Institutional Review Board Management And Function
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Author | : Public Responsibility in Medicine & Research (PRIM&R), |
Publisher | : Jones & Bartlett Learning |
Total Pages | : 1113 |
Release | : 2021-03-01 |
Genre | : Medical |
ISBN | : 1284181154 |
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 |
Total Pages | : 568 |
Release | : 2006 |
Genre | : Institutional review boards (Medicine) |
ISBN | : 9780763730499 |
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 Learning |
Total Pages | : 130 |
Release | : 2021-01-15 |
Genre | : Medical |
ISBN | : 1284233634 |
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 | : Kerm Henriksen |
Publisher | : |
Total Pages | : 526 |
Release | : 2005 |
Genre | : Medical |
ISBN | : |
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author | : Public Responsibility in Medicine & Research (Prim&r) |
Publisher | : |
Total Pages | : |
Release | : 2021-03-08 |
Genre | : |
ISBN | : 9781284236071 |
This best value bundle includes the printed book, Institutional Review Board: Management and Function, Third Edition, and an access code for Navigate TestPrep: Institutional Review Board: Management and Function Study Guide. Navigate TestPrep: Institutional Review Board: Management and Function Study Guide is a unique digital-only resource featuring numerous multiple-choice questions about the IRB rules and regulations as presented in the printed book. NOTE: This digital tool is intended to support learning and application of the material presented in Institutional Review Board: Management and Function, Third Edition. Individuals preparing for professional examinations should review the resources recommended by their professional or certification organization.
Author | : Robin Levin Penslar |
Publisher | : U.S. Government Printing Office |
Total Pages | : 518 |
Release | : 1993 |
Genre | : Education |
ISBN | : |
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 | : Shawn Cole |
Publisher | : Abdul Latif Jameel Poverty Action Lab |
Total Pages | : 618 |
Release | : 2021 |
Genre | : |
ISBN | : 9781736021606 |
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 | : Sarah Babb |
Publisher | : |
Total Pages | : 208 |
Release | : 2020 |
Genre | : Business & Economics |
ISBN | : 9781503610149 |
This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.
Author | : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research |
Publisher | : National Academies Press |
Total Pages | : 284 |
Release | : 2007-01-22 |
Genre | : Political Science |
ISBN | : 0309164605 |
In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.
Author | : Public Responsibility in Medicine &. Res |
Publisher | : |
Total Pages | : |
Release | : 2021-07-08 |
Genre | : Medical |
ISBN | : 9781284251524 |