Top officials at the National Institutes of Health compromised a recent NIH-sponsored study by interfering in the investigative process, according to allegations made in a letter from the public advocacy group Public Citizen.
The controversial study analyzed the effect of different methods and dosages of oxygen on helping extremely premature babies breathe. But an Office of Human Research Protections review of the study found that researchers didn't properly brief the subjects' parents about the risks of the study, according to The Hill..
Public Citizen obtained copies of emails between Department of Health and Human Services (HHS) officials, the Office of Human Research Protections and the NIH, under a Freedom of Information Act request. The group said that several emails contained messages from NIH Director Francis Collins, thanking the officials for allowing the medical research center to contribute to a letter to the University of Alabama at Birmingham on the study in question, the group claimed.
Public Citizen argued that the NIH's level of involvement is a clear conflict of interest, akin to the Food and Drug Administration allowing a pharmaceutical company to review and edit an FDA warning letter about the drug company's sponsorship of a clinical trial.
The emails indicate a "truly disturbing picture" in which NIH interfered and improperly influenced The Office of Human Research Protections' compliance oversight of the study, the group wrote in the letter, and didn't allow the agency to reach its own conclusions. Even more troubling, the group wrote, was that numerous HHS officials facilitated the interference despite the "obvious, actual, direct conflicts of interest."
Rep. Rosa DeLauro (D-Conn.) called on HHS Inspector General Daniel R. Levinson to investigate the allegations and consider moving the Office of Human Research Protections out of HHS to prevent similar incidents in the future, The Hill reported.