• Associated Press

    Public Citizen, a watchdog group founded by Ralph Nader, has alleged that the Department of Health and Human Services (HHS) mishandled informed consent in a federally-funded study evaluating oxygen saturation targets in premature infants.

    The group claimed in a letter to HHS that the agency's Office for Human Research Protections (OHRP) failed to respond appropriately when it uncovered deficiencies in the consent forms used by the trial's participating centers; those problems are blamed for leaving the infants' parents uninformed about the potential risks of the trial and the actual purpose of the research. Public Citizen said the infants' parents should receive a formal apology.

    The study in question is the SUPPORT trial, which was funded by the National Institutes of Health and conducted at 23 U.S. centers from 2005 to 2009. It included 1,316 extremely premature infants who were randomized to either a lower oxygen saturation target of 85% to 89% or a higher oxygen saturation target of 91% to 95%. The primary outcome was a composite of retinopathy of prematurity, death before hospital discharge, or both.

    The trial did not include a control group that received usual care, which entails individualized adjustment of the oxygen saturation levels within the entire range from 85% to 95%.

    The study's stated intent was to determine how much oxygen minimized the chances of blindness without increasing the risks of other problems including death or brain damage. The problem: The informed consent document that parents had to sign to enroll didn't spell out those risks, according to the government's Office for Human Research Protections.

    In a letter to the University of Alabama at Birmingham, which led the study, the government agency concluded the research had violated regulations requiring that patients be fully informed of the risks of a clinical trial. The March 7 letter, which was publicized Wednesday by Public Citizen, asked the university to take steps to ensure consent forms in future studies outline all the risks.

    In a statement, university's vice president for research Richard Marchase said although slightly more babies who received lower-dose oxygen in the study died, those death rates still were lower than was usual for premature babies getting standard care at the time.

    But, "we will ensure that any future consent form clearly delineates risks to all arms of a study as completely as possible, including studies in which all arms are operating within the accepted standard of clinical care," Marchase wrote.