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Checklists for Special Determinations

  • 1.  Checklists for Special Determinations

    Posted 13 days ago
    ​​I was wondering how others handle checklists and/or criteria for approval for Special Determinations (ie, Children, Pregnant, Cognitively Impaired Adults, etc) at Initial review and for Renewals?

    Do you have the criteria for each of the above built into your IRB Reviewer checklist?

    And if so, how do you provide the original determination or checklist to the reviewers at the time of renewal since the regulations require the reviewers to confirm that there are no changes to the original determination? 

    If you don't have the criteria built into your IRB Reviewer checklist, what is your process? 

    I appreciate any feedback!!!

    Beth Lynch
    Senior IRB Analyst
    Einstein Healthcare Network

  • 2.  RE: Checklists for Special Determinations

    Posted 7 days ago
    Thank you Beth, tagging here some experts that might be able to help answer your question: @Marnie Shaffer, @Tim Deering, @Hila Berger, @Matt Zembrzuski, @Deanna Kotila, @Michael Leary, @Jonathan Lyon​​​​​​​. Thank you all and Happy Thanksgiving week!

    Colette Akiki
    Sr. Customer Advocacy Manager

  • 3.  RE: Checklists for Special Determinations

    Posted 2 hours ago
    Hey Beth,

    We have embedded the subpart criteria in the application itself, as modules which expand should an applicant toggle one of the subpart populations. This allows the application to do the heavy-lifting in terms of filtering through the various regulatory decision trees and helps reviewers focus on the relevant protocol details. We then drop a study-specific subpart determination in the minutes. 

    The other component here, which involves Renewals, is handled through the IRB Reviewer Checklist. Here we have checkboxes for the Criteria for Approval and, in the case of Renewals, a checkbox affirming that prior determinations are applicable. We do not provide a copy of the prior determinations, but train our IRB Members to find that by going back to the Study Details page. I would think that a more proactive approach here could be to pull those initial determinations and drop them in the Agenda for each meeting, taking advantage of how Cayuse makes Agenda building so easy.

    Michael Leary
    Director of Research and Compliance, IRB
    Lindenwood University