IRB Letter

IRB Determination Letter.pdf

Focus Groups as Used by the Food and Drug Administration

IRB Letter

OMB: 0910-0497

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Human Research Protection Program
Institutional Review Board (IRB)

IRB Determination
Date: December 30, 2019
Principal Investigator
Dr. Urmimala Sarkar, MD
Study Title:
Study #:
Reference #:

Co-Principal Investigator
Courtney R Lyles

SOLVE Health Tech Stakeholder Interviews
19-29025
261565

We have reviewed your project and have made the following determination:
Based on the information you have provided to us, this is a research activity but it does not
involve human subjects as defined by the federal regulations summarized in 45 CFR 46.102(f),
and hence does not require further IRB oversight.
You are not required to submit anything further to the IRB. Should you have any questions, or
should key project activities change, you may contact me directly, or you can contact the IRB
office at 476-1814.


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