Making the consent and recruitment of pregnant women to research fair and woman centred
In this blog post from Mary Alvarez, Senior Research Midwife at the Bristol site in the Bump2Baby and Me project, she explains the importance of the consent process when recruiting pregnant women to participate in research.
Achieving high quality consent in research trials is more than getting people to sign a form. It is an agreement made by an individual to participate in research after being fully informed of the implications of the research through study information, a discussion with a delegated study team member and documented evidence of an agreement to participate. Informed consent is voluntary, is an ongoing process for the duration of a study, allows the individual to withdraw at any point without question and is based on:
- Information – what information has been disclosed.
- Comprehension – the way in which the information has been conveyed and understood.
- Voluntariness – that the decision to participate in research has been given voluntarily and without coercion.
Discussing consent and research participation
Informed consent and the discussions that take place are often complex but are essential for participation in maternity research. Women are expected to understand unfamiliar and, for some, complex concepts such as equipoise – where it is not known whether one treatment is better than the other. The research midwife should give a clear and accurate account of essential research information to aid understanding, whilst setting aside the needs of the study, and allow women as much time as they require to be confident with their decision.
Understanding the views of women and midwives on how we as researchers can best communicate the informed consent for research are essential if the consent process is to be fair and women centred. Knowing why women do or don’t participate in research needs to be understood if evidence is be generated through research to make pregnancy and childbirth safer for women and their babies.
Currently limited data guides evidence-based practice1 and there is little clarity and questionable guidance on the timing of information provision and the conditions that need to be met before a woman is asked to decide on participation and provide a quality consent.
Qualitative research carried out on behalf of the ASSIST II study2 (a second feasibility study investigating a novel device for assisted vaginal birth) produced new findings and corroborated the findings of the small number of studies that have investigated the consent process.
This transferable knowledge from our previous studies contributed to the successful and rapid recruitment of women by the Bristol Bump2Baby and Me trial site, completed during the COVID-19 pandemic.
So why do women participate in research?
- Helping other women and furthering medicine were the main motivating factors for many women. However, the consent always came with the caveat that there should be no risk to their baby – safety of their baby was women’s primary concern.
- Women believed that taking part in research would provide them with an opportunity to receive enhanced care for themselves and their baby.
Why do women decline participation into research?
- Study information given too late or inappropriate timing of information.
- Women preferred to receive standard care.
- A lack of communication – language barriers (verbal and written), unable to involve family members in decision making.
- Inability to concentrate on information as anxious or in pain.
What women said the recruitment process should look like
- Women would like recruitment to be woman centred.
- Information should be made available throughout pregnancy and given to them by their community midwife.
- A prior awareness of the study was important for an interactive conversation.
- Information provided should be easily understood and engaging.
- Video – this medium helped women understand study procedures and pre-empted questions, whereas the patient information leaflet was least favoured.
However, the discussion and the interaction between the woman and the research midwife were felt to be key in the optimisation of the recruitment discussion. Successful recruitment was dependant on the research midwives’ ability to promote the study whilst assessing feedback from the women.
The research midwives believed prior information was advantageous to the outcome of the conversation; women who were given the time to consider information and their options were felt to be on a level footing with the research midwife, asking more questions and making a more informed decision about participation. This was one of the benefits of the staged telephone calls of the Bump2baby and Me trial where the women had the opportunity to absorb information and formulate questions before their second call with the research midwife and choose to decline or accept participation.
It takes on average 27 years to generate the evidence base for a treatment for pregnant women.3 To speed up the translation of innovations like the Bump2Baby and Me mHealth Coaching Programme into current practice we need to embed research into clinical practice. By making research conversations part of a pregnant woman’s normal care, delivered by her trusted midwife, we can create a culture shift moving from protecting women from research toward protecting them through research.
1Hanrahan V,Gillies K,Biesty L. Recruiters perspectives of recruiting women during pregnancy and childbirth to clinical trials: A qualitative evidence synthesis. PLoS ONE.2020;15(6): e0234783.
2Hotton EJ, Alvarez M, Lenguerrand E, Wade J,Blencowe N, Draycott T et al. The Odon Device for assisted vaginal birth: a feasibility study to investigate safety and efficacy -The ASSIST II study. Pilot Feasibility Stud.2021;(72): 7.
3Krubiner C, Faden R. Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’. J Med Ethics. 2017; 43(10): 664-65.