How are you all processing personnel revisions without an "Administrative Review" type? None of the review types we are given make sense.
Hello Ms. Boyles,
We've had some difficulty in determining how to handle this as well. The first thing that I would recommend is to check the SOPs for your IRB. There should be a way that you've documented that you're going to handle personnel changes. You should definitely follow those procedures.
The way that we generally handle it is that we run personnel changes under an Exempt review and have it reviewed and approved by IRB Administrators/Analysts. That being said, it is very important to ensure that the personnel being added have appropriate training and that they have the appropriate expertise for the study so that risks are not increased.
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
We follow the procedure that Daniel lists, If the changes are only to personnel, we assign a modification submission as exempt review and assign to an analyst.
I think you might be asking wrt HE, so my response might not be especially helpfuI, but in AO, we can process personnel revisions directly from the office role, without having to assign it to any specific reviewer.
We process research personnel changes by approving the modification under the same category that the original study is approved under. We do not change any determination in the modifications unless warranted by the changes requested.
We follow the same procedures that Matt and Daniel describe -- assign as exempt, even if study is expedited, so an analyst can review it.
We used to follow what Alicia described -- assigning the modification the same review type as the overall study -- but stopped this because it required all of our analysts to be listed as IRB Members in Cayuse HE, which caused problems for the attendance information in the full board minutes.
Good Morning Leslyn,
Hi Leslyn,We also processes research personnel changes as Alicia Scott notes; by approving the Modification Submission in which they are added under the same category that the original study is approved under without changing the determination unless warranted by the changes requested. Our analysts are alternate IRB members, so we don't run into the problems with minutes attendance information Scott mentions. As we are a small office this model works well. I can, however, see the benefit of the alternate method Daniel, Matt and Scott describe. We would likely use that model if our current process no longer served.Jenn
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