IRB ID #: IRBAC005
All clinical trial protocols that use recombinant DNA, synthetic nucleic acid materials, or a genetically modified organism or therapeutic must receive prior approval from the Institutional (IBC).
Requirement: Please refer to the documents for Human Gene Transfer Research at Institutional Biosafety Committee (IBC) | UResearch | University of Miami.
Such submissions must be submitted directly to the IBC committee outside of the IRB at IBCsupport@miami.edu
The review process for the IBC and the IRB can occur concurrently, but the HSRO cannot release the IRB approval until IBC signs off.
Modifications to the initially approved study approved for the use of recombinant DNA, synthetic nucleic acid materials
- update to the IB or protocol amendment
- Closure of study
- RNIs
Requirement: Please refer to the documents for Human Gene Transfer Research at Institutional Biosafety Committee (IBC) | UResearch | University of Miami.
Adding personnel for following roles:
- Change of PI
- sub-investogator
- study coordinator
- Individuals administering study products (nurses, etc.)
Lab personnel handing study product:
Biosafety Training is required every three years for all research personnel and for new personnel added to the study during the research. Personnel includes anyone involved with the material/agent (whether administrating it or collecting samples or transporting the material across campus).
This training is available via ULearn as a module titled “IBC Biosafety Training for Clinical Staff”.
IBC NIH Guidelines Training (must be completed once) by PIs, sub-investigators, co-investigators.
This training is a PowerPoint presentation. Contact IBCsupport@miami.edu for review and credit.
CR review requires ESCRO committee approval.
Contacts:
Primary point of contact:
IBCsupport@miami.edu
Secondary Contact:
Liz Meza
Senior Regulatory Analyst
IACUC / IBC / ESCRO
lmeza@miami.edu
