Investigator-initiated studies involving drugs or devices may cause you to wonder if the study needs review by the UAMS Office of Research Regulatory Affairs (formerly known as the Research Support Center). With luck, the various prereview processes each study undergoes should catch the need for a regulatory review before the new submission shows up on an IRB agenda. You can double-check whether this review was done in several ways. First, you can check the study’s “History” tab in CLARA. ORRA staff often document their review in a comment that appears under the “History” tab. Or you can check the “Documents” tab, as any regulatory analysis letter that was completed would be listed there.
If you can’t find what you’re looking for in the History or Documents section, please don’t hesitate to call or email the IRB office to have us check whether the review was done. The study may get through the review process faster if we’re able to confirm that the appropriate reviews were done before the meeting. Keep in mind as well that UAMS does not perform regulatory reviews on industry-sponsored studies, as the sponsor is required to handle that aspect of the research.