Abstract
There has been some controversy recently in the US in regard to an international trial looking at how much oxygen supplementation should be received by very premature babies, and I thought it might be interesting for our readers to think about this issue. 1
Your committee has received an application to conduct a piece of research with very premature babies. The study will look at the level of oxygen supplementation and will measure two outcomes – mortality rate and the rate of retinal damage. Standard care for these infants varies, with oxygen saturations usually being held between 85 percent and 95 percent. In the study, babies will be randomly assigned to be held at either the 85–89 percent or the 91–95 percent level – this will be masked from the clinicians caring for them (who do know they are in a trial) by using a pulse oximeter which has been doctored to produce a reading which is either too high or too low, but both of which should ensure that the infant is kept within the range of standard care.
The parents will be asked for consent when the mother is admitted into hospital to give birth, and an information sheet will be provided for them; however, the researchers have asked your research ethics committee to provide them advice on what the content of the information sheet should be. In particular, they are unsure what they should put under the risks of the trial – one group favours simply stating that there are no risks that are outside those that occur within standard practice – they are concerned that if they specify the risks potential participants might confuse the risks of standard practice with the risks of the research and be put off enrolling their child. The other group favours disclosing the risks of standard treatment (potentially increased mortality or eye damage, depending on which arm they end up in) given that these will be present, and the randomization and artificial division might change the risk profile for specific participants even if these do not make a difference to the risk for the entire cohort.
What advice do you give them?