The Internal Review Board

The Internal Review Board PDF Author: United States. Congress. House. Committee on Education and the Workforce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 216

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The Belmont Report

The Belmont Report PDF Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614

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Conducting the DNP Project

Conducting the DNP Project PDF Author: Denise Korniewicz, PhD, RN, FAAN
Publisher: Springer Publishing Company
ISBN: 082616837X
Category : Medical
Languages : en
Pages : 245

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Book Description
A “how-to” approach to navigating the strenuous path from DNP plan to completed project You completed your DNP proposal and have approval to proceed: What’s next? How do you move from proposal phase to conduct and complete your project? This text is the first to discuss the practical steps to implement and complete the project and will help DNP students to systematically transition from plan to action. Written by an author with extensive experience helping students with their quality improvement projects, the text educates readers on the core components of conducting the clinical scholarly project. With a focus on working effectively with clinical staff, the book addresses IRB approval; ethics; working with human subjects; project planning; collecting, analyzing, and interpreting clinical data; disseminating findings; and how to complete the project in a timely manner. It discusses interprofessional collaboration, team building, and how to debrief project participants. Examples of successful scholarly projects and recommendations for project improvement offer additional guidance, along with consideration of common problems that many students face and how to resolve them. Objectives and review questions are provided in selected chapters. Key Features: Delivers practical, step-by-step strategies for implementing and completing the DNP project Focuses on finding and effectively communicating with team members Explains how to collect, analyze, and interpret clinical data Describes how to establish protocol for working with patients Offers chapter objectives, review questions, and case studies demonstrating major content components

Handbook on Using Administrative Data for Research and Evidence-based Policy

Handbook on Using Administrative Data for Research and Evidence-based Policy PDF Author: Shawn Cole
Publisher: Abdul Latif Jameel Poverty Action Lab
ISBN: 9781736021606
Category :
Languages : en
Pages : 618

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Book Description
This Handbook intends to inform Data Providers and researchers on how to provide privacy-protected access to, handle, and analyze administrative data, and to link them with existing resources, such as a database of data use agreements (DUA) and templates. Available publicly, the Handbook will provide guidance on data access requirements and procedures, data privacy, data security, property rights, regulations for public data use, data architecture, data use and storage, cost structure and recovery, ethics and privacy-protection, making data accessible for research, and dissemination for restricted access use. The knowledge base will serve as a resource for all researchers looking to work with administrative data and for Data Providers looking to make such data available.

The Internal Review Board

The Internal Review Board PDF Author: United States. Congress. House. Committee on Education and the Workforce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 216

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Book Description


Institutional Review Board: Management and Function

Institutional Review Board: Management and Function PDF Author: Public Responsibility in Medicine & Research (PRIM&R),
Publisher: Jones & Bartlett Learning
ISBN: 1284181154
Category : Medical
Languages : en
Pages : 1113

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Book 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.

Institutional Review Board: Member Handbook

Institutional Review Board: Member Handbook PDF Author: Robert J. Amdur
Publisher: Jones & Bartlett Learning
ISBN: 128419714X
Category : Medical
Languages : en
Pages : 204

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Book 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.

Institutional Review Board

Institutional Review Board PDF Author: Elizabeth A. Bankert
Publisher: Jones & Bartlett Learning
ISBN: 9780763730499
Category : Medical
Languages : en
Pages : 568

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Book 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.

Institutional Review Board Member Handbook

Institutional Review Board Member Handbook PDF Author: Robert J. Amdur
Publisher: Jones & Bartlett Publishers
ISBN: 1449609929
Category : Medical
Languages : en
Pages : 224

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Book 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.

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation PDF Author: Gregory D. Kutz
Publisher: DIANE Publishing
ISBN: 1437916074
Category : Health & Fitness
Languages : en
Pages : 21

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Book Description
Millions of Americans enroll in clinical studies of experimental drugs and medical devices each year. The HHS and the FDA are responsible for overseeing independent institutional review boards (IRB), which review and monitor human subjects research, with the intended purpose of protecting the rights and welfare of the research subjects. Kutz investigated 3 key aspects of the IRB system: (1) the process for estab. an IRB; (2) the process through which researchers wishing to apply for fed. funding assure HHS their human subjects research activities follow ethical principles and fed. reg.; and (3) the process that medical research co. follow to get approval for conducting research on human subjects.

Institutional Review Boards, a System in Jeopardy

Institutional Review Boards, a System in Jeopardy PDF Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 184

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Book Description