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  • 1.  Minor Administrative Modifications

    Posted 05-11-2023 10:38

    Is there a quick way to process a modification on a previously approved Expedited study, where the modifications are just typographical errors, the content has not changed.  Wondering if an Analyst can approve or is there an Administrative Approval? Or since it was originally approved through the Expedited process and not Exempt, does it need to go through the whole workflow of assigning a primary reviewer  and making the determination?

    Thank you.

    Leigh Schectman
    IRB Coordinator
    California Lutheran University

  • 2.  RE: Minor Administrative Modifications

    Posted 05-11-2023 12:21
    Edited by Darlene Nawrocki 05-11-2023 13:45

    Hi Leigh!

    That's a great question. I have absolutely been there when I was auditing previously approved studies and came across some minor (dare I say even egregious grammatical mistakes). If someone on the research team is willing to put forward an amendment to clean that up, then yes, there is the ability to assign yourself as the "sole" or Administrative reviewers on an Expedited or Exempt study. The caveat to this is that you can't make changes on behalf of the researcher. In short, it DOES require the need to go through the routing workflow, but you can make yourself that reviewer rather than having to send it out for a review to other committee members. 

    If the researcher knows already what to fix then they can go ahead and do it. Otherwise:

    1. They can submit an unchanged amendment just summarizing that the intent of the amendment is to correct grammatical errors that weren't corrected upon initial approval.
    2. Once submitted, you'll assign yourself as the analyst where you are leaving feedback on a question by question basis of where the grammar changes are required. (that is unless the researcher already KNOWS where to make the corrections before submitting it to you).
    3. Ensure you are listed on the committee so that your reviewer permissions are enabled.
    4. Select an Expedited review type (as an analyst) to retain the approved risk level determination from the initial review (or most recent amendment).
    5. Assign yourself as a Primary Reviewer and proceed through the review process.
    6. You'll be making the determination as an IRB Member/reviewer and confirming that decision as an "Analyst" since the Analyst role is that stop gap between reviewers before it gets back to the PI (so you're "reviewing" it twice).
    7. You can, then, approve the changes as a sole primary reviewer and you'll complete your post review process the same way. Just keep the original expiration date in tact and re-stamp the consent form with the new approval date range so the documents.
    8. You'll want to ensure the same categories are selected from the last determination and notate in the comments that this amendment was for the sole purpose of grammatical correction -- no changes to aims, procedures, or personnel were made and you facilitated an "Administrative" Review.

    **Please know that my recommendations above are how to facilitate these reviews in the system and you'll definitely want to check with your Chair and IRB Members to ensure that this process is acceptable prior to doing it. Again, the fact that the researcher/PI will be the one actually MAKING the changes in the protocol itself assist in maintaining the integrity of the submission.**

    I hope this helps. Please reach out if I, or Cayuse, can help further!

    Darlene Nawrocki
    Solutions Consultant, Compliance

  • 3.  RE: Minor Administrative Modifications

    Posted 05-12-2023 07:40

    As a  quick follow up to Darlene's comment, I would just emphasize that for an expedited study, the "reviewer" must be on the IRB roster as an IRB member within Cayuse IRB.

    This has been an issue for us because not all of our staff that may conduct administrative reviews are IRB members. As a workaround, we used to add our non-member staff to the roster in Cayuse IRB as "fake" members (we'd had a clear note in their roster information that they were not actually members), but we've since abandoned this approach because it made our meeting minutes incorrect (e.g., they'd still be listed as regular members in the minutes, so the auto-populate attendance information in the minutes would be wrong and couldn't be used to confirm quorum).

    Now, we sometimes assign the review type for a modification as exempt (even if the study as a whole is expedited) because this allows an analyst to be the reviewer. However, this is not ideal as the information in the system available to PIs/auditors says that the submission was reviewed as exempt, which can be confusing, even though we still send a standard expedited approval letter.

    To address this issue (and many others), we've asked Cayuse to create a new administrative review type that would allow an analyst to be the reviewer, while still making it clear that the study as a whole is expedited. 

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