Overview

This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects. This extensively updated reference complies to the new federal research regulations released January 2019, known as the ""New Rule"" and provides a step-by-step approach to practical details of IRB administration. It includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

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9781284181159

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About PRIM&R:Since its founding in 1974, PRIM&R (www.primr.org) has pursued two core goals: creating a strong and vibrant community of ethics-minded research administration and oversight personnel, and providing educational and professional development opportunities that give that community the ongoing knowledge, support, and interaction it needs to raise the bar of research administration and oversight above regulatory compliance. PRIM&R’s educational and professional development programs address a range of issues surrounding research involving human subjects and animals. PRIM&R has formalized professional standards and credentials that document the expertise necessary for effective and appropriate research ethics support, and is active in public policy, offering expert opinion and guidance to the rule-making and advisory bodies governing the research enterprise and its practical applications.

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