Study Fails To Inform Parents Of Premature Babies Of Risks
A study designed to discover the effects of differing levels of oxygen saturation in premature babies is under fire for not fully informing participating parents of the possible consequences, which include blindness, neurological damage and death.
The study, called SUPPORT, took place between 2004 and 2009 and included approximately 1,300 newborns, according to a letter from the Department of Heath and Human Services (HHS). Participating infants were randomly assigned either a high or low dose of oxygen saturation, which in most cases amounted to a different level than they otherwise would have had if they not been a part of the study.
The consent form told parents that "because all of the treatments proposed in this study are standard of care, there is no predictable increase in risk for your baby."
However, according to the letter issued by the HHS, while the researchers were "unwarranted to predict, ahead of time, specific outcomes" they did possess "sufficient available information to know, before conducting the study, that participation might lead to differences in whether an infant survived, or developed blindness, in comparison to what might have happened to a child had that child not enrolled in the study."
Michael Carome is the deputy director of Public Citizen's Health Research Group, the same group responsible for releaseing the HHS letter to the general public.
"The word 'unethical' doesn't even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study," he said in a statement.
What's more, Carome said that because the study was funded by the National Institute of Health, the HHS has a "moral obligation" to not only formally apologize, but offer as much information for involved families regarding the study's risks and nature as possible.
The study's lead researcher, Richard Marchase of the University of Alabama at Birmingham, released a statement yesterday defending his actions, citing that the mortality rates of those involved were lower than expected based on historical levels.
And while the HHS has asked the university to provide a plan to ensure future information given to parents and patients fully explains a study's risks, Carome said that isn't enough and that each medical center involved should be required to exhibit how it would prevent similar cases from happening in the future as well as investigate its own oversight of the study. Finally, Carome called for the termination of any other cases of possibly unethical research regarding premature infants that currently receiving funding by the HHS.