Completing Non-exempt Medical Records Review applications in ARROW
Version Date: March 20, 2013
The Initial Review Application: Non-Exempt Medical Records Review application type should be selected for studies that solely involve the collection of medical information from medical charts or databases, with possible follow-up medical information from the subject. If the research study involves any other activities or interventions, such as testing of tissue, a blood draw or other medical procedures, the creation of or submission to a database/registry, or testing of an experimental drug, device or software, this application type should not be selected.
Below is a guidance document outlining specific questions for the non-exempt medical records application type and guidance on responding to these questions. This guidance document does not include all of the questions in this application type, but rather the questions that need to reflect specific details about this type of research. This guidance document is meant to be used for straightforward non-exempt medical records review studies. If you have a complex, multi-site or unique records review study, this guidance document may not address the specific aspects of your study that need to be communicated to the IRB. In these cases, please contact the HS IRBs Office directly for guidance. In addition, the guidance includes suggested responses only. Study teams should use these responses as a starting point for answering the application questions. Any pertinent study-specific information must be incorporated into the responses by the study team. Finally, as with other IRB applications, the answers to the questions should be in language accessible to readers without a specialist's knowledge of the research topic.