Table 1 The REB queries towards the consent method

Denmark: deferred consent

The REB did not find that the time limit of 6 h and the fact that the mother is always in the hospital could justify deferred consent. Opt-out is not legal.

No

Greece: prior, deferred and opt-out

We applied for prior informed consent (standard or ‘opt-out’, depending on the situations surrounding preterm birth, such as time of birth and parental psychological status) and we also asked approval for deferred consent on very specific occasions (e.g. transfer of the neonate from another hospital and single parent family with the mother presenting serious complications postpartum). Our Ethics Committee approved only the prior informed consent (standard or ‘opt-out’, as analysed above). Their rationale was that SafeboosC is not just an observational study but involves interventions which might change the course of the disease. Even if such changes would be for the patient’s short- or long-term benefit, the members of the committee argued that the parents should be informed and give their consent in advance.

Approved only the prior informed consent (standard or ‘opt-out’)

Spain: prior, deferred and opt-out

They wanted a further explanation on the opt-out and deferred consent.

To be acceptable for the members that an infant is randomised without prior consent, I should make a statement with regards to ‘being in the control group would not be a prejudice, because the standard treatment would be adopted; and being in the intervention group would potentially have benefits’ With this arguments, they were happy and the study was approved.

They also wanted me to know about the discussion they had when SafeBoosC-III was presented at REB, as the President considered that this kind of trial should have a waiver for parental consent, as could be considered routine practice.

Yes

Spain: prior, deferred and opt-out

The REB included a suggestion in its report to insist that parents must consent.

Yes

Switzerland: prior and deferred

In Switzerland no opt-out for clinical trials. Clarify the declaration of intent and signature of an independent doctor.

We decided to resubmit with the following process and justification:

Contact the parents before inclusion whenever possible and get informed consent. If not possible and if there are no obvious signs against an inclusion, randomisation might be done and monitoring started. However, informed consent must be obtained as fast as possible. This option allows parents to think about it without missing study participation.

Yes

USA: prior

IRB requires consent from only one parent or legal guardian

IRB required that future use of collected data must be made optional with the choice to opt out

Yes