Study Guide for Institutional Review Board Management and Function .

, by Davis, Amy; Bankert, Elizabeth A.; Hansen, Karen; Kornetsky, Susan

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ISBN: 9780763738662 | 0763738662
Cover: Paperback
Copyright: 11/11/2005

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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.

Preface

vii

List of Contributors

Acknowledgments

PART 1 Background and Overview Topics

(12)

An Ethics Primer for Institutional Review Boards

(1)

Reflections of an Outsider

(2)

A Unified Human-Research Protection Program

(1)

A Shared Responsibility for Protecting Human Subjects

(1)

A Brief History of Public Responsibility in Medicine and Research and Institutional Review Board Education

(1)

The Institutional Review Board: Definition and Federal Oversight

(1)

The Limits of Institutional Review Board Authority

(3)

Answer Key for Part 1

(1)

PART 2 Organizing the Office

(10)

Administrative Reporting Structure for the Institutional Review Board

(1)

Documentation, Policies, and Procedures

(1)

Tracking Systems Using Information Technology

(1)

Support Staff

(1)

Audit Systems

(1)

Charging for Institutional Review Board Review

(3)

Answer Key for Part 2

(1)

PART 3 Organizing the Institutional Review Board Committee

(12)

Reflections on Chairing an Institutional Review Board

(1)

The Institutional Review Board Chair

(1)

The Institutional Review Board Administrative Director

(1)

The Role of an Attorney

(1)

Committee Size, Alternates, and Consultants

(1)

Length, Frequency, and Time of Institutional Review Board Meetings

(1)

Institutional Review Board Subcommittees

(1)

Social Science vs. Biomedical Institutional Review Boards

(3)

Answer Key for Part 3

(1)

PART 4 Review Categories

(12)

Exempt from Institutional Review Board Review

(1)

Expedited Institutional Review Board Review

(2)

Identifying Intent: Is This Project Research?

(2)

Compassionate Use and Emergency Use Exemption

(2)

Waiver of Consent in Emergency Medicine Research

(3)

Answer Key for Part 4

(1)

PART 5 Initial Protocol Review and the Full-Committee Meeting

(22)

Overview of Initial Protocol Review

(1)

Evaluating Study Design and Quality

(1)

The Study Population: Women, Minorities, and Children

(1)

Community Consultation to Assess and Minimize Group Harms

(1)

Privacy and Confidentiality

(2)

Recruitment of Research Subjects

(1)

Advertisements for Research

(2)

Paying Research Subjects

(2)

Provisions for Data Monitoring

(2)

Conflict of Interest: Researchers

(1)

Conflict of Interest: Recruitment Incentives

(1)

Conflict of Interest: Institutional Review Boards

(1)

Administrative Tasks Before Each Institutional Review Board Meeting

(1)

Guidelines for Review, Discussion, and Voting

(1)

Administrative Tasks After Each Institutional Review Board Meeting

(2)

Answer Key for Part 5

(1)

PART 6 Informed Consent

(18)

The Institutional Review Board's Role in Editing the Consent Document

(1)

The Consent Document

(1)

Exculpatory Language in Informed Consent Documents

(1)

Requiring a Witness Signature on the Consent Form

(1)

Deception of Research Subjects

(2)

Research Without Consent or Documentation Thereof

(1)

Selecting a Surrogate to Consent to Medical Research

(1)

Research-Related Injuries

(2)

Informing Subjects about Research Results

(1)

Explaining the Costs of Research Participation

(1)

Improving Informed Consent

(2)

Informed Consent Evaluation Feedback Tool

(2)

Answer Key for Part 6

(1)

PART 7 Continuing Review

(10)

Revisions to Approved Study

(1)

Protocol Renewal

(2)

Institutional Review Board Review of Adverse Events

(1)

Data and Safety Monitoring

(1)

Noncompliance, Complaints, Deviations, Eligibility Exceptions

(1)

Institutional Review Board Closure of Study Files

(2)

Answer Key for Part 7

(1)

PART 8 Administrative and Regulatory Issues

(26)

HIPAA and Research

(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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Study Guide for Institutional Review Board Management and Function .

Summary

Table of Contents

Supplemental Materials