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UNM criticized over its study of infants

ALBUQUERQUE, N.M. — The University of New Mexico is among 18 institutions participating in a government-funded study criticized by an advocacy group for allegedly exposing premature infants to risks without fully informing their parents.

The group, Public Citizen, has asked U.S. Health and Human Services Secretary Kathleen Sebelius to halt recruitment for the new study, which aims to find better ways to treat anemia in premature infants.

Doctors typically use transfusions of hemoglobin, which transports oxygen, to treat anemia in infants born eight to 15 weeks before term. The National Institutes of Health-funded study seeks the best level of hemoglobin to use in transfusions, according to a study description.

The study calls for assigning about 900 infants, or half the total enrolled, in a control group that will receive a low hemoglobin level. Public Citizen contends that consent forms signed by parents don’t fully explain the risks of the low hemoglobin transfusions.

Public Citizen is a nonprofit consumer rights advocacy group based in Washington, D.C. It was founded by activist Ralph Nader in 1971.

UNM Health Sciences Center spokesman Billy Sparks issued a written statement Monday saying UNM plans to withhold comment until the NIH, the study’s lead agency, makes a public response to the criticism. NIH is expected to make a definitive response today, Sparks said.

Reuters reported on Monday that the NIH issued a written statement saying that the consent forms used to notify parents were approved by institutional review boards at the 18 institutions performing the study. But the NIH did not respond to the specific concerns raised by Public Citizen, Reuters said.

Earlier this year, Public Citizen called for an investigation into an NIH-funded study from 2005 to 2009 that was designed to test the effectiveness of different oxygen levels in the treatment of very premature infants.

Public Citizen alleged that study exposed infants to an increased risk of blindness, brain injury and death, without properly disclosing the information to parents.

Sparks said UNM also participated in the so-called SUPPORT study to determine the best oxygen levels needed to ensure infant survival without harmful side effects associated with high oxygen levels.

The 18 participating universities plan to enroll a total of 1,824 premature infants in the transfusion study, according to a study description. The study was launched in December and is scheduled for completion in 2017.