Abstract
Background 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. Aim 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. Methods 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. Findings 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. Conclusion 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.
Highlights
When research involves procedures initiated in the intrapartum period, there is considerable variation in information provision
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)
Aim To investigate how information about a research study with an intra-partum intervention - ASSIST was presented to potential participants, and to report on the acceptability of the information provision given to women by midwives
Summary
There is common agreement that the three key elements of informed consent, voluntarism, information disclosure (Belmont, 1979) and the decision-making capacity of an individual should underpin the ethical basis to a study’s recruitment strategy (Declaration of Helsinki, 1964). Some agree with the forums notion (Hunt, 2016) yet fail to define what makes women vulnerable (Vernon et al, 2006); others such as The Royal College of Obstetricians and Gynaecologists (RCOG, 2016) still recognise the physical and psychological vulnerability of women, whereas The American College of Obstetricians and Gynecologists (ACOG, 2015) believe that pregnant women who participate in research studies should be classed as ‘scientifically complex’ rather than a vulnerable population The application of this concept, despite its intended protective purpose and widespread use within research, has caused significant disagreements within the research ethics standards as to its use (Bracken-Roche et al, 2017). Aim To investigate how information about a research study with an intra-partum intervention - ASSIST was presented to potential participants, and to report on the acceptability of the information provision given to women by midwives. The feasibility and acceptability of the methodology to both women and midwives involved in consent processes for interventions initiated up to, and including the intrapartum period, was studied. No women withdrew consent at the time a decision to perform an AVB was made (Hotton et al, 2019, in press)
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