Treatment Use/Expanded Access Use of Drug/Device
Expanded accessExpanded Accessuse of an investigational (unapproved) drug or device when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The distinction between expanded access and the use of an investigational drug (or device) in research covered under an IND/IDE is that expanded access uses are not primarily intended to obtain information about the safety or effectiveness of a test article. Although not considered research, the FDA requires IRB approval prior to non-emergency use. to investigational drugs for treatment use is available when the local investigator or sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. applies to the FDAFDAabbreviation for US Food and Drug Administration. and the IRB for: 1) individual patients (including in emergencies); 2) intermediate size patient populations; and 3) larger populations under a treatment protocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues. or treatment investigational new drugInvestigational New Drug(or IND) an application filed with the FDA that includes a detailed description of the planned investigation including Phase I, II and III studies. application ( INDINDInvestigational New Drug application with the FDA. ). Expanded Access/Treatment Use is intended to improve access to investigational drugs for patients with serious or immediately life-threateningLife-threateningdiseases or conditions where the likelihood of death is high unless the course of the disease is interrupted. diseases or conditions who lack other therapeutic options and who may benefitBenefitsomething that promotes or protects well-being, an advantage. Compensation cannot be considered a benefit. from such therapies. Requires prior IRB approval, but is not considered researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. . Requires an IND/ IDEIDEInvestigational Device Exemption filed with the FDA from FDA.
Submit the following forms to IRBmail@uthscsa.edu for IRB review and approval:
- Form tA - Signature Assurance Sheet
- 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: