Table 2

Examples of parental quotes and emotions. When asked the following question: ‘If a study drug was administered to your baby as part of an emergency trial without informing you; please tell us what would be your reaction when you would be informed later and asked for consent for continued participation in that trial.’ (examples associated with only one emotion, for the complete list see online supplemental appendix II)

Parent groupExample of parental quotes and emotions associated with them
Positive (total: 19%)Neutral (total: 55%)Negative (total 26%)
‘Positive thoughts: it’s good that the doctors thought of the possibility; Hopefully the drug will work for my child; What would it have been like without it?’
‘I would be glad that everything possible was done for my child.’
‘Assuming prior information: I would try to remain calm, thinking that by doing so you have done everything possible to help the child.'
'Possibly confusion; good or bad depends on the situation'
'Uncertainty at first, but if someone would explain to me what it’s about, then it would be ok.’
‘Concern and the right to be informed in detail afterwards. Side effects. What if the drug had not been administered.’
‘I'd probably be fine with that, if it successfully helped. In the event of complications, I cannot judge how I will react. In general, I have to trust the knowledge and actions of the doctors in such a situation.’
‘Aggravation. After all, it is a drug that has not yet been approved.'
'Doctors ask why there was no brief explanation beforehand! There was enough time!’
‘I wouldn't like that, it’s still a study drug. A tested drug would be more ok! Especially in the case of study drugs, prior information would be particularly important to me!’
‘That would probably depend very much on the success of the treatment. A certain feeling of deceit would probably not be avoidable, even if it is irrational.’
‘If the application brings a positive result, this would lead to joy. It’s better to try something than to refrain from helping.'
'It’s good that my child was given the best possible help. I am grateful because I know the sequalae and damage that can happen after a lack of oxygen’
I would think: ‘The doctors did everything they could to help my child.’
‘I would like a full explanation and exact reasons why the doctors chose this drug and why they acted the way they did.’
‘Disappointment, possibly anger because I wasn't asked in advance!'
'I would lose confidence in the doctors and possibly take legal action against them’
‘I would hope that this would be as helpful to my child as possible, and even if not, that there would be a sense of progress that would help other children in a similar situation.’
‘This triggered so much relief in me. The hope that my child could do well is irreplaceable!’
‘I would be grateful if I knew that everything is being tried to save my child. I also expect that from a university hospital, which is why I go there and not to a birth center’
‘I would first get clarification from the doctor. But basically, I would trust his expertise.’
‘I would be shocked! Extremely angry. Depending on the side effects my child would have afterwards. If there were no adverse effects, I would probably just be shocked that something was done without permission.’
‘Incomprehension, anger, doubts about legality; Would rate the approach as arrogant and high-handed.’
‘That would harm my trust and my confidence. I would then question everything and suspect several things about which I was not informed.’
  • PAx, parents of neonates treated for perinatal asphyxia ; PNeo, parents of healthy newborns; ProP, prospective parents.