U.S. Says Study of Babies Failed to Disclose Risks
Source: NY Times
The lead investigators on a large study of the effects of oxygen levels on extremely premature babies failed to inform the infants’ parents that the risks of participating could involve increased chances of blindness or death, the federal Department of Health and Human Services has warned in a letter.
The Office for Human Research Protections, which safeguards the people who participate in government-funded research, sent a letter to the University of Alabama last month, detailing what it said were violations of patients’ rights.
The university, which was a lead site for the study, had not detailed the risks in consent forms that were the basis of parents’ participation, the office said in the letter. Specifically, babies assigned to a high-oxygen group were more likely to go blind and babies assigned to a low-oxygen group were more likely to die than if they had not participated. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed blindness.
Read more: http://www.nytimes.com/2013/04/11/health/parents-of-preemies-werent-told-of-risks-in-study.html
= new reply since forum marked as read
