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assent

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 . assent. requirements and waivers. assent subjects under 18 may be oral or written may contain less detail than adult consent

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assent

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  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. assent requirements and waivers Developed by: U-MIC University of Michigan IRB Collaborative

  3. assent • 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 Assent Developed by: U-MIC

  4. assent waiver • subjects are incapable of assent • or • direct benefit unavailable outside research • IRB should consider subjects’ • age • maturity • psychological state Assent Developed by: U-MIC

  5. assent waiver • study meets criteria forwaiver 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 Assent Developed by: U-MIC

  6. parental permission signatures • oneparent • no more than minimal risk • or • direct benefit Assent • bothparents • 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 Developed by: U-MIC

  7. 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 Assent Developed by: U-MIC

  8. Assent Assent requirementsand waivers Developed by: U-MIC

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

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