FDA Clinical Trial Projects and Multi-Site Collaborative Projects
Posted October 26, 2022
SIUE's IRB will not review FDA regulated clinical trials and requires all FDA regulated clinical trial projects in which SIUE is the sole or the lead institution to submit to a commercial IRB. To see if your study is FDA regulated, check out this flowchart from the FDA. You should proactively reach out to our office at researchcompliance@siue.edu with any questions or help determining if your project is FDA regulated. Please note, SIUE will not cover the costs of the commercial IRB. Proposals for funding to external agencies or organizations must include the commercial IRB costs in the proposed budget.
SIUE allows faculty to use a commercial IRB for any multi-site research project where SIUE is the awardee. The cost of the commercial IRB in either case must be built into your proposal budget. SIUE will not pay for the commercial IRB if not awarded and the PI elects to continue the research unfunded.
If you are engaged in a multi-site collaborative project involving human subjects where another institution's IRB reviewed and approved, you still must submit to our IRB. Please reach out to researchcompliance@siue.edu to see what will be required.
