Completing Health Care Records Review Only applications in ARROW

Version Date: March 1, 2018

The Initial Review Application: Health Care Records Review Only 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. Health Care Records Review Only studies can qualify for exemption based on the new institutional exemption categories if they are not federally supported or fall under VA purview. For Health Care Records Review Only studies that are federally supported or fall under VA purview, this application type can still be used, but the studies require ongoing IRB oversight at this point and do not qualify for exemption. If the research study involves any other activities or interventions, such as collection of research data, 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.

Guidance for each of the questions for this application type is built into the ARROW application itself. This guidance document is meant to be used for straightforward health care records review studies. If you have a complex, multi-site or unique health care 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.

Keywords:chart review, medical records, HCRRO, retrospective   Doc ID:29306
Owner:Monica E.Group:Health Sciences IRBs
Created:2013-04-02 13:37 CSTUpdated:2018-03-01 14:04 CST
Sites:Health Sciences IRBs
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