Doctors failed to disclose risks in study of baby blindness, says US agency

Michael Cook
13April 2013
Reproduced with Permission

Scientists at a number of top American universities failed to inform parents of the grave risks of enrolling in a clinical trial on blindness in premature babies, says the federal agency overseeing the welfare of people in research projects.

In a letter to dozens of participants in a trial known as the SUPPORT study, the Office for Human Research Protections has demanded an explanation of why parents were not told that their children would have an increased risk of blindness or death.

The researchers, who published their findings in 2010 in the New England Journal of Medicine, were examining one of the major cause of infant blindness in the US, retinopathy of prematurity. If premature infants get too much oxygen their eyesight can be damaged. If they get too little, they can suffer brain damage and death. About 500 babies become blind every year for this reason, out of about 28,000 very low birth weight babies.

However the consent form for the parents, which was approved by researchers at all 28 institutions, including Stanford, Duke and Yale, failed to mention this. The letter from the OHRP says, "the researchers had 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 been enrolled in the study." The risk that was highlighted in the consent form was merely skin abrasion from an oxygen monitoring device. It also mentioned a benefit - possible decreased need for eye surgery later in life.

The New York Times picked up the story after a lobby group, Public Citizen, released the letter and demanded an apology from Health and Human Services Secretary Kathleen Sibelius.

"The word 'unethical' doesn't even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. "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."