Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process

Objectives: To assess whether continuous consent, a process whereby information is given to research participants at different stages in a trial, plus clinician training in that process was effective when used by clinicians gaining consent to the TOBY trial. The TOBY trial is a randomised controlled trial investigating the use of whole body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for TOBY is difficult; as such, it is a good test of the effectiveness of continuous consent.

Methods: Semi-structured interviews were conducted with 30 sets of parents who gave consent to TOBY and with 10 clinicians who sought it using the continuous consent process. Analysis focused on the validity of parental consent based upon the consent components of competence, information, understanding and voluntariness.

Results: 19/27 (70%) couples had no significant problems with consent validity at the point of signature. Problems lay mainly with the parents’ competence and understanding. Mothers particularly had competence problems in the early stages of consent. The understanding problems were primarily to do with side effects. Problems in both areas (competence and understanding) reduced markedly, particularly for mothers, in the post signature phase when further discussion took place. Randomisation was generally understood but unpopular. Clinicians did not always give information in stages during the short period of time available before parents gave consent. However, most clinicians were able to give follow up information.

Discussion: The consent validity compares favourably with similar trials examined in a comparable study (the Euricon study).

Conclusion: Researchers should consider adopting elements of the continuous consent process and clinician training in RCTs, particularly where they have concerns about the quality of consent they are likely to obtain using a conventional process.