Table 2 Concerns raised by clinical staff or parents during the first 6 months of the trial
Who raised the concern? | Subject | Consequence or solution |
|---|---|---|
Part A: Ethical concerns regarding information and consent | ||
Consultant | Some find it uncomfortable to bother the parents with the study consent so soon after delivery. | We are trying, whenever possible, to include the patient before delivery |
Consultant | How much time after birth is it ethical to obtain deferred consent? | We agreed on ‘as soon as possible’, balancing the family´s emotional situation but also fairness not to limit their right to consent. or not to participate in the study. |
Consultant | There is uncertainty about when the baby will be born. Asking for prenatal consent is perceived as an added stressor for the parents. | The opt-out model is perceived as the best prenatal option, an attempt will be made to implement |
Consultant | Wonder if the father of an ELBW (extremely low birth weight infant) in critical care, even after correct information, is in an appropriate emotional state to make such a decision. | None |
Consultant | It is difficult to talk about a baby who is even not born. He/she may need resuscitation and may also die. Also, parents can easily get confused and don’t understand the things that give information about the prognosis of a baby. | None |
Parents | Most parents were anxious about the survival and prognosis of their babies, they were afraid for their baby as they thought of the procedure as an experiment rather than a clinical study. | After a detailed explanation, most of them agreed to give consent prior to birth. |
Resident | Is it ethical to use deferred consent? | Deferred consent and ethical issues were discussed with medical staff. Resident was satisfied and practice was not changed |
Part B: Concerns regarding the consent procedures | ||
Consultant | Limited time to obtain signed informed consent before randomisation. Risk of reduced patient recruitment. | None |
Consultant | It has been difficult to incorporate the opt-out model due to not having a good understanding of the procedure. | It will probably be used more from now on after clarifying doubts in the monitoring visit. The opt-out model will be used in prenatal visits. |
Consultant | The postnatal model is complicated by the large number of tasks in the first hours of life. | Deferred models are preferably used. |
Consultant | Short time period for those who presented in labour and did not have time for an antenatal consent process. | None |
Consultant | When the delivery is urgent and the Obgyn takes the mother to delivery, it becomes impossible to get a prior informed consent and these babies are excluded from the study. | Deferred consent may be helpful in these urgent cases |
Parents | The patient was allocated in the control group and was born during a long weekend, so the doctor on duty gave the parents the consent form in the NICU with basic information about the study. They initially rejected the study arguing that they had been asked prenatally too many times to participate in studies. Five days later, I asked them to talk about the study outside the NICU and I explained in detail the study purpose and what participating in the control group meant. Finally, they accepted the study and they told me that they had changed their minds thanks to the information. | I think that for doctors on duty sometimes is difficult to explain the study to the parents with detail an in a comfortable environment. However, especially for patients in the experimental group, it is necessary to ask them as soon as possible, although we are using deferred consent. |