WIKIMEDIA, USAIDLast year, the US government’s Office of Human Research Protections (OHRP) conducted an independent investigation of alleged ethical lapses in a clinical trial that tested the effects of administering either high or low levels of oxygen to preterm infants. But it turns out that investigation wasn’t so independent after all, according to federal watchdog group Public Citizen. On Tuesday (May 20) the group released e-mails between officials at the National Institutes of Health (NIH) and those at OHRP conducting the ethical investigation of the $20 million, 23-hospital SUPPORT study.
Public Citizen, along with members of Congress, is calling for an investigation of top brass at the Department of Health and Human Services (HHS), which administers the NIH, over the alleged interference. “This interference involved NIH officials reviewing and editing a series of drafts of a pending OHRP compliance oversight determination letter regarding the SUPPORT study, as well as apparently allowing NIH to influence the timing of the release of that letter,” wrote Public Citizen to the HHS Inspector General in a letter that was cosigned by a number of academic researchers.
The SUPPORT trial ran from 2005 to 2009 and recruited more than 1,300 extremely premature babies, treating them with either low or high concentrations of oxygen (O2)—levels that were all within then-accepted standards ...
