Study of Premature Babies Exposes Serious Ethics Issues in Consent Agreement

The Office for Human Research Protections just revealed that some renowned universities neglected to advise more than 1,000 families, participants in a government-funded study, that study risks included increased likelihoods for blindness or death.

The breaking story, released by The New York Times, said that the study was of oxygen levels in very premature infants. The involved families have still not been notified of the study findings by the agency, which is meant to protect people participating in government-financed studies, said The Times. Meanwhile, conclusions were outlined in a detailed letter sent to the University of Alabama at Birmingham, which was the lead study site. A total of 23 schools were involved in the research, including Stanford, Duke, Yale, Tufts, and the University of California, San Diego.

The babies were randomly assigned to two different participant groups, explained Public News Radio (NPR), to determine which of two different oxygen levels helped prevent blindness better and without increasing risks for neurologic damage or death.

According to the letter, the research would affect which of the babies died and which developed blindness, risks that were not appropriately communicated to the babies parents and which raise very serious ethics issues. This means, noted The Times, those parents never received critical information parents would have needed when deciding whether or not to participate in the study.

In all 1,300 infants were included in the study, which ran from 2004 through 2009. Study results were published in 2010 in The New England Journal of Medicine in 2010, said The Times

In the March 7th letter, Lisa Buchanan of the Office for Human Research Protections of the Department of Health and Human Services (HHS) told the researchers that the study “was in violation of the regulatory requirements for informed consent,” given that the babies parents were never advised prior to the study about its “reasonably foreseeable risks,” NPR said. The consent form “did not identify any risks from subjecting the infants to either the low or high levels of oxygen used in the study,” she continued. The consent forms were authored by University of California, San Diego, researchers, according to a University of Alabama at Birmingham spokesman, said The Times. The forms were approved by the review boards of all 23 institutions involved in the research, which was funded by the National Institutes of Health NIH).

The babies were born at 24-27 weeks of gestation, which, said The Times, puts them in an extremely high-risk category and already places the infants at risk for death and optical disease.

According to the letter, the babies in the high-oxygen group were likelier to develop optical diseases and blindness and babies assigned to a low-oxygen group were likelier to die. Of 654 babies assigned to the low-oxygen group, 130 died; 91 of the 509 in the high oxygen group developed a significant eye disorder that can lead to blindness in serious cases, The Times explained.

“… 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 letter stated, wrote The Times. The consent form only discussed a far less serious risk—skin abrasion from the oxygen monitoring device—and discussed a potential benefit to participating in the study concerning a reduced need for optical surgery, which would depend on the assigned group, said The Times.

The study, explained NPR, was meant to address the care issue involving extremely premature babies. Babies who receive too much oxygen may become blind from retinopathy of prematurity. If they do not receive sufficient oxygen, they may suffer from brain damage or death.

In an interview with The Times, Marchase said that the fatalities seen in the low-oxygen group was lower than a similar group of babies born at the same time and who were not involved in the study. Marchase also said that the babies in the study received sufficient oxygen to maintain blood levels in the standard range, said NPR. The HHS disagreed, saying in its letter that the study was created to give the babies in the high-oxygen group “more oxygen than average infants receiving standard care, and infants assigned to the lower range received less.”

“The word ‘unethical’ doesn’t even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study,” Dr. Michael Carome of Public Citizen’s Health Research Group stated in a press release. Carome pointed out that many of the parents involved in this study would never have agreed to enroll their babies in the research had they been made aware of the risks, said NPR, noting that Carome previously worked for the HHS Office of Human Research Protections.

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