Case Reports
If an investigator intends to do a case report for publication, IRB approval may be required.  Most medical and scientific journals are now requiring proof of IRB approval before accepting a manuscript for publication.  Retrospective medical chart review will often be either eligible for Exempt or Expedited review, that is, not requiring full committee review but rather review by the IRB Chair.  Investigators can use ARIA Original Submission as a guide for deciding whether the proposed case report falls into an Exempt or Expedited review category.  Remember, IRB approval cannot be given for a report that is already completed so anticipate that IRB approval will be required by a journal and get your approval prior to submission.  EXAMPLE:  An investigator submits a case report to a journal without prior IRB approval.  The journal editor sends a letter accepting the case report contingent upon receiving an IRB letter of approval.  The investigator then contacts the IRB and requests approval and gets irate at the IRB Chair when the request for approval is denied. 

Jimmie Valentine, Ph.D.
November 30, 2004