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SUPPORT research misconduct: Did Francis Collins have his thumb on the scale?

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Last August, the Allentown Family Health Examiner reported on SUPPORT (Surfactant Pressure and Pulse Oximetry Trial), a clinical trial that aimed to test the effects of different levels of oxygen treatment for prematurely delivered babies. At the time, the Office of Human Research Protection (OHRP) had chastised the researchers for failing to adhere to informed consent protocols. Top NIH officials, including Director Francis Collins, disagreed with OHRP, apparently believing that the importance of gathering clinical trial data outweighed the premature infants' rights.

On May 20, 2014, nearly four years after the results of SUPPORT were published in the New England Journal of Medicine, a series of emails from high-ranking officials in the Department of Health and Human Services (HHS) came to light. These emails, which include communications from NIH Director Francis Collins to individuals at OHRP, give the impression that HHS officials exerted inappropriate pressure to influence OHRP to refrain from executing enforcement actions against the University of Alabama at Birmingham (UAB), the institution where SUPPORT took place.

Both consumer advocacy group Public Citizen and Rep. Rosa DeLauro (D-CT) have called for a full investigation into the "potentially inappropriate HHS interference with OHRP's investigation of SUPPORT." Public Citizen, along with several nationally prominent scientists writing to the HHS OIG, notes that "Documents obtained under FOIA [Freedom of Information Act] strongly suggest that NIH -- apparently desperate to undo OHRP's compliance oversight determinations -- launched an aggressive campaign to undermine OHRP's regulatory authority and regrettably found several willing partners for this campaign at the highest levels of HHS."

In 2008, Dr. Collins was the inaugural winner of the Inamori Ethics Prize, awarded by Case Western Reserve University to "honor outstanding international ethical leaders." There is no word yet from the university as to whether it plans to strip Dr. Collins of the award.