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  • 1.  IRB - Minimal Risk Procedures

    Posted 11-12-2021 09:07
    I am wondering if anyone has seen an IRB determine either of these types of procedures "minimal risk".

    • Leukapheresis for healthy adults performed by experienced blood bank personnel
    • Nasopharyngeal swab for healthy adults performed by RN

    Our IRB has discussed whether these can be classified as "minimal risk" and we are wondering if there is some precedent.
    I realize the initial review would always have to go to the full committee, but we are thinking about using expedite category 9 for continuing review.

    Any insights appreciated.


    Lisa Young
    Senior Compliance Administrator
    La Jolla Institute for Immunology

  • 2.  RE: IRB - Minimal Risk Procedures

    Posted 11-15-2021 06:44
    I have not.  The discomfort level of the nasopharyngeal swab seems to typically push it into more than minimal.  I also recall a number of people I know who would refuse to have one for COVID testing.  So I don't know if it could be considered a discomfort experienced in normal daily activities.

    I have not had a study involving leukapheresis cross my desk before so I do not have anything to contribute on that except for my personal experience donating plasma and winding up with a hematoma at the puncture site.  I don't know if I would go minimal.

    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University