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The neonatal SUPPORT trial, which randomized extremely low birth weight infants to lower or higher levels of oxygen saturation as part of their ventilator management raised ethical issues that are turning out to be among the most controversial topics in research ethics in many years.
The trial was conducted at 22 sites and involved 1300 newborns. The target oxygenation saturations between the two arms were both considered to be within the standard of care, but the consent documents either did not mention or were unclear about the risks of retinopathy of prematurity, impaired brain development, or death in the two arms of the trial.
In March 2013 OHRP issued a compliance oversight determination letter, finding that consent was deficient and violated the regulatory requirements, a judgment that could have broad implications for other forms of comparative effectiveness research. This determination generated a storm of controversy, including questions about how to assess the risks and benefits of “standard of care” interventions, and even whether informed consent is ethically necessary for this type of research.
Ben Wilfond and Ruth Macklin each first-authored opposing letters that were published in the New England Journal of Medicine, with dozens of signatories represented on each side. We are fortunate that they have agreed to come to Boston for a moderated debate on these important and interesting questions.