allegations in federal oversight office has dismissed last year National Institutes of Health (NIH) improperly interfered with monitoring officials another federal office of the ethics of a controversial study funded by the NIH involving premature infants.
issue is the study of $ 20 million, 23-institution SUPPORT (surfactant, positive pressure and Oxygenation Randomized Trial), which from 05 to 09 studied the oxygen levels that preterm infants should receive. In early 2013, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) found that parents of 1316 babies in the study had not been sufficiently informed of the risks and sent a letter impose sanctions at the University of Alabama, Birmingham, who led the study. NIH officials have publicly defended their support, they noted, used the oxygen levels in the standard of care.
Then, in May, a group of public defense, Public Citizen released a flood of emails between NIH, HHS, and officials OHRP in which NIH recommended revisions to OHRP a second letter to the university . Representative Rosa DeLauro (D-CT) and Public Citizen asked the HHS inspector general (IG) to determine if the NIH had improperly intervened in the deliberations of the OHRP.
In six page report dated 15 September, the IG HHS found that officials NIH encouraged OHRP to reconsider and free entry to the follow-up letter . But e-mails "contained no directive or order" that OHRP take a specific position. And OHRP finally took a different position from the NIH, the report notes. "Our research revealed no law, regulation, or a written policy prohibits or restricts the kind of consultation that took place here and make these incorrect consultations, "the report concludes.
The NIH interactions with OHRP were acceptable because OHRP sitting within HHS and with no law bars HHS officials to consult with each other, the IG report found. He added that if Congress wants to OHRP independent, it could do so, as it has other offices.
The Chronicle of Higher Education reported on the IG and a second report concerning the report released this week noting that OHRP has followed the correct procedures when it looked in 2011 original public complaints Citizen SUPPORT. Public Citizen Michael Carome say Chronicle that the audit is "a complete whitewash."
OHRP working on new rules for the protection of human subjects for studies on the quality of care and should be free to the comments in the weeks and months ahead, the Chronicle reports.
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