Kim Annink

266 Chapter 12 Before we can start a clinical trial based on a Master Protocol design, the safety of combinations of different pharmaceutical agents and their interactions should be investigated in preclinical experimental research. Harmonization of consent procedures in the neonatal emergency setting The informed consent procedure in delivery room research is difficult, but early interventions are sometimes essential, as in the ALBINO trial. Possibilities are to ask all expecting parents for informed consent, use the deferred consent procedure or ask short oral consent. All options have pros and cons considering the impact on healthy pregnant women, patient and parent autonomy, the emotional ability of parents to consent during resuscitation of their newborn and the feasibility of the study in a time critical and stressful situation. During the ALBINO study, the different ethical committees in Europe and even within the Netherlands had different opinions about the preference for short oral consent or deferred consent. Consensus about the best approach will save time for ethical committees, will harmonize the procedures in international studies and will make clinicians more confident with this approach by becoming more experienced. Patient participation Patient participation should become more important for future grant applications and trial design (65). The opinion of parents and patients about the importance of a trial and the burden to parents and patients should always be considered. We have to discuss the primary outcome of trials with parents and patients. What parents and patients consider as clinically relevant might differ from the opinion of researchers and clinicians (65). The aim of research should be to improve the quality of life of patients and their opinion about how their quality of life can be improved is therefore essential. Further, parents of patients formerly admitted to the neonatal intensive care unit should be involved in the design of the informed consent procedure, especially in emergency settings, and the text of the patient information letter. Finally, after each study all participating patients and parents should be able to receive the results, so they are informed about what their participation led to and it will also motivate them to participate in future studies. This can be done by a newsletter, a lay-man summary or by a patient symposium.