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  • 1.  Updates to Human Ethics Initial Submission template

    RISING STAR CONTRIBUTOR
    Posted 12-23-2021 07:12
    Happy holidays to all here in the Cayuse Connect Community!

    I am hoping to get some advice on some updates I am currently making to my institution's Initial Submission template in Human Ethics. The changes are related to the new exempt category 4 (Secondary Use). What kinds of questions do you include in the application template so the IRB can determine that the study meets the criteria for this "re-imagined" exemption? What about the other exempt categories? Do you include any questions to lead the IRB to better determine that studies meet those exemptions? It would be great if I could see sample questions regarding these new or revised exemptions! Any help you can provide, I would be most grateful to receive. Please feel free to contact me offline at irb@shsu.edu. Thank you in advance for your help and advice. Be safe this holiday season!
    Christmas treeHappy Holidays & Happy New Year


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    Sharla Miles, M.Ed., CIP
    Director, Research Compliance
    Sam Houston State University
    Huntsville, TX
    (936) 294-4875
    sharla_miles@shsu.edu
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  • 2.  RE: Updates to Human Ethics Initial Submission template

    RISING STAR CONTRIBUTOR
    Posted 12-28-2021 06:01

    Hi, Sharla!  We are a small educational institution, working on primarily SBER-based projects, some federally-funded.

    For secondary uses, we ask the project to specify what data is being analyzed, for what purpose(s) and if the obtained consent covers it.

    Limited reviews are conducted:  to ensure relevant permissions are documented; that only de-identified data is available, including procedures to confirm no re-identification of participants; and, any appropriate paperwork is completed, if outside the institution (e.g., a Data Use Agreement for collaborative research or a non-disclosure for external partners should an identifiable cross-walk be involved).

    Best,

    Dawn 



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    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541
    irb@ets.org
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