Institutional Review Board: Management and Function,9780763730499

Institutional Review Board: Management and Function

by ;
Edition: 2nd
ISBN13: 9780763730499
ISBN10: 0763730491
Format: Paperback
Pub. Date: 2005-11-08
Publisher(s): Jones & Bartlett Learning
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Summary

  This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents.   the updated Second Edition includes seven new chapters: IRB Closure of Study Files Internet Research Research in Public Schools Phase I Clinical Trials in Healthy Volunteers Vulnerability in Research Balancing the Risks and Potential Benefits HIPAA View the accompanying Handbook !  

Table of Contents

Foreword: Jesse's Intent xi
Paul Gelsinger
Preface xxi
Elizabeth A. Bankert
Robert J. Amdur
Contributing Authors xxiii
Acknowledgments xxix
PART 1 Background and Overview Topics
1(28)
An Ethics Primer for Institutional Review Boards
3(6)
Harold Y. Vanderpool
Reflections of an Outsider
9(4)
Mark R. Yessian
A Unified Human-Research Protection Program
13(3)
Sanford Chodosh
A Shared Responsibility for Protecting Human Subjects
16(5)
Steven Peckman
A Brief History of Public Responsibility in Medicine and Research and Institutional Review Board Education
21(3)
Joan Rachlin
The Institutional Review Board: Definition and Federal Oversight
24(2)
Robert J. Amdur
Elizabeth A. Bankert
The Limits of Institutional Review Board Authority
26(3)
Robert J. Amdur
PART 2 Organizing the Office
29(30)
Administrative Reporting Structure for the Institutional Review Board
31(2)
Ernest D. Prentice
Sally L. Mann
Bruce G. Gordon
Documentation, Policies, and Procedures
33(7)
Celia S. Walker
Deborah Barnard
Tracking Systems Using Information Technology
40(5)
Patricia M. Scannell
Denise Niles Canales
Support Staff
45(8)
Helen McGough
Audit Systems
53(4)
Ernest D. Prentice
Ada Sue Selwitz
Gwenn S. F. Oki
Judi Kuhl
Charging for Institutional Review Board Review
57(2)
Ernest D. Prentice
Sally L. Mann
Bruce G. Gordon
PART 3 Organizing the Institutional Review Board Committee
59(32)
Reflections on Chairing an Institutional Review Board
61(3)
Robert J. Levine
The Institutional Review Board Chair
64(4)
Robert J. Amdur
Robert M. Nelson
The Institutional Review Board Administrative Director
68(5)
Elizabeth A. Bankert
Robert J. Amdur
The Role of an Attorney
73(5)
Susan Nicholson
Committee Size, Alternates, and Consultants
78(3)
Robert J. Amdur
Elizabeth A. Bankert
Length, Frequency, and Time of Institutional Review Board Meetings
81(2)
Robert J. Amdur
Elizabeth A. Bankert
Institutional Review Board Subcommittees
83(4)
Robert J. Amdur
Social Science Versus Biomedical Institutional Review Boards
87(4)
Robert J. Amdur
Elizabeth A. Bankert
PART 4 Review Categories
91(26)
Exempt from Institutional Review Board Review
93(4)
Ernest D. Prentice
Gwenn S. F. Oki
Expedited Institutional Review Board Review
97(4)
Gwenn S. F. Oki
John A. Zaia
Identifying Intent: Is This Project Research?
101(5)
Robert J. Amdur
Marjorie Speers
Elizabeth Bankert
Compassionate Use and Emergency Use Exemption
106(3)
Elizabeth A. Bankert
Robert J. Amdur
Waiver of Consent in Emergency Medicine Research
109(8)
Helen McGough
PART 5 Initial Protocol Review and the Full-Committee Meeting
117(80)
Overview of Initial Protocol Review
119(7)
Sarah T. Khan
Susan Z. Kornetsky
Evaluating Study Design and Quality
126(3)
Robert J. Amdur
The Study Population: Women, Minorities, and Children
129(5)
Amy L. Davis
Community Consultation to Assess and Minimize Group Harms
134(6)
William L. Freeman
Francine C. Romero
Sayaka Kanade
Privacy and Confidentiality
140(7)
David G. Forster
Recruitment of Research Subjects
147(2)
Matthew D. Whalen
Felix A. Khin-Maung-Gyi
Advertisements for Research
149(5)
Rachel Hepp
Rachel Krebs
Linda Medwar
Christina Di Tomasso
Anne Dyson
Paying Research Subjects
154(6)
Bruce G. Gordon
Joseph S. Brown
Christopher J. Kratochvil
Toby L. Schonfeld
Provisions for Data Monitoring
160(6)
Robert J. Amdur
Conflict of Interest: Researchers
166(7)
Daniel K. Nelson
Conflict of Interest: Recruitment Incentives
173(4)
Daniel K. Nelson
Conflict of Interest: Institutional Review Boards
177(6)
Daniel K. Nelson
Administrative Tasks Before Each Instutional Review Board Meeting
183(4)
Rebecca Carson Rogers
Guidelines for Review, Discussion, and Voting
187(4)
Robert J. Amdur
Elizabeth A. Bankert
Administrative Tasks After Each Institutional Review Board Meeting
191(6)
Jan Trott
Rebecca Carson Rogers
PART 6 Informed Consent
197(52)
The Institutional Review Board's Role in Editing the Consent Document
199(3)
Robin L. Penslar
The Consent Document
202(3)
Angela J. Bowen
Exculpatory Language in Informed Consent Documents
205(3)
Michele Russell-Einhorn
Thomas Puglisi
Requiring a Witness Signature on the Consent Form
208(2)
Michele Russell-Einhorn
Thomas Puglisi
Deception of Research Subjects
210(6)
Laurie Slone
Jay Hull
Research Without Consent or Documentation Thereof
216(6)
Marianne M. Elliott
Selecting a Surrogate to Consent to Medical Research
222(7)
Robert J. Amdur
Natalie Bachir
Elizabeth Stanton
Research-Related Injuries
229(3)
Daniel R. Vasgird
Informing Subjects About Research Results
232(4)
Thomas G. Keens
Explaining the Cost of Research Participation
236(5)
Kevin M. Hunt
Improving Informed Consent
241(5)
Jeffrey A. Cooper
Pamela Turner
Informed Consent Evaluation Feedback Tool
246(3)
Elizabeth A. Bankert
Robert J. Amdur
PART 7 Continuing Review
249(22)
Revisions to an Approved Study
251(3)
Sherry Bye
Ann O'Hara
Protocol Renewal
254(3)
Karen M. Hansen
Institutional Review Board Review of Adverse Events
257(5)
Christopher J. Kratochvil
Ernest D. Prentice
Kevin J. Epperson
Bruce G. Gordon
Data and Safety Monitoring
262(3)
Allen McCutchan
Noncompliance, Complaints, Deviations, and Eligibility Exceptions
265(3)
Lucille Pearson
Tracy Ostler
Institutional Review Board Closure of Study Files
268(3)
Sandra P. Kaltman
John M. Isidor
PART 8 Administrative and Regulatory Issues
271(64)
Health Insurance Portability and Accountability Act and Research
273(5)
Lawrence H. Muhlbaier
Office for Human Research Protections Federalwide Assurance
278(3)
Jeffrey M. Cohen
International Conference on Harmonisation
281(5)
David G. Forster
Gary L. Chadwick
The Role of the Institutional Biosafety Committee: Human Gene Transfer Research
286(2)
Michael B. Blayney
Understanding the Food and Drug Administration's Investigational New Drug Process
288(6)
Dale E. Hammerschmidt
Differences Between Department of Health and Human Services and Food and Drug Administration Regulations
294(2)
Robert J. Amdur
Veterans Administration Research Guidelines
296(8)
Peter Marshall
Kathy Schulz
State Law
304(4)
Sandra P. Kaltman
John M. Isidor
Institutional Review Board Member Liability
308(3)
Sandra P. Kaltman
John M. Isidor
Certificates of Confidentiality
311(2)
Sandra P. Kaltman
John M. Isidor
Training Institutional Review Board Members
313(2)
Jeffrey A. Cooper
Pamela Turner
Investigator Training
315(4)
Jeffrey A. Cooper
Pamela Turner
Accreditation of Human Research Protection Programs
319(3)
Susan S. Fish
Certification of Institutional Review Board Professionals
322(2)
Susan J. Delano
Sallyann Henry
Gary L. Chadwick
Preparing for a Food and Drug Administration Audit
324(5)
Gary L. Chadwick
Preparing for an Office for Human Research Protections Site Visit
329(6)
Thomas Puglisi
Michele Russell-Einhorn
PART 9 Issues Based on Study Population
335(52)
Vulnerability in Research
337(4)
James M. DuBois
Research in Public Schools
341(5)
Lorna Hicks
Phase I Clinical Trials in Healthy Adults
346(5)
Cynthia S. Way
Requiring Birth Control to Participate in Research
351(5)
Bruce G. Gordon
Toby L. Schonfeld
Ernest D. Prentice
Research Involving Fetuses and In Vitro Fertilization
356(7)
Ronald M. Green
Research Involving Pregnant Women
363(3)
Angela J. Bowen
Research Involving Children
366(7)
Robert M. Nelson
Research Involving Adults with Decisional Impairment
373(5)
Susan J. Delano
Regulatory Issues of Research Involving Prisoners
378(6)
Christopher J. Kratochvil
Ernest D. Prentice
Bruce G. Gordon
Gail D. Kotulak
Research Involving College Students
384(3)
Jennifer J. Tickle
Todd F. Heatherton
PART 10 Institutional Review Board Issues Based on Study Design or Category
387(88)
When are Research Risks Reasonable in Relationship to Anticipated Benefits?
389(5)
Charles Weijer
Paul B. Miller
Internet Research: A Brief Guide for Institutional Review Boards
394(3)
Jeffrey M. Cohen
Qualitative Social Science Research
397(5)
Dean R. Gallant
Alan Bliss
Ethnographic Research
402(8)
Elisabeth Smith Parrott
Health Services Research
410(5)
Ann Barry Flood
Epidemiology/Public Health Research
415(3)
Marjorie A. Speers
Survey Research
418(6)
J. Michael Oakes
Research Involving a Medical Device
424(7)
Erica J. Heath
Humanitarian Use Devices
431(2)
Robert J. Amdur
Banking of Human Biological Materials for Research
433(8)
Mark Sobel
Karen Hansen
The Placebo-Controlled Clinical Trial
441(9)
Robert J. Amdur
C. J. Biddle
Treatment-Withholding Studies in Psychiatry
450(5)
Richard B. Ferrell
Phase I Oncology Trials
455(10)
Matthew Miller
Research Involving Genetic Testing
465(4)
Eric C. Larsen
International Research
469(2)
David A. Borasky
Alternative Medicine Research
471(4)
Timothy Callahan
PART 11 Reference Material and Contact Information
475(46)
Ethical Codes
477(10)
The Nuremberg Code
478(2)
The Belmont Report
480(7)
Selected U.S. Government Regulations
487(32)
Code of Federal Regulations: Title 45, Part 46
488(15)
Code of Federal Regulations: Title 21, Part 50
503(6)
Code of Federal Regulations: Title 21, Part 56
509(8)
Expedited Review Criteria
517(2)
Guidelines and Resources
519(1)
Periodicals, IRB Forum, and Selected Organizations
520(1)
Index 521

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