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  • 1.  Committee Review of Expedited Reviews

    This message was posted by a user wishing to remain anonymous
    Posted 8 days ago
    This message was posted by a user wishing to remain anonymous

    This is one for the IRB Folks,

    I am wondering if anyone has come across the idea of the Committee voting at a meeting to "ratify" protocols that have been reviewed and approved by expedited review.

    Also, what are your thoughts on having "non-voting members" on the the IRB.

    Thanks


  • 2.  RE: Committee Review of Expedited Reviews

    CAYUSE CHAMPION
    Posted 7 days ago

    Hi! Given that an expedited approval is equivalent to a full board approval- and has had to meet specific requirements regarding risk- I am not sure I see the point of adding a "ratification" process. The project has already been approved. It has met its regulatory obligation.

    I see less problem with non-voting members, so long as there is a reason for them to be there. For example, alternate IRB members could attend but not vote, and specialists could be present and not vote. But keep in mind the meetings are confidential, so I would carefully weight each attendee.

    I hope this helps!



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    Dana Lawrence
    Associate Provost for Research and Education
    Parker University
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  • 3.  RE: Committee Review of Expedited Reviews

    Posted 7 days ago
    Expedited approvals do not require "ratification" per se. Notification of their approval must be made to the Board members per regulations. We do take a vote on protocols reviewed via exempt and expedited review, however, the vote is for the verification of receipt of the notification, not to ratify agreement with their approval. Our local VAMC requires this documentation in our minutes since we are their IRB of record.

    We do have non-voting members in attendance (ex-officio's). Most are representatives of entities that our IRB reviews on behalf of, such as the local VAMC, and others are project specific consultants. We do have biomedical ethics graduate students observe the meetings from time-to-time. All are required to sign a confidentiality agreement in order to attend.


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    Whitney McAllister
    Director, Human Research Protection Program
    Wright State University
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  • 4.  RE: Committee Review of Expedited Reviews

    CAB Member
    Posted 7 days ago
    Hi!

    Our IRB has 3 non-voting members, who have the analyst role (previews research applications). I am 1 of those 3, and also serve in the role of IRB Administrator/Director (manage our Human Research Protection Program).

    Your other question is very interesting. However, want to ensure I'm interpreting it correctly. That is, are you describing the review process at convened meetings (i.e., Board "ratifying" previous research materials approved via expedited review)? Or, are you asking about the procedure (i.e., the materials continue to be reviewed for risk as research is conducted within myriad contexts and different populations)?

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    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541
    irb@ets.org
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  • 5.  RE: Committee Review of Expedited Reviews

    Posted 7 days ago

    Protocols reviewed under the expedited procedures are reported to the board to keep members updated on proposals approved; the WMU IRB updates each convened meeting on all new expedited protocols that were approved since the last meeting.  Members may ask questions, can raise concerns; the minutes provide a summary of questions/concerns, should any be raised by members.  The report is accepted/approved and the vote recorded. 

     

    Best,

    Julia

     

     

    Julia A. Mays
    Associate Director Research Compliance  
    Office of Research and Innovation
    1903 W. Michigan Avenue MS 5456
    251W Walwood Hall
    Kalamazoo, MI  49008-5456
    Phone: 269-387-8293
    Fax: 269-387-8276
    julia.mays@wmich.edu

      

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