New submission form changes, plus some tips for completing the form

Those who pay close attention to these things (and we hope that’s all of you!) may have noticed some recent changes to the HIPAA section of the new submission form. The changes include rewording some queries to make it clearer that the form is asking you to indicate which specific PHI elements you are going to use or record for your study. These questions need careful and complete responses. We often see responses such as “name, address, phone number” or “medical records” listed as responses. The former are identifiers only, not PHI, and the identifiers are addressed in a separate form query; the latter isn’t specific enough to indicate which PHI elements will be involved. We also occasionally notice that investigators on chart review studies check “yes” to the query asking if PHI will be obtained directly from participants. That’s a surefire way to get a contingency sent back to correct the form, as it’s impossible to get PHI from participants if you won’t actually see, or talk to, participants.

In fact, the IRB pays close attention to the entire new submission form in an attempt to maximize the accuracy and completeness of its research database. So when completing the form, please make sure all of your answers are complete and specifically address the question being asked. Cutting and pasting the same language in response to multiple questions (something else we see a lot here) is a sign that the form is probably not completed correctly. Even though some of the information you’re asked to provide in the form will also be included in the protocol document, we do need it listed in the new submission form as well. Each form question was designed to address a specific regulatory requirement or guidance, and your responses help the IRB make the determinations it is required to make when it approves studies. We’d like to help you get your study approved as quickly as possible, and completing the form correctly helps with that goal.