Nagata S, Varagic J, Kon ND, et al. Differential expression of the angiotensin-(1–12)/chymase axis in human atrial tissue. Ther Adv Cardiovasc Dis 2015; 9: 168–180. DOI: 10.1177/1753944715589717
A routine Institutional Review Board (IRB) audit discovered that full consent was not obtained from 21 of the 44 patients included in the study; consent specifically for access to unidentifiable clinical information from the patients’ medical records had not been obtained. This error was due to a miscommunication between the researchers conducting the study and the surgeons who had obtained consent.
The IRB determined that data related to the information extracted from the medical records of these 21patients should not have been used in the study. The institutional privacy and compliance officers reviewed the event and determined that it did not meet the criteria of a notifiable event under HIPAA regulations. Per IRB request, all samples and research data collected from the 21 patients have been discarded, and a letter has been sent to each of the 21 patients informing them of the error.