What studies are eligible for WIRB® submission?
Studies may be submitted to WIRB® only if they meet all 5 of the following conditions:
1. The trial is industry-sponsored and FDA regulated (drugs and devices). For Principal Investigators in the College of Medicine, industry authored and supported therapeutic trials MUST be submitted to WIRB®. Non-therapeutic trials that are authored by a UF investigator and only being conducted at UF but are industry sponsored may request an exemption in order to submit to WIRB.
2. The research is not related to behavioral science.
3. The investigator has not previously submitted the clinical trial to another UF IRB.
4. Veteran’s Administration Policies:
- The trial does not involve the use of Veterans Administration facilities, equipment or patients. (VA central office policy)
- Part-time VA employees may be involved in these projects only if the research does not take place in a VA facility (including an approved off-site facility), is not part of the employee’s VA duties and does not occur during his/her VA tour of duty.
- Full-time VA employees may not be involved as PI, Co-I, or Sub-I in any project submitted to WIRB.
5. The study is not supported in whole or part by the CTSI. NOTE: There are times when the study is fully supported by industry and the CRC space and services are paid for. In those cases, WIRB may be used.