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  • 1.  Waivers of Consent Documentation and E-consent

    This message was posted by a user wishing to remain anonymous
    Posted 03-04-2024 10:57
    This message was posted by a user wishing to remain anonymous

    Greetings All,

    After some internal discussions/debates, I wonder how other institutions manage documentation waivers. For example, a minimal-risk study plans on collecting handwritten consent for interviews, but those participants who participate via Zoom will the PI plans to obtain a written signature via electronic means, not just click "agree to participate" like for surveys. Would your HRPP/IRB still require a waiver of consent documentation?



  • 2.  RE: Waivers of Consent Documentation and E-consent

    CAYUSE CHAMPION
    Posted 03-05-2024 05:27

    Our students will sometimes obtain written signatures via online. In those instances, we mandate that they use a program that will collect a handwritten signature via signing by finger or with a stylus. We do not allow electronically generated signatures. Therefore, this is still written consent and does not qualify for waiver of consent documentation. 



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    Alicia Scott
    IRB Director
    The Chicago School of Professional Psychology
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    Original Message


  • 3.  RE: Waivers of Consent Documentation and E-consent

    STAR CONTRIBUTOR
    Posted 03-06-2024 08:58

    We would consider this a waiver or alteration of one element of consent.  We allow for recorded consent before recorded interviews.



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    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
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    Original Message


  • 4.  RE: Waivers of Consent Documentation and E-consent

    Posted 03-07-2024 06:34

    I think that it is critical here to make the distinction between "minimal risk" and "Exempt". If the study is Exempt, you should follow what your organization's HRPP program requires. If the study is minimal risk but non-Exempt, you should follow 45 CFR46.117(c). 



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    Daniel R. Kirienko, Ph.D.
    Preferred pronouns: he, him, his
    IRB Compliance Lead
    Office of Research Integrity
    Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005
    Tel: 713.348.3586
    dk32@rice.edu
    ------------------------------

    Original Message


  • 5.  RE: Waivers of Consent Documentation and E-consent

    Posted 03-14-2024 11:02

    I completely redesigned our consent section. They can choose all that apply. Sample:



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    Tina Aubut
    Human Research Protections Assistant
    University of Southern Maine
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    Original Message


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