Another devastating critique of the OHRP ruling regarding the SUPPORT trial is now available. John Lantos, a world leader in pediatric bioethics (and a good friend) has an article which seems to be open access: ‘OHRP and Public Citizen Are Wrong about Neonatal Research on Oxygen Therapy‘. It is worth reading in its entirety; he refers to criticism of the trial from a group known as ‘Public Citizen’. This group has misunderstood the trial even more than did the OHRP.
John Lantos explains the implications of the OHRP ruling in this way:
Their position is apparently that informed consent forms need to inform parents not only of known risks and of possible risks, but also of risks that the investigators did not think were possible – even after those risks have been shown not to exist. Essentially, there is no risk that does not fall into this category. By these criteria, consent forms should state something like, “ANY risk that you can imagine, and ALL risks that you cannot even imagine, and EVEN RISKS THAT HAVE BEEN SHOWN NOT TO EXIST, are possible as a result of participation in this study.”
Dr Lantos does have some critique of the consent forms, a critique much more subtle and measured than the OHRP. The OHRP state that the consent form did not adequately explain the risks, which claim Dr Lantos destroys with the paragraph reproduced above. On the other hand Dr Lantos does think that the consent form should explain the goals of the study, rather than just the risks. I think he has a point, for the future, to include parents as partners in research projects, rather than as subjects of those projects, we should focus on educating them, and informing them more clearly and completely about why we need to do these projects. I think his criticism of the consent form here goes a little far, if you read the form in its entirety I do think you get a picture of the goals of the study.
For the future we should involve parents in drafting consent forms; forms which describe why the study needs to be done, as well as any reasonably foreseeable risks of the trial. But criticisms of this trial, and claims that it did not meet OHRP standards are clearly misplaced.
John is always very eloquent, in person and in print, I will reproduce his eloquent last paragraph here
It is shocking that OHRP and Public Citizen did not see fit to understand the study or, apparently, to analyze the results before claiming that it was risky to babies. The real risk to babies comes from reckless and ill-informed opinion about highly ethical scientific studies. To minimize this risk, OHRP and Public Citizen should apologize to the investigators and to the parents of the babies in these studies for their sensationalistic misinterpretations of the SUPPORT study. If they do not, and if fewer babies are enrolled in such studies, then more rather than fewer babies will die, more rather than fewer babies will go blind, and OHRP and Public Citizen will have been responsible for those harms to innocent babies.