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  • 1.  Change in Decision from Disapproved to Not Approved

    RISING STAR CONTRIBUTOR
    Posted 12-18-2023 13:29

    Hi All,

    In the     November 16, 2023 - Human Ethics Release Notes it is noted that Decision Type updates have been made and include that the decision type of Disapproved has now been changed to Not Approved and is available across all review types in the system.

    It is also noted that m    ore information about the decision types can be found in the article, Understanding Decision Types in Human Ethics. In the article, the decision table identifies Not Approved as being only for full board decisions to not approve the research (IRB decision to to disapprove), see below:

    Decision Explanation
    Resulting Study Status (Note: Study Status will not change for legacy studies)
    Routing
    Not Approved

    The full board identified major issues with the study or submission and did not approved the research.

    In the case of an initial study that is Not Approved, a new study and submission will need to be created.

    For renewal, modification, etc. submissions that are Not Approved, the research team will need to create a new submission if they wish to proceed.

    		 Not Approved

    The submission and/or study are not approved and no longer editable.

    An initial submission that is not approved is archived.

    So now that Disapproved has been changed to Not Approved, when a convened IRB meets and makes a decision to disapprove, how are you entering that decision in Cayuse now that Disapproved is not an option?



    ------------------------------
    Jennifer B. Dier, CIP, CIM, CHRC, CCRP
    Assistant Director, Office of Research Compliance Administration
    University of California, Santa Cruz
    jdier@ucsc.edu
    ------------------------------


  • 2.  RE: Change in Decision from Disapproved to Not Approved

    TEAM CAYUSE
    Posted 12-26-2023 11:03

    Hello Jenn,

    Thank you for bringing to our attention the content of the article mentioned. We will have our team look at the content and make the necessary corrections. The change made to the decision was a label change to be available across all review types. In a case where a decision is made in a meeting to disapprove the submission, they will now select Not approved which is the same function as before except is available for all review types and just a change in the label.



    ------------------------------
    Jorge Alvarenga
    Senior Product Manager of Risk Management
    Cayuse
    ------------------------------

    Original Message


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