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Lack of informed consent for experiments on premature babies

Experimentation on premature babies has always presented ethical problems. Increasing numbers of babies are born prematurely and babies are surviving at younger gestational ages. Pushing the boundaries of intensive care often steps into the realm of the unknown. This creates problems of informed consent.

In an article on bmj.com, a senior doctor today calls for an  investigation of whether parents of premature babies were fully informed of the risks of a study on the health effects of varying oxygen levels.

Dr Sidney Wolfe, founder and senior adviser to the Health Research Group at Public Citizen, says it is surprising that the adequacy of consent forms for nearly identical studies in the UK, Australia, New Zealand, Canada, and other countries with similar regulation of human research, has apparently not yet been examined.

He argues that there may well be “serious problems” with such risk disclosure that must be addressed.

One such study, called SUPPORT, was funded by the US National Institutes of Health and took place at many universities across the US between 2005 and 2009. A total of 1,316 extremely premature infants were randomly maintained at either higher (91-95%) or lower (85-89%) ranges of oxygen saturation.

The main aim of the study was to see whether the infants were more likely to die or suffer eye damage and blindness at the different oxygen ranges. In the early days of the development of intensive care of very premature babies, many suffered blindness as a result of being given high levels of oxygen. The principal problem for premature babies is that the lungs are very poorly developed. Only from the development of ventilator techniques has it been possible to keep these babies alive.

Wolfe says that parents were not adequately informed about the risks or true nature and purpose of the research, but others have staunchly defended this lack of informed consent. Intensive care for very premature babies, particularly now those born around 23 weeks gestation, is inevitably 'experimental'. The choices are stark. Either they are not kept alive or it must be accepted that the process of doing so will involve procedures the risks of which are difficult to assess.

Nevertheless Dr Wolfe argues that information on risks and possible outcomes was missing from the consent forms, and that the forms “failed to distinguish the important differences between these clearly experimental procedures for managing the oxygen therapy and the usual individualized standard of care the babies would have received had they not been enrolled in the study.” I suspect had they not been enrolled in 'the study' it would have been unlikely they would have survived, or at least it would have been impossible for the neonatologists to have given sufficient information to the parents for informed consent in intensive care. 

But there is one key concern Dr Wolfe highlights that should be addressed. He points out that  “many of the consent forms falsely stated that because all of the treatments proposed in this study are ‘standard of care’ there would be no expected increase in risk to the infants.” This is disingenuous at best. The truth must surely be that all procedures are expected to have risks. Keeping babies alive at all costs is not in itself ethical.

Others, however, have defended the lack of appropriate informed consent in neonatal trials.  In a recent BMJ editorial, eminent neonatologist Neena Modi implicitly argued that withholding some risk information would “reduce the burden of decision making at difficult and stressful times” and “would also reduce the risk of ‘injurious misconception,’ where participation is inappropriately rejected because of an exaggerated and disproportionate perception of risk.”

But Wolfe suggests that the underlying principle behind these arguments “is that it is necessary, via inadequately informed consent, to blur the line between research and standard of care to facilitate more consent and participation.”

This, he concludes, “appears to be exactly what occurred when consent was obtained for the SUPPORT study subjects.”

Indeed I would argue that that is precisely what has led to the development of modern neonatal intensive care procedures. For the very premature babies it is largely experimental. But more babies are now surviving as a result of these techniques and the EPICURE study has tracked reasonably good outcomes through childhood. The difficulty is in being able to predict which babies are likely to be those with a good outcome.

These difficulties in predictive outcome and the risks of treatment should be shared with parents. The key question is not whether this should be so but how it should or can be done so as to enable parents  to share in the decision making process.  


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