Quality Assurance and Quality Improvement Handbook for Human Researchis the first comprehensively designed 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 15 experts with diverse professional experiences from varied organizations
is enhanced with flow charts, examples, sample forms, and templates
incorporates model slide presentations and instructional materials
discusses the respective benefits and challenges of different organizational models
is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutions
Perfect for both seasoned personnel and newcomers to the field, Quality Assurance and Quality Improvement Handbook for Human Research is a needed resource for ensuring investigative accountability.
Contributors: Hila Bernstein, MS, MPH, Barbara E. Bierer, MD, Elizabeth Bowie, JD, MPH, MSc, Susan Corl, MSW, MPH, CIP, CCRP, Jacquelyn-My Do, MPH, Lisa Gabel, CIP, Alyssa Gateman, MPH, CCRP, Jennifer A. Graf, Nareg D. Grigorian, Leslie M. Howes, MPH, CIP, Jennifer Hutchinson, CIP, CPIA, Cynthia Monahan, MBA, CIP, Eunice Newbert, MPH, Sarah A. White, MPH, CIP, Elizabeth Witte, MFA
Contributors
Foreword
Preface
Acknowledgments
Note to Readers
Chapter 1. Introduction to Quality Assurance and Quality Improvement Programs
Hila Bernstein, Jennifer A. Graf, and Jennifer Hutchinson
Chapter 2. Types of QA/QI Programs: A Review of Three Models
Jennifer A. Graf and Jennifer Hutchinson
Chapter 3. Policies and Procedures
Barbara E. Bierer and Eunice Newbert
Chapter 4. Investigator Site Review
Susan Corl, Alyssa Gateman, Nareg D. Grigorian, and Sarah A. White
Chapter 5. Evaluating IRB Compliance
Jennifer A. Graf, Leslie M. Howes, Cynthia Monahan, Eunice Newbert, and Sarah A. White
Chapter 6. Metrics and Communicating Observations of Noncompliance
