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Editorial: UNMH’s past shows informed consent vital

The National Institutes of Health is under fire for not fully informing parents of the risks inherent in its ongoing study of anemia treatment in premature infants.

As one of the 18 institutions administering the study, the University of New Mexico Health Sciences Center should be especially sensitive to that concern.

After all, this is the hospital that suffered a severe crisis in patient trust when one of its physicians modified the protocols for treating acute lymphoblastic leukemia, and neither the institution nor the parents of its young patients found out about it until two subordinates came forward with the troubling disclosures.

More than 10 years and tens of millions of settlement dollars later, UNM is now caught up in the allegations leveled by Washington, D.C.-based advocacy group Public Citizen against the NIH.

The group, founded by activist Ralph Nader in 1971, has asked U.S. Health and Human Services Secretary Kathleen Sebelius to stop recruitment for the new study, designed to find the best level of hemoglobin for transfusions in anemic, premature infants. The group contends the parental consent forms don’t adequately explain the risks of low hemoglobin transfusions.

Around 900 infants will get the low levels.

The group is also challenging the consent forms used in NIH’s 2005-09 study of oxygen levels in treating very premature infants.

NIH has said review boards at the 18 institutions performing the hemoglobin study approved the consent forms. That may in fact prove to be sufficient.

But a review of the section that lays out risks is warranted, especially considering the age of the patients, the controversies facing NIH and the history of parental notification here.

UNM has said it will defer comment until NIH addresses the concerns publicly. But NIH appears loathe to revisit its decisions; on Wednesday, Health and Human Services called police to break up a Public Citizen news conference at its entrance.

The public – those paying for the study, and especially the parents of those infants involved in or being considered for involvement in the trials – deserves better, if not from NIH, then from front-line researchers.

This editorial first appeared in the Albuquerque Journal. It was written by members of the editorial board and is unsigned as it represents the opinion of the newspaper rather than the writers.