Labels: Action , Halts , Researchers , Watchdog

Watchdog Halts Action on Researchers

The federal Office for Human Research Protections announced on Wednesday that it would suspend action against the University of Alabama at Birmingham, which it said in March did not adequately inform parents about the risks to their premature infants of enrollment in a large research trial.

In a letter dated Tuesday, the watchdog office still maintained that researchers had not properly informed parents, and that it could still require that the university and 22 other trial sites, which include many of the country’s top research universities, take corrective action. But it also acknowledged that federal guidelines about a researcher’s obligations needed to be clarified and issued. On the office’s Web site, the federal Department of Health and Human Services announced that a public meeting to debate such guidelines was forthcoming.

The timing of the letter coincided with the publication on the Web site of The New England Journal of Medicine of an opinion article by leaders of the National Institutes of Health that took issue with the agency’s initial condemnation of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial, widely known as Support. Both the agency and the N.I.H. are branches of Health and Human Services.

The Journal also published a letter, signed by 46 doctors and scholars, that criticized the office’s initial action as overreaching and having a potentially chilling effect on essential research.

At the center of the uproar, which has engendered commentary from scientists, is whether researchers needed to disclose to parents the risks of a randomized trial of higher and lower oxygen levels administered to premature infants. The levels of oxygen concentration given to the infants were within the range of 85 percent to 95 percent, the standard treatment recommended by the American Academy of Pediatrics. Researchers wanted to pinpoint more precisely the level at which the risks of eye damage or neurological damage, or even death, were abated.

There were risks to the infants at either end of the narrow band. The results, published in The New England Journal of Medicine in 2010, showed that lowering the oxygen levels led to greater mortality rates than expected.

But as the office wrote, “Some physicians, recognizing the particular concerns about risks near the low (85 percent) and high (95 percent) ends of that range, might choose to avoid one or both of those regions.”

Dr. Joel E. Frader, a pediatrician and professor of medical humanities and bioethics at Northwestern, who signed the letter in The Journal, felt that the office initially did overreach, but also that the researchers did not properly inform parents of all risks. Because there was a band of oxygen saturation levels, he said, there was no clear standard of care for these infants, only an “acceptable range.” And parents should have been told that, he said.

“It’s the obligation of investigators to say, ‘Here’s the debate, here’s how we’re trying to answer the question, and that involves the possibility that there is an additional risk with being a research subject,’ ” he said.

He applauded the effort to clarify guidelines for disclosure, even in standard-of-care trials. Researchers should not shy away from fully informing subjects, he said. “There is no empirical evidence that transparency and clarity decreases participation in clinical research,” he said.

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