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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: 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: 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: 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: 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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309071879
Category : Computers
Languages : en
Pages : 208
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Book Description
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.
Author: Mark A. Suckow
Publisher: Academic Press
ISBN: 0124200656
Category : Medical
Languages : en
Pages : 345
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Book Description
Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book
Author: Public Responsibility in Medicine & Research (PRIM&R),
Publisher: Jones & Bartlett Learning
ISBN: 1284235521
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: John Gerring
Publisher: Cambridge University Press
ISBN: 1316857808
Category : Social Science
Languages : en
Pages : 441
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Book Description
Case Study Research: Principles and Practices provides a general understanding of the case study method as well as specific tools for its successful implementation. These tools are applicable in a variety of fields including anthropology, business and management, communications, economics, education, medicine, political science, psychology, social work, and sociology. Topics include: a survey of case study approaches; a methodologically tractable definition of 'case study'; strategies for case selection, including random sampling and other algorithmic approaches; quantitative and qualitative modes of case study analysis; and problems of internal and external validity. The second edition of this core textbook is designed to be accessible to readers who are new to the subject and is thoroughly revised and updated, incorporating recent research, numerous up-to-date studies and comprehensive lecture slides.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309464870
Category : Medical
Languages : en
Pages : 171
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Book Description
The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource. Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the public's trust in the process of organ donation and transplantation.
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.
