When we see a study submission that describes a project as a retrospective chart review, the IRB needs to make sure the project is truly retrospective. A retrospective chart review involves looking at information that already exists at the time of IRB approval. We may ask that you specify an end date to document that all the records you plan to look at will already have been created at the time the study is approved.
The issue of whether a study is truly retrospective is important as we consider requests to waive the consent process. If the records already exist, you can complete the study without any direct subject contact at all, and we may be able to justify waiving the entire consent process. Things get a little trickier when you say you want to review previously existing records, and then check back in 6 months to review records that haven’t been created yet, but may be in the next 6 months. That plan would mean that subjects would still be coming to UAMS or ACH for care, and there may be an opportunity to obtain their consent to use their information in the project. Per the regulations, we’d have to take another close look at justifying a waiver of consent for those types of studies, and we may require you to obtain consent from those subjects.
So please keep that time frame in mind when designing record review projects. If you are to access records that are not yet created, please either describe your proposed consent process, or specifically address the consent process waiver criteria (as described in UAMS IRB Policy 15.3) in your submission.