Since we all — research teams and IRB alike — like to see research proposals get approved quickly, we thought we’d point out a couple of issues we’ve been seeing a lot of lately that will get you a contingency.
— Incorrectly stacked documents. If your clean and tracked-changes copies of documents are not stacked correctly, your submission will be sent back for the stacking to be corrected. In a nutshell, each CLARA document stack, when created correctly, contains a single type of document. For example, one stack will have all the tracked-changes copies of your protocol, and all the clean copies will be in a separate stack. Both stacks have the most recent iteration of the document on top. If your document stack includes both clean and tracked-changes copies of the same document, it is stacked incorrectly and needs to be fixed. Help with stacking can be found in CLARA — log in and click on the word “Help” in the black bar at the top. Then click “managing documents” under protocols. If you’re new to UAMS or to CLARA usage, you can also ask others in your department to show you the ropes. CLARA has been in use for more than 3 years now, so ask around to see if anyone in your area has experience with it. We in the IRB office can also walk you through the process. Note that it’s much easier for us to help you when you call if your Lync instant messenger system is working; that way you can share your screen with us and we can walk you through the process step by step. If Lync’s not working, or you can’t find it (its icon looks like a blue “S” in a cloud on our computers), please contact IT for help to get it set up and then call us for CLARA help.
— Including language about “samples” for a study that involves no samples, or other non-applicable template language, in a consent form. We’re thrilled to see what looks like an increasing number of research teams use the Plain Language Informed Consent Template on their research studies. However, please keep in mind the template can, and in fact, must, be revised to fit the specifics of your study. In addition to the green guide text directing you to language you’ll need to insert or change, you may need to make changes to the other template text to make it fit your study. The template is just a guideline — really. Feel free to change it as needed to adapt it for your study and your target population.