Exploring informed consent in antenatal screening version 1
Research type
Research Study
Full title
What are midwives and sonographers understanding and experiences of the informed consent process within antenatal screening for fetal anomalies following recent changes in professional and legal guidance?
IRAS ID
317266
Contact name
Alexandra Drought
Contact email
Sponsor organisation
London South Bank University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 10 months, days
Research summary
The birth of a healthy baby is facilitated by antenatal screening for fetal anomalies using ultrasound at 12 weeks and again at 20 weeks of pregnancy. Ultrasound screening can identify fetal conditions that may benefit from intrauterine therapy or postnatal investigations and possible treatment. Guidelines produced by the Royal College of Obstetricians and Gynaecologists in 2015 state that informed consent must be sought and documented for all antenatal screening. Obtaining informed consent is a general, legal and ethical principle prior to any treatment or physical investigation (GMC, 2020). However, in antenatal screening, informed consent is regularly reported as being contentious and poorly understood by healthcare professionals (Nicholls et. al., 2019). This was highlighted recently by the ‘Mordel versus Royal Berkshire NHS Foundation Trust’ legal ruling, where informed consent prior to the 12 weeks ultrasound scan was deemed not to have been obtained. The striking feature of this court case was that it demonstrated the blurred responsibility and accountability between the midwives and sonographers for who should have obtained informed consent from the pregnant woman and when. These two healthcare professionals form part of a social group working within antenatal screening. Yet, whilst working independently of each other, there is an inter-professional reliance to ensure informed consent is obtained from pregnant women at each stage of the process for antenatal screening of fetal anomalies. This study will explore the practices of midwives and sonographers in obtaining informed consent during antenatal screening and investigate their understanding of informed consent. Midwives and sonographers working in antenatal screening, will be purposively recruited from a London NHS Trust, where they will be observed by the Chief Investigator during their normal practice and then subsequently interviewed. The data collection is likely to last three to four months. The findings will potentially inform future education and policy.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0439
Date of REC Opinion
8 Nov 2022
REC opinion
Favourable Opinion