WIKIMEDIA, CEEJAYOZResearchers who led a multi-center clinical trial on the effects of administering oxygen to extremely premature babies can breathe a little easier after the US government agency in charge of protecting research participants has suspended its call to sanction the scientists for failing to fully communicate the risks involved to the subjects’ parents. In a June 4 letter to administrators at the University of Alabama, Birmingham (UAB), which led the so-called SUPPORT trial, the US Office for Human Research Protections (OHRP) stated that it would suspend its previous decision to discipline researchers involved in the study for failing to fully inform parents of the potential risks involved.
The move came as discussion of the decision swirled on the internet and top officials at the National Institutes of Health (NIH), which funded the study, leading bioethicists, and pediatric researchers urged the OHRP to reconsider their move in a pair of articles published in last week’s issue of The New England Journal of Medicine. “[W]e respectfully disagree with the conclusions of the OHRP,” wrote three senior NIH officials, including NIH Director Francis Collins, in one of the pieces.
The SUPPORT trial ran from 2005 to 2009, giving more than 1300 extremely premature babies different concentrations of oxygen—all of which were within then-accepted standards of care—to study the causal relationship between the intervention and blindness. The results, which were published in 2010 in The New ...
