Abstract

Objective: To assess whether continuous consent, a process in which information is given to researchparticipants at different stages in a trial, and clinician training in that process were effective when used byclinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is arandomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidenceof perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test ofthe effectiveness of continuous consent.Methods: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBYtrial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on thevalidity of parental consent based on the consent components of competence, information, understandingand voluntariness.Results: No marked problems with consent validity at the point of signature were observed in 19 of 27(70%) couples. Problems were found mainly to lie with the competence and understanding of the parents:mothers, particularly, had problems with competence in the early stages of consent. Problems inunderstanding were primarily to do with side effects. Problems in both competence and understandingwere observed to reduce markedly, particularly for mothers, in the post-signature phase, when furtherdiscussion took place. Randomisation was generally understood but unpopular. Information was notalways given by clinicians in stages during the short period available before parents gave consent. Mostclinicians, however, were able to give follow-up information.Discussion: Consent validity was found to compare favourably with similar trials examined in the Euriconstudy.Conclusion: Adopting the elements of the continuous consent process and clinician training in RCTs shouldbe considered by researchers, particularly when they have concerns about the quality of consent they arelikely to obtain by using a conventional process.