1. 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

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

3. informed consent document subject signature waiver of documentation
Documentation of informed consent
informed consent document
subject signature
waiver of documentation
subject provides consent
no signature
Developed by:
U-MIC

4. 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

5. 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

6. 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

7. 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

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

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