Study Guide for Institutional Review Board Management and Function,9780763738662

Study Guide for Institutional Review Board Management and Function

by ; ; ;
Edition: 2nd
ISBN13: 9780763738662
ISBN10: 0763738662
Format: Paperback
Pub. Date: 2005-11-11
Publisher(s): Jones & Bartlett Learning
List Price: $120.95

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Summary

Published in partnership with the Applied Research Ethics Association (ARENA), this study guide companion to Institutional Review Board: Management and Function, Second Edition facilitates the application of knowledge acquired from the textbook. Written by IRB people for IRB people, this study guide is a useful resource that promotes the professional development of people working in the field of human subjects protection.

Table of Contents

Preface vii
List of Contributors
ix
Acknowledgments xi
PART 1 Background and Overview Topics
1(12)
An Ethics Primer for Institutional Review Boards
3(1)
Reflections of an Outsider
4(2)
A Unified Human-Research Protection Program
6(1)
A Shared Responsibility for Protecting Human Subjects
7(1)
A Brief History of Public Responsibility in Medicine and Research and Institutional Review Board Education
8(1)
The Institutional Review Board: Definition and Federal Oversight
9(1)
The Limits of Institutional Review Board Authority
10(3)
Answer Key for Part 1
12(1)
PART 2 Organizing the Office
13(10)
Administrative Reporting Structure for the Institutional Review Board
15(1)
Documentation, Policies, and Procedures
16(1)
Tracking Systems Using Information Technology
17(1)
Support Staff
18(1)
Audit Systems
19(1)
Charging for Institutional Review Board Review
20(3)
Answer Key for Part 2
22(1)
PART 3 Organizing the Institutional Review Board Committee
23(12)
Reflections on Chairing an Institutional Review Board
25(1)
The Institutional Review Board Chair
26(1)
The Institutional Review Board Administrative Director
27(1)
The Role of an Attorney
28(1)
Committee Size, Alternates, and Consultants
29(1)
Length, Frequency, and Time of Institutional Review Board Meetings
30(1)
Institutional Review Board Subcommittees
31(1)
Social Science vs. Biomedical Institutional Review Boards
32(3)
Answer Key for Part 3
34(1)
PART 4 Review Categories
35(12)
Exempt from Institutional Review Board Review
37(1)
Expedited Institutional Review Board Review
38(2)
Identifying Intent: Is This Project Research?
40(2)
Compassionate Use and Emergency Use Exemption
42(2)
Waiver of Consent in Emergency Medicine Research
44(3)
Answer Key for Part 4
46(1)
PART 5 Initial Protocol Review and the Full-Committee Meeting
47(22)
Overview of Initial Protocol Review
49(1)
Evaluating Study Design and Quality
50(1)
The Study Population: Women, Minorities, and Children
51(1)
Community Consultation to Assess and Minimize Group Harms
52(1)
Privacy and Confidentiality
53(2)
Recruitment of Research Subjects
55(1)
Advertisements for Research
56(2)
Paying Research Subjects
58(2)
Provisions for Data Monitoring
60(2)
Conflict of Interest: Researchers
62(1)
Conflict of Interest: Recruitment Incentives
63(1)
Conflict of Interest: Institutional Review Boards
64(1)
Administrative Tasks Before Each Institutional Review Board Meeting
65(1)
Guidelines for Review, Discussion, and Voting
66(1)
Administrative Tasks After Each Institutional Review Board Meeting
67(2)
Answer Key for Part 5
68(1)
PART 6 Informed Consent
69(18)
The Institutional Review Board's Role in Editing the Consent Document
71(1)
The Consent Document
72(1)
Exculpatory Language in Informed Consent Documents
73(1)
Requiring a Witness Signature on the Consent Form
74(1)
Deception of Research Subjects
75(2)
Research Without Consent or Documentation Thereof
77(1)
Selecting a Surrogate to Consent to Medical Research
78(1)
Research-Related Injuries
79(2)
Informing Subjects about Research Results
81(1)
Explaining the Costs of Research Participation
82(1)
Improving Informed Consent
83(2)
Informed Consent Evaluation Feedback Tool
85(2)
Answer Key for Part 6
86(1)
PART 7 Continuing Review
87(10)
Revisions to Approved Study
89(1)
Protocol Renewal
90(2)
Institutional Review Board Review of Adverse Events
92(1)
Data and Safety Monitoring
93(1)
Noncompliance, Complaints, Deviations, Eligibility Exceptions
94(1)
Institutional Review Board Closure of Study Files
95(2)
Answer Key for Part 7
96(1)
PART 8 Administrative and Regulatory Issues
97(26)
HIPAA and Research
99(1)
Office for Human Research Protections Federalwide Assurance
100(1)
International Conference on Harmonisation
101(2)
Gene Therapy Oversight
103(1)
Understanding the Food and Drug Administration's Investigational New Drug Process
104(1)
Differences Between Department of Health and Human Services and Food and Drug Administration Regulations
105(1)
Veterans Administration Research Guidelines
106(2)
State Law
108(1)
Institutional Review Board Member Liability
109(1)
Certificates of Confidentiality
110(1)
Training Institutional Review Board Members
111(1)
Investigator Training
112(1)
Accreditation of Human Research Protection Programs
113(1)
Certification of Institutional Review Board Professionals
114(1)
Preparing for a Food and Drug Administration Audit
115(2)
Preparing for an Office of Human Research Protections Site Visit
117(6)
Answer Key for Part 8
120(3)
PART 9 Issues Based on Study Population
123(18)
Vulnerability in Research
125(1)
Research in Public Schools
126(1)
Phase I Clinical Trials in Healthy Adults
127(1)
Requiring Birth Control to Participate in Research
128(1)
Research Involving Fetuses and In Vitro Fertilization
129(2)
Research Involving Pregnant Women
131(1)
Research Involving Children
132(2)
Research Involving Adults with Decisional Impairment
134(2)
Regulatory Issues of Research Involving Prisoners
136(2)
Research Involving College Students
138(3)
Answer Key for Part 9
140(1)
PART 10 IRB Issues Based on Study Design or Category
141(28)
When Are Research Risks Reasonable in Relationship to Anticipated Benefits?
143(1)
Internet Research: A Brief Guide for Institutional Review Boards
144(1)
Qualitative Social Science Research
145(2)
Ethnographic Research
147(2)
Health Services Research
149(1)
Epidemiology/Public Health Research
150(2)
Survey Research
152(1)
Research Involving a Medical Device
153(2)
Humanitarian Use Devices
155(1)
Banking of Human Biological Materials for Research
156(1)
The Placebo-Controlled Clinical Trial
157(2)
Treatment-Withholding Studies in Psychiatry
159(2)
Phase I Oncology Trials
161(2)
Research Involving Genetic Testing
163(1)
International Research
164(1)
Alternative Medicine Research
165(4)
Answer Key for Part 10
166(3)
PART 11 Reference Material and Contact Information
169(7)
The Belmont Report
171(2)
World Medical Association Declaration of Helsinki
173(3)
Answer Key for Part 11
176

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