NIH officials cleared of interfering in oversight of preemie study

A federal watchdog office has dismissed allegations that last year National Institutes of Health (NIH) officials improperly interfered with another federal office’s oversight of the ethics of a controversial NIH-funded study involving premature infants.

At issue is the $20 million, 23-institution SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) study, which from 2005 to 2009 studied the levels of oxygen that premature infants should receive. In early 2013, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) found that parents of the 1316 babies in the study had not been adequately informed of risks and sent a letter imposing sanctions to the University of Alabama, Birmingham, which led the study. NIH officials publicly defended SUPPORT, which they noted used oxygen levels within the standard of care.

Then in May, a public advocacy group, Public Citizen, released a flood of e-mails exchanged among NIH, HHS, and OHRP officials in which NIH recommended revisions to a second OHRP letter to the university. Representative Rosa DeLauro (D–CT) and Public Citizen asked the HHS inspector general (IG) to investigate whether NIH had improperly intervened in OHRP’s deliberations.

In a six-page report dated 15 September, the HHS IG found that NIH officials did encourage OHRP to reverse its decision and offered input for the follow-up letter. But its e-mails “contained no directive or order” that OHRP take a specific position. And OHRP ultimately took a different stance from NIH, the report notes. “Our research disclosed no law, regulation, or written policy that prohibits or restricts the kind of consultation that occurred here or would make such consultations improper,” the report concludes.

NIH’s interactions with OHRP were acceptable because OHRP sits within HHS and no law bars HHS officials from consulting with each other, the IG report finds. It adds that if Congress wants to make OHRP independent, it could do so, as it has for some other offices.

The Chronicle of Higher Education first reported on the IG report and a second, related report released this week finding that OHRP followed correct procedures when it looked into Public Citizen’s original 2011 complaint about SUPPORT. Public Citizen’s Michael Carome told the Chronicle that the audit is “a complete whitewash.”

OHRP is working on new rules for human subjects’ protections for studies involving the standard of care and should be releasing them for comment in the coming weeks or months, the Chronicle reports.