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Full Board Review
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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
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Examples:
- Blood collection through venipuncture
- Non-invasive measurements
- Survey of children
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Repository or Registry
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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
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Examples:
- Chart reviews
- Survey of adults
- Comparing two educational methods
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Non-Human Research
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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
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Examples:
- Quality Improvement
- Health Surveillance
- Program Evaluation
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Humanitarian Use Device
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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
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Emergency Use
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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
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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
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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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