What women think about consent to research at the time of an obstetric emergency: A qualitative study of the views of a cohort of World Maternal Antifibrinolytic Trial participants

Objective: The WOMAN Trial was the first in the UK to use the option of waiver of informed consent at the time of an obstetric emergency. This qualitative study aimed to investigate participants’ views of the acceptability of the recruitment methods used. Design: Qualitative study using in-depth interviews with women who did and did not give consent at the time of their recruitment to the WOMAN Trial. Setting: Highest UK recruitment site for the WOMAN Trial (129/569). Interviews were conducted in participants’ homes. Population: 40 of the 129 women who were recruited to the WOMAN Trial at one UK site were invited to take part, 15 women were interviewed. Methods: Qualitative, interview study Main outcome measures Facilitators and barriers to successful recruitment during obstetric emergencies. Guidance for future researchers. Results: Findings revealed that what is important is not so much the consent process used or a signature on a form, but the way in which consent is obtained. Clinicians who successfully negotiate consent to research during childbirth emergencies engage in a “humane choreography” of words and actions. This emphasises the importance of prompt decision making and treatment, whilst respecting the woman’s personal situation and experience. Conclusions Our findings do not support a single pathway to consent in the context of an obstetric emergency. Women understand that consent to research in an emergency is complex. Clinicians’ skills in considering the clinical, ethical and emotional aspects within the context of the clinical emergency can hamper or promote women’s satisfaction