1 / 9

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

dayo
Télécharger la présentation

assent

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related