When approving research, the IRB is required to make certain determinations, as spelled out in UAMS IRB Policy 7.1. The IRB therefore needs complete information about projects before it can review and approve a new submission.
While we can very occasionally make exceptions, by doing things like issuing an approval letter saying we approve what we’ve been given but need to see more before you actually start the study (done when a funding source requires an approval letter before it will consider your funding request, for example), we far more often return studies unreviewed when a submission is incomplete. Ensuring the following issues have been addressed will get your submission in front of a reviewer faster:
- Is your protocol complete? Does it fully describe the study and include all required elements? If it is coming from another site, does it adequately describe UAMS’ or ACH’s involvement in the project? Please note that if you are using an externally generated protocol that you can’t change, you always have the option of submitting a local protocol supplement addressing in more detail the local site activities and requirements.
- Have all required regulatory prereviews been completed? Please note the IRB typically will NOT review a study if the issue of whether it needs an IND or an IDE remains outstanding. This kind of regulatory concern can lead to substantial changes in study documents and activities, depending on which way the decision goes, and the IRB is unable to review these complex protocols until they are finalized.