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.
Neonatal Research 
Hello. I am a mother to 3 preterm babies (31 weeker singleton and 27 weeker twins.) I am also Chair of Multiple Births Canada’s Preterm Birth Support Network. My twins were participants in a couple of trials while in the NICU. I was recently discussing this topic with another preterm infant/family advocate. We discussed the issue of what advice would we give to current and future parents if they are approached to help with trials and research during the NICU stay. My comment: I would tell them to ask as many questions as they can about the care of their baby while in NICU, whether or not they are being asked to consent to trial(s). When it does come to being approached to participate in a trial or a few, ask about potential long term ramifications to their baby. Ask what factors or indicators are making researchers want to learn more about the specific health concern and do the specialists and researchers see value in the process (such as breathing trials, probiotic trials, fecal microbial transplant trials…the list could go on.) Ultimately it is important for the parents to be comfortable with their decisions. If they are unsure, they can always talk it out with a social worker and their neonatal team.
Thank you for all the work that you do! I enjoy hearing and learning about medical professionals’ viewpoint just as much as I enjoy hearing from the families of preterm infants.
Thank you so much for your comment. I honestly believe, (and I am a cynic in many things) that doctors and others doing research in neonatology really want to improve care and outcomes, and would never do research that might harm babies. That is the starting point, we do research when there are real uncertainties about which approach is best, and very often in neonatology it is not a new drug, or a new machine, but comparing 2 things that might already be done in different NICUs, or even within the same NICU.
So I think that parents in the NICU can start with that premise, that everyone wants the best for their baby, and research is being done to find out what that best might be.
After that Parents have the responsibility to make sure for their baby that they understand what is being done and why, and whether or not they think there are any risks for their baby that are above the usual risks of being in the NICU.
I want to involve parents much more than before in the planning and performance of research in the NICU, I think we have not listened enough to parents, or asked them what they want us to research next.
I believe that people such as you can be the key to the future advance of neonatology. Hope your 3 boys are well.
Keith
I would love to share my thoughts on the NICU and approach to take with parents when it comes to delivering information regarding healthcare options, long term implications of preterm birth, as well as how to address the topic of the value of trials/research. I’ve been looking for your email address, but can’t find it. Thanks.
Hi there.
I agree that parents should be more involved in research. Thanks for bringing this up. Our twins born in 2008 at 27 weeks, were part of the COT study. We enrolled because we believe research is crucial in advancing and optimising the care of premature babies. Canadian Premature Babies Foundation has one of its purposes: to prevent preterm birth through edcuation and research.
Thanks for your thoughts Carolyn.
Katharina Staub