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Office of the Vice President for Research - UT Health San Antonio Office of the Vice President for Research - UT Health San Antonio

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  • UTHSA IRB Review

UTHSA IRB Review

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

      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

               

              Need Help?

              OIRB: IRB@uthscsa.edu; 210-567-8250

               

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              UT Health San Antonio

              8403 Floyd Curl Dr
              San Antonio, TX 78229

              210-567-8270
              vpr@uthscsa.edu

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