In the article “A Randomized Controlled Pilot Trial of Modified Whole Blood versus Component Therapy in Severely Injured Patients Requiring Large Volume Transfusions”,1 which published in the October 2013 issue of Annals of Surgery, the “Regulatory Oversight and Approval” section was incorrectly stated. The following text replaces that section of the existing article:
This study was conducted in accordance with the Office of Human Research Protections (OHRP) criteria for emergency research consent waiver (OPRR Reports, Number 97-01) and the University of Texas Health Science Center at Houston Committee for Protection of Human Subjects (CPHS) policies and procedures for clinical studies requiring exception from informed consent for emergency research. The University of Texas Health Science Center at Houston and the Memorial Hermann Hospital Institutional Review Boards approved this study. Community consultation was performed before the beginning of the study, which allowed for randomization of the patient and initiation of the protocol.
1. Cotton BA, Podbielski J, Camp E, et al. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013;258:527–533.