[This article was first published on June 4 2014]
Pressure from government officials and eminent researchers appears to have pushed a federal agency to postpone enforcement action on violations it found in a government-financed experiment on extremely premature babies.
The agency, which polices ethics in health studies, says the controversy over the study of preemies highlights a “fundamental difference between the obligations of clinicians and those of researchers.”
That ethics body, called the Office for Human Research Protections, is part of the Department of Health and Human Services. The sponsor of the controversial experiment, the National Institutes of Health, is also part of HHS. Officials at both HHS and NIH provided “input” leading to the office’s delay in enforcement.
At issue is SUPPORT, a study in which researchers at two dozen academic institutions randomly manipulated the oxygen levels of 1,316 extremely premature infants without providing their parents the full details of the methods and risks.
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