New Research Forms

Clinical trials must be reviewed and cleared by the Clinical Trials Office (CTO) before the research application can be submitted to the IRB.
Human Research |
Human Research |
Human Research |
||
![]() |
![]() |
![]() |
![]() |
![]() |
Examples: • Quality Improvement • Health Surveillance • Program Evaluation |
Examples: • Only using leftover, de-identified specimens • Only using commercial cell lines • Data / specimens from a repository (de-identified to recipient) |
Examples: • retrospective chart review & not recording identifying information • survey of adults • comparing two educational methods |
Examples: • prospective clinical data and specimens • non-invasive measurements • Survey of children |
Examples: • All greater than minimal risk research • Clinical trials • Any research use of radiation • Any research use of anesthesia • Any research use of invasive procedures |
Non-regulated Research Forms | Non-human Research Forms | Exempt Research Forms | Human Expedited Review Forms | Human Full Board Forms |
|
||||
Other Types of Submissions Forms
|
Emergency Use (single patient) |
Treatment Use (single patient/small group) |
(for use in future, undefined research) |
|
Requirements: - Condition treated/diagnosed affects fewer than 4,000 in US per year - Requires an approved HDE from FDA - Requires prior IRB approval, but is not considered research |
Requirements: - Patient’s condition is life-threatening - No standard treatment available - There is not sufficient time to obtain IRB approval - Requires post-use IRB reporting/ concurrence but is not considered research |
Requirements: - Life-threatening or serious disease - No acceptable alternative - Requires prior IRB approval, but is not considered research - Requires an IND/IDE from FDA |
Examples: - Creation of local biorepository - Creation of Data repository or Registry - Collection of data and/or specimens to be sent and stored at another (non-UTHSCSA) repository |
Examples: - life-threatening, emergency situations |
IRB Review for Multi-Site Research / External IRB Review
Single IRB Review for Multi-Site Research where UTHSA IRB is the Reviewing IRB |
External IRB Review where other external IRB is the Reviewing IRB (link will redirect you to the OCR website) |
|||
Examples: | Examples: | |||
- SMART IRB - Multiple institutions within the state of Texas under an IRB Reciprocity Agreement |
- Collaborative UT system research relying on single non-UTHSCSA IRB - Sponsored Phase III studies relying on commercial IRB - NCI cooperative research relying on NCI CIRB - Other federally funded collaborative research initiatives |