The Irb

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.

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.

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.

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).

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.

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

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.