‘Tis the time of year when student research ramps back up again. Grad students gearing up to begin their final projects are stressed enough as it is, and we’ve noticed that the prospect of dealing with the IRB stresses them out even further. This blog entry is the first of a handful of hints we’ll publish here with these student investigators in mind, with the intent of simplifying the IRB submission and review part of their projects.
–The regulatory definition of research is not as straightforward as it sounds. It is, in relevant part, “a systematic investigation….designed to develop or contribute to generalizable knowledge.” Projects that don’t meet that definition don’t require IRB review. However, figuring out what qualifies as research can be tricky, and it’s something that causes heated discussions among IRB office staff. Quality improvement projects are not research, because they are primarily designed to improve an internal practice or program, rather than to “develop or contribute to generalizable knowledge.” Neither are program implementations or evaluations. And note that just because you hope to publish your project results someday, that intent to publish doesn’t automatically make it research. Also, the regulatory definition of human subjects is also not all that intuitive — your project can involve human subjects even if you never physically interact with any actual humans.
Because the “does my project need IRB review” determination is so tricky to make, and because making it incorrectly can cause big headaches for both the investigator and the institution, we strongly encourage students (and any other PIs, in fact) who are not absolutely, positively, positive regarding whether their project requires IRB review to log into CLARA, click on the “create a new submission” tab, and complete the Human Subject Research Determination Form. This is a much shorter form than the complete new submission form and will only take a few minutes to complete. The more information you can provide on this form, the easier it will be for the IRB staff to make the determination regarding whether your project requires a full IRB submission. Information that is particularly helpful to include is whether the data you will use will be in existence before your project begins, and, if so, whether it includes anything that allows identification of individual subjects. You can also attach your draft proposal at the end of the form. You’ll almost always hear back from the IRB within a week; if you don’t, please call us and see what’s up.
Please note that submission of a Human Subject Research Determination form is NOT required. So if you know that your project is research requiring review, you can start right in with a new submission form in CLARA. Or if you’re certain that your project will NOT require review, you don’t have to submit a determination form (although it’s nice to get official documentation of that determination from the IRB). However, the only way to get an official determination is to submit this form. We do caution you that if you’re going to guess regarding whether your project requires review, please be sure to guess correctly. Reaching the wrong conclusion on your own can cause big problems all around.