Ethical issues related to consent for intrapartum trials

et al. 2023

Preprint

Background Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss, and answer questions whilst maintaining equipoise. However, little is known about these interactions. An integrated qualitative study (IQS) was used to investigate information provision for women invited to participate in the ASSIST II feasibility study investigating the Odon Device - a novel device for use in assisted vaginal birth with an aim to generate a framework of good practice for information provision. Methods Transcripts of in-depth interviews with women participants (n=25), with recruiting midwives (n=6) and recruitment discussions between midwives and women (n=21), accepting or declining participation, were coded and interpreted using thematic analysis and content analysis to investigate what was helpful to women and what could be improved. Results Recruiting women to intrapartum research is complicated by factors that impact on women’s understanding and decision making. Three key themes were derived from the data: i) a woman centred recruitment process, ii) optimising the recruitment discussion and iii) making a decision for two. Conclusion Despite evidence from the literature that women would like information provision and the research discussion to take place in the antenatal period, intrapartum studies still vary in the recruitment processes they offer women. Particularly concerning is that some women are given information for the first time whilst in labour, when they are known to feel particularly vulnerable, and contextual factors may influence decision making, therefore we propose a framework for good practice for information provision for research involving interventions initiated in the intra-partum period as a woman centred, and acceptable model of recruitment, which addresses the concerns of women and midwives and facilitates fair inclusion into intrapartum trials. Trial registration ISRCTN This qualitative research was undertaken as part of the ASSIST II Trial (trial registration number: ISRCTN38829082. Prospectively registered 26/06/2019).

Section: Introductionmentioning

confidence: 99%

Women’s and midwives’ views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study

et al. 2023

Preprint

“…Inadequate information provision, recognition of vulnerability during labour, inappropriate timing of consent and the lack of women’s involvement in research design led to the mantra ‘research should be undertaken with women, not on women’ . However, despite this mantra and accompanying recommendations, there is still evidence that this is not always achieved [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Women’s and midwives’ views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study

et al. 2023

Pilot Feasibility Stud

Background Recruitment to intrapartum research is complex. Women are expected to understand unfamiliar terminology and assess potential harm versus benefit to their baby and themselves, often when an urgent intervention is required. Time pressures of intrapartum interventions are a major challenge for recruitment discussions taking place during labour, with research midwives expected to present, discuss and answer questions whilst maintaining equipoise. However, little is known about these interactions. An integrated qualitative study (IQS) was used to investigate information provision for women invited to participate in the Assist II feasibility study investigating the OdonAssist™—a novel device for use in assisted vaginal birth with an aim to generate a framework of good practice for information provision. Methods Transcripts of in-depth interviews with women participants (n = 25), with recruiting midwives (n = 6) and recruitment discussions between midwives and women (n = 21), accepting or declining participation, were coded and interpreted using thematic analysis and content analysis to investigate what was helpful to women and what could be improved. Results Recruiting women to intrapartum research is complicated by factors that impact on women’s understanding and decision-making. Three key themes were derived from the data: (i) a woman-centred recruitment process, (ii) optimising the recruitment discussion and (iii) making a decision for two. Conclusion Despite evidence from the literature that women would like information provision and the research discussion to take place in the antenatal period, intrapartum studies still vary in the recruitment processes they offer women. Particularly concerning is that some women are given information for the first time whilst in labour, when they are known to feel particularly vulnerable, and contextual factors may influence decision-making; therefore, we propose a framework for good practice for information provision for research involving interventions initiated in the intrapartum period as a woman centred, and acceptable model of recruitment, which addresses the concerns of women and midwives and facilitates fair inclusion into intrapartum trials. Trial registration ISRCTN. This qualitative research was undertaken as part of the ASSIST II Trial (trial registration number: ISRCTN38829082. Prospectively registered on 26/06/2019).

“…here 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).…”

mentioning

confidence: 99%

Investigation of informed consent procedures initiated in the intrapartum period

British Journal of Midwifery

et al. 2020

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.