Successful approach for emergent consent for ECMO research

The HELP-ECMO pilot study (Heparin low dose protocol versus standard care in critically ill patients undergoing ECMO; ACTRN12613001324707) is a randomised controlled phase II study evaluating two levels of heparin anticoagulation in patients with no requirement for full anticoagulation. This work is a substudy of the HELP-ECMO trial and describes the consent process of the parent study. At our site, consent for research is often obtained by the research coordinator with little involvement from investigators. However, the nature of the ECMO population required a modified consent approach to be implemented given that ECMO is often inserted emergently. It required a model that would be successful out of hours and could be delivered by any member of the treating team.