To start the presentation click on this button
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC 1
DOCUMENTATION OF INFORMED CONSENT requirements and waivers Developed by: U-MIC University of Michigan IRB Collaborative
Documentation of informed consent document • subject signature waiver of documentation • subject provides consent • no signature Developed by: U-MIC 3
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 4
Documentation of informed consent Food and Drug Administration (FDA) 21 CFR 56 • minimal risk • no consent requirement outside research context Developed by: U-MIC 5
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 minimal risk no consent requirement outside research context 6
Documentation of informed consent waiver of documentation • subject provides consent • no signature • subjects may receive written material about the research Developed by: U-MIC 7
Documentation of informed consent requirements and waivers Developed by: U-MIC 8
THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 9
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