Behind Closed Doors

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Publisher : University of Chicago Press
ISBN 13 : 0226770869
Total Pages : 242 pages
Book Rating : 4.2/5 (267 download)

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Book Synopsis Behind Closed Doors by : Laura Stark

Download or read book Behind Closed Doors written by Laura Stark and published by University of Chicago Press. This book was released on 2012-02 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drwaing on extensive archival sources, Laura Stark reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working - and 'warring' - on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects.

Institutional Review Board Member Handbook

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Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449609929
Total Pages : 224 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Institutional Review Board Member Handbook by : Robert J. Amdur

Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur and published by Jones & Bartlett Publishers. This book was released on 2010-10-22 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Advances in Patient Safety

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Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)

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Book Synopsis Advances in Patient Safety by : Kerm Henriksen

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

The Censor's Hand

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Publisher : MIT Press
ISBN 13 : 0262028913
Total Pages : 293 pages
Book Rating : 4.2/5 (62 download)

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Book Synopsis The Censor's Hand by : Carl E. Schneider

Download or read book The Censor's Hand written by Carl E. Schneider and published by MIT Press. This book was released on 2015-04-10 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good. Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called “institutional review boards” (IRBs). Do—can—these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience—the law's learning about regulation—and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging—universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Institutional Review Board

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Publisher : Jones & Bartlett Learning
ISBN 13 : 9780763730499
Total Pages : 568 pages
Book Rating : 4.7/5 (34 download)

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Book Synopsis Institutional Review Board by : Elizabeth A. Bankert

Download or read book Institutional Review Board written by Elizabeth A. Bankert and published by Jones & Bartlett Learning. This book was released on 2006 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Regulating Human Research

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Publisher :
ISBN 13 : 9781503610149
Total Pages : 208 pages
Book Rating : 4.6/5 (11 download)

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Book Synopsis Regulating Human Research by : Sarah Babb

Download or read book Regulating Human Research written by Sarah Babb and published by . This book was released on 2020 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Ethics Police?

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Publisher : Oxford University Press, USA
ISBN 13 : 0199364605
Total Pages : 433 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis The Ethics Police? by : Robert Klitzman

Download or read book The Ethics Police? written by Robert Klitzman and published by Oxford University Press, USA. This book was released on 2015 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies on humans have saved countless lives, but sometimes harm participants. Research ethics committees currently monitor scientists, but have been increasingly criticized for blocking important research. How these committees work, however, is largely unknown. This book uniquely illuminates this hidden world that ultimately affects us all.

Protecting Data Privacy in Health Services Research

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Publisher : National Academies Press
ISBN 13 : 0309071879
Total Pages : 208 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Protecting Data Privacy in Health Services Research by : Institute of Medicine

Download or read book Protecting Data Privacy in Health Services Research written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-13 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Evaluating the Science and Ethics of Research on Humans

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Publisher : Johns Hopkins University Press
ISBN 13 : 9780801885020
Total Pages : 0 pages
Book Rating : 4.8/5 (85 download)

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Book Synopsis Evaluating the Science and Ethics of Research on Humans by : Dennis J. Mazur

Download or read book Evaluating the Science and Ethics of Research on Humans written by Dennis J. Mazur and published by Johns Hopkins University Press. This book was released on 2007-02-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research—institutional review boards, or IRBs—is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas—drugs, medical devices, and genetic information—Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.

Ethical Conduct of Clinical Research Involving Children

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Author :
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Conducting Research with Human Participants

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Author :
Publisher : SAGE Publications
ISBN 13 : 1544348606
Total Pages : 343 pages
Book Rating : 4.5/5 (443 download)

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Book Synopsis Conducting Research with Human Participants by : Nathan Durdella

Download or read book Conducting Research with Human Participants written by Nathan Durdella and published by SAGE Publications. This book was released on 2022-02-15 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: Conducting Research with Human Participants: An IRB Guide for Students and Faculty by Nathan Durdella is the only guidebook students and faculty will need to navigate the IRB process and secure swift approval of research protocols. This book serves as an advisor to walk researchers through all the details of drafting, submission, and revision of materials for Institutional Review Boards so they can complete their research projects or dissertations faster. This text walks readers through the history of Institutional Review Boards, the contemporary context of ethical research, strategies to effectively draft, submit, and revise an IRB protocol, and guidance on working with an approved protocol in the field. The latest updates to the Common Rule and other regulatory frameworks, including special protections for working with vulnerable groups, are covered throughout the text. Not every research project goes according to plan, so adverse events and reporting receive special coverage. A final chapter on ethical research practices beyond IRB compliance encourages researchers to think through how to exit the field of research and ensure their research benefits the individuals, families, and communities in which they work. Take the guesswork out of the IRB process from start to finish with this handy guide.

The IRB

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Author :
Publisher :
ISBN 13 :
Total Pages : 400 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The IRB by : Owen McGee

Download or read book The IRB written by Owen McGee and published by . This book was released on 2005 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyzes the ideology and organizational traditions of the Irish Republican Brotherhood (IRB), its role in Irish politics and its place in Irish history. While the IRB has long been associated with the insurrections of 1867 and 1916, Owen McGee argues that it was never primarily an insurrectionary conspiracy; rather it was a popular fraternal organization and propagandistic body, committed to bringing about popular politicization in Ireland along republican lines. Focusing primarily on the new departures in Irish politics between the land war of 1879-81 and the outbreak of the First World War, this study identifies this period as being a critical phase in the evolution of modern Irish republicanism, as well as being the pivotal stage in the history of the IRB itself. It throws fresh light on the social and political origins of the Irish revolution of 1912-23, as well as the IRB's intended political role during that eventful epoch. Prominent members included: Michael Collins, James Stephens, Arthur Griffith, Bulkmer Hobson, Eamonn Ceannt and Edward Daly (the latter two fought in 1916 and were executed as a result of their involvement).

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Institutional Review Board: Management and Function

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Author :
Publisher : Jones & Bartlett Learning
ISBN 13 : 1284181154
Total Pages : 1113 pages
Book Rating : 4.2/5 (841 download)

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Book Synopsis Institutional Review Board: Management and Function by : Public Responsibility in Medicine & Research (PRIM&R),

Download or read book Institutional Review Board: Management and Function written by Public Responsibility in Medicine & Research (PRIM&R), and published by Jones & Bartlett Learning. This book was released on 2021-03-01 with total page 1113 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The IRB

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Publisher :
ISBN 13 : 9781846820649
Total Pages : 0 pages
Book Rating : 4.8/5 (26 download)

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Book Synopsis The IRB by : Owen McGee

Download or read book The IRB written by Owen McGee and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second Edition --- This book analyzes the ideology and organizational traditions of the Irish Republican Brotherhood (IRB), its role in Irish politics and its place in Irish history. While the IRB has long been associated with the insurrections of 1867 and 1916, Owen McGee argues that it was never primarily an insurrectionary conspiracy; rather it was a popular fraternal organization and propagandistic body, committed to bringing about popular politicization in Ireland along republican lines. Focusing primarily on the new departures in Irish politics between the land war of 1879-81 and the outbreak of the 1st World War, this study identifies this period as being a critical phase in the evolution of modern Irish republicanism, as well as being the pivotal stage in the history of the IRB itself. It throws fresh light on the social and political origins of the Irish revolution of 1912-23, as well as the IRB's intended political role during that eventful epoch. Prominent members included: Michael Collins, Arthur Griffith, Bulmer Hobson, Eamonn Ceannt and Edward Daly (the latter two fought in 1916 and were executed as a result of their involvement).

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

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Author :
Publisher : Abdul Latif Jameel Poverty Action Lab
ISBN 13 : 9781736021606
Total Pages : 618 pages
Book Rating : 4.0/5 (216 download)

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Book Synopsis Handbook on Using Administrative Data for Research and Evidence-based Policy by : Shawn Cole

Download or read book Handbook on Using Administrative Data for Research and Evidence-based Policy written by Shawn Cole and published by Abdul Latif Jameel Poverty Action Lab. This book was released on 2021 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.