| Full Board Review | Examples: - All greater than minimal risk research
- Any research use of radiation
- Any research use of anesthesia
- Any research use of invasive procedures
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| Expedited Review | Examples: - Blood collection through venipuncture
- Non-invasive measurements
- Survey of children
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| Repository or Registry | 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-UTHSA) repository
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| Exempt Research | Examples: - Chart reviews
- Survey of adults
- Comparing two educational methods
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| Non-Human Research | Examples: - Only using leftover, de-identified specimens
- Only using commercial cell lines
- Data/specimens from a repository (de-identified to recipient)
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| Non-Regulated Research | Examples: - Quality Improvement
- Health Surveillance
- Program Evaluation
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| Humanitarian Use Device | Requirements: - Condition treated/diagnosed affects no more than 8,000 in U.S. per year
- Requires an approved HDE from FDA
- Requires prior IRB approval, but is not considered research
|
| Emergency Use | 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
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| Treatment Use/Expanded Access | Requirements: - Life-threatening or serious disease
- No acceptable alternative
- Requires prior IRB approval, but is not considered research
- Requires an IND/IDE from FDA
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| Planned Emergency Research | Examples: - Life-threatening, emergency situations
- Requirements: - human subjects research designed to test medical interventions, drugs, or devices in urgent, life-threatening situations
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