Institutional Review Board PDF Download

Author: Elizabeth A. Bankert
Publisher: Jones & Bartlett Learning
ISBN: 9780763730499
Category : Institutional review boards (Medicine)
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: Laura Stark
Publisher: University of Chicago Press
ISBN: 0226770869
Category : History
Languages : en
Pages : 242

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Book Description
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.

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: Sarah Babb
Publisher:
ISBN: 9781503611221
Category : Business & Economics
Languages : en
Pages : 208

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Book Description
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: Nathan Durdella
Publisher: SAGE Publications
ISBN: 1544348606
Category : Psychology
Languages : en
Pages : 343

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Book Description
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.

Author: Kerm Henriksen
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 526

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Book Description
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Author: Carl E. Schneider
Publisher: MIT Press
ISBN: 0262028913
Category : Law
Languages : en
Pages : 293

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Book Description
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.

Author: Robert Klitzman
Publisher: Oxford University Press, USA
ISBN: 0199364605
Category : Medical
Languages : en
Pages : 433

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Book Description
All studies on people involving diseases, from cancer to autism, and behavior. Yet ethical violations persist. At the same time, critics have increasingly attacked these committees for delaying or blocking important studies. Partly, science is changing, and the current system has not kept up. Since the regulations were first conceived 40 years ago, research has burgeoned 30-fold. Studies often now include not a single university, but multiple institutions, and 40 separate IRBs thus need to approve a single project. One committee might approve a study quickly, while others require major changes, altering the scientific design, and making the comparison of data between sites difficult. Crucial dilemmas thus emerge of whether the current system should be changed, and if so, how. Yet we must first understand the status quo to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation.

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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

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Book Description
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.