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  • 1.  Processing Projects overseen by an External IRB in Human Ethics

    Posted 08-24-2023 06:19

    Our team is new to Cayuse Human Ethics and we're seeking insights on how other organizations handle study submissions that are overseen by an external IRB. In our old system, we were able to process these submissions administratively to maintain records, but it seems this isn't an option with HE.

    Any insight you may have is greatly appreciated. 



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    Leslyn Boyles
    IRB - Director
    Texas Tech University, Amarillo
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  • 2.  RE: Processing Projects overseen by an External IRB in Human Ethics

    STAR CONTRIBUTOR
    Posted 08-25-2023 07:34

    Leslyn,

    We have a top-level question about what kind of review is requested.  Reliance on another IRB is one of those choices.  It triggers a unique section for uploading the signed agreement, protocol reviewed by the external IRB, etc.

    This may be too small to really see our design.

    For workflow, we process it as exempt by analyst.  We have a separate letter that states "acknowledge" for the action rather than exempt.

    I'd be happy to demonstrate if that would be helpful.

    Regards,

    Darcy



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    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
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    Original Message


  • 3.  RE: Processing Projects overseen by an External IRB in Human Ethics

    RISING STAR CONTRIBUTOR
    Posted 08-25-2023 07:43

    Hi Leslyn,

    We have a somewhat complicated process for this, so I'll try to explain it here. But please feel free to contact me directly if you have any follow up questions -- srf291@nyu.edu. Here it goes:

    1. We use SSO, so we asked our IT User Account folks to create a special account/login for us. This account allows us to access Cayuse as a user and to share the login information (user name and PW) among our HRPP staff, rather than using one staff member's individual account and limiting access to that person.
    2. Within our initial submission template, we created a few "secret" sections that are specific to when we rely on another IRB -- we don't require a full IRB protocol in these situations and need to document only basic information about the study and reliance, e.g., executed agreement, grant information, external IRB approval letter, etc. These sections populate based on a somewhat complicated logic, where there are a couple "dummy" selections for other questions. We do it in this complicated/"secret" way to prevent investigators from accidently populating the sections when completing a normal application. 
    3. We complete the reliance request and execution process outside of Cayuse (i.e., via Word forms completed by the PI and then reviewed via email). Once we've approved the reliance request and are ready to create a record of the reliance, we use the special account to create a new study in Cayuse HE and then our HRPP staff complete the entire application ourselves. We list the special account as the Primary Contact but the real PI as the PI. However, when it's time to certify, we administratively certify it so the PI doesn't have to do anything at all in Cayuse HE. Unfortunately, Cayuse HE doesn't allow administrative bypass of organizational approval, so if you use the org approval process/feature then they'll still need to do that -- we usually email the org. approvers to let them know what's happening. The HRPP staff then log into their personal account and process the submission by assigning it as an Exempt review type w/ an Analyst serving as the reviewer. The decision is Rely on External IRB and we also flag for External IRB reliance. Unfortunately, there's no Administrative review type, so we have to use Exempt; Cayuse is aware of this issue and says that it's a priority to fix. (We've had some problems with listing the real PI as the PI on the application -- most often with them submitting unnecessary/incorrect modifications/renewals/incidents -- but currently we still list them as the PI for reporting/search purposes). 
    4. Throughout the process we email the PI letting them know that we're completing the record in Cayuse HE for them and that as the PI they will receive some automated emails (e.g., need to certify, etc) that they should ignore. Also, because much of our reliance process is completed outside of Cayuse HE and we really only use Cayuse HE to document/keep a record of the reliance, we have a separate spreadsheet the tracks things, including the Cayuse HE study number for the reliance record. 

    Again, that's a pretty complicated/convoluted process, so please contact me directly with any questions if you think it'd be helpful. (Others on here may have a much simpler/better way so you may want to ignore our process completely). 



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    Scott Fisher \
    Director, Human Research Protection Program
    New York University (NYU)
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    Original Message


  • 4.  RE: Processing Projects overseen by an External IRB in Human Ethics

    Posted 08-25-2023 08:46

    Hello Dr. Boyles,

     

    We actually do this via a fairly intuitive method.

     

    First, once the agreements are all arranged, we have a shortened version of our general IRB protocol page that asks investigators to upload copies of the outside IRB approval, the protocol, the informed consent, and the reliance agreement. From there, there is a decision in the Cayuse HE software that lets the determination be "Rely on External IRB", so we choose that. Finally, we flag the study in the study section hat tit is an External IRB for our recordkeeping.

     

    Once that is done, we administratively authorize it and send out a determination letter requesting our researchers to follow the guidance of the IRB of Record and to report any issues to us promptly. If there are particular or unusual criteria in the reliance agreement, we'll also include those in the determination letter, just in case the investigators didn't notice it before.

     

    Best,

     

    Daniel R. Kirienko, Ph.D.

    Preferred pronouns: he, him, his

    Compliance Administrator II (IBC and SCRO)

    Office of Research Integrity

    Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005

    Tel: 713.348.7349 

    dk32@rice.edu

     

     

     

     




    Original Message


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