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
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Lisa Young
Senior Compliance Administrator
La Jolla Institute for Immunology
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