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Book Synopsis Institutional Review Board Member Handbook by : Robert J. Amdur

Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur. This book was released on 2010-10-22. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Institutional Review Board: Management and Function

2021-03-01 Medical
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Release : 2021-03-01
Genre : Medical
Kind : eBook
Book Rating : 154/5 ( reviews)

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Book Synopsis Institutional Review Board: Management and Function by : Public Responsibility in Medicine & Research (PRIM&R),

Download or read book Institutional Review Board: Management and Function written by Public Responsibility in Medicine & Research (PRIM&R),. This book was released on 2021-03-01. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Advances in Patient Safety

2005 Medical
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Release : 2005
Genre : Medical
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Advances in Patient Safety by : Kerm Henriksen

Download or read book Advances in Patient Safety written by Kerm Henriksen. This book was released on 2005. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Institutional Review Board

2006 Institutional review boards (Medicine)
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Release : 2006
Genre : Institutional review boards (Medicine)
Kind : eBook
Book Rating : 499/5 ( reviews)

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Book Synopsis Institutional Review Board by : Elizabeth A. Bankert

Download or read book Institutional Review Board written by Elizabeth A. Bankert. This book was released on 2006. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Censor's Hand

2015-04-10 Law
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Release : 2015-04-10
Genre : Law
Kind : eBook
Book Rating : 913/5 ( reviews)

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Book Synopsis The Censor's Hand by : Carl E. Schneider

Download or read book The Censor's Hand written by Carl E. Schneider. This book was released on 2015-04-10. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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