UTHSA IRB Review

Full Board Review - Non-clinical Trials

Examples:

• All greater than minimal risk research
• Any research use of radiation
• Any research use of anesthesia
• Any research use of invasive procedures

Expedited Review

Examples:

• Blood collection through venipuncture
• Non-invasive measurements
• Survey of children

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

Exempt Research

Examples:

• Chart reviews
• Survey of adults
• Comparing two educational methods

Non-Human Research

Examples:

• Only using leftover, de-identified specimens
• Only using commercial cell lines
• Data/specimens from a repository (de-identified to recipient)

Non-Regulated Research

Examples:

• Quality Improvement
• Health Surveillance
• Program Evaluation

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

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

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