All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality […]

Sometimes, for whatever reason, a study you’re working on will be audited more than once by the Office of Research Compliance. That means that you’ll be submitting more than one audit response to the IRB during the study. When that happens, the IRB asks that you “stack” new audit responses atop any previous audit responses […]

If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more […]

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 […]

When you’re developing recruitment materials for your study, please ensure that the final product makes it clear that this project is research. We know this can be tricky in tweets or other social media blurbs that don’t give you a lot of characters to work with. However, it’s important to emphasize to prospective participants that […]

When submitting revised documents to the IRB, either in response to contingencies or with modification forms, the IRB asks that you include clean and tracked-changes copies of all of the items being changed (particularly protocols, consents, and HIPAA authorizations). When creating tracked changes documents, please make sure all of your changes are tracked, including deletions. We have […]

ClinicalTrials.gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process.  As part of the process, a member of the ClinicalTrials.gov results team would be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]

You can now earn credit toward earning or maintaining your Certified Research Specialist (CRS) credential at your convenience, just by reading the IRB’s Research News Blog! Online quizzes based on blog entries are now available! So – Read the blog, pass the (open-book) test, and earn 0.5 credit hours! At your convenience!  We plan to […]

ARIA, the IRB’s old electronic submission system, is no longer active, but you can still find items that you uploaded to current studies that originated in the ARIA system. How? By looking in the right place in CLARA. When you log into a study, go to the “Forms” tab. If the study was open before […]

When submitting studies to CLARA, please keep in mind that the IRB does NOT routinely need to see case report forms (CRFs). If they are submitted with a study, the IRB will not review them closely and will, in fact, try to remember to ask you to delete them from the submission before we approve […]