Check list of points to consider when talking to parents about the possible inclusion of a neonate into a clinical trial
| Points to consider during informed consent process | Done | Delayed | Not applicable | Comments |
| Informed consent setting | ||||
| Consider approaching parents prior to delivery.33 | ☐ | ☐ | ☐ | |
| Both parents should be present.15 | ☐ | ☐ | ☐ | |
| Both parents should be asked for consent.15 | ☐ | ☐ | ☐ | |
| Offer the possibility to have the responsible nurse and/or doctor, trusted friend and/or family member or a parent from an NICU association joining the conversation.49 | ☐ | ☐ | ☐ | |
| Introduce the investigator/HCP who will be seeking consent during routine contacts with the parents.45 46 | ☐ | ☐ | ☐ | |
| Ensure parents are comfortable and trust the investigator/HCP seeking consent.49 | ☐ | ☐ | ☐ | |
| In multinational trials local beliefs, customs and traditions should be taken into consideration.55 | ☐ | ☐ | ☐ | |
| Consent information | ||||
| Information needs to be clear and well structured.58 59 | ☐ | ☐ | ☐ | |
| Information should be provided in the parent’s native language.15 | ☐ | ☐ | ☐ | |
| Pause for questions—do not rush.28 | ☐ | ☐ | ☐ | |
| Provide written information where parents can find additional, independent information and NICU parent organisations.48 | ☐ | ☐ | ☐ | |
| Reassure that their decision to participate or not will not change the level of care.52 | ☐ | ☐ | ☐ | |
| Clarify that parents can always change their mind and that this does not have any consequences for the routine treatment of their child.52 | ☐ | ☐ | ☐ | |
| Be prepared to re-explain and reconsent.49 66 | ☐ | ☐ | ☐ | |
| Adapt communication to what the parents can take in at the time.23 67 | ☐ | ☐ | ☐ | |
| If parents are struggling with the decision-making process, acknowledge that it is difficult.49 52 | ☐ | ☐ | ☐ | |
| If parents are anxious provide more support and ask how you can help them, reassure them that they should take their time to decide.49 52 | ☐ | ☐ | ☐ | |
| Benefits of study treatment | ||||
| Do not exaggerate benefits.49 | ☐ | ☐ | ☐ | |
| Explain how the study will benefit the child.52 | ☐ | ☐ | ☐ | |
| Explain how the study will benefit neonates with the same condition.52 | ☐ | ☐ | ☐ | |
| Risks of study treatment | ||||
| Be upfront about potential risks of the study treatment and the comparator.48 49 | ☐ | ☐ | ☐ | |
| Explain how study related risks will be minimised.52 | ☐ | ☐ | ☐ | |
| Address concerns about pain and discomfort proactively.68 | ☐ | ☐ | ☐ | |
| Study procedures | ||||
| Explain whether and how the study will interfere with routine clinical care.52 | ☐ | ☐ | ☐ | |
| Be clear about additional procedures and follow-up—other than what is normally done.63 | ☐ | ☐ | ☐ | |
| Explain how additional follow-up (other than routine) will be organised and address any questions about reimbursement of costs for transport and additional child care.63 | ☐ | ☐ | ☐ |
HCP, healthcare professional; NICU, neonatal intensive care unit.