General Discussions

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  • 1.  Continuing Review Processing

    CAYUSE CHAMPION
    Posted 04-11-2023 13:44

    For those using Human Ethics Platform, how do you process a Continuing Review Submission that falls under the "no longer need review?" Noticed there isn't a decision for "Close." Do you approve the submission, then close the study on the Administrative end?

    What is your process?



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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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  • 2.  RE: Continuing Review Processing

    RISING STAR CONTRIBUTOR
    Posted 04-12-2023 05:55

    Hi Amanda,

    When you say "no longer need review," do you mean that the study no longer involves human subjects activities so the IRB protocol can be closed? Or do you mean that the study no longer needs continuing review, even if it still includes human subjects activities?

    I don't think we've encountered the former much, but if we did, then I'd say that we'd probably just administratively close the study and not bother with approving the renewal.

    If the latter, then we'd approve the renewal but not assign as expiration date. 



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    Scott Fisher
    Director, Human Research Protection Program
    New York University (NYU)
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  • 3.  RE: Continuing Review Processing

    CAYUSE CHAMPION
    Posted 04-12-2023 06:18

    Hi Scott,

    Appreciate your response. "No longer need review" as in "K" in the Continuing Review Guidance (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html)

    Our Customer Success Manager mentioned the closure would be a separate submission. Either created by Admin or submitted by the PI. Guessing the PI and Research Team would receive two letters?



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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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