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.
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.
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 -- email@example.com. Here it goes:
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).
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.
Daniel R. Kirienko, Ph.D.
Preferred pronouns: he, him, his
Compliance Administrator II (IBC and SCRO)
Office of Research Integrity
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