Investigation of informed consent procedures initiated in the intrapartum period
When research involves procedures initiated in the intrapartum period, there is considerable variation in information provision. If midwives are to optimise the process of information provision and facilitate good understanding of the research, we need to understand how information is currently being provided.
To investigate the feasibility and acceptability of an approach to investigating information provision for informed consent to research involving interventions initiated during the intrapartum period.
Audio recordings of seven study recruitment consultations and six structured interviews were transcribed and analysed to construct a ‘hints and tips’ for recruitment document for midwives.
Most women and three out of five midwives agreed to audio-recording consultations. All participants confirmed the acceptability of audio-recording recruitment consultations. Midwives varied in their experiences.
This approach to exploring the informed consent processes is feasible and acceptable to women and midwives. Findings will inform further investigation of information provision in the ASSIST II study.
There is common agreement that the three key elements of informed consent, voluntarism, information disclosure (Office for Human Research Protections, 1979) and the decision-making capacity of an individual should underpin the ethical basis to a study's recruitment strategy (World Medical Association, 1964). However, it can be challenging to ensure that these elements apply when seeking informed consent from women who choose to participate in research studies where interventions are initiated during the intrapartum period (Dhumale and Gouder, 2017). Decision-making capacity can be hindered by a number of factors which interfere with truly informed consent: lack of sleep, opiate analgesia and pain (Vernon et al, 2006).
The process of deciding whether to take part in such studies is also influenced by contextual factors such as the environment, timing of consent in relation to birth, birthing support, the participant's physical and/or mental state and the user-friendliness of the study information given to women (Tooher et al, 2008). Maternity research interventions can be particularly complex. Women are required to understand the purpose of the study, the study interventions, as well as their right to withdraw, risks and benefits of participation for both themselves and their baby, how results will be shared, and how confidentiality will be maintained. It could be argued that the recruitment consultation, the sharing of study information and the researcher's assessment of the woman's capacity to have a full understanding of all aspects of the study, are fundamental to the validity of the consent process (Flory and Emanuel, 2004; Nishimura et al, 2013).
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