I am interested in conducting a research study using a commercially available drug for the approved purpose. Does the UTHSC IRB need to review this research before my study is initiated?
Yes. All clinical investigations (which means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration (FDA), or is not subject to requirements for prior submission to the FDA, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit) require UTHSC IRB review and approval.
Related Questions
- I am conducting a study using medical records under an IRB approved waiver of consent obtained prior to April 14, 2003. Do I need to do anything with respect to the Privacy Rule?
- What is the purpose of conducting a literature review for a research proposal?
- How do I submit a change to an IRB approved research study to the IRB?
