Informed Consent/Impossible Choice

The Providence Journal says that some Rhode Island babies were entered into a study that raises ethical concerns…

R.I. babies part of study cited over risk disclosure
Study looked at oxygen levels for early births
By FELICE J. FREYER JOURNAL MEDICAL WRITER
Premature babies at Women & Infants Hospital were among those enrolled in a research study that last week came under fire, accused by a federal agency of failing to inform parents of the risks.

The study, which took place between 2004 and 2009, sought to refine doctors’ understanding of how much oxygen to give premature babies . Of the 1,316 infants enrolled at 23 institutions, 124 were at Women & Infants.

Because their lungs are underdeveloped, premature babies need extra oxygen. But too much oxygen causes eye damage that can lead to blindness. Doctors have long struggled to find the right balance.

The babies in the study were given oxygen within the range of standard practice. None got more or less oxygen than what was considered good care, but half received higher amounts and half lower . Infants treated with lower oxygen were significantly less likely to develop eye disease but slightly more likely to die. Of the 654 babies in the low-oxygen group, 130 died and 41 survivors developed eye disease. Of the 662 in the high-oxygen group, 107 died and 91 survived with severe eye disease.

Last month, the Office for Human Research Protections of the U.S. Department of Health and Human Services found fault with the consent forms used in the trial, because they “failed to describe the reasonably foreseeable risks of blindness, neurological damage and death.”

I just wonder about the parents, and what kind of choice could they have made if the results of the study were known before it was done? Increasing odds of survival but also the odds of blindness? With no sure answers no matter what they do? Trying to guess how the probabilities will affect their baby? What a terrible, impossible decision to present to parents already dealing with a premature birth.

Premature babies have a much better chance of health and survival today than in the past, that’s the good news. The bad news is that preventable and treatable conditions that raise the risk of prematurity are not addressed with the best prenatal care a great nation can provide.

Some causes of prematurity are not predictable or treatable, even with the best care. But other risk factors may be reduced with measures as simple as access to a dentist.

There are too many misfortunes we cannot prevent. What’s our excuse for not investing in the basic care that could spare at least some families these impossible decisions?

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