redOrbit Staff & Wire Reports – Your Universe Online
The researchers behind a large study on the effects of oxygen levels on premature infants have been reprimanded by the US Department of Health and Human Services (HHS) for failing to inform the parents of those children of the risks involved with the study.
In a letter dated March 7, Lisa R. Buchanan of the HHS Office for Human Research Protections (OHRP) wrote that a portion of the University of Alabama-Birmingham (UAB) study “was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably forseeable risks of blindness, neurological damage and death.”
As part of the study, over 1,300 severely premature infants were randomly chosen to receive one of two different levels of oxygen in order to determine which was better at preventing blindness without increasing the risk of brain damage or death, NPR´s Richard Knox reported on Wednesday.
Those studies, which were funded by the National Institutes of Health (NIH) and conducted at nearly two dozen medical facilities between 2004 and 2009, were “ethically flawed” because the consent form given to parents did not adequately warn them of the dangers involved in the research, he added.
The research was published in the New England Journal of Medicine (NEJM) in 2010 and reported that infants who had received higher levels of oxygen were twice as likely to go blind, but those receiving the lower levels were slightly more likely to die. A total of 130 out of 654 babies in the low-oxygen group died, and 91 out of 509 babies in the high-oxygen group developed blindness, according to the study, as reported by Sabrina Tabernise of the New York Times.
The letter, which was made public by consumer rights group Public Citizen on Wednesday, also said that the consent form failed to address two other vital pieces of information — that the purpose of the research was to determine if those premature infants were more likely to die if given higher levels of oxygen rather than lower levels, and a description of how the children would be treated if they did not participate in the study versus how they would be treated if they chose to take part in the research.
“The word ℠unethical´ doesn´t even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study,” Dr. Michael Carome, deputy director of the organization´s Health Research Group, said in a statement. “The failure to disclose such critically important information about the research undoubtedly directly affected parents´ decisions to enroll their extremely premature infants in this study. It is highly likely that had they been appropriately informed about the nature of the research and its risks, many, if not most, parents would not have allowed their babies to be in this study.”
UAB vice president for research Richard B. Marchase told Tabernise that a similar group of infants born around the same time — children which were neither participants in the study nor an official control group — actually died at higher rates than those who participated in the low-oxygen group (a 24 percent mortality rate versus a 20 percent mortality rate for the low-oxygen study group).
He added that the infants were kept within the standard band of treatment for oxygen levels (85 to 95 percent) and that the results of the study were to form the basis of a definition by the American Academy of Pediatrics (AAP) as to what the standard of care should be. A university spokesman also told the Times that researchers from another participating academic institution had written the consent forms in question, and that all 23 universities that took part in the study had approved the documents.
“The research sought to determine the ideal balance between the survival benefit for premature babies who received high levels of oxygen and their risk of a form of blindness linked to premature birth,” reported Bloomberg‘s Anna Edney and Michelle Fay Cortez.
“The infants in the study were born from 24 weeks to 28 weeks of gestation. Newborns are considered to be full term after 40 weeks,” they added. “The amount of oxygen given was within the range commonly used to treat premature infants at the time. Doctors until then guessed the best level for each baby based on their understanding of earlier research and personal experience.”