When adding staff to a new or current study in CLARA, you will be asked to assign roles and responsibilities to each person included on the study. Please be careful to select only roles and responsibilities that are actually applicable. For example, we see a lot of submissions come through indicating a staffer will be providing or receiving a limited data set under a Data Use Agreement (DUA). DUAs are a creation described in that monster known as the HIPAA regulation, and certain very specific legalese conditions need to be met before a DUA comes into play in research. In fact, while we never say never, DUAs are as rare as hen’s teeth in the research we see coming through the UAMS IRB. So all the vast majority of people who say they’re receiving or providing data under a DUA really aren’t, and they shouldn’t check those boxes in the responsibilities list. The same holds true for things like checking the “obtaining informed consent” box on a chart review study for which you’re requesting a waiver of informed consent, or “budget manager” on a study that has no budget. Making sure these roles and responsibilities are accurate helps ensure the CLARA database is correct.
So please put some thought into accurately describing your staff responsibilities on those check boxes. You may save yourself a “correct the responsibilities” contingency, and maybe get your study through the IRB faster.