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NIH Officials Accused of Improperly Influencing Investigation of Premature Infant Study

A new controversy has erupted over a federally funded study involving premature infants that drew ethical concerns last year. A public interest group accuses the National Institutes of Health (NIH) of intervening in the drafting of a letter about the study from a research ethics watchdog office within the Department of Health and Human Services (HHS). The group, Public Citizen, and a member of Congress are calling for an investigation by the HHS inspector general.

“NIH, despite having obvious substantial conflicts of interest, was allowed to interfere and improperly influence OHRP’s [the Office for Human Research Protections’] investigation of the SUPPORT study. Most troubling, it appears that numerous officials at the very highest levels of HHS were aware of this interference,” writes Representative Rosa DeLauro (D–CT) in a letter today to the HHS inspector general.

The $20 million, 23-hospital study known as SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) ran from 2005 to 2009 and examined what oxygen levels premature infants should receive. In March 2013, OHRP sent a letter to the University of Alabama, Birmingham (UAB), the study leader, imposing sanctions because informed consent documents did not adequately inform parents of the 1316 babies in the study of risks. Those risks included that infants receiving the highest oxygen levels might be at elevated risk for blindness, and those treated with the lowest levels could be at risk of death or developmental delays. Both were statistically significant outcomes found in the study.

After Public Citizen drew public attention to the letter, NIH officials and some researchers rushed to SUPPORT’s defense. NIH Director Francis Collins and other agency officials wrote a commentary published online on 5 June in The New England Journal of Medicine (NEJM) defending the study’s design as ethical and arguing that some OHRP opinions should be vetted by outside experts. On the same day, several dozen bioethicists and researchers backed NIH’s position, arguing that because the oxygen levels were within the accepted standard of care there was no requirement to inform parents of risks. In a second letter to UAB dated 4 June, OHRP put on hold its actions against UAB. It then invited public comments and held a hearing in August to discuss the issues.

Writing to the HHS inspector general today, Public Citizen and several bioethicists charge that NIH officials were involved in drafting the second letter from OHRP. The letter quotes from about 400 pages of e-mails and documents the group obtained. The e-mails were exchanged from April to June 2013 by NIH and HHS officials, including HHS Assistant Secretary for Health Howard Koh as well as OHRP Director Jerry Menikoff. In the e-mails, Collins and other NIH officials discuss revisions to the letter and plans to coordinate its release with the NEJM commentary. It is difficult to discern from the heavily redacted documents exactly what wording was changed, but NIH officials express approval of the changes.

In a statement, an HHS representative did not directly address the charges of interference but stated that “OHRP regularly works with entities such as NIH, IRBs [institutional review boards] and others to ensure the protection of human subjects in research.” OHRP is still reviewing the comments about the SUPPORT study and drafting “guidance,” the representative said.

As Public Citizen notes in its letter, OHRP came into being 14 years ago when a similar office was moved out of NIH to avoid conflicts of interest involving NIH. DeLauro’s letter suggests that the HHS inspector general examine “whether OHRP needs to be relocated, and if so where.”