Institutional Review Board: Management and FunctionThis 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. |
Contents
CHAPTER 12 Reflections of an Outsider | 9 |
Definition and Federal Oversight | 24 |
CHAPTER 21 Administrative Reporting Structure for the Institutional Review Board | 31 |
Copyright | |
35 other sections not shown
Other editions - View all
Institutional Review Board: Management and Function Elizabeth A. Bankert,Robert J. Amdur Limited preview - 2006 |
Institutional Review Board: Management and Function Robert J. Amdur,Elizabeth A. Bankert No preview available - 2002 |
Common terms and phrases
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
References to this book
Playing Politics with Science: Balancing Scientific Independence and ... David B. Resnik Limited preview - 2009 |