Institutional Review Board: Management and Function

The field of human subject protections oversight has grown and evolved considerably. 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 National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference work for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight"--
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.