Leaders of Infant Trial Will Not Yet Face Sanctions

US watchdog suspends plans to discipline researchers who failed to disclose the full risks of an experimental trial conducted with premature infants.

By Bob Grant | June 10, 2013

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 England Journal of Medicine, indicated that babies receiving lower oxygen concentrations were more likely to die but less likely to go blind.

In March 2013 the OHRP wrote a letter to UAB officials stating their concern that informed consent forms provided to parents enrolling their children in the SUPPORT trial—in which 23 prominent medical centers and research facilities participated—were inadequate. According to the OHRP, the forms failed to disclose to the parents any of the risks of the experimental oxygen-management interventions, including severe retinal damage, possible blindness, neurologic injury, and death. The agency asked that UAB administrators provide a “corrective action plan” to address the concerns.

But in the recent OHRP letter, the agency stated that it “does not and has never questioned whether the design of the SUPPORT study was ethical. It was a study that asked important questions and produced information that promises to advance both scientific knowledge and clinical care.”

And although it has decided to delay any corrective actions against the researchers involved, the OHRP also said that it would be conducting an “open public meeting” on the topic, after which it would reconsider measures to be taken.

Hat tip to ScienceInsider.

Correction (June 11): The original version of this article mistakenly gave the impression that the OHRP had decided not to recommend any disciplinary actions against the researchers who led the SUPPORT trial. In fact, the OHRP has only suspended activities to decide appropriate corrective actions until a public meeting is held to explore the complex matters raised in this case. The Scientist regrets the error.

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Avatar of: peteraleff


Posts: 2

June 10, 2013

This decision returns medical "ethics" to its status before the establishment of the Nuremberg Code which stipulated as its bedrock principle the researchers' duty to obtain the informed consent of the research subjects. It thereby now opens the door to continued abuses like those in the SUPPORT experiment of suffocating premature babies. The designers of that experiment expressed their concern for the safety of the infants in the low oxygen group because they knew about the risk of increased mortality but failed to inform the parents, and they went ahead with their knowingly lethal experiment anyway. As a result of their restricting the oxygen breathing help they predictably killed an "extra" 23 preemies in that group -- actually they had predicted a slightly higher percentage of death and/or severe brain damage to expect from their intervention.

The top leaders of the NIH defended this reckless sacrifice of human babies to scientific research and claimed falsely that prior studies had safely reduced the oxygen saturation levels to as low as 70 percent, but the text of the single study they cite does not bear them out because the infants were always kept in the upper half of their nominal 70 to 90 percent range.

This willfully baby-killing SUPPORT experiment was still being conducted when President Obama publicly apologized to the government and people of Guatemala for the willful infecting of unconsenting subjects there with syphilis by American researchers. With the continuing pattern of winking at present gross ethics violations and apologizing for them decades later, we can expect some future U.S. President to show contrition for the premeditated SUPPORT killings while similar abuses are happening under his or her watch. The more things change the more they remain the same.

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