Retrospective chart reviews: Assessing delays in IRB approval

Federal regulations require that retrospective chart reviews RCRs be reviewed and approved by a local institutional review board (IRB) prior to conducting the research [3]. The aim of our study is to review research proposals submitted to the Institutional Review Board (IRB) at one academic medical center to 1) determine the proportion of research protocols that use data exclusively from chart reviews; and 2) assess and quantify the kinds of documentation deficiencies commonly seen. Suggestions to potential investigators include: eliminate partial responses to IRB questions, obtain statistical consult prior to submission, have another investigator pre-review submission, update required research training and conflict of interest questionnaires, use IRB templates when possible, and include a description of safeguards to adequately protect retrospective data from a breach of confidentiality.