Quality Assurance and Quality Improvement Handbook for Human Research is the first comprehensive instructional manual aimed at teaching human research protection program (HRPP) professionals how to create, implement, evaluate, and improve QA/QI programs. Geared toward institutions and individuals responsible for establishing new QA/QI programs or functions, the book offers several organizational models for consideration. It also provides practical information for improving and strengthening established programs, both big and small. Written in a conversational style, the book’s step-by-step instructions make it easily accessible to those who may not be well versed in QA/QI concepts and fundamentals. Developed by the QA/QI Subcommittee of the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program, which is committed to designing and strengthening QA/QI programs and functions, this volume includes contributions by fifteen experts with diverse professional experiences from varied organizations, enhanced with flow charts, examples, sample forms, and templates, model slide presentations, and instructional materials. It discusses the respective benefits and challenges of different organizational models and is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutions.