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Health Agencies Update
May 22, 2013

Neonatal Trial Criticized for Inadequate Consent

JAMA. 2013;309(20):2087. doi:10.1001/jama.2013.5928

The US Office for Human Research Protections (OHRP) has determined that a large multisite clinical trial comparing the effects of differing levels of oxygen supplementation for neonates failed to obtain proper consent from the parents of enrolled infants.

The study, the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), enrolled 1300 infants between 2004 and 2009. Children in the study were randomized to receive oxygen in either a lower or higher range to determine the effects of these ranges on survival, neurological development, and risk of developing visual impairment. However, in a letter to study leaders at the University of Alabama at Birmingham, the OHRP concluded that the investigators failed to adequately inform parents of the risks of enrolling their child in the study (http://tinyurl.com/cgekadq).