“The court’s summary judgment against the plaintiff s has no implications for judging the ethics of the SUPPORT study”, agrees Henry Silverman, chair of the ethics advisory committee (University of Maryland, Baltimore, MD, USA). Silverman believes too little about the study was disclosed: “It would have been appropriate for the consent forms to explain that in one randomised group, some infants would receive more oxygen than they otherwise would have, in which case there would be a greater risk of going blind; and in the other group, some infants would receive less oxygen than they otherwise would have, thereby decreasing the risk of going blind, but possibly increasing the risk of brain injury or death”.

But “there is no reason to think the babies who go into a comparative eff ectiveness study like SUPPORT are worse off than babies who don’t and, actually, the data show that they did better than babies who didn’t enter the trial”, counters Nancy Kass (Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA). “What makes comparative eff ectiveness research diff erent from traditional research is that it is almost never testing investigational approaches. It just helps determine which standard approach is best for patients.”

“Many of us have argued that the standards of informed consent should be somewhat diff erent for comparative eff ectiveness studies than for experimental studies”, says Kass. “The point of informed consent is to further patients’ interests, in part by protecting them from unreasonable risks. And yet standard of care studies like SUPPORT are providing options to patients that they might have received anyway and are indeed standard. That is, thousands of babies are getting these oxygen levels already—but we’re just not learning much about what happens to those babies. The SUPPORT study was designed to learn systematically and rigorously, once and for all, what the eff ects of diff erent levels of oxygen saturation are on babies’ outcomes.”

image Geoffjw1978 CC BY SA 3.0

Be the first to like.

Like

Unlike