No ethical breakdown here

As I mentioned at the end of my first post about this, the New York Times have jumped into the fray with an editorial entitled ‘An ethical breakdown‘ published today.

They take as ‘gospel’ the OHRP findings concerning the study, and show their lack of understanding of this kind of research, they note the following:

But, in this case, the federal Office for Human Research Protections concluded that the consent forms failed to reveal that there was a greater risk of dying in the low-oxygen group and a greater risk of severe eye damage in the high oxygen group. The form also stated that, because both groups would receive oxygen within the standard of care, there would be no predictable increase in risk no matter which group a baby was in.

But the federal agency found that many infants could have faced greater risks by participating. For example, if a baby whose clinical needs might ordinarily have led doctors to deliver a relatively high level of oxygen was enrolled in the study, the infant might be randomly assigned to receive lower levels of oxygen.

It is obviously much more understandable that a journalist does not comprehend the issues, but they lay out in those two segments the findings of the OHRP, which points out how misguided they are. The consent form could not reveal those different risks, because we didn’t know about them before the trial. The idea that neonatologists somehow know which baby has clinical needs that require a higher level of oxygen, and that the baby might be denied that because of the study would be concerning if it were true, but it is not. Firstly we did not have any reason for choosing one level of oxygen over another, as there had been no prior studies to help us choose. Secondly if there were such a situation the ethical imperative is to take the baby out of the study and treat them according to their clinical needs. There is no reason to believe that would not have been done to these babies; it is reported as a protocol violation, and counted at the end of the study.

Earlier on in the editorial they report the usual saturation limits used in most US NICUs as being 85 to 95%. They don’t seem to realize that the ranges tested in SUPPORT were all within those limits.

I am very concerned about this ruling, (as you can see from 3 posts). I think it is a stain on the reputation of the researchers, it calls into question the integrity of their IRBs, and puts at risk other clinical research in the NICU which might possibly be shown to have unexpected outcomes. Furthermore the other oxygen studies, including COT which will be presented at this year’s PAS meeting, will likely also be tainted by association.

About keithbarrington

I am a neonatologist and clinical researcher at Sainte Justine University Health Center in Montréal
This entry was posted in Neonatal Research and tagged , , . Bookmark the permalink.

One Response to No ethical breakdown here

  1. Martin Offringa says:

    Surely a concerning, probably misguided ruling!
    Today, Jeffrey Drazen, Caren Solomon, and Michael Greene wrote:
    http://www.nejm.org/doi/full/10.1056/NEJMe1304996?query=TOC
    “When .. (premature babies) are born today, their chances of survival to adulthood are greatly improved, thanks to research made possible by thousands of parents and their children. We are dismayed by the response of the OHRP and consider the SUPPORT trial a model of how to make medical progress.”
    Maybe we have to point this out to the general public, our patients (rand) parents.

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