Paperback / softback
November 5, 2019
9781421432823
English
240
47597
15
9.00 Inches (US)
6.00 Inches (US)
0.59 Inches (US)
.9 Pounds (US)
$80.00 USD, £59.00 GBP
v2.1 Reference
Electronic book text
November 5, 2019
9781421432830
9781421432823
English
240
47597
15
9.00 Inches (US)
6.00 Inches (US)
$80.00 USD, £59.00 GBP
v2.1 Reference

Quality Assurance and Quality Improvement Handbook for Human Research

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

About the Authors

Leslie M. Howes, MPH, CIP, is the director of the Office of Regulatory Affairs and Research Compliance for the Harvard Longwood Medical Area Schools. Sarah A. White, MPH, CIP, is the executive director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. 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.

Endorsements

"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
Johns Hopkins University Press
From 17

9781421432823 : quality-assurance-and-quality-improvement-handbook-for-human-research-howes-white-bierer
Paperback / softback
240 Pages
$80.00 USD
9781421432830 : quality-assurance-and-quality-improvement-handbook-for-human-research-howes-white-bierer
Electronic book text
240 Pages
$80.00 USD

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