Institutional Review Board: Management and FunctionJones & Bartlett Learning, 2006 - 530 sider 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,and HIPAA. |
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... Protocol Review and the Full - Committee Meeting CHAPTER 5-1 Overview of Initial Protocol Review 119 Sarah T. Khan and Susan Z. Kornetsky CHAPTER 5-2 Evaluating Study Design and Quality 126 Robert J. Amdur CHAPTER 5-3 The Study ...
... Protocol Review and the Full - Committee Meeting CHAPTER 5-1 Overview of Initial Protocol Review 119 Sarah T. Khan and Susan Z. Kornetsky CHAPTER 5-2 Evaluating Study Design and Quality 126 Robert J. Amdur CHAPTER 5-3 The Study ...
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Innhold
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 Compassionate Use and Emergency Use Exemption | 106 |
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 |
CHAPTER 92 Research in Public Schools | 341 |
CHAPTER 94 Requiring Birth Control to Participate in Research | 351 |
CHAPTER 51 Overview of Initial Protocol Review | 119 |
CHAPTER 54 Community Consultation to Assess and Minimize Group Harms | 134 |
CHAPTER 56 Recruitment of Research Subjects | 147 |
CHAPTER 59 Provisions for Data Monitoring | 160 |
Recruitment Incentives | 173 |
CHAPTER 514 Guidelines for Review Discussion and Voting | 187 |
Informed Consent | 197 |
CHAPTER 65 Deception of Research Subjects | 210 |
CHAPTER 68 ResearchRelated Injuries | 229 |
CHAPTER 612 Informed Consent Evaluation Feedback Tool | 246 |
CHAPTER 74 Data and Safety Monitoring | 262 |
CHAPTER 75 Noncompliance Complaints Deviations and Eligibility Exceptions | 265 |
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 |
Andre utgaver - Vis alle
Institutional Review Board: Management and Function Robert J. Amdur,Elizabeth A. Bankert Utdragsvisning - 2002 |
Institutional Review Board: Management and Function Elizabeth A. Bankert,Robert J. Amdur Utdragsvisning - 2006 |
Institutional Review Board: Management and Function Robert J. Amdur,Elizabeth A. Bankert Ingen forhåndsvisning tilgjengelig - 2002 |
Vanlige uttrykk og setninger
18 April activity application appropriate audit Belmont Belmont Report benefits Bioethics biomedical chapter clinical trials Code of Federal committee compliance conducted confidentiality conflict of interest consent document consent form consent process consider criteria decision Declaration of Helsinki determine device DHHS discussed Drug Administration DSMB enrolled ethical evaluate example exempt expedited review Federal Regulations fetus Food and Drug guidance guidelines harm Health and Human HIPAA Human Research Protections Human Services identified individual informed consent Institutional Review Board investigational new drug investigator IRB administrative IRB approval IRB chair IRB meeting IRB members IRB office IRB review IRB's issues ment minimal risk monitoring Nuremberg Code OHRP patients person Phase placebo potential procedures Protection of Human recruitment regulatory research involving human research participants research study research subjects responsibility review board IRB specific sponsor standard Subpart tion tissue treatment Updated vulnerable waiver
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