The Office of Human Research Protections questions informed consent in recent study

The Office for Human Research Protections discovered that a study involving premature babies did not disclose potential risks of the associated treatment with the involved families as indicated by a recent article published April 11, 2013 in the New York Times. The study examined the effects of different oxygen levels for extremely premature babies, but OHRP claims that participating families were not informed that potential risks may include increased chances of blindness or death. Twenty-three universities took part in the government-financed study, which examined 1,300 infants born 24 to 27 weeks between 2004 and 2009. Although the consent forms were approved by all 23 institutional review boards, the federal office criticized the form for not mentioning evidence from previous studies that described the potential detrimental effects of giving oxygen to infants. The researchers involved in the study defended it, claiming that treatment was flexible and babies were kept in the standard range of oxygen levels (85-95%). To read the full article on nytimes.com, click here.