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\nTable of Contents  \nUse of the Investigators Manual ..................................................................................................... 3  \nHuman Participants Research Overview ........................................................................................ 3  \nIs submission to the IRB required? ............................................................................................. 3  \nGoverning Principles: The Belmont Report (Foundation for 45 CFR 46) .............................. 4  \nBeneficence ............................................................................................................................. 4  \nAutonomy/Respect.................................................................................................................. 4  \nJustice...................................................................................................................................... 4  \nFunction of the IRB ........................................................................................................................ 7  \nOU-Norman Campus .................................................................................................................. 7  \nOUHSC ....................................................................................................................................... 7  \nStudies Conducted in Collaboration between Norman and OUHSC Faculty............................. 7  \nComposition of the IRB .................................................................................................................. 8  \nResponsibilities of Sponsors ........................................................................................................... 9  \nQualifications and Responsibilities of Principal Investigators ..................................................... 10  \nEducation Requirements ........................................................................................................... 10  \nResearch Submission Requirements ......................................................................................... 10  \nVA Research Requirements ...................................................................................................... 10  \nIRB Submission Forms ............................................................................................................. 11  \nIRB review categories ................................................................................................................... 12  \nExempt From Review ............................................................................................................... 12  \nExpedited Review ..................................................................................................................... 12  \nFull-Board Review .................................................................................................................... 13  \nAdditional (Non-IRB) Reviews that may be Required................................................................. 14  \nOffice of Research Administration (OUHSC) or Office of Research Services (Norman) ....... 14  \nVeterans Affairs Medical Center (VAMC), Oklahoma City .................................................... 14  \nInstitutional Biosafety Committee (IBC) .................................................................................. 14  \nRadiation Safety Committee ..................................................................................................... 14  \nCancer Center (OUHSC) Scientific Review Committee .......................................................... 14  \nIRB Initial Review and Criteria for Approval .............................................................................. 15  \nIRB Categories of Act","cbCaihnFK2WELFGF","https://ap.wps.com/l/cbCaihnFK2WELFGF","pdf",323385,24,"English","# Use of the Investigators Manual\n# Human Participants Research Overview\n# Governing Principles: The Belmont Report (Foundation for 45 CFR 46)\n# Function of the IRB\n# Composition of the IRB\n# Responsibilities of Sponsors\n# Qualifications and Responsibilities of Principal Investigators\n# Research Submission Requirements\n# IRB Submission Forms\n# IRB review categories\n## Exempt From Review\n## Expedited Review\n## Full-Board Review\n# IRB Initial Review and Criteria for Approval\n# IRB Communication & Notification\n# Advertising and Recruitment of Research Participants\n# Special Populations\n# IRB Categories of Action\n# Suspension or Termination of IRB Approval","[{\"question\":\"When is IRB submission required for research involving human participants?\",\"answer\":\"The manual includes a section explicitly addressing whether submission to the IRB is required, guiding investigators on when IRB involvement is necessary.\"},{\"question\":\"What principles guide IRB review under the Belmont Report?\",\"answer\":\"The manual lists governing principles from the Belmont Report, including Beneficence, Autonomy/Respect, and Justice, providing the foundation for ethical review.\"},{\"question\":\"What are the IRB review categories and how do they differ?\",\"answer\":\"The manual describes review categories including Exempt From Review, Expedited Review, and Full-Board Review, indicating different levels of review for various study types.\"}]","Investigator's Manual - Research Involving Human Participants - Human Research Participant Protection Program - January 15, 2010 | PDF",1789849912,8]