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IAAs in Human Ethics

  • 1.  IAAs in Human Ethics

    Posted 08-30-2021 07:26
    We are the Relying IRB for a protocol that received Expedited Category 5 approval. The research team uploaded all relevant documents to Cayuse, including the signed IAA. My question is what do I do with the protocol now? If I assign the review type as expedited, I have to assign someone to the review when really all I want to do is push the protocol through Cayuse myself so we can issue a letter to the PI. This is our first IAA and perhaps I'm missing something, so any procedural guidance will be greatly appreciated. 

    Thanks in advance for your help!

    Marnie Shaffer
    IRB Manager
    Franklin University

  • 2.  RE: IAAs in Human Ethics

    Posted 08-31-2021 13:29
    At this point, I think you are correct - you will need to assign it to someone to review and approve. This will of course appear in your reports as an expedited approval from your institution, which is not completely accurate.

    At this point, we do not enter IAAs where we are ceding review into Cayuse.

    I know some institutions build in an option in the initial submission template ( @Hila Berger did a presentation on this last year) to simplify reliance on other IRBs. I did not want to have that as the first question because it caused more confusion for our investigators, and combined with other required fields in an initial submission, made a great deal of effort on our PI. From my experience,  all that really needs to be retained is the executed IAA and the approval from the other institution.  I know not every institution operates this way, but my office handles almost all of the work on processing the IAA and we simply inform the PIs (and grants office if applicable) when the executed agreement is in place and they are approved.

    I am hoping to see a new submission type that an analyst can enter and approve to allow items such as IAAs, 118 determinations, and probably a few others (administrative change of PI perhaps?)​​​

    Matt Zembrzuski
    Research Compliance Manager
    American University