When reviewing studies, please remember to take a look at the notes and draft contingencies already entered into CLARA by the office staff. We use these CLARA functions to indicate areas that we think need may need additional input by the IRB, and to note draft contingencies the IRB may want to consider. Please note […]

Here’s a quick recap of the options available to reviewers to note comments and contingencies when they’re reviewing CLARA submissions. The “contingencies” option is for items that require a response from the study team. The “note” option can be used when you want to make a suggestion to the study team, or to bring something […]

Please take a quick look at all the items on your meeting agenda – even the ones assigned to other reviewers. You may have some expertise in a particular area that would be helpful to the IRB as it reviews a particular study that you’re not assigned to. Your contributions on *all* agenda items are […]

When reviewing a proposed modification, remember that reviewers can (and should!) ask for summaries of complicated submissions and/or a description of what the modification means for the study. These items are sometimes within the revised document itself, e.g. a revised Investigator’s Brochure (IB) will have a list of revisions in the first few pages of […]

Reviewers: Please remember to briefly check your review assignments as soon as you receive them, usually the Wednesday or Thursday before the meeting. The IRB needs to know as soon as possible if you have a conflict and cannot review a particular item. Please also let us know as soon as you can if you […]

The criteria for approval of research are spelled out in federal regulations and in UAMS IRB Policy 7.1. Please review these criteria and keep them in mind when drafting contingencies. Some institutions, in fact, require IRB members to specifically state which criterion draft contingencies are addressing. While we do not go quite that far here […]