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documentation of Informed consent requirements and waivers Developed by: U-MIC University of Michigan IRB Collaborative

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Department of Health and Human Services (HHS) 45 CFR 46 Documentation of informed consent Department of Health and Human Services (HHS) 45 CFR 46 minimal risk no consent requirement outside research context or consent document links subject to study privacy/confidentiality risk Developed by: U-MIC

Food and Drug Administration (FDA) 21 CFR 56 Documentation of informed consent Food and Drug Administration (FDA) 21 CFR 56 minimal risk no consent requirement outside research context Developed by: U-MIC

Documentation of informed consent Department of Health and Human Services (HHS) 45 CFR 46 minimal risk no consent requirement outside research context or consent document links subject to study privacy/confidentiality risk Food and Drug Administration (FDA) 21 CFR 56 Developed by: U-MIC

waiver of documentation subject provides consent no signature Documentation of informed consent waiver of documentation subject provides consent no signature subjects may receive written material about the research Developed by: U-MIC

Documentation of informed consent requirements and waivers Developed by: U-MIC

thank you. Brian Seabolt IRBMED Developed by: U-MIC