CLARA generally allows only one form at a time to be under IRB review. This restriction means, for example, you can’t submit a modification on a study until your new submission is approved, or, importantly, you can’t submit a continuing review (CR) form while a modification is outstanding. The only exceptions are that CLARA will […]

CLARA has always given you an overview of your whole study’s progress through the submission and review process via the “History” tab. The new “Timeline” option can quickly update you on a particular form’s progress. To access the timeline, log into your study in CLARA, click on the form you’re interested in, and then look […]

The most recent online blog quiz that allows you to earn 0.5 hours of Certified Research Specialist education credits will only be available for a few more weeks. We’ll post a new quiz in January, but we don’t want you to miss this opportunity to a half-hour closer to meeting your CRS requirements. Remember, you […]

Exempt – in the dictionary, it means “not subject to or bound by a rule.” That definition does not apply to IRB-land, however. Studies that qualify for exempt review status are still subject to IRB oversight and must be submitted through CLARA. “Exempt,” in this case, means that a study is not subject to the usual […]

Many (but by no means all) human subject research studies require using a written informed consent form to document the subjects’ agreement to participate. Federal regulations and IRB policies have specific requirements for the information that must be conveyed during the informed consent process, and when you’re using a written consent form, that form should […]

Many UAMS students, residents, and/or fellows must complete a research project as part of their education. The research project part, they can cope with. The IRB submission process that precedes the research project, on the other hand, seems weird and mysterious and maybe a little unnerving to them. IRB staffers are happy to provide information about […]

Researchers are encouraged to get in touch with the IRB office whenever they have a question. We’re happy to take queries by phone or email, and to provide guidance regarding IRB submissions when appropriate. Some queries are best handled through a submission process in CLARA, however. The big one is, “Does my project need IRB […]

We know that, per IRB Policy 10.2, certain events need to be reported to the IRB right away. But how about all those other little incidents that don’t require immediate reporting, but instead are sent in with the study’s continuing review form? What does the IRB need to know about those? We have a handy-dandy […]