(WSJ) The federal agency that protects patients in U.S. clinical trials has concluded that leading universities didn’t adequately inform parents of the risk of death or blindness in a study of how much oxygen should be given to very premature infants.
The Office for Human Research Protections concluded that the study of 1,300 babies at the University of Alabama at Birmingham and elsewhere between 2004 and 2009 posed risks to the patients that weren’t adequately described to parents. The federal patient-safety office, which is part of the Department of Health and Human Services, notified UAB of its conclusions last month and requested that the university respond.
UAB was the lead site for a major portion of the research that tested whether too much oxygen might lead to blindness in the infants and whether too little might result in death. About 20 other universities participated in the study.