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Quality Assurance and Quality Improvement Handbook for Human Research

edited by Leslie M. Howes, MPH, CIP, Sarah A. White, MPH, CIP, and Barbara E. Bierer, MD
Publication Date
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Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs.

Quality Assurance and Quality Improvement Handbook for Human Research is 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...

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Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs.

Quality Assurance and Quality Improvement Handbook for Human Research is 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 fifteen 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

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Reviews

A practical handbook outlining considerations for quality assurance and quality improvement program development. This book will appeal to human research protection program professionals, institutional officials who must oversee an HRPP, and institutional review boards considering how best to structure their QA/QI functions.

— Megan Kasimatis Singleton, Assistant Dean for Human Research Protection, Office of Human Subjects Research, Johns Hopkins University School of Medicine

Offering helpful, needed, and uniform guidance to IRB members asked to review quality assurance and quality improvement proposals, this book is of value to researchers and other stakeholders struggling with the issue of if, when, and how to review and monitor QA and QI projects in their home institutions.

— Sean M. Philpott-Jones, Director of Research Ethics, The Bioethics Program, Clarkson University
About

Book Details

Publication Date
Status
Available
Trim Size
6
x
9
Pages
240
ISBN
9781421432823
DOI
Illustration Description
15 line drawings
Subject
Table of Contents

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
Chapt

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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
Leslie M. Howes and Sarah A. White
Chapter 7. Educational Programming
Elizabeth Bowie and Leslie M. Howes
Appendix A. Abbreviations and Acronyms
Appendix B. Resources

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Author Bios
Featured Contributor

Leslie M. Howes, MPH, CIP

Leslie M. Howes, MPH, CIP, is the director of the Office of Regulatory Affairs and Research Compliance for the Harvard Longwood Medical Area Schools.
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Featured Contributor

Sarah A. White, MPH, CIP

Sarah A. White, MPH, CIP, is the executive director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard.
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Featured Contributor

Barbara E. Bierer, MD

Barbara E. Bierer, MD, is the faculty director of the Multi-Regional Clinical Trials Center, a professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and the director of the Regulatory Foundations, Ethics, and Law Program at Harvard Catalyst / The Harvard Clinical and Translational Science Center.
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