General Discussions

In Human Ethics I have a reviewer who made a decision so the submission moved to Post Review; however, we actually need to have the reviewer make a change to their decision as they chose the wrong decision from the drop down by mistake.  As the Analyst, do I click on "Redo"?  What actually will this do?  Will this send it back to the reviewer but still maintain all the previous rounds of review/comments?  I just want my reviewer to go back in and change the decision from the drop down.

Thanks.

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Leigh Schectman, MPH
Research Protections Coordinator
California Lutheran University
Thousand Oaks, CA
lschectman@callutheran.edu
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Good day, Leigh!

I really appreciate this question and so many IRBs do things in different ways. In this case, you have a couple of options. 

1. From the Post-Review submission screen, you could click "change" then drop-down and select "Reviewers" which then stops the review from sticking and enables you to "reassign" the same reviewer(s) to modify their review and decision. They'll receive the notification to complete the review again and can make the change there. Essentially, this accomplishes the same thing as the "Redo" button when you asked what it would do.
2. An Admin/Analyst (often a shared role) can edit the "Make Decision" screen and go in to adjust the drop down the reviewer elected, modify the categories, and even clean up clerical issues in the "Findings" or "Researcher Notes" sections if desired. If you make the adjustment on behalf of the reviewer(s), I would encourage you to add an "internal note" at the bottom of the record indicating that this was done just to track it on your end. The internal note does not appear on the communications to the researcher and will live within the record.

The option you elect will, of course, depend on how your IRB wishes to proceed (perhaps even devising an internal SOP so that it is documented practice in the event it happens again). I had to develop several of these in my time as a research admin for knowledge transfer and consistency to present in the event an auditor made their way to my office.

You would probably want to utilize option 2 in the circumstance where a reviewer would not easily be able to access their review again (i.e., recently removed from the reviewing board, or other extenuating circumstances where the reviewer could not/would not redo their review to ensure tracking is automated rather than manual).

Thank you for the question and keep them coming! We're happy to help!

*Note: I amended this slightly since my first post of this response.

Warm regards,
Darlene

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Darlene Nawrocki
Sr. Solutions Consultant, Compliance
Cayuse

Original Message:
Sent: 11-01-2023 13:49
From: Leigh Schectman
Subject: Change a Decision

In Human Ethics I have a reviewer who made a decision so the submission moved to Post Review; however, we actually need to have the reviewer make a change to their decision as they chose the wrong decision from the drop down by mistake.  As the Analyst, do I click on "Redo"?  What actually will this do?  Will this send it back to the reviewer but still maintain all the previous rounds of review/comments?  I just want my reviewer to go back in and change the decision from the drop down.

Thanks.

------------------------------
Leigh Schectman, MPH
Research Protections Coordinator
California Lutheran University
Thousand Oaks, CA
lschectman@callutheran.edu
------------------------------