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.
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2. requirements and waivers
assent
requirements and waivers
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U-MIC
University of Michigan IRB Collaborative

3. Assent assent parental permission subjects under 18
may be oral or written
may contain less detail than adult consent
parental permission
must contain all required elements of informed consent
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4. Assent assent waiver subjects are incapable of assent or
direct benefit unavailable outside research
IRB should consider subjects’
age
maturity
psychological state
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5. Assent
assent waiver
study meets criteria for waiver of informed consent
minimal risk
waiver will not adversely affect subjects’ rights or welfare
research could not be conducted without waiver
where appropriate, subjects will receive information after participating
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U-MIC

6. parental permission signatures
Assent
parental permission signatures
one parent
no more than minimal risk or
direct benefit
both parents
more than minimal risk
and
no direct benefit
IRB may allow one signature if
one parent has sole legal custody
other parent is deceased
unknown
incompetent
not available
document in study record
contact IRB for guidance
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U-MIC

7. parental permission waivers
Assent
parental permission waivers
HHS regulations (45 CFR 46)
parental permission not a reasonable requirement to protect subjects
abuse
neglect
substitute mechanism to protect minors
must be consistent with all laws
waivers of parental permission are not allowed in FDA-regulated research
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8. Assent
Assent
requirements and waivers
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U-MIC

9. thank you.
Brian Seabolt
IRBMED
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U-MIC