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US researchers failed to disclose risks of newborn study, finds government office

BMJ 2013; 346 doi: (Published 12 April 2013) Cite this as: BMJ 2013;346:f2367
  1. Michael McCarthy
  1. 1Seattle

Researchers who enrolled more than 1300 premature newborns in a study to identify the optimum levels of blood oxygen saturation did not adequately disclose to parents the risks of eye damage, neurological impairment, and death that study participation posed, the United States Office of Human Research Protections (OHRP) has found.

The study was part of the influential Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) study that also looked at the use of continuous positive airway pressure and surfactant in these patients.

The OHRP detailed its concerns about the study’s arm relating to blood oxygen saturation in a letter on 7 March to Richard Marchase, vice president for Research and Economic Development at the University of Alabama at Birmingham, which was the lead site for that portion of the study.1

The letter was written by Lisa Buchanan, compliance oversight coordinator at OHRP.

In the part of the trial criticized in the OHRP review, premature infants of low birth weight …

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