Expanded access to investigational drugs for treatment use is available when the local investigator or sponsor applies to the FDA and the IRB for: 1) individual patients (including in emergencies); 2) intermediate size patient populations; and 3) larger populations under a treatment protocol or treatment investigational new drug application (IND). Expanded Access/Treatment Use is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Requires prior IRB approval, but is not considered research. Requires an IND/IDE from FDA.
Submit the following forms to IRBmail@uthscsa.edu for IRB review and approval:
- Form tA - Signature Assurance Sheet (Please note: Assure that both the PI and the PI’s chair sign this form or we will not be able to accept the submission. The PI cannot be the same as the chair due to the conflict of interest that presents.)
- Form tB - General Information Sheet
- Form tB-2 - Study Personnel List
- Form tC - Research Description (For use if no summary letter or treatment protocol has yet been created for submission to the FDA, otherwise replace this form with a copy of the FDA submission package.)
- Form t-Inst - Institutional Treatment Form
And, if applicable: