I'll give the moral of this story right at the outset. If somebody asks you to sign your baby up for a "study" when you're being wheeled into the delivery room, telling you only that it is a way to "help" your baby, don't sign.
Tell them, "I am in no position right now to give informed consent to my child's being enrolled in any study. Just give my child the best treatment possible, and we can discuss this later when I can ask questions and get full information."
This story is outrageous:
[I]n reality, the study was much more than that. It was a national, government-funded experiment on 1,316 extremely premature infants in which their fate may as well have rested with the flip of a coin.
The government-backed study is called SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” The experiment was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health, part of the Department of Health and Human Services.
All three women now say they never would have agreed to take part if they had known the NIH-funded study’s true nature—to randomly manipulate preemie oxygen levels. They discovered that just last year.
It gets even worse:
Doctors say babies are at risk of complications even when born at 37 weeks, now considered early term. The stated goal of SUPPORT was to identify the best oxygen level for extremely preterm infants—generally those born before 25 weeks, and so especially in distress.
Medical personnel routinely give supplemental oxygen to babies who are born with immature lungs. Too much oxygen can cause severe eye damage, including a blood vessel disease and blindness called retinopathy. Too little oxygen can lead to brain damage and death.
The NIH-funded experiment used the test babies in an attempt to find the sweet spot for preemies yet to be born: the lowest level of oxygen that would preserve vision, yet be sufficient to prevent brain damage and death.
To get the answer, researchers arbitrarily assigned infants to either a high-oxygen or low-oxygen group. Because, researchers say, all oxygen levels fell within the generally accepted range, they argue the babies received the same “standard of care” as babies not in the study. None of the consent forms mentioned a risk of death from the oxygen experiment.
But it turns out there were key differences in how researchers treated babies in the study compared with those not in the study.
Normally, medical personnel constantly adjust oxygen as preemies’ conditions change, based on their individual needs. But the SUPPORT study was designed to keep infants in their randomly assigned range, despite a baby’s individual needs.
And in a decision that one government source says shocked seasoned researchers when they learned of it, the babies’ oxygen monitors intentionally were altered to provide false readings. The reason: so medical staff wouldn’t be tempted to adjust oxygen out of the babies’ study-assigned range. (emphasis added)
Yes, you read that right. But this was all said to be "within standard of care" by the sophistical logic that the oxygen levels given to the babies all lay within the range that is the "standard of care." Obviously, the real standard of care is to vary the oxygen levels within that range, based on knowledgeable medical assessment of the best treatment of the patient as an individual. But these babies weren't individuals to the researchers. They were variables in a study.
I can only imagine how the nurses and doctors must have felt if they learned later that their instruments were deliberately tampered with by higher-ups to give false readings.
If you wonder if this is part of a larger trend, read Wesley J. Smith's blog Human Exceptionalism regularly, as I do, and ask yourself this: Does it or does it not seem that scientists are increasingly impatient at limitations on their ability to experiment on and make use of human beings? Embryonic stem-cell research is an obvious example. But so too is the move toward "presumed consent" in organ donation laws. Then there is this interesting article about bioethicists promoting experimentation in hospitals without patient consent. Then there is this one, from the UK. Oh, and this proposal for allowing people to "consent" ahead of time to being experimented on when they are dying.
Perhaps in the preemie study the scientists were more willing to experiment without true informed consent from the parents because of special disdain for the lives of preemies. That may be true. But the phenomenon of pushing for more and more experimentation on human subjects without informed consent affects other ages and stages of human development. It may be that what we are seeing here is a general disregard for all merely individual human lives, even those previously considered "sufficiently valuable." This disdain comes from a toxic combination of scientific hubris and decades of attacks on human exceptionalism.
May God help us to negotiate our way through these shoals for ourselves and our loved ones.
HT for main story link: Sage McLaughlin