The IRB staff has noticed an uptick in recent weeks of IRB submissions describing projects that have already been completed. Fortunately, none of the projects in question met the regulatory definition of research requiring IRB review. However, please note that the IRB cannot review or approve projects that have already been completed. In fact, researchers found to be doing human subject research without prior IRB review risk losing the ability to use or disseminate their study findings. If you think your project may need IRB review but aren’t sure, please submit a human subject research determination form BEFORE carrying out any project activities.
One question we hear a lot at the IRB is along the lines of, “What if I’ve done a quality improvement project and want to publish the results? Can I submit the project then for IRB review and approval so I can publish the findings?” In this case, it’s important to note the the very clear distinction between IRB approval and the ability to publish or disseminate results. An intent to publish or present project results does NOT automatically make something human subject research requiring review. When reviewing human subject research determination forms, the IRB considers the primary intent of the activity, rather than the intent to publish findings, in deciding whether something is research. Research, according to the regulations, is “a systematic investigation…designed to develop or contribute to generalizable knowledge.” Results from projects that do not meet the definition of research, such as internal quality improvement or needs assessment activities not primarily intended to develop or contribute to generalizable knowledge, can still be disseminated, even if they didn’t need IRB approval to be conducted.