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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.
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.
Author: Public Responsibility in Medicine & Research (PRIM&R),
Publisher: Jones & Bartlett Learning
ISBN: 1284181154
Category : Medical
Languages : en
Pages : 1113
Get Book Here
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.
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.
Author: Amy Davis
Publisher: Jones & Bartlett Publishers
ISBN: 9780763738662
Category : Ethics committees
Languages : en
Pages : 0
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Book Description
Companion book to: Institutional review board : management and function, 2nd ed. (Sudbury, Mass : Jones and Bartlett, c2006) ; first ed. by Robert J. Amdur and Elizabeth A. Bankert was published in 2002 by Jones and Bartlett (Boston, Mass.).
Author: Pramod M. Lad
Publisher:
ISBN: 9781795730549
Category : Examinations
Languages : en
Pages : 269
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Book Description
PRODUCT DESCRIPTION This study guide provides one tool for the preparation and study for the CIP examination. It is a companion book to the CIP Exam Workbook. The sequence of chapters in the study guide follows the same sequence as in the CIP exam workbook and the flow of ideas in each chapter is concordant with the sequence of questions in the workbook. It is recommended that the two books be studied together for the most effective exam preparation. The study guide is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The study material is designed to instruct on core information relevant to the examination. However it is hoped that the study guide can also function as an IRB Handbook. The study guide is therefore designed not only to prepare for the CIP examination but also to educate IRB professionals and Clinical Research Coordinators on matters which arise frequently in IRB administration. The Institutional Review Board (IRB) is responsible for the review of a wide variety of clinical research. As the complexity of clinical research has grown over the years, the duties and responsivities of the IRB have grown increasingly complex. This complex environment demands that the IRB be staffed and managed by professionals. As a part of affirming the professionalism of IRB staff, administrators and directors the Public Responsibility in Research and Medicine (PRIM&R) provides an important forum for education and affirmation of ethical standards for the performance and management of clinical research. An important component of this program is the certification exam known as the CIP (Certified IRB Professional). This examination which is offered twice a year covers a wide range of regulatory topics.The book addresses the key issues in federal regulations outlined in statutes including Title 45 part 4 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CIP exam covers material based not only on these regulations but also on guidances issued by OHRP and the FDA. Special attention has been devoted to material covered in these guidances. Also addressed are interactions of the IRB with other committees in the institutional environment.
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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Book Description
Author: John T. Finnell
Publisher: Springer Nature
ISBN: 3030937658
Category : Medical
Languages : en
Pages : 427
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Book Description
This completely updated study guide textbook is written to support the formal training required to become certified in clinical informatics. The content has been extensively overhauled to introduce and define key concepts using examples drawn from real-world experiences in order to impress upon the reader the core content from the field of clinical informatics. The book groups chapters based on the major foci of the core content: health care delivery and policy; clinical decision-making; information science and systems; data management and analytics; leadership and managing teams; and professionalism. The chapters do not need to be read or taught in order, although the suggested order is consistent with how the editors have structured their curricula over the years. Clinical Informatics Study Guide: Text and Review serves as a reference for those seeking to study for a certifying examination independently or periodically reference while in practice. This includes physicians studying for board examination in clinical informatics as well as the American Medical Informatics Association (AMIA) health informatics certification. This new edition further refines its place as a roadmap for faculty who wish to go deeper in courses designed for physician fellows or graduate students in a variety of clinically oriented informatics disciplines, such as nursing, dentistry, pharmacy, radiology, health administration and public health.
Author: Marilyn J. Hockenberry
Publisher: Elsevier Health Sciences
ISBN: 0323497748
Category : Medical
Languages : en
Pages : 297
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Book Description
Corresponding chapter by chapter to the completely reorganized and revised Wong's Nursing Care of Infants and Children, 11th Edition, this study guide helps you apply pediatric nursing concepts to real-world practice. It assesses, reinforces, and strengthens your understanding of pediatric nursing with learning activities, review questions, and case studies with critical thinking questions. Learning Key Terms — consisting of matching and fill-in-the-blank questions — test your ability to define all key terms highlighted in each textbook chapter. An answer key for the review questions and learning activities is included in the back of the study guide. Pages are perforated, so submitting assignments is easy. - Reviewing Key Concepts and Content includes questions in various formats to provide you ample opportunity to assess your knowledge and comprehension of information covered in the text. Activities include matching, fill-in-the-blank, true/false, short answer, and multiple choice to help you identify the core content of the chapter — and test your understanding upon completion of reading the chapter. - Thinking Critically case-based activities require you to apply the concepts found in the chapters to solve problems, make decisions concerning care management, and provide responses to patient questions and concerns. - Learning Key Terms consists of matching and fill-in-the-blank questions that let you test your ability to define all key terms highlighted in the corresponding textbook chapter. - An answer key is included at the end of the Study Guide. - Perforated pages allow you to submit assignments to your instructor. - NEW! Updated chapter organization and content matches revised and reorganized text.
Author: Robin Levin Penslar
Publisher: U.S. Government Printing Office
ISBN:
Category : Education
Languages : en
Pages : 518
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Book Description
2d edition. Issued in looseleaf form with index dividers and a spinelabel. Prepared under contract by Robin Levin Penslar, at IndianaUniversity, Poynter Center for the Study of Ethics and AmericanInstitutions. Includes sections on: institutional administration (ofthe Institutional Review Board, the IRB); regulations and policies;biomedical and behavioral research, an overview; special classes ofsubjects (such as fetuses, women, children, prisoners, comatosepatients, and volunteers); bibliography; glossary; texts ofinternational human rights documents (Nuremburg, Helsinki, andBelmont); lists of contacts; Federal regulations; and otherinformation.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
