BIRMINGHAM, Ala. (CN) - The University of Alabama exposed premature babies to death and blindness in a study that was "unethical by design," parents claim in a federal class action.
The defendants assigned premature babies with low birth weight varying oxygen levels by "the flip of a coin," without disclosing the risks to their parents, five sets of parents with six children say in the complaint.
The parents claim their children who were born or treated at The University of Alabama-Birmingham Hospital suffered permanent neurological and vision damage, and that other babies died as a result of the study.
The complaint states: "The Office of Human Research Protection ('OHRP') recently determined that the University of Alabama's 'conduct of this study was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death,' and further determined that 'participating in the study did have an effect on which infants died, and on which developed blindness.'"
Lead plaintiffs the Looney family sued University of Alabama Institutional Review Board Director Sheila Moore, its chairman Dr. Ferdinand Urthaler, the individual members of the board, and Dr. Waldemar Carlo, the neonatologist who led the study at the university's hospital in Birmingham.
The plaintiffs, whose babies were born weighing less than 2 pounds, seek to represent all babies who were injured in the study, and their families.
"This case involves clinical research performed on infants born very prematurely with extremely low birth weights, who depend upon receiving the appropriate quantity of oxygen in order to survive and thrive, and depend upon the individuals responsible for their treatment to act in their best medical interests," the complaint states.
"The standard of care dictates that a physician treating a premature, low-birth-weight infant must select an appropriate blood oxygen saturation level of between 85 and 95 percent, as dictated by the infant's specific medical needs, and that level should be adjusted in accordance with the infant's individual specific needs and progress.
"The plaintiffs, who were all born prematurely and with low birth weights, participated in a study at the University of Alabama that was conducted between 2004 and 2009 wherein they randomly received a fixed amount of oxygen (either low or high).
"The study was unethical by design because, among other things, the infants who were the human subjects were randomized into the two arms of the study; in other words, the amount of oxygen initially received by each subject was determined by 'the flip of a coin,' and that amount was not adjusted in accordance with individual medical needs.
"The study was further unethical by design because the informed consent document failed to disclose to the parents of the subjects any risks whatsoever with respect to which arm of the study their infants were randomized into, beyond the small risk of a minor skin breakdown.
"The researchers should have known that, because of what is referred to as 'the therapeutic misconception,' parents of such infants desired one thing and one thing alone: that their newborn babies receive the best care to fit their individual needs and that they would never consent to their children receiving care based only on the need of researchers achieving some generalized knowledge.
