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  • 1.  Cayuse HE - Timelines for Closure/Withdrawal of IRB Submissions Returned to Investigators for Clarification/Revision

    CAYUSE CHAMPION
    Posted 18 days ago

    Hello Colleagues,

    My institution is refining our policy regarding IRB applications that have been reviewed and returned to investigators with review comments/request(s) for revision(s) but are languishing in our online system with no additional response from the investigators. So I'm hoping to get input on whether or not other institutions have a policy in this regard. Specifically, I'm interested in finding out whether or not your institution has a policy regarding withdrawal/closure of an IRB application/submission by your office due to a lack of response by investigators. If your institution has such a policy;
    • Is the policy unofficial or official (posted on website, noted in the notification of review comments/request(s) for revisions, etc.)?
    • What is the timeframe after which your office would withdraw/close the application/submission (e.g., 90 days, one year)?
    • Does your office send a reminder/notification that the study will be closed/withdrawn after a certain date and, if so, can the investigators request an extension?
    • Have you had any issues arise after withdrawing/closing a study?
    • Is there any other relevant/related information you'd like to share?

    If your institution does not withdraw/close for a lack of response, I'm interested in the reasoning for not doing so.

    I thank you in advance for any input you can provide!
    Jenn



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    Jennifer Dier CIP, CIM, CHRC, CCRP
    Assistant Director, Office of Research Compliance Administration (ORCA)
    University of California Santa Cruz
    jdier@ucsc.edu
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  • 2.  RE: Cayuse HE - Timelines for Closure/Withdrawal of IRB Submissions Returned to Investigators for Clarification/Revision

    CAB Member
    Posted 18 days ago

    Hi, Jenn!

    Our institution does not have investigators or projects who do not address IRB reviewer feedback.  I sometimes need to remind PIs/ project teams to certify submissions so they are routed to IRB for review; or, I inquire about unsubmitted forms sitting for over a month.


    * our institution does not have a policy nor a timeline for projects to address reviewer feedback (most take no more than 2 weeks)
    * if a submission were to languish, I would meet with the PI/team to understand the situation; if needed, I would ask the PI to withdraw
    * N/A, unless requested by the PI/team for the IRB to Withdraw it; for those that don't languish HE has notifications/ability to extend
    * N/A; however, for non-languishing forms, we have not experienced an issue with form withdrawals
    * the regulations allow for and provide institutions to have the much needed leeway to deal with internal institutional issues

    I'm confident you and your institution will devise a solution that meets the needs of the IRB, it's office and the investigators and teams.

    Best,
    Dawn



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    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541
    irb@ets.org
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  • 3.  RE: Cayuse HE - Timelines for Closure/Withdrawal of IRB Submissions Returned to Investigators for Clarification/Revision

    Posted 14 days ago
    Hi Jennifer.
    At previous institutions we had a 90 day rule. The investigator was required to respond (to request for mods required or a deferral) within 90 days or that submission/application would be administratively closed. The exception was if the response could not be provided (such as when other things had to occur first or where out of the researcher's control). Before any actions were taken, there was a documented attempt or two to reach out to the PI to remind of response lag, see if more time  or help were needed, etc.
    Perhaps this is what you had in mind?

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    Gabrielle Rebillard
    HRPP Director
    WellSpan Health
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