Was NIH independence compromised in study?

Top officials at the National Institutes of Health injected themselves into the investigation of a highly controversial NIH-sponsored study and compromised its independence, according to a public advocacy group.

Public Citizen says a Freedom of Information Act request revealed email communication between top officials at the Department of Health and Human Services, the Office of Human Research Protections (OHRP) and the NIH to draft a letter about the controversial SUPPORT study.

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Among the emails were several letters from NIH Director Francis Collins thanking HHS and OHRP officials for letting the NIH give its input on a letter to the University of Alabama at Birmingham about OHRP’s ethical conclusions about the controversial study.

The OHRP’s opinion was meant to be developed independent of the NIH and, says Public Citizen, such emails show the agency’s involvement in an investigation with which it had a direct conflict of interest.

The SUPPORT study involved giving different dosages of oxygen and using different methods to help extremely premature babies breathe. However, a review by the OHRP, which is tasked with monitoring ethics in research, found parents were not adequately briefed on the risks of the study to the babies, including blindness, brain injury and death.

Now Public Citizen is calling on Daniel Levinson, HHS inspector general, to investigate the potential conflict of interest in a letter signed by Sidney Wolfe and Michael Carome, founder and director of Public Citizen respectively, and several top bioethicists.

“The series of email communications among NIH, the HHS OS, and OHRP obtained by Public Citizen documents a truly disturbing picture in which NIH — a conflicted, regulated entity — was allowed to interfere with and improperly influence OHRP’s compliance oversight investigation of the SUPPORT study,” states the letter. “Most troubling, numerous officials at the very highest levels of HHS facilitated this interference by senior NIH officials, despite the fact that NIH had obvious actual, direct conflicts of interest in the research under investigation.”

Rep. Rosa DeLauro (D-Conn.) wrote a separate letter to Levinson calling for an investigation into the affair and asked whether the OHRP needed to be moved out of HHS to prevent such an incident in the future.

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