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Stratification of Potential Risk to Human Subjects |
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Group I -Interview/Questionnaire -Observation -Teaching/Focus Group -Retrospective Chart Review -Designated by IRB as “minimal risk” Group II -Non-invasive diagnostic procedures -Venipuncture for blood sample (less than five percent total blood volume per month) -Approved device for approved indication -Approved pharmaceuticals at approved dose for approved indication -Vulnerable populations: -Students, prisoners, children, pregnant women, cognitively impaired individuals -Studies collecting sensitive information Group III -Non-approved drug -Approved drug-new indication, new dose, new population -Non-approved device -Approved device– new indication, new dose, new population -Gene therapy -Principal Investigators with more than ten protocols open Group IV -Investigators with managed conflicts of interest -SAE attributed to study -Excessive SAEs reported Exceptions 1. Will not be monitored unless requested by Vice Chancellor for Research -Cancer Center (QASM review) -Research using GCRC (Patient Advocate Review) 2. External Monitoring reports will be reviewed. Additional monitoring will be at the discretion of the Committee. -Industry-sponsored trials -Studies with DSMBs (Data Safety Monitoring Board)
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