Abstract
Objective: To assess whether continuous consent, a process in which information is given to research
participants at different stages in a trial, and clinician training in that process were effective when used by
clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a
randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence
of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of
the effectiveness of continuous consent.
Methods: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY
trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the
validity of parental consent based on the consent components of competence, information, understanding
and 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 in
understanding were primarily to do with side effects. Problems in both competence and understanding
were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further
discussion took place. Randomisation was generally understood but unpopular. Information was not
always given by clinicians in stages during the short period available before parents gave consent. Most
clinicians, however, were able to give follow-up information.
Discussion: Consent validity was found to compare favourably with similar trials examined in the Euricon
study.
Conclusion: Adopting the elements of the continuous consent process and clinician training in RCTs should
be considered by researchers, particularly when they have concerns about the quality of consent they are
likely to obtain by using a conventional process.