Institutional Review Board: Management and Function

Overview

Biomedical and social science research involving the use of human subjects presents society with a wide range of ethical questions. At the heart of the current system for protecting human research subjects is the Institutional Review Board (IRB). This book is designed as an instructional manual that gives the IRB members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research...
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Overview

Biomedical and social science research involving the use of human subjects presents society with a wide range of ethical questions. At the heart of the current system for protecting human research subjects is the Institutional Review Board (IRB). This book is designed as an instructional manual that gives the IRB members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations.
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Editorial Reviews

From The Critics
At the heart of the current system for protecting human subjects in biomedical and social science research is the institutional review board (IRB). This book is designed to provide IRB members and administrators with information for running an effective system for protecting research subjects in compliance with federal research regulations. Step-by-step instructions for IRB administration are provided, as well as case studies, sample forms, and sample policy documents. Material is in sections on background, organizing the office and the IRB committee, review categories, initial protocol review and the full-committee meeting, informed consent, administrative and regulatory issues, issues based on study population, and reference material. Amdur is affiliated with the University of Florida Health Science Center. Bankert is affiliated with Dartmouth College. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9780763716868
  • Publisher: Jones & Barlett Learning
  • Publication date: 11/21/2001
  • Series: Other Nursing Titles of Interest Series
  • Edition description: Older Edition
  • Pages: 622
  • Product dimensions: 8.50 (w) x 11.10 (h) x 1.70 (d)

Table of Contents

Acknowledgments
Foreword: Jesse's Intent
Preface
Contributing Authors
Pt. 1 Background and Overview Topics 2
Ch. 1-1 An Ethics Primer for IRBs 3
Ch. 1-2 Reflections from the Office of the Inspector General 9
Ch. 1-3 A Unified Human-Research Protection Program 13
Ch. 1-4 A Shared Responsibility for Protecting Human Subjects 17
Ch. 1-5 The Tension Between Science and Ethics 22
Ch. 1-6 A Brief History of PRIM&R and IRB Education 24
Ch. 1-7 The IRB: Definition and Federal Oversight 27
Ch. 1-8 The Limits of IRB Authority 30
Pt. 2 Organizing the Office 33
Ch. 2-1 Administrative Reporting Structure for the IRB 35
Ch. 2-2 Documenting Compliance with Federal Regulations 37
Ch. 2-3 IRB Policies and Procedures 43
Ch. 2-4 Tracking Systems 50
Ch. 2-5 Support Staff 58
Ch. 2-6 Audit Systems 66
Ch. 2-7 Charging for IRB Review 75
Pt. 3 Organizing the IRB Committee 77
Ch. 3-1 Reflections on Chairing an IRB 79
Ch. 3-2 The IRB Chair 82
Ch. 3-3 The IRB Administrative Director 86
Ch. 3-4 The Role of an Attorney 91
Ch. 3-5 Committee Size, Alternates, and Consultants 96
Ch. 3-6 Length, Frequency, and Time of IRB Meetings 99
Ch. 3-7 IRB Subcommittees 101
Ch. 3-8 Social Science Versus Biomedical IRBs 105
Pt. 4 Review Categories Other Than Full Board Review 109
Ch. 4-1 Exempt from IRB Review 111
Ch. 4-2 Expedited IRB Review 114
Ch. 4-3 Identifying Research Intent 118
Ch. 4-4 IRB Triage of Projects That Involve Medical Record Review 125
Ch. 4-5 "Compassionate Use" and Emergency Exemption from IRB Approval 129
Ch. 4-6 Waiver of Consent in Emergency Medicine Research 132
Pt. 5 Initial Protocol Review and the Full-Committee Meeting 141
Ch. 5-1 Overview of Initial Protocol Review 143
Ch. 5-2 Evaluating Study Design and Quality 152
Ch. 5-3 The Study Population: Women, Minorities, and Children 155
Ch. 5-4 Community Consultation to Evaluate Group Risk 160
Ch. 5-5 Requiring Birth Control to Participate in Research 165
Ch. 5-6 Privacy and Confidentiality 169
Ch. 5-7 Recruitment of Research Subjects 176
Ch. 5-8 Advertisements for Research 180
Ch. 5-9 Paying Research Subjects 185
Ch. 5-10 Provisions for Data Monitoring 191
Ch. 5-11 Conflict of Interest: Researchers 197
Ch. 5-12 Conflict of Interest: Recruitment Incentives 204
Ch. 5-13 Conflict of Interest: IRBs 208
Ch. 5-14 Administrative Tasks Before the Meeting 214
Ch. 5-15 Guidelines for Review, Discussion, and Voting 219
Ch. 5-16 Administrative Tasks After Each IRB Meeting 226
Pt. 6 Informed Consent 231
Ch. 6-1 The IRB's Role in Editing the Consent Document 233
Ch. 6-2 The Consent Document 236
Ch. 6-3 Exculpatory Language in Informed Consent Documents 239
Ch. 6-4 Requiring a Witness Signature on the Consent Form 242
Ch. 6-5 Deception of Research Subjects 244
Ch. 6-6 Research Without Consent or Documentation Thereof 250
Ch. 6-7 Active Versus Passive Consent 256
Ch. 6-8 Selecting a Surrogate to Consent to Medical Research 258
Ch. 6-9 Research-Related Injuries 265
Ch. 6-10 Informing Subjects About Research Results 268
Ch. 6-11 Explaining the Cost of Research Participation 272
Ch. 6-12 Improving Informed Consent 277
Ch. 6-13 Informed Consent Evaluation Feedback Tool 282
Pt. 7 Continuing Review 287
Ch. 7-1 Revisions of an Approved Protocol 289
Ch. 7-2 Protocol Renewal 293
Ch. 7-3 IRB Review of Adverse Events 297
Ch. 7-4 Data and Safety Monitoring 303
Ch. 7-5 Noncompliance/Complaint Procedure 306
Pt. 8 Administrative and Regulatory Issues 311
Ch. 8-1 OHRP Federal-Wide Assurance 313
Ch. 8-2 International Conference on Harmonisation 316
Ch. 8-3 Gene Therapy Oversight 321
Ch. 8-4 Understanding the FDA's IND Process 323
Ch. 8-5 Differences Between DHHS and FDA Regulations 329
Ch. 8-6 Veterans Administration Research Guidelines 331
Ch. 8-7 State Law 339
Ch. 8-8 IRB Member Liability 342
Ch. 8-9 Certificates of Confidentiality 345
Ch. 8-10 Educating IRB Members 347
Ch. 8-11 Investigator Training 349
Ch. 8-12 Accreditation of an IRB 353
Ch. 8-13 Certification of IRB Professionals 356
Ch. 8-14 Preparing for an FDA Audit 359
Ch. 8-15 Preparing for an OHRP Site Visit 365
Pt. 9 Issues Based on Study Population 371
Ch. 9-1 Research Involving Fetuses and in Vitro Fertilization 373
Ch. 9-2 Research Involving Pregnant Women 380
Ch. 9-3 Research Involving Children 383
Ch. 9-4 Research Involving Adults with Decisional Impairment 389
Ch. 9-5 Research Involving Prisoners 394
Ch. 9-6 Research Involving College Students 399
Pt. 10 IRB Issues Based On Study Design or Category 401
Ch. 10-1 Qualitative Social Science Research 403
Ch. 10-2 Ethnographic Research 407
Ch. 10-3 Oral History Research 415
Ch. 10-4 Health Services Research 419
Ch. 10-5 Epidemiology/Public Health Research 424
Ch. 10-6 Survey Research 428
Ch. 10-7 Research Involving a Medical Device 434
Ch. 10-8 Humanitarian Use Devices 441
Ch. 10-9 Banking of Biological Materials for Research 443
Ch. 10-10 The Placebo-Controlled Clinical Trial 450
Ch. 10-11 Research Involving Sham Surgery 458
Ch. 10-12 Treatment-Withholding Studies in Psychiatry 461
Ch. 10-13 Phase I Oncology Trials 465
Ch. 10-14 Research Involving Genetic Testing 476
Ch. 10-15 International Research 481
Ch. 10-16 Alternative Medicine Research 483
Pt. 11 Reference Material and Contact Information 487
Ch. 11-1 Ethical Codes 489
Ch. 11-1A The Nueremberg Code 490
Ch. 11-1B The Belmont Report 492
Ch. 11-1C World Medical Association Declaration of Helsinki 499
Ch. 11-2 Selected U.S. Government Regulations 501
Ch. 11-2A Code of Federal Regulations: Title 45, Part 46 502
Ch. 11-2B Code of Federal Regulations: Title 21, Part 50 517
Ch. 11-2C Code of Federal Regulations: Title 21, Part 56 523
Ch. 11-2D Expedited IRB Review Criteria 532
Ch. 11-3 U.S. Government Guidance and Resources 534
Ch. 11-4 International Guidelines 535
Ch. 11-5 Selected Books 536
Ch. 11-6 Periodicals and IRB Forum 537
Ch. 11-7 Video Recordings 538
Ch. 11-8 Selected Organizations 539
Ch. 11-9 Standardized IRB Forms 540
Index 571
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