“The consent form was written in a slanted way,” said Jerry A. Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was “in violation of the regulatory requirements for informed consent” required by federal law.
“They went out of their way to tell you that your kid might benefit,” he said in an interview. “But they didn’t give the flip side, which is that there is a chance your kid might end up worse off. You can’t have it both ways.”
Research done more than 50 years ago showed that supplemental oxygen can cause blindness in preemies but that withholding it can increase the risk of death. The study in question was trying to discover whether a sweet spot exists between too much and too little oxygen where premature babies avoid both blindness and a higher risk of death.
It found — contrary to expectations — that babies who got supplementary oxygen in the higher end of the acceptable range had no more blindness, but greater survival, than babies that got slightly less oxygen. As a result, practice is starting to shift.
“People are thinking twice about keeping babies in the lower part of the range,” said Yvonne E. Vaucher, a neonatologist at the University of California at San Diego, who published a paper in December describing the health of the infants at age 2.
The study, called SUPPORT, was funded by the National Institutes of Health and ran from 2005 to 2009 at 23 research hospitals. Some of the babies died and some became blind, but most avoided both of those tragic outcomes. As a group they fared no worse — and possibly better — than preemies not enrolled in the experiment.
People associated with SUPPORT defended the consent form and noted that it was approved by 23 “institutional review boards’” (IRBs), which are the committees each research hospital must have to oversee the design and ethics of medical studies involving human beings.
“I don’t have any regrets. Everybody went into this with their best intention. Nobody was trying to deceive anybody,” said Neil N. Finer, a neonatologist at the University of California at San Diego who ran the trial.
“Because all the infants were being treated within the standard of care, investigators agreed that the extent to which risks and benefits were delineated in the consent form was appropriate,” said Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, which was one of the study’s sites.
OHRP, which investigates issues involving the protection of human subjects in research for the Department of Health and Human Services, sent a chastising letter to Marchase on March 7. Its contents became widely known this week when advocacy organization Public Citizen’s Health Research Group called upon Kathleen Sebelius, the HHS secretary, to publicly apologize to the parents of the infants for what it called “indefensible, highly unethical” research.