Introduction
Informed consent is a key principle in research participation.1 Ethical procedures require that potential participants receive adequate information and have time to consider participation prior to giving written consent. In emergency situations this may not be possible and has the potential to delay treatment. In order to improve outcomes for women/patients it is vital that research into treatments and management of emergency situations is completed. Labour and childbirth is a particular example of this, as obstetric emergencies may occur rapidly requiring immediate intervention. Due to the emergency situation, labour pain and disorientation due to medication women may be classed as vulnerable.2.3 Additionally, some may be unable to consent due to incapacity, for example if there is loss of consciousness. In situations where women are unable to consent due to incapacity, the Health Research Authority (HRA) allows for enrolment without prior consent, subject to certain conditions. Other studies have used proxy consent procedures, with consent given by a representative followed by written consent.4 Where there is no incapacity, current guidance suggests that verbal consent may be obtained in acute situations, with informed written consent obtained in retrospect.3 This approach was taken in a Phase 2 clinical trial in which a novel device known as the PPH Butterfly was used to treat postpartum haemorrhage (PPH) (PPH Butterfly Phase II study, II-LA-0715-200008).5
Alongside the main study, a qualitative exploration of experiences of the use of the PPH Butterfly was undertaken. This enabled greater understanding and multiple perspectives to be obtained. A specific aim of the study was to understand the experiences of women, partners and health professionals around the issue of taking verbal consent, followed by retrospective written consent, for the main study.