What is the prereview process and how does it differ from IRB review?
The prereview process has at least two parts. First, depending on the type of study, other institutional offices may need to review the submission. These reviews help ensure we have enough resources available to safely carry out the research, appropriate study budgets are created, and that any required contracts, agreements, or FDA submissions are completed, among other factors. These prereviews are independent of the IRB and may take several weeks.
Only after these prereviews are completed will the study come to the IRB for review. Once the IRB receives it, it will undergo a prereview focusing on human subject protections and ensuring the regulatory requirements pertaining to human subject rights, safety, and welfare are sufficiently addressed.
The Institutional Review Board pre-reviewer may send you a contingency letter asking you to address certain items in your submission. These items need to be resolved before the pre-reviewer can move the submission forward to be reviewed.
What types of final reviews does the IRB do?
The majority of the studies we receive qualify for exempt or expedited status reviews. These reviews and approvals are handled in the IRB office and never go before the convened IRB. Only studies fitting into one of the exempt or expedited categories can be reviewed using these procedures.
Studies not qualifying for either of these review types are sent to the full board for review.
Note that you may get further contingency letters during the final review process. These contingencies must be addressed before final approval can be granted.
There are studies where the UAMS IRB has deferred review to an external IRB. For those studies, the UAMS IRB’s role is limited to ensuring the submitted study materials are appropriate for our local population. However, all the other offices that participate in the prereview process will still do their usual reviews.
How does my study get assigned to a full board agenda?
The convened board meets on the first four Tuesdays of each month. Agendas for each week’s meeting typically close the Tuesday afternoon or Wednesday morning the week prior. A particular study can make an agenda if the entire prereview process is completed before the agenda closes.
Note that while we try to place studies on the next open agenda, we occasionally reschedule them to ensure the reviewers who will review the research have the appropriate expertise, and that individual reviewers, all of whom are volunteers, are not overloaded.
Does IRB review and approval cost anything?
Industry sponsored studies are subject to IRB review fees. Our fee schedule is available here.