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.
Lay summary of study results:
Obtaining informed consent is a legal and ethical principle prior to medical procedures. In antenatal screening, informed consent is reported as being poorly understood by healthcare professionals (HCPs). This was highlighted by a UK legal ruling, ‘Mordel versus Royal Berkshire NHS Trust’ (2019), where informed consent prior to a dating ultrasound scan was deemed not to have been obtained, due to blurred responsibilities between midwives and sonographers.
Focused ethnography was carried out in two London hospitals in Spring 2023, drawing on observations of midwives and sonographers during antenatal appointments and ultrasound scans. Semi-structured interviews were carried out with six midwives and six sonographers. Data was analysed using reflexive thematic analysis to identify key themes.
Six themes were identified which suggested that obtaining valid informed consent in antenatal screening is very complicated and beset with challenges due to a miscellany of variables: deficits in midwives and sonographers’ knowledge of antenatal screening and informed consent; gaps in their training; organisational constraints such as lack of time; increasing cultural and linguistic diversification and disparities in professional cultures. Consumerism and the social dimensions of ultrasound screening have also contributed to the routinisation of antenatal screening, which has fashioned informed consent to appear less relevant than in other areas of medicine.
Obtaining informed consent in antenatal screening is very complex. Both midwives and sonographers face challenges associated with their roles. Therefore, further training is required to assist them in determining women’s values and beliefs; better interprofessional education could mutually increase their knowledge around antenatal screening and ameliorate the lack of interprofessional collaboration. Finally, more attention needs to be paid to delivering culturally competent care.
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