Although you can (and should) do this work before getting your full protocol approved, you still have to make some “representation” that you are conducting a review preparatory to research. There are several important restrictions. In addition to feasibility, you might also use the preparatory to research activities rule to refine your research question. You can review the charts to see if the information that you need to abstract is available and easy to code.Īll of these fall under the realm of feasibility. Depending on what you find, you can examine what impact modifications to the inclusion criteria or changes in the date ranges of your study have on the number of charts that you find. There’s no point doing a retrospective chart review if you only have a couple of charts that you could use in the study. You can investigate how many patient charts there are that might fit your inclusion criteria. There are several things that you can do here. “Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose.” ( HIPAA > For Professionals > Special Topics > Research). Department of Health and Human Services, preparatory to research means You should start off by taking advantage of the HIPAA regulations that allow for “ Reviews preparatory to research.” The provisions of this regulation, found at 45 CFR 164.512(i)(1)(ii), allow you to review medical charts prior to getting IRB approval, if the purpose is to plan the research. Here is a broad overview of these issues. There are lots of statistical issues that you must think about during the concept development phase of your research. If you are designing a retrospective chart review, you should talk to a statistician early in the process.
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