Feds say study of babies at UM, elsewhere should have disclosed risks



Almost two dozen U.S. medical centers, including the University of Miami’s Miller School of Medicine, conducted a four-year study of the effects of oxygen levels on severely premature newborns without explicitly informing parents that their children potentially faced blindness, brain damage or death as a consequence of the experiment, records show.

The U.S. Department of Health and Human Services criticized the lead medical center, the University of Alabama at Birmingham, in a letter for providing families with a consent form that failed to disclose risks to the newborn babies who were part of the study, other than skin irritation where a device was attached to measure the saturation of oxygen in the infant’s blood.

“The conduct of this study was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the foreseeable risks of blindness, neurological damage and death,” wrote Lisa R. Buchanan, who heads compliance oversight at HHS’ Office of Human Research Protections in Maryland.

“For many of those infants, the level of oxygen they received was different from what they would have received had they not participated in the study,” HHS wrote.Calling the conduct of the study “highly unethical,” the Washington-based consumer advocacy group Public Citizen on Wednesday called on HHS Secretary Kathleen Sebelius to issue expanded findings concerning the participating universities’ procedures for obtaining consent from the parents of the premature newborns, and to require corrective actions from the medical schools and their institutional review boards, academic committees that oversee the ethical and other details of human research.

UM, which conducted the study along with 22 other research institutions, defended its work.

“Our No. 1 priority is the health and safety of our patients,” according to a statement from the university. “We participate in research to advance medicine and the quality of patient care. Patients and their families are always carefully instructed of any known risk that might be involved in research, and they were in this case.”

From 2004 until 2009, 1,316 infants born extremely prematurely were enrolled in the clinical studies at 23 research hospitals throughout the United States, including such prestigious universities as the Stanford, , Yale, Brown, Duke and Emory. In its letter, Public Citizen took issue with the informed consent procedures at all 23. Under long-accepted ethical standards, the subjects of medical research, or their guardians, must clearly understand the risks they take before they can agree to participate in a clinical trial or study.

For more than a half-century, doctors have known that they faced a terrible dilemma: too high a concentration of oxygen left frail preemies at risk of permanent damage to their retinas, or even blindness. But not enough oxygen could lead to brain damage or death. The purpose of the research was to pinpoint a specific level of oxygen saturation that would reduce the risk of blindness among premature infants — without increasing the chances of either death or neurological and developmental damage.

The problem with the study, according to both HHS and Public Citizen, is that parents were never told that their babies were going to be subjects of an experiment that was fraught with risks. Of 509 newborns who were given a higher concentration of oxygen during treatment, 91, or almost 18 percent, suffered the side effect of severe damage to the retina, compared with 8.6 percent whose oxygen saturation was lower. And among 654 newborns whose oxygen level was on the lower side, 130, or nearly 20 percent, died. Among the babies given a higher oxygen concentration during the study, 107, or 16.2 percent, died.

“Many, if not most, of the subjects’ parents likely would have refused to let their newborn infants participate in the study had they been adequately informed of, and understood, the purpose and known risks of the research,” Public Citizen wrote in the letter.

G. Kevin Donovan, director of the Pellegrino Center for Bioethics at Georgetown University Medical School in Washington, said he was particularly surprised to learn that no clinicians or ethicists at any of the 23 medical centersraised any red flags.

“Particular care has to be paid to how a consent form reads so that people who are not terribly sophisticated or well-educated can pick up and understand the risks and potential benefits, and all those things that can help them make a good decision for their child,” he said.

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