Watchdog Agency Asked To Investigate ‘Serious Ethical Lapses’ In Preemie Study
Researchers who tested oxygen levels delivered to premature infants have long faced questions over whether the work was ethically and accurately performed.
The Wall Street Journal:
Group Calls For Expanded Probe Of Premature-Infant Clinical Trial
The consumer group Public Citizen said it has found new, “serious ethical lapses” in a premature-infant study that it contends should lead a federal medical-research watchdog agency to expand an investigation into the research. Public Citizen said it has unearthed documents showing that oxygen-measurement instruments used in the baby study gave inaccurate readings, which could have harmed the babies. The group called for the federal Office for Human Research Protections (OHRP) to look into the matter. (Burton, 6/14)
Stat:
Controversial Trial Of Premature Infants Facing Fresh Scrutiny
The trial was intended to determine whether premature babies fare better with lower or higher levels of oxygen. It resulted in a clear conclusion: Lower oxygen levels were associated with higher rates of death among babies enrolled in the trial (Ross, 6/14)
