INSTITUTIONAL REVIEW BOARD : A REFERENCE GUIDE

Author by : Michele K. Russell-Einhorn
Languange Used : en
Release Date : 2001
Publisher by :

ISBN :

Description : ...

Author by : Elizabeth A. Bankert
Languange Used : en
Release Date : 2006
Publisher by : Jones & Bartlett Learning

ISBN :

Description : 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 by : Public Responsibility in Medicine & Research (PRIM&R),
Languange Used : en
Release Date : 2021-03-01
Publisher by : Jones & Bartlett Learning

ISBN :

Description : 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 by : Robert J. Amdur
Languange Used : en
Release Date : 2021-01-15
Publisher by : Jones & Bartlett Learning

ISBN :

Description : 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. This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Third Edition (ISBN: 978-1-284-18115-9) and the Study Guide that IRB members can access and refer to quickly and easily. The book has three sections: -Part 1: Background Information, containing background information on human subject research -Part 2: The Full Committee IRB Meeting, comprised of eight chapters focused on the research proposal review process....

Author by : Robert J. Amdur
Languange Used : en
Release Date : 2010-10-22
Publisher by : Jones & Bartlett Publishers

ISBN :

Description : 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 by : Robert A. Greenwald
Languange Used : en
Release Date : 2013-11-11
Publisher by : Springer Science & Business Media

ISBN :

Description : For an increasing number of hospitals and universities the institutional review board (lRB) has become a way of life. Spurred into existence by public outcries about the unethical nature of certain modern scientific experiments, the IRB represents the most visible evidence of institutional commitment to ethical review of clinical research. However, this exponential growth of IRB activities has not occurred without growing pains. Like the Environmental Protection Agency, IRBs have had to develop procedures and standards without a clear consensus as to what would be optimal for science and society. Each IRB has perforce devised its own modus operandi, subject to general principles and guidelines laid down by others but still relatively free to stipulate the details of its functioning. Thus one can applaud the general idea as well as the overall performance of IRBs without asserting that the millenium has arrived. The composition, philosophy, efficiency, responsibilities, and powers of IRBs remain topics suit able for debate. It is still possible (and appropriate) for IRB members to worry both about the propriety of their decisions and the personal costs of their service....

Author by : Simon N. Whitney
Languange Used : en
Release Date : 2015-11-02
Publisher by : Springer

ISBN :

Description : This manual will help Institutional Review Boards (IRBs) conduct ethics review that balances the major moral considerations in research with human subjects. Current challenges in the IRB environment are addressed with arguments and insights from dozens of scholars. Useful to the IRB member at any level of experience, Balanced Ethics Review provides the necessary tools needed to create a systemic blueprint for promoting the research and dissemination of scientists and scholars within the standard norms of regulation....