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.