Institutional Review Board: Management and Function

Forside
Jones & Bartlett Learning, 2006 - 530 sider
This book is designed as an instructional manual that gives Institutional Review Board (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. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

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CHAPTER 13 A Unified HumanResearch Protection Program
13
CHAPTER 17 The Limits of Institutional Review Board Authority
26
CHAPTER 22 Documentation Policies and Procedures
33
CHAPTER 25 Audit Systems
53
CHAPTER 33 The Institutional Review Board Administrative Director
68
CHAPTER 36 Length Frequency and Time of Institutional Review Board Meetings
81
CHAPTER 42 Expedited Institutional Review Board Review
97
CHAPTER 44 44 Compassionate Use and Emergency Use Exemption
106
CHAPTER 74 Data and Safety Monitoring
262
CHAPTER 75 Noncompliance Complaints Deviations and Eligibility Exceptions
265
CHAPTER 82 Office for Human Research Protections Federalwide Assurance
278
CHAPTER 86 Differences Between Department of Health and Human Services
294
CHAPTER 89 Institutional Review Board Member Liability
308
CHAPTER 814 Certification of Institutional Review Board Professionals
322
CHAPTER 815 Preparing for a Food and Drug Administration Audit
324
Issues Based on Study Population
335

Initial Protocol Review and the FullCommittee Meeting
117
CHAPTER 52 Evaluating Study Design and Quality
126
CHAPTER 54 Community Consultation to Assess and Minimize Group Harms
134
CHAPTER 55 Privacy and Confidentiality
140
CHAPTER 56 Recruitment of Research Subjects
147
CHAPTER 58 Paying Research Subjects
154
CHAPTER 59 Provisions for Data Monitoring
160
Researchers
166
Recruitment Incentives
173
CHAPTER 513 Administrative Tasks Before Each Instutional Review Board Meeting
183
CHAPTER 515 Administrative Tasks After Each Institutional Review Board Meeting
191
Informed Consent
197
CHAPTER 65 Deception of Research Subjects
210
CHAPTER 68 ResearchRelated Injuries
229
CHAPTER 612 Informed Consent Evaluation Feedback Tool
246
CHAPTER 92 Research in Public Schools
341
CHAPTER 94 Requiring Birth Control to Participate in Research
351
CHAPTER 96 Research Involving Pregnant Women
363
CHAPTER 98 Research Involving Adults with Decisional Impairment
373
CHAPTER 910 Research Involving College Students
384
A Brief Guide for Institutional Review Boards
394
CHAPTER 104 Ethnographic Research
402
CHAPTER 106 EpidemiologyPublic Health Research
415
CHAPTER 109 Humanitarian Use Devices
431
CHAPTER 1012 TreatmentWithholding Studies in Psychiatry
450
CHAPTER 1014 Research Involving Genetic Testing
465
CHAPTER 112 Selected U S Government Regulations
487
CHAPTER 113 Guidelines and Resources
519
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Om forfatteren (2006)

Dartmouth IRB

Robert Amdur was a member and Chairman of the IRB at Dartmouth College/Dartmouth Hitchcock Center for several years. Dr. Amdur currently focuses on advancing medicine in the field of radiation oncology.

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