A five-year study performed on premature babies has been deemed unethical by the Public Citizen Health Research Group.
The study, funded by the National Institutes of Health (NIH), lasted from 2004 until 2009, and was led by researchers at the University of Alabama at Birmingham along with 22 other medical centers across the nation – including the Yale School of Medicine. Consent forms given to parents to sign were approved by local ethics committees, but did not include an adequate description of the risks to the premature infants, said Michael Carome, deputy director of the Health Research Group.
On April 10, Public Citizen issued a letter to the Department of Health and Human Services, which includes the NIH, calling for an apology to all the parents who entered their children in the study, according to the New Haven Register.
The 1,300 premature babies enrolled as subjects were randomly divided into two groups. The first received high levels of oxygen exposure, which Carome said increases the risk of eye injury or blindness, while the second received low levels of oxygen exposure, which Carome said increases the risk of brain damage and death. But the consent forms did not clearly stipulate any of these risks, instead “misleading” parents, Carome added.
“Consent is an absolutely essential ethical requirement, and we consider this research highly unethical,” he said. “The Department of Health and Human Services should apologize to parents of the children and that apology should be accompanied by a detailed description of what they weren’t told.”
Yale University spokesman Tom Conroy declined to comment on the issue, and told the New Haven Register that the Department of Health and Human Services is investigating the flawed protocol.
Carome said the study is indicative of a “systemwide failure” to protect the rights of human subjects in clinical trials and medical research. In order to prevent further dangerous trials on premature infants without “valid” consent from parents, he added that he suggests thoroughly investigating why this unethical procedure occurred at 23 prestigious medical centers and making documents on research protocol publically available.
“Independent experts and patient advocate groups like ours can make sure other trials aren’t conducted that are unethical – we can take action to make sure this doesn’t happen again,” Carome said.
The University of Utah and Duke University were also among the 23 medical centers conducting the study.