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CHAPTER 12 Reflections from the Office of the Inspector General
CHAPTER 15 The Tension Between Science and Ethics
CHAPTER 21 Administrative Reporting Structure for the IRB
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Access date 18 activities adverse event application appropriate audit Belmont Report benefits biomedical clinical trials Code of Federal committee compliance conduct confidentiality conflict of interest consent document consent form consent process consider criteria date 18 Apr decision Declaration of Helsinki determine device DHHS discussed Drug Administration DSMB ensure evaluate example exempt expedited review Federal Regulations fetus Food and Drug full-committee gene therapy guidelines harm Health and Human Human Services identified individual informed consent Institutional Review Board investigator involving human subjects IRB administrative IRB approval IRB Chair IRB meeting IRB members IRB office IRB review IRB's issues Jesse medical records ment minimal risk monitoring Nuremberg Code OHRP patients persons placebo potential Protection of Human recruitment regulatory research participants research subjects responsibility revision specific sponsor staff standard Subpart therapy tion treatment waiver World Wide World Wide Web written procedures